Studies in Big Data 83

Suyel Namasudra
Ganesh Chandra Deka   Editors

Applications
of Blockchain
in Healthcare
Studies in Big Data

Volume 83

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Suyel Namasudra · Ganesh Chandra Deka
Editors

Applications of Blockchain
in Healthcare
Editors
Suyel Namasudra Ganesh Chandra Deka
Department of Computer Science and Directorate General of Training
Engineering Ministry of Skill Development and
National Institute of Technology Patna Entrepreneurship
Patna, Bihar, India Government of India
New Delhi, India

ISSN 2197-6503 ISSN 2197-6511 (electronic)

Studies in Big Data
ISBN 978-981-15-9546-2 ISBN 978-981-15-9547-9 (eBook)
https://doi.org/10.1007/978-981-15-9547-9

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Preface

Nowadays, there are many hackers and malicious users over the internet. So, confi-
dential and sensitive data face security and privacy issues. Blockchain is a novel
technique to solve these issues, which allows a radical way of transaction among
several entities, such as businesses, individuals and machines. Blockchain can be
defined as a Distributed Ledger Technology (DLT) that secures and records transac-
tions in a Peer to Peer (P2P) network instead of using single or many servers. Here,
each record is saved on many interconnected systems, which keep the identical
information. In Blockchain, numerous transactions of value exchange are grouped
into several blocks, and each block is linked to the previous block and information
is immutably recorded across a P2P network by each block. Bitcoin is one of the
well-known applications of Blockchain. Blockchain has many applications, such as
healthcare, finance, Internet of Things (IoT), data storage and many more.
Health information about any patient is very critical, and currently, health records
are saved in the databases controlled by individual user or organization or large
groups of organizations. As there are many malicious users, these information are
not shared with other organizations due to security issues and chance of the data being
modified or tampered. Blockchain can be used to securely exchange healthcare data,
which can be accessed by organizations sharing the same network, allowing doctors
and practitioners to provide better care for patients. The key properties of decentral-
ization, such as immutability and transparency improve healthcare interoperability.
As estimated by BRSofTech (www.brsoftech.com), the healthcare market of DLT
will be worth $829 Million by 2023.
This book discusses the core concepts of Blockchain as well as its applications
in healthcare. Chapter 1 discusses healthcare data management by using Blockchain
technology. Chapter 2 is an analytical study to modernize the healthcare industry by
using Blockchain technology, while Chap. 3 deliberates upon security, privacy, trust
management and performance optimization of Blockchain Technology. Chapter 4
discusses securing healthcare data by using Blockchain. Chapters 5–7 deal with the
case studies of Blockchain in healthcare by using different novel technologies, such
as IoT. Chapter 8 represents a supply chain process to detect fake drug by using
Blockchain technology. Chapter 9 is a study on Blockchain technology to accelerate

v
vi Preface

research in life sciences. Finally, Chap. 10 concludes the book by discussing chal-
lenges and future work directions in healthcare data management using Blockchain
technology.

Patna, India Suyel Namasudra

New Delhi, India Ganesh Chandra Deka
Contents

1 Healthcare Data Management by Using Blockchain

Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Soeren Bittins, Gerhard Kober, Andrea Margheri,
Massimiliano Masi, Abdallah Miladi, and Vladimiro Sassone
2 Modernizing Healthcare by Using Blockchain . . . . . . . . . . . . . . . . . . . . 29
Mario Ciampi, Angelo Esposito, Fabrizio Marangio,
Mario Sicuranza, and Giovanni Schmid
3 Security, Privacy, Trust Management and Performance
Optimization of Blockchain Technology . . . . . . . . . . . . . . . . . . . . . . . . . 69
Mayank Swarnkar, Robin Singh Bhadoria, and Neha Sharma
4 Securing Healthcare Data by Using Blockchain . . . . . . . . . . . . . . . . . . 93
Meenu Gupta, Rachna Jain, Meet Kumari, and Gaurav Narula
5 Secure and Decentralized Management of Health Records . . . . . . . . 115
Subramanian Venkatesan, Shubham Sahai,
Sandeep Kumar Shukla, and Jaya Singh
6 IoT-Based Healthcare Monitoring Using Blockchain . . . . . . . . . . . . . . 141
Monireh Vahdati, Kamran Gholizadeh HamlAbadi,
and Ali Mohammad Saghiri
7 Healthify: A Blockchain-Based Distributed Application
for Health care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
Pratima Sharma, Rajni Jindal, and Malaya Dutta Borah
8 Blockchain in Pharmaceutical Sector . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
Meet Kumari, Meenu Gupta, and Chetanya Ved
9 Accelerating Life Sciences Research with Blockchain . . . . . . . . . . . . . 221
Wendy Marie Charles

vii
viii Contents

10 Challenges and Future Work Directions in Healthcare Data

Management Using Blockchain Technology . . . . . . . . . . . . . . . . . . . . . . 253
Denis A. Pustokhin, Irina V. Pustokhina, and K. Shankar
Editors and Contributors

About the Editors

Dr. Suyel Namasudra is an Assistant Professor in the

Department of Computer Science and Engineering at
the National Institute of Technology Patna, Bihar, India.
Prior to joining the National Institute of Technology
Patna, Dr. Namasudra was an Assistant Professor in
the Department of Computer Science Engineering at
the Bennett University, India. He has received Ph.D. in
Computer Science and Engineering from National Insti-
tute of Technology Silchar, Assam, India. His research
interests include Cloud Computing, Information Secu-
rity, DNA Computing and Blockchain. Dr. Namasudra
has edited 1 book and 25 publications in refereed jour-
nals, book chapters and conference proceedings. He
has participated in many international conferences as
an Organizer and Session Chair. Dr. Namasudra is a
member of the Editorial Board and Reviewer of many
journals.

ix
x Editors and Contributors

Ganesh Chandra Deka ISDS is Deputy Director

at Regional Directorate of Skill Development and
Entrepreneurship, Assam under the Directorate General
of Training, Ministry of Skill Development and
Entrepreneurship, Government of India.
His research interests include NoSQL Database,
Blockchain Technology and Bigdata Analytics. He has
authored 2 books on Cloud Computing published by
LAP Lambert, Germany. He is the Co-author of 4 text
books on Fundamentals of Computer Science (3 books
published by Moni Manik Prakashan, Guwahati, Assam,
India and 1 IGI Global, USA).
Till now, he has edited 22 books (7 IGI Global, USA,
7 CRC Press, USA, 4 Elsevier and 4 Springer including
1 International Conference proceeding) on Big data,
NoSQL, Blockchain Technology and Cloud Computing
in general and authored 10 Book Chapters.
He has published 8 research papers in various reputed
journals including Elsevier (1) and IEEE (2) and already
published around 47 research papers in various IEEE
conferences.
He is the Editor-in-Chief of the International Journal
of Computing, Communications and Networking. He
has published 4 Special Issues as Guest Editor in
different International Journals, which are indexed in
SCI and SCOPUS. Deka has organized 08 IEEE Inter-
national Conferences as Technical Chair held in India.

Contributors

Robin Singh Bhadoria Computer Science and Engineering, Birla Institute of

Applied Science, Bhimtal, India
Soeren Bittins Fraunhofer FOKUS, Berlin, Germany
Malaya Dutta Borah Department of CSE, National Institute of Technology
Silchar, Silchar, Assam, India
Wendy Marie Charles Life Sciences Division, BurstIQ, Denver, CO, USA
Mario Ciampi Institute for High Performance Computing and Networking of the
National Research Council of Italy, Naples, Italy
Angelo Esposito Institute for High Performance Computing and Networking of the
National Research Council of Italy, Naples, Italy
Editors and Contributors xi

Kamran Gholizadeh HamlAbadi Young Researchers and Elite Club, Qazvin

Branch, Islamic Azad University, Qazvin, Iran;
Faculty of Computer and Information Technology Engineering, Qazvin Branch,
Islamic Azad University, Qazvin, Iran
Meenu Gupta Department of CSE, Chandigarh University, Punjab, India
Rachna Jain Department of CSE, Bharati Vidyapeeth’s College of Engineering,
Delhi, India
Rajni Jindal Department of CSE, Delhi Technological University, Delhi, India
Gerhard Kober Tiani “Spirit” GmbH, Vienna, Austria
Meet Kumari Department of ECE, Chandigarh University, Punjab, India
Fabrizio Marangio Institute for High Performance Computing and Networking of
the National Research Council of Italy, Naples, Italy
Andrea Margheri University of Southampton, Southampton, UK
Massimiliano Masi Tiani “Spirit” GmbH, Vienna, Austria
Abdallah Miladi Tiani “Spirit” GmbH, Vienna, Austria
Gaurav Narula Department of CSE, Bharati Vidyapeeth’s College of Engineering,
Delhi, India
Denis A. Pustokhin Department of Logistics, State University of Management,
Moscow, Russia
Irina V. Pustokhina Department of Entrepreneurship and Logistics, Plekhanov
Russian University of Economics, Moscow, Russia
Ali Mohammad Saghiri Computer Engineering and Information Technology
Department, Amirkabir University of Technology (Tehran Polytechnic), Tehran, Iran
Shubham Sahai Department of Computer Science and Engineering, Indian Insti-
tute of Technology, Kanpur, India
Vladimiro Sassone University of Southampton, Southampton, UK
Giovanni Schmid Institute for High Performance Computing and Networking of
the National Research Council of Italy, Naples, Italy
K. Shankar Department of Computer Applications, Alagappa University,
Karaikudi, India
Neha Sharma Computer Science and Engineering, IPS College of Technology &
Management, Gwalior, India
Pratima Sharma Department of CSE, Delhi Technological University, Delhi, India
Sandeep Kumar Shukla Department of Computer Science and Engineering,
Indian Institute of Technology, Kanpur, India
xii Editors and Contributors

Mario Sicuranza Institute for High Performance Computing and Networking of

the National Research Council of Italy, Naples, Italy
Jaya Singh Department of Information Technology, Indian Institute of Information
Technology, Allahabad, India
Mayank Swarnkar Computer Science and Engineering, Indian Institute of Tech-
nology (BHU), Varanasi, India
Monireh Vahdati Young Researchers and Elite Club, Qazvin Branch, Islamic Azad
University, Qazvin, Iran
Chetanya Ved Department of Information Technology, Bharati Vidyapeeth’s
College of Engineering, Delhi, India
Subramanian Venkatesan Department of Information Technology, Indian Insti-
tute of Information Technology, Allahabad, India
Chapter 1
Healthcare Data Management by Using
Blockchain Technology

Soeren Bittins, Gerhard Kober, Andrea Margheri, Massimiliano Masi,

Abdallah Miladi, and Vladimiro Sassone

Abstract Electronic healthcare solutions permit interconnecting hospitals and clin-

ics to enable sharing of electronic medical records according to interoperability
and legal standards. However, healthcare record data is siloed across hospitals and
data sharing processes are unsuccessful in providing accountable audit of the data.
Blockchain technology has been successfully applied to support the management
of distributed data. Its decentralisation and immutability features can underpin the
development of next-generation services for health data sharing. This chapter posi-
tions recent blockchain research outcomes within the healthcare legal and technical
standard frameworks (e.g. IHE and FHIR). It then presents how blockchain can be
applied to healthcare data sharing practices in order to enhance trust with automated
provenance tracking and accountable credential verification. The data sharing prac-
tices related to international organ transplant processes are used as motivating and
application case study.

Keywords Blockchain · IHE · eHealth · Provenance · SSI · Organ donation

S. Bittins
Fraunhofer FOKUS, Berlin, Germany
e-mail: [email protected]
G. Kober · M. Masi (B) · A. Miladi
Tiani “Spirit” GmbH, Vienna, Austria
e-mail: [email protected]
G. Kober
e-mail: [email protected]
A. Miladi
e-mail: [email protected]
A. Margheri · V. Sassone
University of Southampton, Southampton, UK
e-mail: [email protected]
V. Sassone
e-mail: [email protected]

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 1
S. Namasudra and G. C. Deka (eds.), Applications of Blockchain in Healthcare,
Studies in Big Data 83, https://doi.org/10.1007/978-981-15-9547-9_1
2 S. Bittins et al.

1.1 Introduction

The healthcare domain is one of the pillars of critical infrastructure, as signified

through the European NIS directive (European Parliament and the Council (2016)) or
the American (Health Insurance Portability and Accountability Act (HIPAA) security
rule (Scholl et al. (2008)). Healthcare services are indeed highly regulated in terms of
accessibility and cybersecurity. Paired with complementary regulations, for instance
the right of access of Art. 15 GDPR or the principle of patient ownership of health data
in public health insurance systems, the healthcare domain has to embrace innovative
technology to fulfil its obligations towards society. It is therefore not surprising that,
for instance, the European Commission prioritises health care for the adoption of an
artificial intelligence-based approach (European Commission 2020d) and recognises
the need of a common European health data space, focussing on extending and
reusing the current exchange of health data aiming at enabling health authorities to
take evidence-based decisions (European Commission 2020a). All of this is yet to
be achieved, but initial results should be expected by 2022 (European Commission
2020b). What has been materially achieved in the European context is the execution
of patients’ rights, such as a comparatively seamless access to their health data
throughout the member states ELGA GmbH (2017); Niaksu et al. (2017). However,
following the letter of the many applicable laws, the implementation of basic data
access tools does not guarantee all health information being available electronically
or instantly. The overwhelmingly uncoordinated number of access channels and
means of access to health data, such as many health portals, complicate obtaining a
complete set of medical information as well as moving health information from one
data controller to the next.
Consequently, a massive drive of innovation is imposed on the digitalisation of
healthcare records and its explicit international interoperability; these innovations can
have immediate impact on our lives: we are all patients. Some rapid growth areas of
investment in new technology in the electronic health (eHealth) include: (i) treatment
of rare diseases (Gulhan 2020), where a fully interoperable health passport (Royal
College of Physicians of Ireland 2019) among European Reference Networks would
have a tremendous impact on the way patients are treated across the union; (ii)
establishment of traceable clinical pathways (Xia et al. 2019), where the analysis
of health record data can enhance patient treatment procedures; and (iii) clinical
research (Benchoufi and Ravaud 2017), via the application of blockchain technology,
can pave the way to a transparent and accountable enforcement of data regulation by
enabling secure sharing of clinical data.
Blockchain technology is an innovative yet sufficiently established mechanism.
It has already proven itself to be able to support the need of heterogeneous sectors
with disparate stakeholders through cryptocurrency. Given its pioneering approach,
blockchain technology has been object of academic and industrial research,1 with
multiple efforts in eHealth (Hardin and Kotz 2019). Initially, the eHealth applica-
tions of blockchain have targeted the creation of new data management use cases to

1 See the HIMSS blockchain in healthcare page (HIMSS 2020).

1 Healthcare Data Management by Using Blockchain Technology 3

start crowdfunding (i.e. creating a financial ecosystem over the selling of cryptocur-
rencies). The variety of such eHealth cases (Shoeb 2018) has not yet led to a clear
impact on the eHealth industry. Blockchain data management solutions are instead
emerging to deal with the integration of data silos. In fact, despite many established
eHealth interoperability initiatives,2 medical record data is still siloed within hos-
pitals (Miriam 2017). Those silos may increase in dimensions (e.g. encompassing
the whole EU continent (European Commission 2019), or the USA (The Sequoia
Project 2019)), but interoperability at global scale is not yet a reality. In such a con-
text, the application of blockchain can support the development of sharing practices
to overcome the challenges posed by the distribution of data. At the same time,
blockchain-based management of healthcare data poses compelling privacy-related
questions (Staff 2019).
This chapter reports the analysis and design of a blockchain-based architecture for
healthcare systems. By building on established international standards for healthcare
data sharing (e.g. Fast Healthcare Interoperability Resources (FHIR) and Integrat-
ing the Healthcare Enterprise (IHE)), the requirements to drive the development
of a blockchain-based architecture for health data exchange are discussed. These
requirements are put in practice on a blockchain data sharing architecture featur-
ing automated data provenance and credential verification. The presented high-level
architecture is then applied to organ transplant scenario in order to enhance trans-
parency and accountability of current practices. The current legal frameworks are
discussed to contextualise the blockchain challenges and opportunities with respect
to the emerging needs of the health sector.
Structure of the Chapter. Section 1.2 introduces the technology underpinning
the management and sharing of health information. Section 1.3 reports on how
blockchain complements and innovates such foundational technology. Section 1.4
outlines a healthcare case study on organ transplant. Section 1.5 presents the
blockchain architecture for enhanced healthcare services, its specialisation on the
case study and an implementation roadmap. Section 1.6 discusses upon legal aspects
and patient centricity in deploying blockchain-based services. Section 1.7 touches
upon future work and concludes.

1.2 Electronic Health Records

Research on innovative and more efficient ways to share medical data among clin-
ics and hospitals started in the 1960s (Kim et al. 2019). After several decades of
research efforts and results, techniques and technologies have been consolidated.
Hence, standardisation organisations started to build interoperable services for the
exchange of medical data. However, after many years of standardisation efforts, we

2 See the IHE (Integrating the Healthcare Enterprise 2020), HL7 (Health Level 7 2020), DICOM (The

Digital Imaging and Communications in Medicine (DICOM) 2020), SNOMED (SNOMED CT

2020) standardisation organisations.
4 S. Bittins et al.

are far from achieving global Electronic Health Record (EHR) sharing: data is still
locked in silos (Miriam 2017).
It is also worth noting that healthcare return of investments is typically over a multi-
year period. For example, the design of the European sharing of patient summary
started in 2008, with first production deployment in 2018. Indeed, the healthcare
context requires incremental innovation so not to affect already existing services.
In the following, the EHRs and relevant standards are introduced (Sect. 1.2.1).
Then, the main challenges of dealing with data silos are discussed (Sect. 1.2.2),
followed by the main international initiatives in this context (Sect. 1.2.3).

1.2.1 Interoperability and International Standards

Integrating the Healthcare Enterprise (IHE) (Integrating the Healthcare Enterprise

2020) is an initiative by healthcare professionals and major industries to improve
the way computer systems in health care share information. IHE promotes the coor-
dinated use of established standards to address specific clinical needs in support of
optimal patient care.
In the 1990s, electronic health care was a set of technologically isolated areas.
Professionals started to cooperate and build international standards for informa-
tion encoding. Initiatives such as Digital Imaging and Communications in Medicine
(DICOM) (The Digital Imaging and Communications in Medicine (DICOM) 2020)
and Health Level 7 (HL7) (Health Level 7 2020) were launched to define the stan-
dards for radiological images and electronic medical records, respectively. Despite
the global adoption of these standards, the development of infrastructures for sharing
healthcare information among hospitals, clinics and laboratories did not begin until
2001, when IHE was established. With the support of industry, academia and public
bodies, IHE aimed to provide a governance model for building the infrastructure to
securely share medical records.
Notably, IHE does not provide standards. Yet, it selects standards using specific
criteria (e.g. market penetration, security, support, specific use cases) and further
profiles the standards to establish interoperability and security by-design. Like any
other software assets, standards have to be maintained, improved and patched. The
worldwide span of IHE permits governing the adoption of the standards by different
vendors and within different countries, therefore preventing the lack of interoper-
ability among organisations from hindering patients’ safety.
Figure 1.1 illustrates the IHE governance model (Integrating the Healthcare
Enterprise 2020). For each domain,3 clinical use cases focussed on interoperabil-
ity problems are submitted to a cohort of technicians which, after public discussions,
select the standards that could potentially address the problems. These standards are
constrained into a profile, a specific set of functionalities and their implementation
details.

3A domain is an application context of IHE profiles. At the moment of writing, IHE is composed
by 11 domains, including eye care, cardiology, quality, research and public health.
1 Healthcare Data Management by Using Blockchain Technology 5

Fig. 1.1 IHE process

The profiles are grouped according to their domain into technical frameworks and,
when published, are implemented by vendors. Connect-a-thons events are organised
by IHE to experimentally validate the interoperability of the implementation of the
profile between vendors’ products. Information on successfully integrated products is
released to the public and typically used by health sector policymakers, IT architects
and project managers to use and create tenders.
The IHE methodology is endorsed by (i) the European Commission (Decision
2015/1302 and Recommendation 2019/800) as the European Electronic Health
Record Exchange Format; (ii) the World Health Organization with the guide-
line: “Recommendations on Digital Interventions for Health System Strengthening”
(World Health Organisation 2019); and (iii) the USA by the Department of Health
and Human Services Interoperability Standards Advisory (Official Website of The
Office of the National Coordinator for Health Information Technology (ONC) 2020).
Cross-Enterprise Document Sharing. The core of the IHE IT infrastructure is
the Cross-Enterprise Document Sharing (XDS) model. Logically, the XDS model
defines (i) a registry containing searchable meaningful (meta)data of documents; (ii)
a repository of where the documents are physically stored; and (iii) consumers and
sources of the (meta)data and documents. Figure 1.2 shows the interactions between
the XDS profile actors. Interactions, known as transactions, define the messaging
between actors of the architecture.
XDS is an IHE profile upon which secure medical document exchanges can be
defined. XDS, together with the IHE security architectures, defines the technical
and integration requirements for laboratories and hospitals, for both facility and
6 S. Bittins et al.

Fig. 1.2 Healthcare document sharing with XDS

national document exchanges. The key concept pursued by XDS is the so-called
affinity domain (IHE 2019): all enterprises participating in the document exchange
have agreed to work together using a common set of policies and share a common
infrastructure.

1.2.2 Challenge: Integrating Data Silos

Despite the results achieved in providing technological interoperability, the man-

agement of EHRs is characterised by numerous data silos distributed across organ-
isations (e.g. hospitals and laboratories). This is mostly caused by the variegate
legislations and policy requirements. In Europe, with the introduction of the Euro-
pean Interoperability Architecture (European Interoperability Reference Architec-
ture (EIRA) 2020) that takes into account legal and political interoperability aspects
as well, this problem is mitigated and a process towards a continental interoperability
is in place (Electronic cross-border health services 2020). The USA has a similar
initiative (The Sequoia Project 2019). However, patients have the right to move in
order to seek, e.g., optimum treatment or different working conditions. Therefore,
the sharing of EHRs is a key requirement to cope with the mobility of patients while
offering the expected level of health services.
The definition of data silos varies from hospitals to regions. The higher the request
of mobility is, the more the eHealth infrastructures have to evolve to support the
demand. Mobile devices are increasing this tendency, as patients may access their
data in different legal and technical contexts. IHE, together with the Personal Con-
nected Health Alliance (Personal Connected Health Alliance 2020) (a standardisation
development organisation devoted to the creation of standard methods for medical
devices), is applying XDS-based scenarios also to mobile devices.
Technically speaking, a silo is usually identified as a single XDS affinity domain.
In order for organisations located in different affinity domains to communicate, IHE
1 Healthcare Data Management by Using Blockchain Technology 7

introduced the concept of community: an identifiable set of federated healthcare

facilities that cooperate to share data exposing a single point of contact, i.e. the Cross-
Community Access (XCA) community gateway (IHE 2019). The gateway is in charge
of implementing the functionalities to achieve syntactic and semantic interoperability
across domains. The principled use of gateways allows communities to securely share
medical records. It however increases the complexity required to follow the secondary
use of data and to enforce data quality.

Challenge 1 Discovering the origin, and the full chain of custody of a medical
data handled by clinics spread across different siloed communities
In such distributed scenario, establishing trust across communities is a complex
issue. At the same time, outsourcing medical analysis (e.g. tissue and blood analysis)
to other laboratories is a common task for hospitals. Third-party accreditation can
guarantee trust on the medical processes carried out by each party. However, to
trust document sources and exchanged identities and credentials, a set of validation
processes must be in place.

Challenge 2 Recognising and validating the credentials of the parties originating

or exchanging medical data across different siloed communities
As it is will be illustrated, the principled application of blockchain, together with
IHE standards, allows to address these challenges.

1.2.3 Healthcare Initiatives Worldwide

Several national initiatives worldwide use IHE, including XDS and XCA, to manage
and exchange healthcare information. Some of them are outlined below.
The Austrian nationwide electronic health record sharing programme, ELGA
(Elektronische Gesundheitsakte) (ELGA GmbH 2017), is built upon IHE profiles and
connects regions across the country. Each hospital, doctor, pharmacy and care facility
having treatment relationships are connected and share medical data electronically.
ELGA is a distributed system, where each region is identified by an XCA gateway
acting as trust broker (Masi and Maurer 2010).
The Albanian Nationwide Electronic Health Record programme started in 2014
(Niaksu et al. 2017). Starting from a fragmented existing health information system
of poor quality and with no IT expertise, it successfully delivered a production-
state implementation in 2016. Similarly to the Austrian project, Albania uses XDS
and XCA over the public Internet to share records from the centralised data centre
located in the premises of the Ministry of Health, with other 79 organisations over
the country. It is worth noting that in this model the centralised data centre has a
view of different communities, including the European Space: Europe is seen as yet
another community to share data with, enabling Albanian patients to travel across
Europe potentially having access to their health data.
8 S. Bittins et al.

Seamless support for patient mobility across Europe is the aim of the pan-
European exchange of patient summaries. The European Commission started a plan
to establish the cross-border exchange of patient summaries and e-prescriptions
among member states (including Albania, Turkey, Switzerland and other stakehold-
ers) in the early 2000s. The first project that laid down the technical specifications
was the European Patients Smart Open Services (epSOS) project. With 25 mem-
ber states participating and more than 50 beneficiaries (Cross-border health project
epSOS 2014) (mostly governmental), epSOS was carried out between 2008 and 2014
and set up 16 pilots that exchanged test data.
In detail, the European architecture works similarly to the systems illustrated
above: each member state has an XCA gateway, named National Contact Point
for eHealth (NCPeH) (OpenNCP Community Home 2020). The trust is direct and
brokered: each hospital trusts only its own NCPeH, and every NCPeH is trusted
against the others. By using the NCPeH-to-NCPeH communication channels, the
member states can locate the data of a patient in their home country and use them in a
remote member state. The NCP network is under production, and it is governed by the
eHealth Digital Service Infrastructure (European Commission 2019) to coordinate
activities among member states.
In the USA, the introduction of the Healthcare Insurance Portability and Account-
ability Act(HIPAA) (Centers for Medicare & Medicaid Services 1996) of 1996, and
the Health Information Technology for Economic and Clinical Health (HITECH)
(HITECH Act Enforcement Interim Final Rule 2009) Act of 2009, established the
legal foundation for eHealth services. Many initiatives started to address the data silos
challenges; e.g. the BlueButton (Mohsen and Aziz 2015) had the aim to allow patients
to download all their medical history onto removable media. Despite the remark-
able innovation, the solution was error-prone and lacking usability (i.e. patients are
required to bring the removable media along). In 2011, the first implementation of the
Nationwide Health Information Network (NwHIN) was made available (Bouhaddou
et al. 2012; Kuperman et al. 2010) to enable seamless healthcare document shar-
ing across the USA. Similarly to the European Architecture, it is a fully distributed
network where each NwHIN community is an XCA community.
Given the similarities among the two projects, the European Commission and
the Department of Homeland Security started the Trillium Bridge project (Trillium
Bridge II 2020), whereby two gateways implement the necessary semantic transla-
tions to achieve interoperability between the European and North American health-
care systems.4
Therefore, IHE is a set of worldwide technical and organisational guidelines
widely applied in production in many countries and unions.

4 This is now achieved by using the International Patient Summary (IHE Developing Integration
Profile for the International Patient Summary 2020).
1 Healthcare Data Management by Using Blockchain Technology 9

1.3 Managing Distributed Health Data with Blockchain

Blockchain technology has been successfully employed in scenarios with highly

distributed data (Chang and Chen 2020; Hardin and Kotz 2019; Krishnan et al.
2020; McGhin et al. 2019; Bhabendu et al. 2019; Namasudra et al. 2020; Wang
et al. 2019). The integrity and immutability guarantees are ensured by decentralised
blockchain systems and allow building trust in data exchanged between distributed
parties, without requiring any centralised entity. Blockchain builds such trust relying
on decentralised means that permit addressing the challenges of health data exchange
across siloed communities: assessing data quality and certifying data sources.
Decentralised Data Provenance (Margheri 2018; Margheri et al. 2020) offers
blockchain-based functions to collect, store and retrieve annotations on data creation
and manipulation, e.g. describing how EHR data has been produced.
Self-sovereign identity (SSI) (Mühle et al. 2018; Andrew and Drummond 2018) is
a blockchain application that enables entities (either users or applications) to securely
control identity claims over any number of authorities, e.g. multiple organisations
from different countries.

1.3.1 Assessing Data Quality with Provenance

Provenance is a wide field of data management, focussing on the collection, storage

and usage of metadata describing, e.g. creation, exchange and update of some data of
interest. Therefore, the role of provenance in data management lies in supporting the
assessment of the quality of data, e.g. presenting semantically connected metadata
for the attribution of sources.
The definition of provenance standard has been the target of substantial efforts
in the last decades. The W3C standard PROV (Missier et al. 2013) is a widely
accepted standard for provenance management. Its development started in the Web
Science community, but it is nowadays applied in multiple contexts, including health
care.5 PROV follows an ontological approach to represent concepts, and it allows
the creation of highly expressive provenance annotations, e.g. based on casual and
temporal relationships of the activities on the monitored data, in a convenient way.
In practice, tracking the provenance of some data corresponds to building a graph
of semantically connected concepts that describe entities (i.e. the data of interest),
activities (i.e. the operation carried out on the data) and agents (i.e. who performed
that operation) involved in the monitored business process.
Data provenance is of paramount importance in ubiquitous and federated sys-
tems (Chang and Chen 2020; Bhabendu et al. 2019; Wang et al. 2019)—e.g.
IoT, supply chains and health care— where data created or modified by a log-
ically stand-alone entity (e.g. a hospital in a siloed community or a local sen-

5 See
the HL7 FHIR standard that uses a mapping to PROV to embody provenance information in
FHIR resources.
10 S. Bittins et al.

Fig. 1.3 Decentralised health provenance

sor in distributed sensor network) is key assets for offering a trustworthy service
by other system entities. In healthcare, provenance is defined by the US Office
of the National Coordinator for Health Information Technology, “attributes about
the origin of health information at the time it is first created and tracks the uses
and permutations of the health information over its lifecycle” (Data Provenance
Glossary 2016). Thus, provenance can offer the means to reconstruct the clinical
context within which medical documents were created or updated.
Figure 1.3 illustrates how blockchain can be applied and integrated with existing
healthcare systems to introduce a transparent provenance management (Margheri
et al. 2020). The architecture integrates with XDS to annotate all XDS transactions
(i.e. all exchanged medical documents) with provenance documents written in PROV.
The creation and retrieval of the provenance documents are fully transparent and
automated. By introducing the so-called PROV Proxy, all the XDS read (Query and
Retrieve) and write (Provide and Register) document transactions are intercepted
and manipulated.
When PROV Proxy intercepts write transactions (i.e. the “Provide and Register”
arrow in Fig. 1.3), it collects the metadata of the document (e.g. author, hash, locality,
action performed) and triggers the creation of the corresponding PROV document.
The PROV documents so generated are based on standard templates compiled by a
smart contract and stored on the blockchain. The use of templates is advocated to
tailor provenance annotation to the needs of each project (Curcin et al. 2017), e.g. to
enable ontology-based processing and reasoning.
The provenance documents stored on a blockchain do not contain any patient-
related medical information. Instead, the blockchain smart contract only uses hash
indexes that correspond to the canonicalised signatures of the medical documents. It
follows that when the PROV Proxy intercepts a read transaction (i.e. the “Query and
Retrieve” arrow in Fig. 1.3), it computes the hash index of the contained document
1 Healthcare Data Management by Using Blockchain Technology 11

and uses it to query the blockchain to retrieve the corresponding PROV document.
Notably, these provenance functionalities are controlled and regulated by patient-
informed consent authorisation policies of XDS. In this way, provenance documents
can be linked to a patient’s medical document only if the consumer of the document
(say a doctor) is entitled to retrieve the said document.
Therefore, this blockchain architecture enhances siloed communities with auto-
mated creation and retrieval of provenance information to attach clinical context to
exchanged patients’ records. These functionalities contribute to addressing Chal-
lenge 1 above by reconstructing the full medical documents’ custody chain.

1.3.2 Leveraging Self-sovereign Identity

Self-sovereign identity (SSI) is a novel paradigm which allows organisations and

users to create and share identity traits in a controlled and interoperable way.
Blockchain facilitated the realisation of SSI by implementing so-called (DID),
a persistent, immutable “globally unique identifier that does not require a cen-
tralised registration authority because it is registered with distributed ledger tech-
nology” (Reed et al. 2020). DIDs are used to refer uniquely to Verifiable Identity
Claims (e.g. a diploma, a university degree or the affiliation to an organisation) that
are linked to a subject (i.e. a verifier). By using cryptographic techniques, the issuer
of a claim (e.g. a university) certifies on the blockchain the claim with the verifier (i.e.
the claim is hashed and linked to the subject’s identifier). This allows any authorised
users to assess the integrity of the claim by checking the list of verifiable claims
stored on the blockchain (Windley 2016).
The concepts of SSI and DID are the basis of the European Blockchain Service
Identifier (EBSI) (European Blockchain Service Infrastructure 2020). EBSI, together
with other specifications—such as eID, eSignature and eDelivery—forms the Euro-
pean Commission “Building Blocks”: reusable set of specifications, software and
services aimed at facilitating the delivery of high-quality, interoperable and secure
digital public services across the EU borders (European Interoperability Reference
Architecture (EIRA) 2020; Pavleska et al. 2019).
Figure 1.4 shows the architecture overview of the EU SSI framework. The EBSI
blockchain is composed with the eID block which implements the electronic IDen-
tification, Authentication and trust Services (eIDAS).6 Regardless of the country,
any EU identity can use the EBSI via the eIDAS bridge. Connecting the EBSI with
eID creates the required trust among issuers and verifiers. Verifiers’ credentials are
certified as signed DID documents which contain the public keys of the issuer and
the verifier’s eID identity.
Therefore, in the healthcare context, by building on the SSI infrastructure, the
deployment of community-wide eHealth services relies on standard subjects’ infor-
mation (i.e. identity traits) that ease the administrative burden of credentials and

6 See the eIDAS regulation EU 910/2014.

12 S. Bittins et al.

Fig. 1.4 European self-sovereign identity

source validation for healthcare bodies and patients. More specifically, integrating
SSI with XCA gateways allows to address Challenge 2 by introducing a distributed
mechanism to verify, in an automated manner and with confidence, the credentials
of, say, laboratories and professionals across communities.

1.4 A Healthcare Data Sharing Case Study: Organ

Transplant

Data sharing has become fundamental to enable new and innovative healthcare ser-
vices. Data sharing has indeed enabled ubiquitous care services, from remote mon-
itoring to multi-country healthcare networks. Development of such networks for
organ donation and transplant processes are recent and prominent initiatives.
Organ donation is when a person consents to remove legally organs of theirs,
either lively (by donating a portion of an organ like liver or kidneys), or in case of
death (deceased donation), by the next of kin. Donated organs are given to someone
in the need of transplant, eventually saving their lives.
Organs are donated mostly from deceased donors (4 out of 5). In case of a deceased
donor died of accidental causes (e.g. a car accident), a prompt response is required:
1 Healthcare Data Management by Using Blockchain Technology 13

the first responder shall immediately inform the social services about a potential
organ donation, so that they can organise a safe donation without having the risk
to deteriorate the tissue or the organ. Efficiency is therefore crucial. Determining
whether someone is a candidate for organ donations depends on a multitude of
factors. The purely medical indicators are well documented with robust procedures in
place, backed by a stable legal framework and frequent significant legal adjustments
to assure a transparent, fair and successful transplant. However, before the medical
procedures can be properly invoked, first responders have to quickly and safely
identify someone’s qualification and determine authorisation for organ donation.
Although organ donation is an essential treatment, it suffers from severe chal-
lenges (Reza and Kenari 2014), in particular organ shortage. Indeed, transplant wait-
ing list is outstanding; e.g. in Germany (EurotransplantWeb Page 2020), more than ten
thousand patients were in a transplant waiting list in 2017, and only one-third of them
received an organ donation, and similarly in 2018 (Weigand 2018). In order to max-
imise the possible match between donors and receivers, international organisations
such as Eurotransplant (EurotransplantWeb Page 2020) and BaltTransplant (Rosental
et al. 1997) were started. For instance, the Eurotransplant network coordinates organ
transplants across Austria, Belgium, Germany and other East European countries.
Continuous interactions between accredited laboratories dramatically help reducing
the receiver’s waiting list. However, laboratories face organisational challenges: they
have to show continuous compliance with the standards, and they have to demon-
strate transparency on their operations, to maintain trust in the process (Almassi et al.
2014; Schulte et al 2018).
On the other hand, the development of such pan-European data sharing initiatives
has magnified interoperability and privacy challenges. Enabling secure, yet account-
able and transparent exchanges of healthcare data across facilities located in different
countries can support the improvement of the current transplantation processes.
Transplant Standards: the European Federation for Immunogenetics (EFI)/
American Society for Histocompatibility and Immunogenetics (ASHI). The basic
rules for coordination and cooperation of transplant laboratories are set by interna-
tional standards.
In Europe, the European Federation for Immunogenetics (EFI) identifies “min-
imal criteria, which all histocompatibility laboratories must meet if their services
are to be considered acceptable” (EFI 2017), which are then used for laboratory
accreditation and enrolment in transplantation networks, e.g. the Eurotransplant.
Similarly, in the USA, the American Society for Histocompatibility and Immuno-
genetics (ASHI) defines analogous rules. For the sake of presentation, only the EFI
rules are commented.
The EFI guidelines are paper-based, and the laboratory accreditation programme
consists of on-site and documental inspection of conformity with the guidelines. At
the time of writing, over 260 laboratories are accredited in 36 countries. Further-
more, as organs and stem cells are exchanged across national boundaries (Harmer
et al. 2018), a continuous improvement programme is in place across the transplant
network. Such regulatory requirements prompt the need to have full control on the
14 S. Bittins et al.

custody chain of documents, even during interactions and collaboration with third
parties located in different countries.
Organisation part of multi-country transplant networks must meet all these require-
ments. This requires high coordination and cooperation to share data with all network
members. These processes are complex and contain aspects which are not yet digi-
talised: attesting trust and reviewing paper- and electronic-based documents, showing
compliance to the standards and sharing audit results.
These are examples of tasks that can be automatised by using blockchain technol-
ogy as a trustworthy mechanism to securely share results without the intervention of
any trusted third party, yet guaranteeing the necessary transparency and accountabil-
ity. In Sect. 1.5.2 is shown how these case studies can be implemented by relying on
a blockchain architecture for enhanced data sharing.

1.5 Blockchain for Health Data Sharing

To overcome the distribution of healthcare data across data silos, data is made avail-
able through the EHR approach. The use of IHE profiles enabled an interoperable
health information exchange, from the syntactic to the semantic level. It is not only
the preferred approach to share data among the different actors of a community, but it
became also the de facto solution to integrate distant communities. In addition, many
countries rely on it to build their national infrastructure. Built upon well-established
IHE Integration Profiles, these infrastructures are on production and allowed to create
secure and resilient nationwide healthcare exchanges. The usage of these Integration
Profiles, which rely on mature technical standards, ensures the architecture sus-
tainability. However, the advent of blockchain technology allowed to envision new
possibilities.
More specifically, blockchain can provide the decentralised means to enable
secluded healthcare organisations operating in data silos to achieve not only inter-
operable but also trustworthy exchanges of medical documents. Blockchain acts as
a decentralised, yet controlled repository of information to build trust in the inter-
actions among organisations, e.g. in collaborative cooperation across countries such
as the Organ Donation European networks.
Our proposal of a healthcare blockchain integrates provenance tracking and SSI
credential management. The solution is offered ‘as-a-service’ and can be deployed
in multiple healthcare contexts, because of its transparent integration with the XDS
document management systems.
Below, it is reported the main requirements that should steer the design and deploy-
ment of a blockchain system for health care (Sect. 1.5.1). Then, it introduced our
blockchain architecture (Sect. 1.5.2) and commented on its application to organ
transplant (Sect. 1.5.3).
1 Healthcare Data Management by Using Blockchain Technology 15

1.5.1 Requirements for an Healthcare Blockchain

Blockchain is being explored for healthcare applications by both academia and indus-
try (Hardin and Kotz 2019; Krishnan et al. 2020; McGhin et al. 2019). When dealing
with exchange of medical documents, the set of legal and technical requirements is
substantial. Therefore, in order to address the need of enhancing document exchanges
across siloed communities, it is needed to set precise requirements that take into
account the key challenges and stakeholders: the role of privacy, the patients and the
systems already deployed.

• Privacy-aware: The data managed by the blockchain should provide tamper-proof

evidence of the integrity of the represented healthcare concept (e.g. credentials or
documents), yet it must avoid any personal data to be stored on the blockchain.
• Patient Centricity: The enforcement of the blockchain-enhanced functionality
must be completely transparent and accountable for the patients. The system must
be integrated with patient privacy tools to perform enquires on each data access
(e.g. read and write), either by exploiting an existing healthcare system (e.g. with
the help of a hospital’s administrative clerk) or by using a mobile application (e.g.
a smartphone access).
• Modularity and Interoperability: The blockchain architectural design must pursue
a modular approach to cope with the distribution of data and to favour seamless
interoperability with existing legacy systems. Vendor-neutral architecture must be
created so to ensure that the quality of a specific software solution does not depend
on the vendor, i.e. preventing the so-called vendor lock-in effect.

Implementing these requirements enables healthcare blockchain technologies to

be smoothly and transparently integrated with already deployed document exchange
systems, as well as by being compliant with the current legal and technical frame-
works of the healthcare industry.

1.5.2 Blockchain Architecture

The blockchain architecture for health data sharing is composed of two modular
blocks: provenance management and SSI blockchain. Figure 1.5 reports the high-
level architecture.
The EBSI and provenance blockchains provide the means to enhance the trust rela-
tionships established by the XCA communities. The EBSI, via the eIDAS bridge,
permits notarising and verifying credential claims (e.g. accreditation and qualifica-
tions), while provenance allows via the PROV Proxy to create provenance documents
to validate the quality of the exchanged medical data.
These blockchain functions are designed to be modular and interoperable with
legacy systems. The integration with XDS and its Security Assertion Markup Lan-
guage (SAML)/eXtensible Access Control Markup Language (XACML) (IT Techni-
16 S. Bittins et al.

Fig. 1.5 Healthcare blockchain high-level architecture (trust among XCS communities is enhanced
by using the blockchain systems)

cal Committee 2009) authentication and authorisation frameworks allow the enforce-
ment of patient-informed consent. In particular, consent declaration (e.g. opt-in/opt-
out or advance directive) can be enforced to regulate the application of blockchain-
based services.
Therefore, the integration of blockchain functionalities in routine document
exchanges enables to increase the trust among communities’ members on the cre-
dentials (via SSI) and documents (via provenance) of their counterparts.

1.5.3 Towards an Healthcare Blockchain for Organ

Transplant

In this section, it presented the application of the blockchain architecture described

above to the organ transplant case study. First, it is outlined how the accountability
and transparency requirements mandated by the EFI standard can be implemented
1 Healthcare Data Management by Using Blockchain Technology 17

Fig. 1.6 Blockchain architecture functions at work on organ transplant processes (between brackets
the references to the corresponding EFI standard sections)

through blockchain functionalities (Sect. 1.5.3.1). Then, it introduced an implemen-

tation roadmap, highlighting technical and deployment activities (Sect. 1.5.3.2).

1.5.3.1 Addressing Transplant EFI Rules with Blockchain

The rules set by the EFI standard can be fulfilled by blockchain-enabled

functionalities—i.e. provenance and SSI. Figure 1.6 summaries the relationships
between EFI rules and the functionalities.
Laboratory Accreditation. The EFI section A contains the General Policies for
accreditation of laboratories performing tests, either as primary laboratory (rules
A11) or subcontracting (A12.1.1 and A13.2.1). The policies prescribe that all labo-
ratories involved must be EFI accredited. In order to easily validate the credentials
of laboratories, the blockchain SSI schema can be used. Specifically, the EFI auditor
(i.e. the credential issuer) will register with the eIDAS-compatible identity of the
laboratory the certificate of compliance. Any laboratory will then be able to verify
the accreditation of other laboratories with accountable and interoperable guarantees.
Personnel Qualifications. The EFI section B contains the requirements for the per-
sonnel qualifications. Similarly to section A, laboratories must ensure that all the
working personnel is accredited. For instance, the director of the laboratory must
hold a qualification approved by EFI, relevant experience in immunogenetics, etc.
These rules can be addressed with blockchain SSI as well. In this case, the EFI
18 S. Bittins et al.

laboratories submit personnel (identified using eIDAS) experience reports to the

blockchain. Notably, adopting a permissioned blockchain allows credential holders
to maintain control on the disclosure of their credentials.
Quality Assurance. The EFI section C is about quality assurance. It is required
for a laboratory to implement quality controls on all activities and to maintain doc-
umentation adequate to international standards. In particular, compliance must be
guaranteed with national laws on management of chemical and biological material
(C1.4). Similarly to previous sections, credentials on compliance can be managed
via the SSI blockchain.
All documentation related to laboratory analysis must also be collected according
to quality requirements. These requirements specifically focus on adverse events,
where fully fledged investigations must be conducted (C3). As laboratory activ-
ities may involve multiple parties and rely on multiple actors, this rule can be
addressed by using blockchain provenance. The enhancement of XDS transactions
with provenance—integrated with the IHE profiles from the laboratory domain, e.g.
the Laboratory Barcode Labelling (Laboratory Barcode Labeling 2020)—allows the
creation of tamper-proof ledgers of the documentation (e.g. content creators and
consumers).
Testing Processes. The remaining EFI sections D, E and F address the testing pro-
cesses with focus on laboratory data quality, analysis and post-analysis, respectively.
The External Proficiency Testing is set of rules to ensure that all analysis activi-
ties meet the expected quality (D1). These rules are defined by the Eurotransplant
Reference Laboratory (ETRL) (Reference Laboratory 2020). Credentials to witness
the ETRL certification can be managed and made available via the SSI blockchain.
All laboratory analysis and post-analysis processes must be described and docu-
mented (E and F). Besides the chemical and biological requirements, it is required to
control adequately the whole supply chain (e.g. for reagents and incubators). Many
standards already exist (Boyens et al. 2015; Cadzow et al. 2015), as well as innova-
tive blockchain applications (Allen et al. 2019; Chang and Chen 2020). By relying
on XDS document management, the blockchain provenance functionalities can be
used to enable the full auditability of the laboratories’ supply chain.

1.5.3.2 An Implementation Roadmap

Below, it is commented the deployability at the time of writing of the blockchain

architecture and the integration of the XDS systems with organ transplant organisa-
tions.
Blockchain Platform. Blockchain technology platforms are nowadays widely avail-
able off-the-shelf. Multiple blockchain implementations exist, and therefore the tech-
nological building block for this aspect of our architecture is ready for immediate
deployment.
1 Healthcare Data Management by Using Blockchain Technology 19

The blockchain provenance management has been prototyped with an Hyper-

ledger Fabric deployment (Fabric 2020) and integrated with production eHealth
systems. Fabric enables the development of updatable smart contracts (named chain-
code) written in a high-level general-purpose language named Golang. Provenance
smart contracts are ready to be deployed (Masi 2018) and integrated with industrial-
level PROV Proxy, with performance of the blockchain that can scale up to 3.500
transactions per second (Behind the Architecture of Hyperledger Fabric 2018). How-
ever, this implementation targets application at country level. To move towards multi-
country deployments, international communities (e.g. the eHealth DSI (European
Commission 2019)) or organisations (e.g. the Eurotransplant) should lead the devel-
opment process so to ensure absence of vendor lock-in and to better take into account
all stakeholder requirements (e.g. how blockchain is geographically distributed and
to who).
The EBSI building block, at its core, is based on Hyperledger Fabric and
Ethereum (European Commission 2020c). At the moment of writing, 19 blockchain
nodes are running in the European member states, still on testing stage. The imple-
mentation of the fully functional eIDAS bridge is yet to be concluded, with planned
released for new use cases in 2021 (European Blockchain Service Infrastructure
2020).
eHealth Standards. To deploy the EFI rules based on blockchain functionalities,
it is necessary for organ transplant organisations to adopt IHE-enabled document
management.
With the focus on laboratories, IHE defines the necessary profiles to build a Lab-
oratory Information System which is used to share observations and results through
standardised documents (e.g. HL7 messages of the type Observation Reporting).
These messages can then be converted and serialised into structured medical docu-
ments (Boone 2011). Multiple formats are available (e.g. HL7 Clinical Document
Architecture (CDA) (Health Level 7 2020) and FHIR (HL7 2018)) which, in turn,
can be managed via XDS and hence by our blockchain system.
Based on the document structure thus identified, the provenance and SSI credential
templates can be defined and properly configured on the blockchain smart contracts.
All in all, although the technology is fundamentally ready and at production level,
the design of a multi-country blockchain platform has first to overcome legal and
organisational issues. As per the IHE community experience, a large-scale deploy-
ment should be driven by clear organisation and semantic interoperability guidelines.
The approach followed by the EU to implement, consolidate and integrate reusable
building blocks should have as target objective to design a multi-country, general-
purpose blockchain that can be tailored to the specific needs of many application
contexts, e.g. healthcare use cases such as organ transplant.
20 S. Bittins et al.

1.6 Addressing Legal Requirements for Healthcare Data

Sharing

The deployment of blockchain systems just presented can offer many opportunities
in multiple healthcare scenarios. Due to the sensitivity of the health data, the deploy-
ment of blockchain in such data-intensive applications must take into account legal
requirements related to patient centricity when exchanging data.
In this section, it presented the role of patients in health data exchanges
(Sect. 1.6.1), then the outstanding privacy challenges to address for responsible
design and deployment of blockchain-based healthcare services (Sect. 1.6.2).

1.6.1 On the Patient Role in Health Data Exchange

One fundamental issue of health data exchange is the lack of immediate patient
involvement and focus. Although health systems are claiming to embody the princi-
ple of patient centricity throughout the entire life cycle of medical data, all industry
standards and best practices focus exclusively on health providers (for instance,
hospitals and laboratory), rather than meaningfully including patients. The patient-
facing health data exchange landscape is scattered and inherently incompatible in
itself. Recent developments in health frameworks, in particular the FHIR-based elec-
tronic health records of Google Fit (Google Fit 2020) and Apple Health Kit (Apple
HealthKit 2020), address this issue and move towards re-integrating the patient into
established data exchanges. However, additional regulatory, statutory and ethical
challenges remain to be addressed.
Patient Authorisation for Health Proceedings. In too many cases, healthcare-
related activities require patients’ notarised or certified documents (e.g. patient dec-
larations, informed consents and authorisations). Capturing and making such docu-
ments available electronically suffer from the continued need to be primarily paper-
based and necessitate a third party—such as a notary public or a health professional—
to acknowledge form, circumstances and validity of the patient’s assertion.
There are several means of stating ones wishes electronically, for instance the
qualified electronic signature, that are regulated by public authorities such as the
European Union. Their practical usability and cost are disfavourable compared to
readily available smartphone applications already integrated with health records.
These applications enable fine-grained sharing of medical data, as well as easing the
access and use of electronic health services.
Patient Remote Monitoring. Governments and health authorities have widely inves-
tigated the application of remote monitoring of patients to maintain and improve
public health. Several factors related to the (privacy) law and ethics have hindered
wide deployment of healthcare tracing applications. In the light of the COVID-19
pandemic, all these factors have been effectively devoid of any applicability.
1 Healthcare Data Management by Using Blockchain Technology 21

The entirely new category of health applications for contact tracing has spawned
new cooperation between governments, health authorities and private telecommu-
nication services to create, manage and share patients’ medical properties. For
instance, these applications enable management of immediate, current and authen-
ticated evidence about being either immune or non-contagious (so-called immunity
passport (Robert and Lukasz 2020), which are requested by authorities as a pre-
requisite for being authorised to continue with regular life activities. The latter is
not only a fundamental potential infringement of human rights, but also a principal
shift of how health information is consumed, from infrequent access in very narrow
circumstances to the need of being available at any given moment with a very short
“best before” date.
This challenge has been even magnified with the development of healthcare solu-
tions integrated into social media (Bock et al. 2020) and mobile devices (Apple
2020). This poses an even bigger challenge to the public health systems (George-
town University Medical Center 2020): How to transport a particular compilation
of medical data authenticated, promptly, legitimately, reliably, transparent and fully
traceable throughout all relevant stakeholders for legitimate purposes?
Therefore, smartphone applications may become the next-generation health pass-
port for patients that can be used to promptly present health credentials. However,
they require privacy-aware, fully digital system to rely on. Blockchain health data
platform can be leveraged to offer this service. Its decentralised platform is devoted
to digitally represent with tamper-proof guarantees physical artefacts, e.g. national
health insurance cards, immunisation attestation, etc. More importantly, the close
coupling with the EBSI SSI infrastructure provides reliable yet almost anonymous
proof of someone’s identity trait while retaining full control by the data subject. One’s
attributes, e.g. non-contagious attribute of the immunity passport, can be proved with-
out releasing the whole passport.

1.6.2 Outstanding Privacy Challenges for Healthcare

Blockchain

The development of novel blockchain-based services, especially in health-related

domains, must embody by-design the enforcement of individual privacy rights in
order to target a responsible design and deployment of blockchain services. In the
following, it commented the key non-functional requirements to take into account

• Anonymity versus Public Health: When tracing patients, all geolocation infor-
mation and specific proof are collected and processed under the assumption of full
anonymity. As emergent public health needs can arise (e.g. the COVID-19 pan-
demic), the need for more exhaustive information rises exponentially. Applications
like the contact tracing ones are fundamentally incompatible with a truly anony-
mous data collection. Similarly, businesses and organisations need to demonstrate
sufficient compliance with imposed restrictions, for instance, occupancy limits
22 S. Bittins et al.

or spot checks of immunity verification, which practically disqualifies the use of

anonymous records.
• Voluntary Adoption: As stated bluntly in (Bock et al., 2020), the truly voluntary
adoption in such functions is plainly illusory, as long as participating in regular
life activities depends on providing the right proof in the right form from the
right authority at the right time. For most functions, the collection, processing and
communication of the complete identity of the natural person are not required,
as usually only a single property is actually requested, such as a proximity to a
certain location at a certain time.
• Transparency: Even with the available guidance of the national and international
supervision bodies, it is almost impossible for the regular person to assess which
personal information is communicated whom to, what for and under whose author-
ity. For instance, the guidance provided by the European Data Protection Board
specifically names (i) electronic communication service providers, and applica-
tions of (ii) information society service providers whose functionality requires the
use of such data as the two principal sources of location data (Guidelines 04/2020
on the Use of location data and contact tracing tools in the context of the COVID-
19 outbreak 2020). What applications and providers actually encompass is rather
debatable. For instance, neither Apple nor Google clearly fall under either cat-
egory despite offering operating system-level API functions to facilitate contact
tracing as well as geolocation. End users may not be able to easily determine whom
a consent is given to, who is originally collecting what data and what low-level
functions their consent includes.
• Verifiability and Authenticity: Both private organisations and businesses, as well
as public health systems, do hold a valid and currently vital interest in the verifi-
ability and authenticity of data. Being able to present a forged immunity passport
or to manipulate location data erodes the purpose and justifying benefit of such
functions. Consequently, a sufficient degree of reliability needs to be provided,
such as certifying through a mutually trusted entity that a singular property of a
laboratory report states a negative infection at a certain point in time for an identity
linked irrefutably to the natural person bearing and presenting it.
• Robustness of Authenticity: Many declarations regarding health require advance
statements in written form, and sometimes even notarised. Picking the example
of one’s willingness to donate organs, traditional means of stating such decision
are incompatible with today’s expectation of immediacy. Furthermore, carrying
a physical card or an additional physical property on a driver’s licence to signify
being an organ donor potentially restricts better participation because any change
of mind is usually tied to a significant amount of effort and cost. There is no
streamlined and fully digital means of exercising the right to change one stance
and to communicate the effect immediately.

Generally speaking, according to the Fundamental Rights Study (European Union

Agency for Fundamental Rights 2020), “41% of the of respondents reveal that they
do not want to share any personal data with private companies"; hence, there is
a general negative belief on how personal data is managed for highly innovative
1 Healthcare Data Management by Using Blockchain Technology 23

health applications. The development of specific anchor points and understandable

guidelines to co-develop privacy-enhancing functionalities and technologies must be
defined in the technology and adequately reflected in law.

1.7 Conclusions and Future Works

The blockchain-based architecture presented in this chapter aims at enhancing the

trust of current data exchange solutions based on IHE technical profiles. This archi-
tecture, which can be seamlessly integrated with legacy healthcare systems, includes
(i) the automatic creation of provenance annotations based on the W3C PROV stan-
dard for patients’ medical documents, and (ii) SSI credential verification based on
the EBSI infrastructure. This principled integration permits enhancing the trust of the
data interactions among communities. Presenting an organ donation and transplant
use case, it is illustrated how our architecture addresses the EFI rules for transplant
processes. By commenting on the role of patients in emergent healthcare services,
such as mobile healthcare and patient tracing, it described the legal requirements that
should be embodied in the design and deployment of next-generation blockchain
healthcare services.
In the near future, the aim is to integrate the presented blockchain functionalities
into new healthcare use cases, with the focal objective of empowering the patient
centricity and usability of the sharing practices of medical data.
The automatic provenance management can support the creation of reproducible
clinical research (McGhin et al. 2019). Such problem has been amplified by the
urgency posed by the COVID-19 pandemic: poorly assessed clinical data resulted
in inaccurate published and then retracted research (Mehra et al. 2020) which could
have endangered patients’ safety.
The integration of SSI within multiple healthcare contexts can lead to more flexible
and usable services for patients. From fine-grained consent verification to immediate
validation of certifications, SSI can pave the way to implement the “Once Only
Principle” for all healthcare services.

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Chapter 2
Modernizing Healthcare by Using
Blockchain
Mario Ciampi, Angelo Esposito, Fabrizio Marangio, Mario Sicuranza,
and Giovanni Schmid

Abstract Electronic health record (EHR) systems are designed and deployed to
store data accurately and to capture the state of a patient across time, and they have
been one of the major drivers to advance care in the last decade. However, the EHR
is not eligible in supporting a model that is beyond episodic visits, nor the idea of an
integrated care plan that all care team members can view and contribute to. On the
other hand, the concept of a longitudinal record and the idea of a “smart care plan”
are key factors for paving the way toward Predictive, Preventive, Personalized and
Participatory (P4-medicine), which arguably will be in a near future the only effective
and sustainable approach for pandemics and “silent” chronic diseases. At the current
state-of-the-art, the HL7 FHIR standard and distributed ledger technologies (DLTs)
are two very promising areas of research and development in the context of health
information management, and a proper synergy among their approaches, concepts
and tools could overcome the limitations of EHR systems, giving rise to the hub of the
IT infrastructure for P4-medicine. This chapter explores the potential and challenges
of integrating the FHIR standard into DLTs, also through a concrete example of
implementation.

Keywords Electronic health record · FHIR · Care planning · Blockchain ·

Hyperledger fabric

M. Ciampi (B) · A. Esposito · F. Marangio · M. Sicuranza · G. Schmid

Institute for High Performance Computing and Networking of the National Research Council of
Italy, Naples, Italy
e-mail: [email protected]
A. Esposito
e-mail: [email protected]
F. Marangio
e-mail: [email protected]
M. Sicuranza
e-mail: [email protected]
G. Schmid
e-mail: [email protected]

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 29
S. Namasudra and G. C. Deka (eds.), Applications of Blockchain in Healthcare,
Studies in Big Data 83, https://doi.org/10.1007/978-981-15-9547-9_2
30 M. Ciampi et al.

2.1 Introduction

Population health information management is a key factor for paving the way toward
Predictive, Preventive, Personalized and Participatory medicine (P4-medicine),
which in turn represents the main answer to the two most challenging threats to
population health: pandemics and “silent” chronic diseases. Arguably, P4-medicine
will be in a near future the only effective approach for containing public spending
and the sustainability of national health systems (Góngora Alonso et al. 2019).
In the last decade, electronic health record (EHR) systems have been designed
and deployed to store data accurately and to capture the state of a patient across
time, and they represent one of the major drivers to advance care in many Countries.
However, the EHR is not eligible in supporting a model that is beyond episodic visits,
nor the idea of an integrated care plan that would draw on all of the relevant data
about an individual at any point in time, and that all care team members can view and
contribute to. These smart care plans could represent the linchpin of P4-medicine
approaches if they were housed on collaborative care platforms that can access to
and perform cognitive computing on the patient data from a variety of sources.
Distributed ledger technologies (DLTs)—and, in particular, blockchain architec-
tures—are widely recognized as having the potential to transform health care, placing
patients at the center of the healthcare ecosystem and increasing the availability, reli-
ability and usefulness of their data (Ciampi et al. 2019). However, an analysis of
the current state-of-the-art of DLTs in healthcare shows that it is very challenging
to design and implement dependable, interoperable and scalable blockchain plat-
forms upon which health information can be connected, searched for and computed
in compliance with privacy and safety regulations (Namasudra et al. 2020). In fact,
data and workflows in healthcare are by far more complex, variegate and interdepen-
dent than in other application domains, and major efforts have to be done in order
to guarantee that the proposed solutions actually permit to store medical data in a
certified manner (Kim and Deka 2019) and adhere to emerging standards.
The HL7 Fast Health Interoperability Resources (FHIR) standard and the use of
open application programming interfaces (APIs) are very promising approaches for
developing IT platforms aiming at managing population health information, now
that new sources, formats and processing tools for health data are emerging, and
that interoperability among health IT systems and with patient’s own data sources
will be required (Kilintzis et al. 2019). The characteristics of this new standard,
which permits to represent health information in simple and formal data structures
(named “resources”) based on XML or JSON formats, facilitate the implementation
of numerous applications for the healthcare sector that need to exchange and memo-
rize data. In particular, it represents an enabling standard to support all the actors
involved in care plans according to a patient-centric approach. These aspects are
dealt with the IHE Dynamic Care Planning (DCP) profile, which specifies the struc-
tures and communication protocols based on FHIR resources for planning, creating,
updating and sharing care plans among many users (like providers, patients and
payers), with particular reference to patients with chronic conditions.
2 Modernizing Healthcare by Using Blockchain 31

The recent technological innovations have been permitting to significantly

improve healthcare services: (i) healthcare informatics standards consent to struc-
ture clinical data and processes in an unambiguous way, (ii) artificial intelligence
technologies allow to derive new medical knowledge, (iii) regulations and norms
enable to develop privacy- and security-by design solutions, and so on. However,
the event clinics regarding patients occurred after physicians’ prescriptions are not
always traceable and very often the health processes are carried out in a wrong or
not completed way.
This issue represents the motivation of this chapter, which is devoted to explore
potentialities and challenges of integrating the FHIR standard in distributed ledger
technologies for managing clinical processes. After introducing concepts, frame-
works and emerging needs for the health domain, the chapter will explore the rela-
tionships of permissioned blockchain technologies with FHIR and IHE DCP. Then, a
concrete example concerning the implementation of IHE DCP profile in Hyperledger
Fabric is illustrated and discussed.
The rest of the chapter is organized as follows. Section 2.2 provides an overview on
Distributed Ledger Technologies and on the Hyperledger Project. Section 2.3 illus-
trates the most important needs of the health domain and the desired tools. Section 2.4
describes the key characteristics of the health informatics standards for data repre-
sentation and care planning, such as HL7 FHIR and IHE PCC DCP. Section 2.5
illustrates the mechanisms to adopt to manage and monitor clinical information
included in health records in a secure and standard way. Section 2.6 proposes a novel
blockchain network based on Hyperledger Fabric opportunely designed to manage
resources represented in HL7 FHIR. Section 2.7 presents a case study that shows
how to manage care plans by means of a blockchain-based platform opportunely
designed. Section 2.8 concludes the chapter.

2.2 Distributed Ledger Technologies

The natural recording system for recordkeeping business actions is the ledger, an
append-only register, where asset transfers to or from it. These actions, also known
as transactions, are recorded according to contracts, which set conditions for trans-
actions to occur. Therefore, a ledger is a registry acting as a historical memory, with
the aim of checking, verifying and managing all the transactions made and the assets
involved therein.
In the context of the modern society, an asset is anything, tangible or intangible,
that is capable of being owned or controlled to produce value, and assets are more
and more made available through sets of companies and organizations, each having
a different role, function and geographical location but common strategic and oper-
ational objectives. Such business networks can be quite complex in processing, and
can be deployed on a very large scale, but each participant keeps their own system
of record and runs their own form of the business process to update their ledger.
32 M. Ciampi et al.

This reflects the centralized nature of the data base management systems (DBMSs)
realizing these recording systems. Although a DBMS, through its deployment, could
implement a traditional ledger with various degrees of replication and/or distribution
among multiple network nodes (in order to avoid a single point of failure), data in
these systems are stored and managed under the control and responsibility of a single
authority. This lack of decentralization may lead to substantial costs and risks in
business networks, where multiple ledgers have to be kept synchronized between all
the interacting parties. Establishing data provenance can be very laborious, tracking
back a chain of transactions can take days, contracts must be signed and executed
manually, and every database in the network can represent a single point of failure
since it contains unique information.
A distributed ledger is a ledger replicated among multiple parties. All the replicas
are kept synchronized without a central authority, through to a consensus protocol
(that is, a protocol among a set of peers designed to ensure that all participants
agree on a common value or status). In addition to data being shared, the software
protocols (well known as smart contracts) that implement the logic related to assets
and transactions can also be shared through the ledger. Specifically, a smart contract is
a piece of code defining the transaction logic that controls the lifecycle of a business
object (asset) contained in the world state. One or more smart contracts can be
packaged into a chaincode, which is then deployed to a communication subnet,
where a consensus protocol allows a set of peers to determine which transactions
can be written to, and their total ordering in the shared ledger. This way, a unique
copy of the ledger is shared among participants (consistency), and they will have a
common view of the business processes flowing throughout the network. Moreover, a
consensus protocol for a distributed ledger system is usually designed to be resilient to
a certain percentage of peers that can arbitrarily diverge from following the protocol,
thus assuring both the liveness and integrity of the network below a threshold of
such faults. With the ability to coordinate their business data and processes through a
shared ledger also in untrusted environments, business networks can overcome many
of the drawbacks and limitations of current systems.

2.2.1 Introduction to DLTs

Distributed ledger technologies generically refer to a set of data structures, proto-

cols and networking technologies that, when appropriately combined, give rise to a
distributed ledger system. At the current state-of-the-art, many DLT-based systems
exist, differing in the kind of registers, consensus protocol, network and smart
contracts programming. These technical differences often reflect the diverse key
requirements from which distributed ledger systems are designed and implemented.
DLTs emerged from the consumer-to-consumer market with the exchange of cryp-
tocurrencies, as a decentralized method of value transfer without third-party inter-
mediaries. Originally designed in 2008 as the core data and programming structure
of the Bitcoin cryptocurrency, blockchain technology is an application of DLTs that,
2 Modernizing Healthcare by Using Blockchain 33

in the last two decades, has widely spread and evolved beyond the scope and context
of financial industry.
In a blockchain network, any transaction task concerns endpoints that are authen-
ticated through public keys of a given digital signature scheme, and the blockchain
ledger composes of a continuously growing list of transaction records that are grouped
in blocks, where each block contains a cryptographic hash of the previous block.
Assuming that a given block cannot be altered, all the previous blocks in the chain—
with high probability—cannot be altered, too, because of the properties of the hash
function. In particular, if the last block in the chain is supposed to be uniquely gener-
ated and unforgeable, then these properties are inherited with high probability by
all the other blocks, and the overall blockchain satisfies both the consistency and
integrity properties.
Blockchain technology is quickly evolving and consolidating around two basic
models of decentralized network, realizing two different types of blockchain: permis-
sionless and permissioned. Bitcoin and Ethereum are examples of permissionless
blockchain: anyone can participate to the management of the ledger through the
consensus protocol without a specific identity. Permissionless blockchains typi-
cally involve a native cryptocurrency and often use consensus based on a “proof
of X” block proposal scheme, unfinished block finalization (as explained below)
and economic incentives. In permissioned blockchains, on the other hand, the ledger
is managed by a restricted set of known, identified participants in the system, and
consensus can be realized through more efficient approaches achieving determin-
istic finality like byzantine fault tolerant (BFT ) protocols. BFT and “proof of X”
based protocols are both designed to tolerate byzantine faults, in which one or more
peers involved in consensus behave arbitrarily against the goal of reaching agree-
ment (liveness) or that of adding to the blockchain the true block intended by the
protocol (integrity). BFT protocols have been studied since the early 80 s (Pease
et al. 1980; Lamport et al. 1982; Dwork et al. 1988), and modern instantiations can be
deployed on asynchronous networks (e.g.; Miller et al. 2016) and also be optimized
for different objectives like BEAT (Duan et al. 2018). These protocols have a marginal
computing cost and result in a definite agreement, but can manage consensus only
on small scale (up to few dozens of nodes), since they require explicit communi-
cation rounds among participants in order to select the peer in charge of uploading
the new block to the blockchain. On the contrary, “proof of X” based protocols
select the uploader through a sort of cryptographic puzzle, which does not require
explicit communication, so they scale well and can be used to manage consensus
among a large and open set of participants. In the face of such advantages, however,
these protocols: (i) are quite expensive in terms of specific resources of participants
(e.g.; computational power, owned coins, network bandwidth), and (ii) suffer from
unfinished consensus, that is they select the uploader just with high probability so
that temporary forks in the blockchain could occur before reconciliation. The first
unfinished consensus protocol was the Nakamoto protocol introduced with Bitcoin
(Nakamoto 2008), which is based on the proof of work (PoW ) block proposal scheme
and uses the longest chain rule for block finalization. In this last decade, many alter-
natives to the PoW have been introduced, primarily in order to avoid its energetic
34 M. Ciampi et al.

high inefficiency, such as the proof of stake (PoS) (King and Nadal 2012), the proof
of activity (PoA) (Bentov 2014; Bentov et al. 2016) and the proof of elapsed time
(PoET ) (Chen et al. 2017). Other recent proposals (e.g.; Kogias et al. 2016; Micali &
Vaikuntanathan 2017; Daian et al. 2019) try to overcome the limitations of the two
above approaches by combining them in hybrid protocols that first randomly select
a small subgroup of participants and then reach consensus through explicit voting
ballots in this subset.
Overall, there are currently substantial efforts and investments for not only devel-
oping and deploying mature DLT-based systems in many industry sectors like finance,
manufacturing, banking, insurance, retail, healthcare and telcos, but also to improve
public administration and e-governance.
The next Subsection illustrates the Hyperledger project, one of the major consor-
tium established so far as a result of the great interest of industry toward DLTs; it
is of particular interest in the context of business networks, since its main goal is to
promote a modular approach that provides a wide range of open-source blockchain
solutions across many industries.

2.2.2 The Hyperledger Project

The Hyperledger project was started in 2015 by the Linux Foundation to advance
cross-industry collaboration by developing blockchains and distributed ledgers,
with a particular focus on improving the performance and reliability of these
systems, so that they are capable of supporting global business transactions by major
technological, financial and supply chain companies.
The philosophy underlying this project is that DLT is not one-size-fits-all tech-
nology: since different organizations have different needs, there will never be one
single, standard blockchain; instead, many blockchains with different features will
provide a wide range of solutions across many industries.
Hyperledger provides a “greenhouse” structure that can incubate new ideas,
support each one with essential resources, and distribute the results widely. Modular
programming allows this structure to support many different solutions while
consuming far fewer resources.
So far, the available Hyperledger projects enabling the implementation of DLTs
are: Besu, Burrow, Fabric, Indy, Iroha, Sawtooth.
All the Hyperledger projects are designed so to be composed of software modules
that can be reused and replaced. This way, developers can experiment and build
blockchain suitable for different requirements. Through this feature, for instance,
different consensus protocols can be tried in order to find the one that best suits
a given application scenario. The Hyperledger Architecture Work Group (AWG)
is a technical workgroup focused on identifying common and critical components,
providing a functional decomposition of a blockchain stack into component layers
and modules, regularizing interfaces between the components, and interoperability
between ledgers. Another important aspect of the blockchain solutions hosted by the
2 Modernizing Healthcare by Using Blockchain 35

Hyperledger projects is that they do not require any cryptocurrency or token in order
to work; however, some of these projects allow implementing a cryptocurrency, or
giving developers the possibility to create tokens so to manage assets and currencies
through them. A cryptocurrency is a digital medium of exchange designed so that
individual coin ownership records are stored in a database using strong cryptography,
so to control the creation of additional digital coin records and to guarantee the correct
flow of coin transactions avoiding double spending. Instead, a token represents an
asset or utility tied to, and evaluated in term of, a given blockchain cryptocurrency.
Tokens are tradable and transferable among the various participants of the blockchain,
and they are often used to fundraise for crowd sales.
At the time of writing this chapter, the Hyperledger project hosts the frameworks,
libraries and tools illustrated in Fig. 2.1. Six different frameworks for implementing
complete DLT-based systems are currently provided, all based on the blockchain
technology but with major differences in the consensus protocols supported, the
membership service, the smart contract programming models, and the APIs for the
interactions of the application layer with the blockchain network. Some frameworks,
like Burrow and Indy, are focused on specific tasks, whilst others (e.g.; Fabric)
are general frameworks that aim at providing solutions for different application
scenarios.
The main characteristics of the Hyperledger projects designed to realize DLTs are
provided below.
Besu is a client designed to create public or private permissioned networks on top
of Ethereum, but that can also be ran on test networks such as Rinkeby (Rinkeby 2020)
or Ropsten (Ropsten 2020). It supports different consensus algorithms including
IBFT2.0 (Saltini and Hyland-Wood 2019), Ethash (Zamanov et al. 2018), and RCPA
(Schwartz et al. 2014).
Burrow provides a modular blockchain client with a permissioned smart contract
interpreter built in part to the specification of the Ethereum Virtual Machine (EVM).
It was designed to be a general-purpose smart contract machine. It supports both

Fig. 2.1 The Hyperledger Project “greenhouse” structure. (source www.hyperledger.org)

36 M. Ciampi et al.

EVM and WASM based smart contracts and uses BFT consensus via the Tender-
mint algorithm (Kwon 2014). Governance and permissioning is built in and can be
amended by on-chain proposal transactions. It is optimized for public permissioned
proof of stake use cases, but can also be used for private/consortium networks.
Fabric is a platform for building distributed ledger solutions, with a modular
architecture that delivers high degrees of confidentiality, flexibility, resiliency, and
scalability. Fabric allows main components, such as consensus and membership
services, to be plug-and-play. This way, solutions developed with Fabric can be
adapted for any industry. It leverages container technology to host and orchestrate the
various components of a blockchain network, and offers the possibility to write smart
contracts in different general-purpose programming languages like Go, Javascript,
and Java.
Indy is a special-purpose distributed ledger for the deployment and manage-
ment of digital identities. Indy provides tools, libraries, and reusable components
for creating and using independent digital identities rooted on blockchains or other
distributed ledgers. These identities are interoperable across administrative domains,
applications, and any other organizational silos.
Iroha is an easy to use, modular distributed blockchain platform with its own
unique crash fault tolerant consensus and ordering service algorithms, rich role-based
permission model and multi-signature support. Iroha was designed to be simple and
easy to incorporate into infrastructural or IoT projects that require distributed ledger
technology.
Sawtooth offers a flexible and modular architecture that separates the core system
from the application domain, so smart contracts can specify the business rules for
applications without needing to know the underlying design of the core system.
Hyperledger Sawtooth supports a variety of consensus algorithms, including Prac-
tical Byzantine Fault Tolerance (PBFT) (Castro and Liskov 1999) and PoET (Chen
et al. 2017).
The four libraries currently provided by the Hyperledger project aim to reduce the
development effort in writing distributed ledger software from scratch, but can also
be used to enrich the above frameworks with new functionalities or for implementing
interoperability among different blockchains. Aries is a shared, reusable, interoper-
able tool kit designed for creating, transmitting and storing verifiable digital creden-
tials, with the cryptographic support provided by Ursa. Quilt provides all core Java
primitives required for sending and receiving payments in a ledger-agnostic manner,
enabling payments across any payment network. Transact is a library used to imple-
ment virtual machines or interpreters, called smart contract engines, for processing
smart contracts. Ursa is a shared cryptographic library designed to avoid duplicating
cryptographic work for Hyperledger and non-Hyperledger projects, so to increase
security in the process.
Hyperledger provides also a set of tools to facilitate the interaction with blockchain
platforms. Avalus aims to enable the secure movement of blockchain processing off
the main chain to dedicated computing resources. Cactus is a blockchain integration
tool designed to allow users to securely integrate different blockchains. Cello is a
blockchain provision and operation system, which helps people use and manage
2 Modernizing Healthcare by Using Blockchain 37

blockchains in a more efficient way. Last but not least, Explorer is a user-friendly
web application used to query and view any relevant information stored into a ledger.
The most important Hyperledger project is Fabric (HLF 2020), a highly modular
and configurable open source permissioned DLT platform, designed for use in enter-
prise contexts: its modularity is the strength of the platform, since companies can
develop architectures that meet specific requirements. At a high level, Fabric is
comprised of the following modular components:
• An ordering service establishes consensus on the order of transactions and then
broadcasts blocks to peers. The ordering service is logically decoupled from the
peers that execute and endorse transactions, thus separating agreement on execu-
tion order (i.e.; ledger status) from agreement on the execution of applications.
This approach is much more suitable for commercial networks than the consensus
implemented for cryptocurrencies, as it allows to tailor agreement among parties
in function of the specifics of business. Moreover, since the ordering service is
implemented as a pluggable module, it can be chosen on the basis of the trust
assumption of a particular deployment or solution. Well-established protocols for
crash fault-tolerant or byzantine fault-tolerant consensus are being provided for
the latest Fabric release.
• A pluggable membership services provider (MSP) is responsible for associating
entities in the network with cryptographic identities. The MSP defines the rules
in which identities are validated, authenticated, and allowed access to a Fabric
network. Each MSP makes use of a Certificate Authority (CA) and X.509 public
key certificates, and there is a default CA that can be implemented through the
Fabric-CA API. Organizations can however implement external CAs of their
choice; as a result, a single Hyperledger Fabric network can be controlled by
multiple MSPs, where each organization brings its own favorite.
• A gossip protocol performs three primary functions: (i) peer discovery and channel
membership management, (ii) ledger data dissemination across all peers on a
channel and, (iii) peer-to-peer state transfer update of ledger data. A channel is
a private “subnet” of communication among several members, with the aim of
exchanging confidential transactions. Each channel has its own members, anchor
peers per member, shared ledger, chaincode and ordering service. Each trans-
action on the Fabric network is executed on a channel, where each party must
be authenticated and authorized to transact on that channel through a MSP. Each
gossiped message is signed, thereby allowing participants sending faked messages
to be easily identified and the distribution of messages to unwanted targets to be
prevented. Peers resulting in missed blocks will eventually be synced up to the
current ledger state by contacting peers in possession of these missing blocks.
• Smart contracts are implemented and deployed as chaincode, which runs within
a container environment (e.g. Docker) for isolation rather than on the ledger. A
smart contract can be written in standard programming languages and defines the
different states of a business object or asset through transactions.
• The ledger subsystem can be configured to support a variety of DBMSs and
comprises two components: the world state and the transaction log. The world
38 M. Ciampi et al.

state is the database of the ledger and describes the state of the ledger at a given
point in time, whilst the transaction log has a blockchain structure and records
all transactions, which have resulted in the current value of the world state.
• A pluggable endorsement and validation policy enforcement that can be indepen-
dently configured per application.
A Hyperledger Fabric network can be used by different organizations forming
a so-called consortium. Since not all the organizations within a consortium can be
interested or permitted to share the same assets with all the others, Fabric provides the
notion of channel, and allows the use of multiple channels in the same network. Each
channel has its own ledger, chaincode and ordering service: only the nodes registered
to a given channel can interact with the underlying blockchain, as specified by the
access control, endorsement and validation policies enforced on that channel. A node
can be connected to multiple channels, so it can interact with multiple blockchains
maintaining a separation between them.
In a Fabric network, there are two basic types of nodes: orderers and peers.
Orderers are the nodes composing the ordering service, which is responsible for
ordering transactions in a consistent manner so to ensure that the updates of the
world state are valid after being committed to the network. Peers are the nodes that
commit transactions and maintain the state and a copy of the ledger; moreover, some
peers can enforce specific functions. Endorsing peers must have chaincode installed,
since they simulate transactions and prepare transaction responses. Anchor peers act
as gateways for the communication between different organizations connected to the
ledger. Finally, leading peers use the gossip protocol to disseminate messages from
the ordering service to the other peers of the same organization.
As shown in Fig. 2.2, clients are applications interacting with the network through
the Fabric SDK, which provides a simple API to submit transaction proposals to a
ledger or query its content with minimal code.
In case of a transaction proposal, the Fabric SDK sends the proposal to the
endorsing peers, which verify and execute the transaction, generating an output
(transaction response) which is sent back to the client. If the transaction response
certifies that the endorsement policy provided for the transaction was satisfied, then
the client can send the response to the ordering service. The orderers then assemble
the above transaction alongside with other received transactions in a block, and send

Fig. 2.2 Transaction proposal workflow in a fabric network

2 Modernizing Healthcare by Using Blockchain 39

this block to the committers. All and only the peers that register to a Fabric channel
play the role of committers for the blocks proposed on that channel. They check all
the transactions encoded in a block against their world state database, reporting each
as valid or invalid and updating the database only in the first case; lastly, they add
the new block in their copy of the blockchain.

2.3 Needs and Tools for the Health Domain

The change in the needs and expectations of the patient-citizen, mostly caused by the
aging process of the population, along with the spread of the technological innovation
and the development of science in the medical field, is pushing towards the definition
of new models of health care and delivery of services, according to a “patient-
centric” vision. In the recent years, the health domain has shown an adequate attention
towards the introduction in a systematic way of communication and information
technologies in the entire social and health processes (eHealth). In this context,
eHealth becomes a strategic and enabling instrument for the management of the socio-
health systems. It allows not only the systematic collection and retrieval of health
information, but also its correct interpretation, according to models able to support the
decentralization of the care, the optimization of clinical and organizational resources
and the improvement of the quality of health processes.
The technological and methodological solutions currently available have several
limitations, as they are not able to manage the dynamism of health processes in a
synergic and intelligent way, due to the interaction between organizational flows and
care protocols. These limitations are reflected in the efficiency in the use of resources
and in the adequacy of the care processes, causing inhomogeneity of the care levels
on the territory. The main innovations that must be provided to the health system
mainly have to be able to provide:
• a universal model for health focused on the person (every time, and not only for
a specific clinical event);
• a proactive approach to the health domain, by means of novel tools aiming at
involving the patient-citizen in the care processes;
• an integrated process management, by creating cooperative care models through
the digital connection among all the actors involved in the prevention, treatment
and follow-up processes;
• a certification of the health protocols adopted and of the clinical data produced, in
order to encourage a native use of knowledge technologies, which allow to offer
intelligent services capable of integrating and configuring themselves dynami-
cally with respect to the operational context with a view to socio-health care
comprehension as a complex adaptive system.
In light of these reasons, the health domain needs innovative IT platforms and
services that comply with the most consolidate health informatics standards, able to
support stakeholders in the development of innovative and natively secure, certified,
40 M. Ciampi et al.

Table 2.1 Possible solutions for the main health issues

Issue Solution
Secure sharing of health data Consolidated syntactic and semantic interoperability models
and secure protocols have to be adopted for exchanging
heterogeneous information coming from different sources (like
hospitals, first aids, laboratories, general practitioners, etc.),
assuring unambiguity and privacy preservation
Personalized health care Specific IT systems have to be designed to collect, process, and
store patient health and wellness information in a certified
manner directly in the patient’s home, in order to transfer
prevention and treatment to the territory
Health processes Advanced models and tools for the optimization, certification,
and handling of the health processes need to support the
decision-making phase
Evidence-based medicine An information model have to be used for facilitating the
integration and analysis of large amounts of socio-health data,
based on the adoption of the Big Data Analytics paradigm
Internet of things Practical tools have to be specifically developed to facilitate an
effective integration of the data produced by the numerous
existing biomedical sensors and wearable devices with other
patient-related data

and interoperable eHealth applications. With reference to the problems and limita-
tions previously exposed, such IT platforms and services will have to provide new
solutions concerning a set of specific issues, as shown in Table 2.1.
Blockchain technology permits to implement innovative platforms in the health
domain, facilitating the management of the different phases of the health processes,
identifying and certifying activities and procedures to be followed. This will facil-
itate above all the scheduling of the resources to be used, in order to monitor and
optimize overall efficiency and effectiveness with a reduction of the major process
inefficiencies in terms of time, duplication or uselessness of some phases/activities
making up each process. Moreover, they will simplify the activities of medical and
health personnel, also offering patients a better and faster treatment service. The
certification of clinical data produced and health processes performed will permit to
provide “controlled” intelligent services to doctors both in: (i) the management of
decision-making processes carried out in diagnostic, therapeutic and rehabilitation
practice, and (ii) the assessment of the appropriateness of the interventions to be
carried out to provide patient health care. Indeed, this would allow training artificial
intelligence based systems on correct, verified and shared information rather than on
fake ones. This would also permit to improve the overall quality of services and to
reduce health risk, ensuring alignment with reference clinical guidelines.
This Section firstly provides an overview on the most important European
initiatives undertaken to implement homogeneous and interoperable electronic and
2 Modernizing Healthcare by Using Blockchain 41

personal health records. Then, it illustrates the main aspects regarding clinical work-
flows and the importance to respect the health paths formalized, in order to follow
best practices and provide a homogeneous care service.

2.3.1 Electronic and Personal Health Records

EHRs offer the great advantage to make it possible for healthcare professionals
to easily consult the patient’s clinical history, if they have the access right to such
information. Many efforts have been performing worldwide to realize exhaustive and
distributed EHR systems, even if with several critical issues. Indeed, the implementa-
tion of such systems can be really completed only with the development of numerous
subsystems by many different actors (hospitals, clinical laboratories, general prac-
titioner ambulatories, institutional authorities, etc.) and by paying much attention
to user privacy. Despite this, the importance of having a great amount of clinical
information available pushes the authorities to finance this kind of projects.
Differently, a Personal Health Record (PHR) is devised to collect personal health
information maintained by the patient, like clinical reports, annotations or data
produced by biomedical sensors. They represent an important tool complementary
to EHRs, considering their ability to classify and memorize all the data provided by a
patient, thus offering to him/her an individual’s medical history. The main difference
between EHR and PHR lies on the nature of the health information collected. EHRs
gather certified clinical information produced by healthcare facilities, whereas PHRs
collect information held by the patients and, for this reason, these data are not certi-
fied. So far, several PHR systems have been implemented from private enterprises or
public organizations, also in order to take advantage of the widespread of biomedical
sensors and wearable devices, which are able to produce great amount of physiolog-
ical data. However, even if many Countries have issued norms for establishing their
realization, a comprehensive technical framework for assuring the implementation
of homogeneous and interoperable systems is still in progress (NCHIT 2018).
Instead, many efforts have been performed in the last two decades to develop
IT systems able to gather the great amount of clinical documents (like clinical
reports, prescriptions, discharge letters and so on) produced by the healthcare facil-
ities. The great part of these systems are based on the registry/repository paradigm:
the digital healthcare documents are stored in repositories, which are information
systems managed directly by the healthcare facilities or by more high-level organi-
zations; a set of metadata related to such documents (including the reference to the
repositories where they are stored) is memorized in a registry.
These systems are typically distributed and managed by the organizations deputed
at different levels to their implementation: healthcare enterprises, regional admin-
istrations, Countries. Considering that many EHR systems are implemented by
different organizations, much attention has been paid in the last years by the Euro-
pean Commission to promote initiatives aimed at making such systems interoperable
42 M. Ciampi et al.

each other at a European level. The most important European projects focused on
such a theme are described in Table 2.2.

2.3.2 Clinical Pathways

Clinical Pathways (CPs) or clinical workflows represent a health methodology used

everywhere, which aim at standardizing the clinical approach to provide care to
specific categories of patients. More in detail, they are structured plans of care defined
to realize the implementation of clinical guidelines. CPs are standardized descrip-
tions of clinical processes for defined combinations of symptoms adapted to clinical

Table 2.2 Main European projects on eHealth

Project Duration Description
epSOS (2014) 2008–2014 The aim of the project was to update, test
and evaluate cross-border eHealth
services. Attention was paid to high
quality services for the exchange of two
main clinical documents between
European Countries: (i) Patient Summary
(PS) and (ii) e-prescription and
e-dispensation documents
CALLIOPE network (2010) 2008–2010 The project was part of the Open eHealth
Initiative, led by the health
administrations of the Member States. It
was initiated by 17 health authorities and
10 organizations representing networks
of doctors, pharmacists, patients, industry
and other stakeholders in the health
sector. The project represents a targeted
effort to establish an open discussion
forum, properly managed, composed and
structured, with the main objective of
supporting the Member States in the
implementation of interoperable e-health
solutions, in close collaboration with the
main interested parties, including users
and industry
eHealth Governance Initiative—eHGI 2011–2014 The initiative established a governance
(2014) structure for eHealth in Europe in order
to ensure continuity of both national and
international health care. This aim was
pursued through the development of
strategies, priorities, recommendations
and guidelines aimed at providing
e-health in Europe in a coordinated way
(continued)
2 Modernizing Healthcare by Using Blockchain 43

Table 2.2 (continued)

Project Duration Description
Thematic Network Antilope (2015) 2013–2015 The project was launched by the
European Commission for promoting the
use of standards and profiles for eHealth
interoperability and their adoptions
throughout the European Union. The
policies concern services that are based
on the availability of reliable and
interpretable data exchanged between the
health systems used by health
professionals and patients
Trillium Bridge (2015) 2013–2015 The project aimed to align the use of
standards and in particular the Patient
Summary specifications between the EU
and the United States, in order to share
basic patient data between EU and US
healthcare professionals, subject to
consent from the patient. By creating a
transatlantic interoperability “bridge” for
sharing specifications on Patient
Summary that will benefit both EU and
US citizens, Trillium Bridge helped
implement the EU-US eHealth roadmap
and support the improvement of
healthcare, economic growth and
innovation
e-SENS (2016) 2013–2016 The project was launched by the
European Commission and involved over
100 private actors from 22 Countries. Its
aim was to consolidate the work done by
the previous large-scale pilot programs,
by providing generic IT solutions for
cross-border communication that can be
applied to any domain
EXPAND (2015) 2014–2015 The project aimed to address the
challenge of moving from a series of pilot
solutions projects to large-scale
deployment of cross-border structures
that support Member States in delivering
their local e-health plans and services and
providing cross-border assistance. In
particular, the goal of the network was to
maintain and expand existing
infrastructure resources and act as a
catalyst for real operational use by the
Member States
(continued)
44 M. Ciampi et al.

Table 2.2 (continued)

Project Duration Description
VALUeHEALTH (2017) 2015–2017 The project was established with the aim
of developing a model and a business
plan for the sustainability of cross-border
eHealth services. It focused on the
cross-border exchange of information
between Member States that foster the
right to health of citizens who move
within the EU and are in need of
receiving health care or who are
deliberately called to receive health care
in a Country different from their own
Trillium Bridge II (2019) 2017–2019 The project responds to the request of the
EU-US interoperability roadmap, with an
exceptional consortium to further
promote the interoperability of the EHR
systems. Activities that revolve around
IPS (International Patient Summary)
standards can foster digital health
innovation, reduce trade barriers and
advance patient safety and confidence,
bridging the gap between strategic intent
and SDOs (Standards Development
Organizations) action capacity that seek
interoperability, quality, and safety
through the adoption of standards
eHealth Digital Service Infrastructure Since 2019 The initiative was activated within the
(eHDSI) 2015 Work Programme Connecting
Europe Facility (CEF). Two cross-border
eHealth services were derived from the
epSOS project: Patient Summary and
ePrescription/eDispensing. Cross-border
eHealth services are integrated
end-to-end processes that deploy
activities in more than one Member State
and in more than one professional
environment, involving both healthcare
professionals and ICT professionals

conditions. They are tools that allow to outline, with regards to one or more patholo-
gies or clinical problems, the best possible path within an organization and among
organizations for taking care of the patient and his/her family. CPs lie on the concept
of putting a patient in a therapeutic diagnostic path where, according to the needs
and phases of the disease, the medical team defines the most appropriate therapy in
agreement with the interested parties. CPs thus have the aim of representing the best
temporal and spatial sequence for the patient care. CPs, according to the European
Pathway Association, have to:
2 Modernizing Healthcare by Using Blockchain 45

• Include a clear explanation of the objectives and key elements of clinical

healthcare based on scientific evidence;
• Make an easier communication among team members, caregivers and patients;
• Manage the healthcare processes by coordinating roles and implementing the
activities of multidisciplinary teams;
• Include documentation, monitoring and evaluation of the outcomes;
• Identify the resources necessary to implement the path.
• To increase the quality of clinical care, improving outcomes and promoting patient
safety through the use of the right necessary resources;
• To support health professionals, clinicians and care operators, by continually
improving the quality of services and safeguarding high standards of care.
One of the main purposes of the application of Information and Communication
Technology (ICT) in the healthcare domain is to improve quality in the patients’
continuity of care. ICT can be the enabler for an amplified personalization within
a communication network, improving the overall coordination of shared treatment
activities and the degree of participation of the diverse stakeholders such as patients,
care providers, healthy people interested in prevention or fitness (Schlieter et al.
2017).
Clinical pathways are being applied in different medical domains. However, their
application is typically difficult without an appropriate ICT environment, such as
health information system or an appropriate IT architecture. Without a system able
to support the physicians in using efficiently the collected data, performing actions,
analyzing results, and so on, is very complex to implement the follow-up of the
clinical process defined throw a specific clinical pathway.
CPs are devised to support the professionals in this complex procedure: the design
of the path, the execution, the evaluation of the different parameters that could lead
to an improvement of the pathway and the possibility of managing the patient’s
conditions with respect to the specific identified needs. In addition, this process
has to be performed in complete security. The more salient benefits of CP include
improved patient involvement in treatment procedures, reduced hospitalization times,
improved overall medical quality, reduced medical costs, reduced incidence of poor
practices, and provision of clinical training tools (Fico et al. 2016).
While patients’ journeys should be carefully led according to CPs planned on
evidence based guidelines, EHRs have the ability to track such journeys. For this
reason, much effort has been putting to integrate clinical workflows with the patient’s
EHR (Ainsworth and Buchan 2012). The integration and use of care plans with health
information systems would allow supporting a multidisciplinary team of profes-
sionals and informal caregivers across a range of statutory, private, or voluntary
organizations along all phases of the care process (i.e. from prevention, to rehabili-
tation; inpatient, outpatient and home care) (Billings 2005; Kodner and Spreeuwen-
berg 2002). In the recent years, the use of clinical pathways has gradually changed,
from a central concept of care to one process-oriented and coordinated healthcare
among different heterogeneous systems, which are diverse departments, hospitals,
and systems (Kinsman et al. 2010; Panella and Vanhaecht 2010). This change leads to
46 M. Ciampi et al.

the improvement of the decision making process of physicians, helping to adapt the
medical treatment for the patient’s needs. Studies show the reasonableness of inter-
department pathways in terms of decreasing lengths of hospital stays or a better
coordination of the whole care procedure (Rotter et al. 2010; Rotter 2013).
The use of care plans among different departments and systems has allowed
improving the quality of patient care. Once the most suitable treatment path for the
specific problem (such as pathology, disease, state of health, etc.) is identified, it
is essential that all health professionals who are part of the process and the patient
follow the whole workflow. In the same manner, logging all the actions undertaken
for patient care is necessary for research purposes and the improvement of the process
itself, as well as for identifying responsibilities in a care plan. The ability to update
the treatment plan is also essential to follow the specific needs of a patient during
the start of the treatment path or during the therapy, in order to set the treatment plan
with respect to any patient’s needs, thus obtaining a personalized dynamic pathway.
These ones are flexible tools that go beyond the traditional installation of clinical
pathways. The management of care plans through a health service architecture has
to support the personalization of care for specific patient requirements, as well as the
addition of patient interactions with the care process, in order to achieve objectives
that bring healthcare to improve the quality of care.
An integrated environment in which the healthcare treatment can represent the
link among different departments in the process of a specific patient treatment, as
well as the possibility of making the patient fully experience for her/his path, allows
realizing the so-called patient empowerment. It is a key element allowing patient to
acquire trust towards the therapy to be followed and towards the IC technologies
to be used in order to improve the quality of care. Moreover, it is the core element
to decrease the risk of the escalation of the pathologies, especially of comorbidities
(Chaudhry et al. 2006).
Figure 2.3 shows an example of care plan modeled according to the OMG BPMN
2.0 standard, which may be represented in a CP document. It is possible to note that
the all the care journeys carried out from the patient follow strictly the planned path:

Fig. 2.3 Example of a care plan

2 Modernizing Healthcare by Using Blockchain 47

from a general visit by the General Practitioner (GP) to a diagnostic exam performed
by a specialist center or to a medication dispensed by a pharmacy.
The definition of the IT services architecture based on informatics health standards
(such as HL7, FHIR, IHE, etc.) and on the use of blockchain technologies will
allow in a simple way to make the care plans: (i) interdisciplinary (among different
departments and systems); (ii) connected to each other, and consequently allowing
interaction among different actors (such as doctors with diverse specializations) with
different roles, in order to favor the second opinion, use different medical skills and
permit the communication in an easy manner. In addition, an enabling platform able
to track all the phases of a clinical workflow would allow incentivizing and enticing
the patient to take part in the treatment process: in this way, it would be possible to
obtain the trust from the patient and therefore increase the probability that he/she
correctly follows the therapy. Then, it would increase the degree of personalization
of the clinical pathway in a secure way. The use of blockchain technology in the
architecture of such a platform would offer the following important benefits:
• Identification of an integrated and verified treatment plan;
• Management of care paths in a secure way, by satisfying confidentiality and
integrity;
• Log all the operations carried out on the clinical pathways for subsequent analysis
phases, useful to certify the actions taken in the care process and possibly identify
responsibilities in the process;
• Guide physicians and patients to comply with the specific treatment plan
identified;
• Verification of the correct application of the CP specific to the situation: the system
made up of blockchain technology is in fact able to identify a deviation from the
modeled CP and thus notify the observed deviation.

2.4 Standards

Many health informatics standards have been produced by the Standard Developing
Organizations (SDOs) to assure homogeneous implementation and interoperability
of health IT systems. These standards provide important benefits in the development
of homogeneous, interoperable, reusable IT systems for healthcare. For this reason,
they are used to implement health record and workflow systems. These standards have
to be used and integrated with all the new technologies (like blockchain) introduced
in a health domain to implement additional IT applications.
This Section illustrates the most recent health informatics standards and technical
specifications, which refer to clinical data representation and care planning: HL7
FHIR and IHE PCC DCP.
48 M. Ciampi et al.

2.4.1 Fast Healthcare Interoperability Resources

Fast Healthcare Interoperability Resources (FHIR) is a new generation standards

framework developed by Health Level Seven (HL7) International, which provides
interoperability specification for the exchange of electronically healthcare infor-
mation. The main goal of FHIR is to simplify the implementation of health IT
applications, without sacrificing information integrity. It provides a consistent, easy
to implement, and rigorous mechanism for exchanging data between healthcare
applications.
In FHIR, a basic building block is a Resource, which is designed to provide a
standard method to communicate various pieces of health information. A resource
is a FHIR entity that can be used to store and exchange data in order to manage
healthcare information and processes, both clinical and administrative. A resource is
univocally identified and contains a set of structured data items and a human-readable
XHTML representation of its content. These resources can easily be assembled into
working systems that solve real-world clinical and administrative problems.
The FHIR basic philosophy is the expression of the following key concepts: (i)
focus on developers; (ii) support for common scenarios; (iii) leverage web tech-
nologies; (iv) human readability as a basis for interoperability; (v) making content
available for free. FHIR represents a step forward in the world of healthcare, a push to
pass from offline to online, from PC to tablet, from the web to apps, from desktop to
cloud. About transparency of data, it acts as an ‘open API’ to access the data present
in the various EHR systems (silos-like). About analytics, FHIR uses data structures
that allow to dissect and decompose information for data analysis.
FHIR offers several improvements over existing standards, in particular: (i) a
strong focus on implementation; (ii) multiple implementation libraries with many
examples; (iii) the specification is free; (iv) interoperability out-of-the-box—base
resources can be used as are, but can also be adapted for local requirements; (v)
evolutionary development path from HL7 v2 and CDA—standards can co-exist and
leverage each other; (vi) based on web standards like XML, JSON, HTTP, Atom,
OAuth, etc.; (vii) support for RESTful architectures and seamless exchange of infor-
mation using messages or documents; (viii) concise and easily understandable spec-
ifications; ix) based on a human-readable format for ease of use by developers; (x)
solid ontology-based analysis with a rigorous formal mapping for correctness.
The current version of the FHIR specifications is 4.0.1—Technical Corrections to
R4: Oct-30, 2019, available on the website (HL7 FHIR 2020). The specifications are
organized into several levels; each of them detail a particular aspect of the standard.
Level 1 is responsible for the overall infrastructure of the FHIR specification, main-
taining the basic documentation for the FHIR specification. Level 2 supports imple-
mentation and binding to external specifications. Level 3 links real-world concepts
in the healthcare system. Level 4 gives resources to record and exchange data for
the healthcare process. Level 5 provides the ability to reason about the healthcare
process. The main concepts of the FHIR standard are described below.
2 Modernizing Healthcare by Using Blockchain 49

Resources
Resources are the smallest discrete concepts that can be maintained independently.
They are collected in the following classes:
• Administration: covers basic data that can be represented in FHIR, such as Patient,
Practitioner, CareTeam, Device, Organization, Location, Healthcare Service;
• Clinical: contains clinical records (e.g. Allergy, Procedure, CarePlan/Goal,
ServiceRequest);
• Diagnostics: holds clinical diagnostics, including laboratory tests, imaging, and
genomics;
• Medication: contains the ordering, dispensing, administration of medications;
• Workflow: includes the resources for managing assistance processes (e.g. appoint-
ment, order, encounter, etc.);
• Financial: supports billings and payments (e.g. coverage, claim, etc.);
• Clinical Reasoning: permits to provide the ability to reason, such as artifacts of
clinical knowledge, clinical decision support rules, quality measures, etc.

Data Types
The data types are used for categorizing the resource elements. They are organized
into the following four categories:
• Simple/primitive types, which are single elements with a primitive value;
• General-purpose complex types, which are re-usable clusters of elements;
• Metadata types, which are a set of types used with metadata resources;
• Special purpose data types, which are defined elsewhere in the specification for
specific usages.

Bundling
A common operation performed with resources is to collect them into a single
instance, containing correlated data with respect to a specific context. In FHIR,
this is called “bundling”, i.e. a group of resources. The “Bundle Resource” includes
the whole content of all resources, not only their metadata and references.
Profile
Another important aspect of the FHIR specifications concerns the concept of Profile.
Profiles are part of the standard that describe the adoption of FHIR in particular use
cases. Some specific use cases are common or important enough to be described as a
part of the specification itself. A FHIR profile is thus a set of rules that allow a FHIR
resource to include specific constraints or extensions, so that additional attributes
can be added.
50 M. Ciampi et al.

2.4.2 IHE PCC DCP

Integrating the Healthcare Enterprise (IHE) is an international organization

promoted by healthcare professionals and industries with the aim of improving the
way computer systems in healthcare share information by using consolidated stan-
dards (IHE 2020). IHE is organized by clinical and operational domains, where
interoperability and issues related to clinical workflows, information sharing and
improved patient care in the respective areas of healthcare is addressed. Each domain
develops and maintains its own set of Technical Framework (TF) documents. The
current IHE domains are: Cardiology; Dental; Eye Care; Endoscopy; IT Infrastruc-
ture (ITI); Pathology and Laboratory Medicine; Patient Care Coordination (PCC);
Patient Care Device (PCD); Pharmacy (PHARM); Quality, Research and Public
Health (QRPH); Radiation Oncology; Radiology.
IHE is based on a process in which dedicated groups gather case requirements,
identify standards and develop technical specifications. The documents produced,
named Integration Profiles, describe the solutions individuated to interoperability
problems. These documents specify how actors use standards to address a definite
healthcare use case, by exchanging a set of structured messages named transactions. It
is worth noting that in IHE a transaction is an interaction between actors that transfers
the required information through standards-based messages. Numerous transactions
are specified by IHE: they are used within the Integration Profiles to formalize how
the actors interact with each other to exchange information.
The Integration Profiles are published by each IHE domain as part of their TFs.
The publication process is organized in different states (IHE Wiki 2020):
• Final Text (FT): stable;
• Trial Implementation (TI): frozen for trial use; changes permitted prior to FT;
• Public Comment (PC): a TI profile republished or a new profile published for
receiving public comments;
• Draft Supplement: not yet ready for Public Comment;
• Deprecated/Retired: no longer recommended or maintained by IHE.
Vendors can evaluate the conformance of their implementations of Integration
Profiles with respect to the technical specifications during periodical events named
IHE Connectathons, which provide a detailed implementation and testing process.
These events are organized annually by the Associations affiliated to IHE Inter-
national, which are IHE Europe, IHE North America, IHE South America, IHE
Asia-Oceania, IHE Middle East.
The broad diffusion and adoption of IHE specifications in Europe is evidenced
by the European Commission Norms Commission Decision (EU) 2015/1302 of 28
July 2015 on the identification of ‘Integrating the Healthcare Enterprise’ profiles for
referencing in public procurement and Commission Recommendation (EU) 2019/243
of 6 February 2019 on a European Electronic Health Record exchange format, which
identified 27 IHE Integration Profiles as reliable means of electronic exchange of
information.
2 Modernizing Healthcare by Using Blockchain 51

General clinical care aspects such as document exchange, order processing, work-
flows and coordination with other specialty domains are dealt within the IHE PCC
domain, sponsored by HIMSS (Health Information Management Systems Society)
and ACP (American College of Physicians). Some solutions to these issues have
been described in numerous Integration Profiles (IHE PCC 2020).
Specifically, the structures and transactions for care planning, creating, updating
and sharing Care Plans that meet the needs of interested users are provided in
the Dynamic Care Planning (DCP) Integration Profile, whose Revision 3.1 was
published in September 2019 as Trial Implementation (IHE PCC DCP 2019).
The DCP profile permits to dynamically update Care Plans by the different actors
involved in the care processes each time a patient interacts with the healthcare system.
The profile takes advantage of these standards:
• From a functional point of view, it is based on HL7 Service Functional Model:
Coordination of Care Service (CCS) (HL7 CSS 2018);
• With regards to the data model, it derives its concepts from the HL7 Care Plan
Domain Analysis Model (DAM) (HL7 DAM 2016);
• With concerns to technical aspects, the profile is based on HL7 FHIR Resources
and transactions.
The data that a system compliant to IHE PCC DCP has to be able to process have
to be represented in the following HL7 FHIR resources:
• CarePlan: tool used by clinicians to plan and coordinate care for an individual
patient;
• PlanDefinition: contains an action definition that describes an activity to be
performed;
• ActivityDefinition: specific actions to be performed as part of care planning.
The actors formalized in this profile are described below:
• Care Plan Contributor: reads, creates and updates Care Plans and Plan Definitions,
generates Care Plans and requests resources based on a selected activity definition;
• Care Plan Service: manages Care Plans received from Care Plan Contributors and
provides updated Care Plans to subscribed Care Plan Contributors;
• Care Plan Definition Service: manages Plan Definitions received from Care Plan
Contributors and provides updated Plan Definitions to subscribed Care Plan
Contributors;
• Care Team Contributor: reads, creates and updates Care Teams;
• Care Team Service: manages Care Teams received from Care Team Contribu-
tors and provides notification of updates and access to updated Care Teams to
subscribers.
52 M. Ciampi et al.

2.5 Managing and Monitoring Health Records

The management and monitoring of health processed information are complex activ-
ities because they provide for the adoption of specific mechanisms to guarantee the
security and control of the actions about health data. In the healthcare context, it is
essential to adequately manage data qualitatively as well as quantitatively. For this
reason, it is necessary to assure the integrity and availability of health data, as well
as confidentiality, being the health data contain sensitive information. The manage-
ment of health information must be monitored so as to allow the identification of the
users and the operations on health data done (creation/update/cancellation), in this
way performing the so-called integrity monitoring. At the same time, the operations
carried out by the user who reads the data must also be monitored and controlled, in
order to provide data confidentiality.
This Section provides information related to the way health records should be
securely managed and monitored in a standard way. Thus, the concept of security
(in particular, integrity and confidentiality) will be explored by adopting the FHIR
standard. The next Section illustrates how these issues can be satisfied by using
blockchain technology.

2.5.1 FHIR Security and Privacy

FHIR takes in due account security issues. Specifically, authentication and authoriza-
tion of the actors on the system are a necessary requirement. FHIR defines exchange
protocols and content models to be used with the well-known IT security protocols.
Among these, there are:
• Time Keeping, using NTP/SNTP;
• Communications Security: all data exchanges must be protected via TLS (e.g.
HTTPS);
• Authentication: the use of OAUTH is recommended;
• Access Control: defines a Security Label infrastructure to support access control
management, in addition to the extended CRUD (Create, Read, Update, Delete)
scheme;
• Audit: defines useful resources for auditing (audit event and provenance).
The mechanisms to guarantee privacy and security directly depend on the analysis
of the requirements of the specific system to implement and must protect against the
security risks of the data to protect. FHIR is based on a RESTful protocol: each
of the wide set of clinical, administrative, financial, and infrastructure resources
formally defined has a different protection requirement. It supports basic operations
on resources, so assuming that adequate protocols like OAuth and TLS are in place to
authenticate parties and protect their communications. Thus, it is sufficient to define
2 Modernizing Healthcare by Using Blockchain 53

an appropriate access control mechanism to properly guarantee the supported oper-

ations (for example, concerning the Query and Read operations, the FHIR standard
classifies the resources in several classes).
Business Sensitive Resources
This typology is characterized by resources that contain business (referring to compa-
nies, organizations, offices, or groups) and sensitive data. Therefore, these resources
require client-side authentication to ensure that only authorized actors are granted
access. FHIR indicates possible client authentication methods, such as: TLS with
mutual authentication, APIKey, JWT with signed app or JWT OAuth client ID per
app.
Individual Sensitive
This typology refers to resources that do not contain patient data, but provide infor-
mation about other process participants. Example of such resources are: Practitioner,
PractionerRole, CareTeam or other type of users. Access to these other identities is
often regulated by appropriate company rules. To this purpose, the access to the indi-
viduals represented by these resources will tend to be role-specific. For this reason, it
is important using appropriate access control mechanisms based on roles or attributes.
Patient Sensitive
Most FHIR resources belong to the “Patient Sensitive Class”. These resources contain
very sensitive or are linked to very sensitive health information. They use security
labels to differentiate various confidentiality levels. Access to these resources requires
that the user expresses the “purpose of use”, controlled by a privacy consent.
Not Classified
These resources do not fall into any of the above classifications, as their sensitivity
is highly variable. These resources need special management. They are often used
to describe content in a way that can be used for access control decisions.
The resources and mechanisms presented above provide the foundation elements
to design a FHIR-based blockchain network able to assure the realization of health
business processes in a secure, standard and structured way.

2.5.2 Authentication and Access Control

FHIR servers should authenticate clients: to this aim, they can either (i) authenticate
and trust the client system or (ii) authenticate the individual user with a variety of
techniques. For web environments, the standard recommends using OpenID Connect.
It also recommends using OAuth to authenticate and/or authorize the client and user.
The Smart-On-FHIR profile on OAuth is a recommended method for using OAuth.
The OAuth 2.0 protocol framework defines a mechanism to allow a resource
owner to delegate access to a protected resource for a client application, optionally
54 M. Ciampi et al.

limited by a set of scopes. This specification profiles the OAuth 2.0 protocol scopes
to be used with the FHIR protocol to increase baseline security, provide greater
interoperability, and structure deployments in a manner specifically applicable to (but
not limited to) the healthcare domain (Richer and Mandel 2018). A set of privacy and
security specifications are developed: they allow authorization to access the health
data sharing features made available through the RESTful API (https://openid.net/
wg/heart/). The correct identification of an actor on a system is one of the bases on
which the security system is based. In fact, most security applications (authentication,
access control, digital signatures, etc.) are based on the correct mapping between the
relevant resources and the underlying systems. The data owner should not allow
the disclosure of data unless there are sufficient guarantees that the other party is
authorized to receive it. This applies to a client that creates/updates a resource via
PUT/POST, as much as it is managed by a server that returns resources required via
GET.
Two of the classic Access Control models are Role-Based Access Control
(RBAC), where the access policies are based on the role assumed by a user, and
Attribute-Based Access Control (ABAC) (Esposito et al. 2013; Shen & Hong 2006),
where the access policies are evaluated by analyzing several attributes of the user
(and not only on the role). Some other access control models have successfully been
proposed (Namasudra 2019).
A possible approach to create a specific access control model, accompanied by
appropriate security policies, is through the use of the FHIR API. In particular,
HAPI FHIR is a complete implementation of the HL7 FHIR standard for healthcare
interoperability in Java. HAPI FHIR 3.8.0 introduces a new interceptor framework
that is used across the entire library. Interceptor classes may “hook into” various
points in the processing chain in both the client and the server. The interceptor called
Authorization Interceptor permits to determine preliminarily whether a user has the
appropriate permission to perform a given task on a FHIR server. This is done by
declaring a set of rules that can selectively allow (whitelist) and/or selectively block
(blacklist) the access to a resource.
The Authorization Interceptor, opportunely used, is an important mechanism that
can be used to intercept a client request sent to a server in order to: (i) apply the access
control policies in order to grant or deny the access to a health service/resource
requested by a user (for example, a service able to return a clinical report or a
set of metadata related to a patient); (ii) send the same request to the blockchain
network, with the aim of recording the operation, as shown in Fig. 2.4. This way, the
authorization protocol can be performed in two phases: (i) one at application level
(that is, health business level); (ii) one at network level (that is, blockchain level).

2.5.3 Integrity and Auditing

FHIR provides an AuditEvent resource used for event logging. This audit logging
action records specific details when the event occurs to ensure security and privacy.
2 Modernizing Healthcare by Using Blockchain 55

Fig. 2.4 The FHIR authorization interceptor

This form of audit logging records details about the security event that happened.
The AuditEvent can then be used by authorized applications in order to support audit
reporting, alerting, filtering, and forwarding. This model is developed and used by the
widespread IHE ATNA profile. The events of the ATNA logs can be automatically
converted into FHIR resources and therefore the applications are able to search for
audit events or to register for notifications. As regards HTTP logs, developers need
to consider the implications of distributing access to the logs, in fact, HTTP logs
should be regarded as being as sensitive as the resources themselves. Therefore,
FHIR allows, through the appropriate use of the AuditEvent resource, to guarantee
the data integrity on the system, by using the hash attribute of the resource. It is hard
to guarantee integrity at the health process level, because there are different resources
and actors that take part in the process.
A platform based on the FHIR framework and blockchain technology would
permit to assure integrity at a process level, satisfying the key needs of the
health domain, such as interoperability of data and applications, structured data,
unambiguous representation of information.

2.6 FHIR Resource Management with Hyperledger Fabric

As illustrated in the previous Section, the integrity protection of healthcare data and
processes is a key factor for the success of digitized medicine and medical research.
Diagnostic processes and care plans can be more easily implemented, controlled
and updated by assuring that medical records and the actors, actions, devices and
circumstances producing and/or consuming them are reliably tracked through a kind
of tamper-proof ledger. Effective and efficient tools rooted in blockchain concepts
can be designed to promote research integrity values in medical sciences; indeed, the
concept of transaction can be used to encode a potential cause-effect relation that can
56 M. Ciampi et al.

later be analyzed with backward reasoning. By one side, the recording of data and
procedures should mitigate the physician’s or scientist’s bias on the outcome, or the
tendency to rule out data which do not support the hypothesis, or even the failure to
estimate quantitatively systematic errors. On the other hand, feedbacks from patients
and records of their significant health parameters can be comprehensively collected,
analyzed and correlated to care processes.
FHIR resource management can greatly benefit from the adoption of blockchain
networks, since these can be used to enforce resource authentication and the integrity
of their related workflows, which are two aspects not covered by the standard. FHIR
is devoted to interoperability for the exchange of electronic healthcare informa-
tion, and this goes well with the decentralized nature of a permissioned blockchain
network, where code and data are replicated among a set of authorized parties and
kept synchronized without a central authority by means of a consensus protocol. The
model of trust better fitting with modern healthcare ecosystems is indeed that real-
ized through open consortia, where well-recognized healthcare providers (hospitals,
nursing homes, diagnostic centers and medical associations) cooperate in order to
offer a multidisciplinary, flexible and complete care support.
As detailed in Subsect. 2.2.2, Hyperledger Fabric was designed so that a network
can be worked under a governance model based on the trust among the partici-
pants, such as a legal agreement or framework for handling disagreements, although
the participants may not fully trust one another. This is precisely the trust model
of open consortia. The multi-channel architecture of Hyperledger Fabric allows
the various kinds of FHIR resources to be managed independently, sharing them
among different participants and according to specific access control policies. This
way, interoperability can be achieved without sacrificing privacy, and the backbone
network supporting FHIR services can be built incrementally over time in a modular
fashion with respect to managed resources (i.e.; number of services) and the set of
participants and their roles.

2.6.1 Coupling FHIR Services with Fabric Channels

FHIR specifications are based on the REST architectural style (RESTful): for this
reason, the kind of possible operations that can be performed on a resource are
the same for each resource type. This aspect permits to manage the resources in a
highly granular fashion. Such operations are carried out by means of client/server
interactions based on the HTTP primitives (like GET, PUT, POST, DELETE): they
can be relative to interaction types, interaction instances or the whole system (as
shown in Table 2.3), and collectively constitute the Resource-Oriented Architecture
based on the FHIR API. Coherently with context and scope of the standard, this
API does not directly address authentication, authorization, and audit collection; nor
it provides methods for assuring the integrity of information supplied by servers:
implementers can choose which of the interactions are made available, and which
resource types are supported by servers.
2 Modernizing Healthcare by Using Blockchain 57

Table 2.3 The FHIR RESTful API

Instance Level Interactions Type Level Interactions Whole System Interactions
Get a
Read the
Create a new capability
read current status create capabilities
resource statement for
of the resource
the system

Read the state Search the

Update, create
of a specific resource type batch/
vread search or delete a set
version of a on the basis of transaction
of resources
resource specific criteria

Retrieve the Retrieve the

Update an
change history change history
update existing history history
for a specific for all
resource
resource type resources

Update an Search across

existing all resource
patch resource with search types on the
specific basis of
changes specific criteria

Delete a
delete
resource

Retrieve the
change history
history
for a specific
resource

In order to realize an integrated architecture based on a blockchain network able

to address the needs outlined in Sect. 2.3, Hyperledger Fabric may be used to act
as a network underlying the application layer implemented with FHIR, and upon
which FHIR services rely for the integrity and the proper synchronization of the
resources that they provide and share among the set of participants. Each FHIR
server is coupled with one or more Fabric peers through a Fabric client, which acts
as an interface between the FHIR and the Fabric layers. The Fabric client is in
charge of intercepting the interactions with the FHIR server and issuing appropriate
transaction requests on a suitable Fabric channel (as defined in Subsect. 2.2.2). The
Fabric channel is selected on the basis of the FHIR resource being managed, whereas
the transaction request depends on the type of interaction performed on the resource.
Using different channels for different resources is not mandatory; however, it should
help in defining integrity protection controls, which are tailored for the specific
workflow of a given resource. Different Fabric channels can indeed implement in a
different way the transactions corresponding to the same FHIR interactions through
58 M. Ciampi et al.

Fig. 2.5 The hyperledger fabric—HL7 FHIR integrated architecture

a diverse chaincode, whilst each channel can have its own set of participants and
access control policy. The integrated architecture is shown in Fig. 2.5.
One main point in this design is the choice of the FHIR resources, or part of them,
that must be coded as Fabric assets. For the purpose of data and process integrity, it
is not efficient to store on the ledger the full specification of a resource, since it can
consist of many elements, and some of them are quite narrative and not important
to be recorded as such. Blockchain ledgers are not usually designed to store large
assets, since they are intended to log transactions (i.e.; state changes in assets) for
large amount of time and in a replicated way, and this can easily result in large
amounts of data and scalability issues. Resources are already stored and managed
by the FHIR server, thus replicating them on the Fabric ledger would only result in a
harmful computational and storage overhead. Moreover, FHIR resources are closely
related to each other: it is often the case that a FHIR resource contains references to
other FHIR resources, which can be managed by the same server or even by a remote
server. Fully reproducing these interdependencies at the blockchain layer would be
too complex and useless, since this is managed by the application layer. Thus, it
is mandatory in this proposed approach to select a few primary FHIR resources on
which the others depend and keeping explicitly track on the ledger only of the first
ones.
Another main point in the proposed design concerns how resource instances are
named and addressed in the context of a single server and the overall network. The
name space has to be defined not only to avoid name collisions under the assump-
tion that FHIR servers give names independently from each other to newly created
instances, so to get globally unique assigned names. A more stringent requirement is
that the naming convention must not disclose sensitive information (e.g.; patient iden-
tifiers) and must be immune to enumeration attacks. The proposed approach involves
2 Modernizing Healthcare by Using Blockchain 59

resource names consisting of three parts: a prefix that uniquely identifies the FHIR
server in the network and its service,1 a unique pseudo-random string (nonce) in the
namespace of the server to univocally identify each resource managed by the server,
and a sequential integer that identifies the version of the given resource. This naming
schema is compatible with the FHIR standard and major naming conventions for
computer networks (e.g.; DNS).

2.6.2 Participant Management

A final relevant point of the design concerns participants in the Fabric network. Being
a permissioned blockchain, Fabric relies on Member Service Providers to manage the
identities of participants, which in turn are constructed from public-key certificates
and a X.509 public key infrastructure. Managing the identities at the application
layer through Fabric would result in a large-scale, time-varying process which is
quite cumbersome to administer via the MSPs, and that it would also significantly
deviate from current standards. As detailed in Subsect. 2.5.2, FHIR applications
have their own authentication and authorization requirements that are very different
from those concerning a permissioned blockchain network. FHIR recommends to
use OAuth 2.0 (Hardt 2012) to authenticate and/or authorize the client and user.
Moreover, for the purpose of data and process integrity, handling user authentication
and authorization at the Fabric layer is completely useless, whereas it is instead
important to keep track of “who does what” in the ledger, where “who” and “what”
are defined at the application layer.
The identities managed at the Fabric level will be therefore those concerning
the FHIR servers operating at the application layer, which will be casted as Fabric
clients, plus those related to the peers and orderers composing the Fabric network, as
provided by the organizations belonging to the consortium defined at the application
layer and enforced at the blockchain layer. This way, the FHIR layer has the aim of
managing participants at business level, whereas the Fabric layer at network level.

2.7 Case Study: IHE PCC DCP

This Section illustrates a case study in which a two-tier blockchain-based platform

implemented on the top of FHIR and Fabric is opportunely designed to effec-
tively manage care plans, by respecting the health informatics standards, health
requirements, security and privacy.

1 It may be the case that a single server offers multiple services (i.e.; resources): thus it is important
to distinguish among different services deployed by the same server, for example through FHIR
resource acronyms.
60 M. Ciampi et al.

The IHE Dynamic Care Planning (DCP) Profile provides the structures and trans-
actions for managing and sharing care plans that meet the needs of providers, patients
and payers. As illustrated in Subsect. 2.4.2 and fully detailed in (IHE PCC DCP
2019), this profile is built around the HL7 FHIR Care Plan resource and is made up
by the Care Plan, Care Team and Care Plan Definition services. Care Plan captures
basic details about who is involved and what actions are intended in a care plan-
ning, without dealing in discrete data about dependencies and timing relationships.
A Care Plan can be dynamically created from tools used to support evidence-based
practice, allows the inline definition of activities using the activity.detail element,
and is updated by the Care Plan contributors. The Care Plan contributors constitute a
Care Team, which can be made up of a single individual (e.g.; a self-caring patient),
a single group of individuals or multiple groups of individuals providing various
types of services. In the context of DCP Profile use cases, it is therefore natural to
consider Care Plan as the primary resource that needs an explicitly track on the ledger
through a dedicated Fabric channel. On this basis, the other external FHIR resources
characterizing it are managed by means of a suitable cryptographic hash values, so
to get the overall integrity of the plan. It is worthwhile to note in this respect that
retrieving an external resource and computing its hash value is only required if such
a resource is not managed with integrity protection by its related server. Otherwise,
it will suffice to guarantee the integrity of the reference to the resource by explicitly
tracking it into the ledger, without communication and computing overhead.
The architecture of the proposed platform is shown in Fig. 2.6. It is composed of
the following components:

Fig. 2.6 The proposed two-tier architecture for care plan management
2 Modernizing Healthcare by Using Blockchain 61

• REST Interface: represents a REST server able to receive requests and send
responses according to the FHIR protocol;
• Authorization Manager: is deputed to verify the access rights to the resources;
• Storage Manager: interacts with the FHIR DB for storing/retrieving FHIR
resources;
• Asset Composer: has the aim of coupling a service managing a primary FHIR
resource to a Fabric channel of the same name;
• FHIR DB: is a database where FHIR resources are stored;
• Digest Analyzer: computes and verifies the digests of the FHIR resources;
• Transaction Management: identifies the Fabric transactions to be performed
according to the user request;
• Fabric Ledger: is a distributed and shared registry where transactions are
immutably stored.
A high level sketch of the interactions among the components is illustrated for the
Care Plan create/upload workflow in Fig. 2.7. However, it should be noted that the
architecture depicted in Fig. 2.6 is valid for any FHIR resource or service, although
its implementation can vary and, at the time of writing, it was developed only for the
Care Plan resource in the context of the IHE DCP Profile.
A request containing a FHIR Care Plan resource, sent through the REST Interface,
is intercepted by the Authorization Manager, in order to verify if the user has the
rights to access the service. In this case, the request is sent to the Storage Manager,
which parses the incoming FHIR transaction and, depending on the request type, it
creates or updates the FHIR DB resource database. Then, using a resource specific
configuration file, the Digest Analyzer interface selects the elements of the resource

Fig. 2.7 Software components interactions for creating/updating a care plan

62 M. Ciampi et al.

that have to be explicitly tracked in Fabric and computes some digest values through
the use of an hash function, thus obtaining a memory buffer that encodes the Fabric
asset (named Resource Digest), which corresponds to the resource targeted in the
FHIR transaction (Care Plan Digest in Fig. 2.7). The FHIR interface is also in
charge of assigning names (Resource ID) to newly created resources and their related
Resource Digests, according to the naming schema described in Subsect. 2.6.1.
The Fabric interface of the Asset Composer represents the client of the Fabric
channel implementing the tamper-proof logging for a given FHIR resource or service.
It is called by the FHIR interface with the Resource ID and the string encoding the
Resource Digest as parameters, and it returns to the caller a status condition. This
interface makes use of the Fabric SDK to connect to the Fabric network, access
to the channel provided for the given resource, and submit transactions, trough the
Transaction Manager, to the ledger according to the application transactions inter-
cepted by the FHIR interface. Figure 2.7 shows two types of transactions: create and
update. Fabric transactions are then managed by the peers and endorsers composing
the network, with chaincode installed and instantiated on the endorsing peers which
is appropriate for the processing of the given resource.

2.8 Conclusions

A crucial aspect for the improvement of the health domain is to make medicine
predictive, preventive, personalized and participatory (P4-medicine). An enabling
factor to reach such an objective is represented by the availability of operating plat-
forms connecting the various actors, actions, devices and circumstances producing
and/or consuming health records, while guaranteeing the authenticity of the infor-
mation acquired and its correct processing in compliance with current regulations
and health informatics standards. Distributed ledger technologies, and in particular
permissioned blockchain platforms, have the right requirements but must be correctly
deployed and implemented in order to solve some technological and research prob-
lems that stand in the way of their effective use. Most important, these technologies
can be used only for the network layer, and they have to be appropriately integrated
with the application layer to get the required platforms. In this chapter, potentialities
and challenges of integrating the emerging health informatics HL7 FHIR standard in
distributed ledger technologies are explored. The great advantage of such an integra-
tion is to satisfy an important necessity for the health domain: certify and verify the
clinical events occurred for development of the health processes. After introducing
concepts, frameworks and current challenges for distributed ledgers and the health
domain, the adoption of FHIR for the particular use case of dynamic care planning, as
defined in the IHE DCP profile, is illustrated. Then, in order to show how blockchain
technologies can be used to enforce the authentication of FHIR resources and the
integrity of their related workflows, a concrete example of integration of the permis-
sioned blockchain platform Hyperledger Fabric with some of the services considered
by the IHE DCP profile is provided.
2 Modernizing Healthcare by Using Blockchain 63

Key Terms and Definitions

Blockchain: A special kind of distributed ledger technology, where the ledger
composes of a linked list of transaction blocks. Transaction records are grouped
in blocks, and each block contains the fingerprint of the previous block realized by
means of a system-wide cryptographic hash function. Because of the properties of
the hash function, if the last block in the chain is supposed to be uniquely generated
and unforgeable, then this occurs with high probability for all the other blocks, and
the overall blockchain is both unique and unforgeable.
BFT Protocol: A consensus scheme where the peer in charge of taking the next action
(e.g.; uploading the new block to a blockchain) is selected via explicit communication
rounds among participants. These protocols have a marginal computing cost and
result in a definite agreement, but scale poorly in the number of participants.
Clinical Pathway: Represents a health methodology used everywhere, which aims
at standardizing the clinical approach to provide care to specific patients’ categories.
A clinical pathway is a multidisciplinary management tool based on evidence-based
practice for a specific group of patients (for example characterized by a pathology),
in which the different tasks (clinical actions, therapies and others) to be carried out
for the treatment of the patient is well defined and optimized. The clinical pathways
can vary from the simple use of drugs to a complete treatment plan with indication,
for example, of clinical tests to be carried out. Clinical pathways aim at greater
standardization of therapeutic regimens as well as at better results, both from the
point of view of quality of life and from the point of view of clinical results.
Distributed Ledger: An append-only log of transactions, which is replicated among
multiple nodes, alongside with the code (smart contracts) implementing transaction
logic. These nodes constitute a network of peers with respect to the management of
the ledger, and are usually spread around different geographical sites and institutions.
This way, a decentralized management of authority and trust can be enforced: partici-
pants share a consistent historical register of data processing, and the smart contracts
producing it, using a consensus protocol to agree on the validity of transactions and
their order on the ledger. The enabling technology consists in a set of data structures,
protocols and networking technologies that, when appropriately combined, give rise
to a distributed ledger system.
Proof of X: An algorithm for block proposal where the uploader is selected through
a sort of cryptographic puzzle, whose solution requires a cost in terms of some
specific resource of participants (e.g.; computational power, owned coins, network
bandwidth).
64 M. Ciampi et al.

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Mario Ciampi is technologist at CNR-ICAR. He received his M.Sc. degree in Computer Engi-
neering from the University of Naples “Federico II”, and a Master’s degree in European Master
on Critical Networked Systems and a Ph.D. degree in Information Engineering from the University
of Naples “Parthenope”. His topics of interests include e-health interoperability, software archi-
tectures and standards. He has held numerous leadership roles within international and national
research projects. He is member of the Technical-Strategic Committee of HL7 Italy and the
UNINFO Commission of Medical Informatics. He is Adjunct Professor of Computer Science at
the University of Naples “Federico II”.

Angelo Esposito is a technologist at CNR-ICAR. He received his (BS) degree in Computer

Science in 2005 and his (MS) degree in 2009 from the University of Salerno, Italy, a Master
in Interoperability for Public Administration and Networked Enterprises from the University of
Roma “La Sapienza” in 2013, and a Ph.D. in Information Engineering in May 2017 from the
University of Naples “Parthenope”, Italy. His research interests include e-Health and Information
Security.

Fabrizio Marangio is a research fellow at CNR-ICAR and a Ph.D. student at the University of
Naples “Parthenope”. He received his (MS) degree (cum laude) in 2018 in Telecommunications
Engineering from the University of Naples “Parthenope”. His research interests include e-Health
and Information security.

Mario Sicuranza received his BEng in Computer Engineering in 2006, MEng in 2011 from the
University of Naples ‘Federico II’, and a Ph.D. degree in Information Engineering on Cyber-
security for Health Information System in 2016. Currently, he is a technologist at CNR-ICAR.
His research interests include e-health, web services, and security architectures. Since 2017, he is
Adjunct Professor of Elements of Computer Science at the University of Naples “Federico II”.
2 Modernizing Healthcare by Using Blockchain 67

Giovanni Schmid received his MS degree (cum laude) in Mathematics and his Ph.D. in Applied
Mathematics and Computer Science from the University of Naples “Federico II”. Since 2012 he is
a Certified Information System Security Professional (CISSP), and currently he works as research
scientist at CNR-ICAR. His main research interests are Computer and Network Security, Cryp-
tography, Secure Programming, Distributed and Cloud Computing. Since 2012 he is member of
the technical-scientific board of CLUSIT (www.clusit.it), and member of the International Infor-
mation Systems Security Certification Consortium (www.isc2.org). He carries out teaching and
consulting activities both at universities and companies, in the fields of Secure Programming,
Information Security and Cryptography.
Chapter 3
Security, Privacy, Trust Management and
Performance Optimization of Blockchain
Technology

Mayank Swarnkar, Robin Singh Bhadoria, and Neha Sharma

Abstract Blockchain is a developing technology which provides data storage,

secure transactions and establishing trust in an open environment. Blockchain is
widely implemented in cryptocurrency systems like Bitcoins, smart contracts, smart
grids over IoT devices etc. Blockchain also has wide applications in healthcare, auto-
mobile industries, private and public sectors. This growing popularity of Blockchain
is luring hackers to perform various cyber-attacks in order to detect vulnerabilities
in the applied Blockchain system. A vulnerable block chain system is open for net-
work breaches, data thefts and information manipulations. Therefore, it is important
to design a Blockchain system with proper security, privacy and trust management.
However, increasing security and privacy in Blockchain reduces its performance
because security and privacy policies are overhead to the applied Blockchain sys-
tem. Therefore, it is also important to optimize the performance of Blockchain system
with proper implementation of security and privacy. This chapter discuss the current
scenarios of security, privacy and trust issues in Blockchain. The chapter also discuss
the proposed solutions regarding these issues. Further, the chapter discuss the per-
formance analysis on increasing security and privacy in the Blockchain technology
and proposed optimizations in the literature. This chapter is then conclude by provid-
ing few research directions for improving security, privacy and trust in Blockchain
technology while keeping its performance optimized.

Keywords Block chain · Security · Privacy · Trust management · Performance

optimization · Network attacks · System attacks

M. Swarnkar (B)
Computer Science and Engineering, Indian Institute of Technology (BHU), Varanasi, India
e-mail: [email protected]
R. S. Bhadoria
Computer Science and Engineering, Birla Institute of Applied Science, Bhimtal, India
e-mail: [email protected]
N. Sharma
Computer Science and Engineering, IPS College of Technology & Management, Gwalior, India
e-mail: [email protected]

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 69
S. Namasudra and G. C. Deka (eds.), Applications of Blockchain in Healthcare,
Studies in Big Data 83, https://doi.org/10.1007/978-981-15-9547-9_3
70 M. Swarnkar et al.

3.1 Introduction

In the past few years, internet has grown a lot leading to changes in various tech-
nologies worldwide. One such growing technology is Blockchain. As per the reports
of Statista (Statista, n.d.), worldwide market of Blockchain is 3.9 billion USD in
2020 and expecting to grow to 23.3 billion USD by 2023 A block chain is a temporal
series of unchangeable records of data stored in the computers belong to distributed
systems. The copy of data is stored in more than one computers and these comput-
ers communicate with each other securely using data encryption. Blockchain has
many applications but cryptocurrency Bitcoin is its most widely used application
(Yuan and Wang 2018). Bitcoin was invented in 2008 by Satoshi Nakamoto. He
made the source code open in 2009 for public use. Bitcoin is a digital and crypto-
graphic secured currency designed for secure online transaction. This technology
become popular among product based websites, investment startups etc from 2013.
Moreover, Blockchain gave a proper platform to Bitcoin for secure and trustable
transactions. However, Blockchain is also gaining popularity among applications
like Insurance, Healthcare, Smart Appliances, Passports, Online ID verification etc.
This growing popularity of Blockchain is luring hackers towards it for data stealing,
data corruption, Denial of Service attacks on Blockchain network, network breaches
etc. (Li et al. 2017). A vulnerable Blockchain system if applied to the sectors such
as Healthcare, document storage etc. which contains sensitive and confidential data,
it can be attacked by hackers for data stealing and selling it (Namasudra et al. 2020).
Moreover, integrity of data or transaction is still a problem in Blockchain system
(Otte et al. 2017; Anjum et al. 2017).
Therefore, it is important to design a secure Blockchain system to prevent it
from such attacks and vulnerabilities (Namasudra and Deka 2018). However, it is
known that increasing security in any interconnected system decreases its working
efficiency (Wu 1988; Acharya et al. 2006). The same also implements in Blockchain.
For example, if high number of security policies are implemented on Blockchain
system then each packet of inbound and outbound network traffic needs to be checked
with those implemented policies. This will increase the load of the interconnected
Blockchain system and sometimes become a performance bottleneck. Therefore, it
is also important to consider the performance optimization of secure Blockchain
system. This book chapter discuss the following points in detail:
1. Blockchain design from security perspective using hash pointers and Merkel tree.
2. Digital signature in Blockchain using Elliptical Curve Digital Signature Algo-
rithms.
3. Blockchain transaction models for privacy like UTXO model and Account based
model.
4. Cyber-attacks in Blockchain and its defense mechanisms
5. Privacy and trust management in Blockchain by mix-coin, signature anonymity
and privacy decentralization
6. Performance optimization of Blockchain by using methods like sharding, chain
optimization and system optimization.
3 Security, Privacy, Trust Management and Performance … 71

The rest of this book chapter is divided into following sections: Sect. 3.2 as
Literature Survey, Sect. 3.3 as Security in Blockchain, Sect. 3.4 as Privacy and Trust
Management in Blockchain, Sect. 3.5 as Performance optimization in Blockchain,
Sect. 3.6 as Case Study of Smart Home and conclude with Sect. 3.7 as Conclusion
and Future Research Directions.

3.2 Literature Survey

In this section, we discuss the work done in Security, Privacy, Trust Management and
Performance Optimization of Blockchain Technology. Following are the subsections,
each describing the previous work done briefly.

3.2.1 Security in Blockchain

Eclipse attack proposed by Heilman et al. (2015) allows an adversary to remotely

command and control the sufficient number of computers to monopolize bidirectional
connection for victim computer. However, the attack works only on Peer to Peer
Bitcoin network. Various Double Spend attack models described by Pinzón and
Rocha (2016) in which a user can spend the Bitcoins at-least twice in any Bitcoin
design and such attacks cannot be mitigated. This is supported by theoretical proof
of concept given by Fischer et al. (1985) for the FLP impossibility result. Moreover,
it was also described that Eclipse attack makes Double Spend attack much easier to
perform on any Cryptocurrency based systems (Heilman et al. 2015). Luu et al. (2016)
reported that 45.61% of Ethereum contracts which is second largest cryptocurrency
platform after Bitcoin are vulnerable to adversarial manipulation. The authors created
a tool Oyente to find bugs in contracts and enhance the contracts by removing bugs
and adding bug related semantics to the contracts. Other security issues in Blockchain
includes variety of malware (Moubarak et al. 2018; Pletinckx et al. 2018) which are
either crafted and transmitted using Blockchain or implemented over Blockchain
technology.

3.2.2 Privacy in Blockchain

Zyskind et al. (2015) implemented a protocol to automate the access control manager
of Blockchain system to avoid the trusted third party to increase the data and account
privacy. However in this method, a malicious user can do much more harm to the
Blockchain system as third party cannot verify the actions of users. Hawk which
is a method for privacy preservation of smart contracts was designed by Kosba
et al. (2016) which encrypts and store the financial transactions in intuitive manner.
72 M. Swarnkar et al.

This method also adds processing complexity in the Blockchain system because
of the implementation of additional cryptographic algorithm. Provchain by Liang
et al. (2017) which collect, store and verify the origin of the data for cloud based
data with very low overhead to cloud storage applications. However, the method
is limited to cloud computing only. Li et al. (2018) proposed CreditCoin which is
a Blockchain based vehicular announcement system for authentic announcements
in Vehicular Adhoc Network which also preserves the privacy of the announcer.
CreditCoin is temper resistant and traces malicious users identities in the Blockchain
system. However, the proposed method is tested in simulated environment only.

3.2.3 Trust Management in Blockchain

Anjum et al. (2017) suggested various theoretical Blockchain standards compliance

for trust management in the system. The article provided the theoretical overview and
provided future direction for the increasing trust in the implemented Blockchain sys-
tem. Blockchain based trust management system for vehicular network is proposed
by Yang et al. (2018). In this article, authors provided the method to validate the
message received by the neighboring vehicles using Bayesian Interference model.
Simulated results showed the strong trust values in the deployed vehicular network.
Kochovski et al. (2019) proposed a method to increase the trust management in
Blockchain using Fog Computing.The method uses decenter fog computing plat-
form that uses the Blockchain based Smart Contracts and trust-less smart oracles.
Moreover the work is practically implemented on Ethereum Ledger. Mlik et al. pro-
posed TrustChain (Malik et al. 2019) which is a three layered trust management
framework and uses consortium Blockchain to track interactions among the partici-
pants of the supply chain and to dynamically assign trust and reputation scores based
on these interactions. However, the model increases the notable time complexity
of the working of the Blockchain system because of multilayered trust verification
process.

3.2.4 Performance Optimization in Blockchain

García-Bañuelos et al. (2017) provided optimized execution of Business process in

Blockchain by compiling Business Process Model Number with smart contracts and
deployed on Ethereum platform. Thakkar et al. (2018) identified bottlenecks in the
Hyperledger Fabric which is a Blockchain platform in Linux environment. Authors
identified three bottlenecks in the performance of Fabric Hyperledger as endorsement
policy verification, sequential policy validation of transactions in a block, and state
validation with commit. Authors implemented various existing optimization tech-
niques to increase the performance of all three bottlenecks by 3 times, 7 times and 2.5
times respectively. Huang et al. (2018) proposed an network performance optimized
3 Security, Privacy, Trust Management and Performance … 73

decentralized security model for electric vehicle and charging piles using lightning
network and smart contract in the Blockchain ecosystem. Li et al. (2018) devel-
oped a queuing theory of Blockchain systems using the matrix-geometric solution
and then evaluated the Blockchain system performance. Authors reported improved
performance of the system under few assumptions. Liu et al. (2019) proposed deep
reinforcement learning based performance optimization framework for Blockchain-
enabled Industrial IoT systems for improving scalability maintaining security and
latency of the system.

3.3 Blockchain Design from Security Perspective

A secure Blockchain system is far away from simplicity in terms of real implemen-
tation. There are many features associated with Blockchain system which provide
security. However, two of the most important security features are consensus and
immutability. Consensus is the ability of the nodes or end devices within a dis-
tributed Blockchain system to agree on the true state of the Blockchain network and
on the transaction validity. Efficiency of Consensus depends on the implementation
of Consensus algorithms. Anomaly can introduce fake nodes or bots in the system
for data theft but strong consensus algorithm protects the Blockchain system from
such attacks. In other words, Consensus prevents any unwanted state the distributed
Blockchain. On the other hand, Immutability refers to the ability of the Blockchain
system to prevent any modification in the confirmed transactions. Immutability pre-
vents anomaliness such as fake transactions, genuine transaction alterations etc.
Blockchain system implements hash chain storage to maintain security features like
consensus, immutability etc. In the following subsections, we study the secure way
of storing and validating transactions in the distributed Blockchain system.

3.3.1 Hash Chained Storage in Blockchain: Hash Pointer

and Merkel Tree

Hash chain means successive hashing of any message to improve authenticity of that
message. However in Blockchain, Hash chained storage consist of two elementary
building blocks which are Hash pointer and Merkle tree. Figure 3.1 shows Hash
chained storage in Blockchain.
It can be observed from Fig. 3.1 that both Hash pointer and Merkel tree is imple-
mented simultaneously for Hash chained storage in Blockchain. Hash pointer and
Merkel tree are explained in the following consecutive subsections.
Hash Pointer: It is basically a pointer that contains the address of a previous block
and the cryptographic hash of the information inside the previous block. The pointer
can be used to access the information stored in the predecessor block. Moreover, the
74 M. Swarnkar et al.

Block-1 Header Block-2 Header Block-3 Header Block-n Header

Hash of Previous Hash of Previous Hash of Previous Hash of Previous

Block Header Block Header Block Header Block Header

Merkle Root Merkle Root Merkle Root Merkle Root

Block-1 Transactions Block-2 Transactions Block-3 Transactions Block-n Transactions

Fig. 3.1 Hash Chain Storage in Blockchain

Pointer to Block-0 Pointer to Block-1 Pointer to Block-(n-1)

Hash of Block-0 Hash of Block-1 Hash of Block-(n-1)

Data

Data Data Data

Block-0 or Genesis Block Block-1 Block-2 Block-n

Fig. 3.2 Hash pointer implemented in blockchain

hash can be used to verify that information has not been tampered. A Blockchain
can be referred as a linked list that uses hash pointer to link data blocks together. A
simple implementation of Hash pointer is shown in Figure.
From Fig. 3.2, we can observe that Blockchain is a distributed ledger that can
record data between two parties in an efficient way. Each block contains data, hash,
and hash of previous block. Data stored inside the block depends on the type of
Blockchain. For example, Bitcoin Blockchain stores data as sender-id, receiver-id
and number of coins transferred in the transaction process. Second element is the
hash of the previous block which is always unique and can be called as fingerprint.
It identifies the block and all of its contents. Once the block is created, its hash is
being calculated. Any changes made inside the block will cause the hash to change.
Thus, it is useful to detect any change inside the block and thus used for validation.
Third element is the hash of the previous block. The hash of the first block is not
stored in any other block therefore called genesis block. When the data is changed in
any block the hash of the block is changed which will cause all the following blocks
invalid because it will no longer store the valid hash of the previous block. Thus, a
chain of blocks is created which keeps this technique secure.
Merkle Tree: It is named after Ralph Merkle, who patented the concept in 1979.
Merkle tree is a binary search tree where each non-leaf node is a hash of its respective
child nodes. A merkle tree is also shown in Fig. 3.3.
3 Security, Privacy, Trust Management and Performance … 75

Top Hash
(Hash-1 + Hash-2)

Hash-0 Hash-1
(Hash-00 + Hash-01) (Hash-10 + Hash-11)

Hash-00 Hash-00 Hash-00 Hash-00

Hash (L1) Hash (L2) Hash (L3) Hash (L4)

L1 L2 Data Blocks L3 L4

Fig. 3.3 Merkle tree structure

We can see in Fig. 3.3 that the leaf nodes are present at the lowest level in the
tree which are data blocks in Blockchain. Merkle tree is a significant data structure
for building a Blockchain where nodes are connected to each other by using hash
pointers. In this tree disjoint groups are formed by grouping two nodes present at
the lower lever into one at the parent level and for each pair of lower level nodes,
hash value is calculated and stored in a new data node created at an upper level. This
process is repeated until reaching the root node of the tree. Merkle tree has three
salient features which are as follows:

• Tamper evident: In a Merkle tree, only hash pointer of the root node is memorized
which makes it temper evident as one change disturbs whole Merkel tree.
• Traversal efficiency: In a Merkel tree, one data block can be verified by only
traversing the path to that node because of unique hash values of child nodes.
The complexity of traversal in the Merkle tree is O(log(n)) which is much more
efficient compared with O(n) of a linked list like Blockchain.
• Non-Membership proof : This property means that there is no space left between
the nodes if they are present in the sorted order in the tree.

3.3.2 Digital Signature

A digital signature is a technique that can verify that the data is received from
the authentic source and is remained unaltered in the transmission channel. There
are two important properties of a digital signature: Verifiability and Unforgeability.
Verifiability means the data obtained at receiver end can be verified using digital
signature and Unforgeability means digital signature cannot be forged as per forged
data by an anomaly. Digital signature has three core components: key generation
algorithm, signing algorithm, verification algorithm. The key generation algorithm
creates a public key and a private key. A key that is made available to the public
76 M. Swarnkar et al.

is known as the public key and the key that is used to sign the messages is known
as the private key. The signing algorithm is used to produce a signature on the
input message by using the private key. The verification algorithm takes signature,
message, and a public key as inputs and returns a Boolean value by validating the
message’s signature with a public key. The digital signature can close deals between
the two parties within a few minutes by right-clicking the document, sign digitally
using their secure pin code, and then send it off by email. This process is completely
paperless and in the European Union, a digital signature is just as valid as one made
with ink. Digital signature benefits everyone from common citizens and enterprises
to the governments. It raises productivity, efficiency, and reduces our impact on the
environment.
Blockchain uses Elliptic Curve Digital Signature Algorithm (ECDSA) for for
storing, processing, and securing encrypted data and digital transactions. EC DS A
is a modified elliptical curve cryptography algorithm proposed in 2001 (Johnson et al.
2001). ECDSA is a digital signature algorithm which also works in three steps: Key
Generation Algorithm, Signing Algorithm and Signature Verification Algorithm. All
three algorithms are shown in Algorithm 1, Algorithm 2 and Algorithm 3 respectively.
The parameters used in all the algorithms are abbreviated in Table 3.1.

Algorithm 1 Key Generation Algorithm for ECDSA

Input: F(C), n, G
Output: d A , Q A
1: Sender generate d A such that d A ∈ [0, n − 1]
2: Sender generate Q A as Q A = d A × G

ECDSA is resistant to forgery in the presence of a chosen-message attack or side

channel attack if the elliptic curve group is modeled by a generic group and if the
hash function employed is collision-resistant (Fournaris et al. 2019). ECDSA also
prevents forgery attacks against a legitimate entity by fabricating a valid signature
on any unknown message after obtaining the entity’s signature by sending a set of
selected probing queries on a set of messages (Mehibel and Hamadouche 2020).

Table 3.1 Parameter description for ECDSA

Parameter Description
F(C) Function used for elliptic curve field
G Elliptic curve base point that generates a subgroup of large prime order n
n Integer order of G such that n × G = O where O is the identity element.
dA A private key (randomly selected)
QA A public key (calculated by elliptic curve)
m Message to send
3 Security, Privacy, Trust Management and Performance … 77

Algorithm 2 Signature Generation for ECDSA

Input: Message m to be signed
Input: F(C), G, n, d A , Q A
Output: Generated signature s with message m
1: Calculate e = H AS H (m)
2: Calculate z = L n (e) where L n is the leftmost bits of group order n
3: Select k such that k ∈ [1, n − 1]
4: while True do
5: Calculate curve point (x1 , y1 ) = k × G
6: Calculate r = x1 mod(n)
7: Calculate s = k − 1(z + r × d A )mod(n)
8: if (r = 0  s = 0) then
9: Break
10: end if
11: end while
12: Signature is the pair (r, s)

Algorithm 3 Signature Verification for ECDSA

Input: Signed Message m
Input: F(C), G, n, Q A , r, s
Output: Generated signature s with message m
1: if (r ∈
/ [0, n − 1])  (s ∈
/ [0, n − 1]) then
2: Invalid Signature
3: Break
4: else
5: Calculate e = H AS H (m)
6: Calculate z = L n (e) where L n is the leftmost bits of group order n
7: Calculate u 1 = zs −1 mod(n)
8: Calculate u 2 = r s −1 mod(n)
9: Calculate curve point (x1 , y1 ) = u 1 × G + u 2 × Q A
10: if (x1 , y1 ) = O then
11: Invalid Signature
12: Break
13: end if
14: if r ≡ x1 mod(n) then
15: Valid Signature
16: else
17: Invalid Signature
18: end if
19: end if

3.3.3 Consensus

The consensus mechanism is a way to make decisions with no authoritative figure in

a decentralized peer-to-peer system. This mechanism is used to ensure that records
are true and honest. There are three types of consensus mechanisms:

• Proof of Stake: In this system, the creator of a new block also known as the validator
is randomly chosen based on the number of stakes they commit to the network. The
78 M. Swarnkar et al.

more number of stakes results in higher chances to become a validator. Blockchain

protocols like Cardano’s Ouroboros & EOS adopt the Proof of Stake consensus.
• Proof of Work: In this system transaction data is stored in blocks attached to a
complicated math problem. Such data is only validated when people solve it.
This task is performed by powerful computers and process is known as “Mining”.
A reward in the form of cryptocurrency is issued to the first miner who cracks
the problem. Cryptocurrencies like Bitcoin and Ethereum use a Proof of Work
mechanism.
• Proof of Authority: It is a modified version of Proof of Stake. In this system only
approved parties are selected based on their reputation. IBM’s Hyperledger Fabric
and Ethereum’s Koven Testnet Blockchain systems use Proof of Authenticity.

A good consensus mechanism has two important properties: persistent and liveli-
ness. Persistence ensures the consistent response from the system about the state of
a transaction. Liveliness states that all nodes agree on a decision or a value.

3.3.4 Consistency

Consistency refers to the property that says all nodes have the same ledger at the
same time. Some people argue that eventual consistency is provided by the bitcoins
(Wattenhofer 2016) while other argue that bitcoins guarantee strong consistency
(Sirer 2016). Comparison between eventual consistency and strong consistency is
shown in Table 3.2.

3.3.5 Temper Resistant

It refers to the resistance to an entity by the users or the adversaries. Entity can
be a system, product or physical/logical object. In context of Blockchain, tamper-
resistance means that any transaction cannot be harmed or tampered during and after
the generation of a block. In bitcoin system, new blocks are generated by mining
nodes. Information can be tampered in following two ways:

Table 3.2 Comparison between eventual and strong consistency

Property Eventual consistency Strong consistency
Data Offers stale data Offers up-to-date data
Data update policy Lazy data update Frequent data update
Performance Low latency High latency
Cost Cheap Expensive
3 Security, Privacy, Trust Management and Performance … 79

• Information of received transaction may be tampered by the miners.

• Information that is stored on the block may get tamper by an adversary.
For the first kind of tampering, secure hash functions- SHA-256, ECDSA can be
used and for the second kind of tempering, hash pointer-a cryptographic technique
can be used.

3.4 Blockchain Transaction Models for Privacy

Blockchain is also known as distributed ledger that is created and maintained for
online transactions. However, maintaining privacy of end users, stored data and
transaction is a challenging task in distributed environment. To handle privacy in
distributed Blockchain systems, there are two transaction models for privacy: The
Unspent Transaction Outputs (UTXO) model and the Account Based Online Transac-
tion (ABOT) Model. Both models are explained in the following subsections respec-
tively.

3.4.1 UTXO Model

UTXO model was initially introduced by Bitcoin (Bitcoin). This model resembles
the bank’s account record-keeping system, owner of accounts, and account balances.
UTXOs are processed continuously and are responsible for beginning and ending of
each transaction. Unspent transaction output is a result of a transaction that the user
receives and spends in the future. Every UTXO can only be spent once; meaning it
cannot be used again in the future. Working of UTXO model is shown in Fig. 3.4.
Validation of each transaction is important in terms of privacy and Security. In
UTXO, each transaction can be validated if it meets following three constraints:

Unconfirmed Broadcast
Ti
User A Transaction Pool Blockchain
Confirmed Network
(T1, T2, T3 ... Tn) Block

Yes No
Block Validation Remove the Block
Block Block Block Block (Consensus) and Report
Add Block
to Blockchain

Fig. 3.4 UTXO model

80 M. Swarnkar et al.

• Every referenced input in the transaction must be signed by its owner and not yet
spent.
• If the transaction has multiple inputs, then each input must have a signature match-
ing the owner of the input.
• A transaction is legal if the total value of its inputs equals or exceeds the total value
of its outputs.
The benefits of implementing UTXO model in Blockchain system are:

• Scalability: UTXO enables parallel transactions to process multiple UTXOs at the

same time.
• Privacy: UTXO can maintain higher level of privacy as long as each transaction
uses new address.

3.4.2 ABOT Model

ABOT model was introduced by Ethereum. This model is simpler as compared to

the UTXO model. It explicitly operates on all the transactions to improve consensus
efficiency and to achieve faster block time at the cost of a higher degree of risk.
ABOT model is also shown in Fig. 3.5.
Each transaction with a token value is validated if it meets following constraints:

• The token is signed by the message writer i.e. sender.

• The writer’s ownership of token value can be attested.
• The writer’s spending account has sufficient balance for the transaction.

T1

T2 Reciever-1

Sender-1 T3 Reciever-2

Tn

Transaction Chain

Fig. 3.5 ABOT model

3 Security, Privacy, Trust Management and Performance … 81

After the validation of a transaction, token value is debited from the sending
account and the value is credited to the receiving account. Thus, in Ethereum system,
user’s account balance refers to the sum of the ETH coins for which the user has
a private key for producing a valid signature. The benefits of Account based online
Transaction model are:
• Simplicity: Account/Balance model does not force transactions to include states
thus making the design of the model simple.
• Efficiency: Account/Balance model is efficient because each transaction only needs
to validate that the sending account has enough balance for the payment in a
transaction.

3.5 Security in Blockchain

Blockchain system means Blocks in Chains attached to each other. Its design only
make it very secure as compared to other data storage systems. If an anomaly wants to
make a change in one node or try to compromise one block, it has to make changes to
its consecutive nodes. However this requires a lot of computational power to break
such encryption is small amount of time. Even if the anomaly makes successful
change in the Block, the Block synchronization of Blockchain reveals the compro-
mised blocks. Nevertheless their are many motivated hackers in the world who can
damage the distributed Blockchain system in various other ways. In the following
subsections, few attacks are discussed which are effecting the security of Blockchain.

3.5.1 Distributed Denial of Service Attack

Denial of service attack is performed on the host. In DOS attack, host machine and
its network resources are made unavailable to the intended recipients by disrupt-
ing the hosted Internet services. DDoS attack refers to “distributed” DOS attack.
DDoS attack uses multiple end machines as bots to disrupt the service or empty the
resources of the targeted server. Bitcoin exchange servers in the BitCoin Blockchain
system are the main targets of the attackers for DDoS attacks. As per the report of
cloudflare, one popular coin exchange service has been flagged for 76 application
layer DDoS attacks over about a year. However, there are various defense mechanism
available to detect DDoS attacks in applied distributed Blockchain system (Mirkin
et al. 2019).The fully decentralized mechanism of the Blockchain system and the
consensus protocol mechanism effectively ensure the working of Blockchain would
prevent the Blockchain system from DDoS attacks. Moreover, exchange servers are
installed with powerful Intrusion Detection Systems.
82 M. Swarnkar et al.

3.5.2 Double-Spending Attack

Double-spending attack refers to the spending of a coin more than once. In other
words, it is an ability to use same Bitcoin for multiple transactions by an attacker.
However, this attack is not possible if the attacker has massive computing power. To
overcome such issues, attackers used to combine double spending with other attack
like Sybil attack to make significant harm to the Bitcoin system (Zhang and Lee
2019). Such type of attacks poses major challenge in trading digital currency in a
decentralized network. However. there are few solutions provided by the researched
community to prevent double spending in distributed Blockchain systems. Double-
spending attack can be prevented by evaluating and verifying the authenticity of each
transaction using transaction logs in a Blockchain with a consensus protocol. Each
transaction is publicly verified with a consensus protocol before adding the block
into the global Blockchain. Additionally, each transaction is signed by its sender
using a secure digital signature algorithm.

3.5.3 Majority Consensus Attack

Majority Consensus attack is also known as 51% attack. Presence of cheating risks
in the majority consensus protocol gives rise to the 51% attack. This attack is caused
by the group of miners controlling more than 50% of the Blockchain network’s
computing power. If attackers control the majority of the computing power on the
Blockchain network, an attacker or group of attackers can interfere with the process
of recording new blocks. Thus, attackers can prevent other genuine miners from
completing blocks and allowing attackers to monopolize the mining of new blocks
and earn all of the rewards every-time. There were multiple instances of 51% attack in
the world. Krypton and Shift which are two Blockchain based on Ethereum, suffered
51% attacks in August 2016. Similarly in May 2018, Bitcoin Gold which was the
26th-largest cryptocurrency at that time, suffered a 51% attack. These attacks can be
prevented by strong end user monitoring and surveillance systems.

3.5.4 Pseudonymity

Pseudonymity refers to a state of disguised identity or holding someone else identity.

In Blockchain, attacker can disguise as genuine user by stealing genuine user’s cre-
dentials. In this way, attacker can freely perform anomalous tasks in the Blockchain
system without worrying about identity disclosure. Such attacks directly effect the
genuine user. In case of bitcoins, address stored in the Blockchain is a hash of public
keys of a node in the network. Users can interact with the system as anonymous
entities without revealing their names. Thus, the address provided by the user is
3 Security, Privacy, Trust Management and Performance … 83

seen as a pseudo-identity. Moreover Pseudonymity directly hinders confidentiality

in Blockchain. This problem can only be prevented by the end user itself. Genuine
user must protect its credentials and does not get caught in the identity theft attacks
like Phishing etc.

3.6 Privacy and Trust Management in Blockchain

Secure sharing and storage of trust information are important for maintaining con-
fidentiality and integrity in the Blockchain systems. Privacy leakage leads to trust
issues in Blockchain system. Identity integrity makes applied Blockchain system
trustworthy for its users. There are few techniques discussed in this chapter to main-
tain privacy and build trust in Blockchain systems. These techniques are discussed
in the following subsections.

3.6.1 Mixing

Mixing is the process of hiding the linkages between the input and output of individual
transactions by combining (mixing) with inputs and outputs of other transactions.
There are two popular methods for Mixing which are as follows:

• MixCoin: It is a bitcoin mixing protocol that was proposed for providing transaction
accountability. It allows users to send their transactions to trusted third party who
act as mixing peers and then receive back the same amount of the transactions
submitted by other users. This is done to provide anonymity to bitcoin transactions.
Trusted third party uses mixing server simply called as mix. Later, the mix decrypts
the new addresses, randomly shuffles them, and sends the funds back to each
participant. MixCoin also provides signed warranties to participants as a recovery
in case of error by the Third party. MixCoin can also provide anonymity to external
participants. The major disadvantage of this approach is that the participants deal
with a third party and have to trust the mix.
• CoinJoin: It solves the drawback of MixCoin by involving the combination of
inputs by multiple users into a single transaction for protecting the privacy of bit-
coin users when they conduct transactions with each other. It provides anonymity
by using multi-signature transactions. Multi-signature requires the involvement of
more than one party in the transaction. In CoinJoin, the participants mix their joins
by generating one single mixed transaction. The transaction with multiple inputs
is considered valid only if has been signed with all the keys related to the input
addresses. Hence, the generated mix is verified by each user and refuses to sign
the transaction to stop the exchange. CoinJoin provides external unlinkability. It
is a process in which no external party can determine which input corresponds to
which user. In this way, ownership of Bitcoins is hidden from external parties by
84 M. Swarnkar et al.

joining them with others in a single mixed transaction. The disadvantage of Coin-
Join is that one of the involved parties can learn the process of linking transactions
between inputs and outputs.

3.6.2 Signature Anonymity

Anonymous digital signatures are required because basic digital signature does not
provide signer anonymity or unlinkability. Anonymous digital signature retains the
public verifiability. Two of the popular method for anonymous digital signature are
Group signature and Ring signature which are discussed below:

• Group Signature: It was introduced by Chaum and van Heyst in 1991. In this
signature, there exists a group manager who is responsible for handling registration
of group members and providing each group member with a group certificate (or
a group signing key). Each member of the group can sign anonymously on behalf
of the whole group. Meanwhile, the group manager can identify the real signer of
a valid group signature.
• Ring Signature: It was introduced by by Rivest, Shamir and Tauman in 2001. In
this signature, there is no involvement of a ring manager and thus, each user has a
complete freedom in selecting other ring members. Similar to group signature, a
ring signature allows a ring member to sign anonymously on behalf of other ring
users. Moreover, no one is able to revoke the anonymity of a ring signature.

3.6.3 Homomorphic Encryption and Attribute Based

Encryption

Encryption that allows one to perform calculations on the encrypted data without
decrypting it first is called Homomorphic encryption. Applications of Homomorphic
encryption are healthcare, smart grids, education, and machine learning as a service
(MLASS). Figure 3.6 shows MLaaS Application of Homomorphic Encryption.

Encrypted
Public Key
Result

Encryption Model for Decryption Decrypted

Algorithm Calculations Algorithm Result

Message Secret Key

Sender Side Reciever Side

Fig. 3.6 MLaaS application of homomorphic encryption

3 Security, Privacy, Trust Management and Performance … 85

Homomorphic encryption is used in the sectors where input privacy is important

and making use of data is highly complex due to the presence of several regulations
and security concerns. There are two main advantages of Homomorphic encryption
which are as follows:

• Inference is performed on the encrypted data thus; model can never see the private
data of the client. Therefore, data is not misused or leaked.
• There is no requirement of any interaction between the client and the model owner
for performing any computation.

However thee are two disadvantages also of Homomorphic encryption which are
as follows:

• Computation cost makes this technique expensive.

• Restricted applications.

Attribute-base encryption is an algorithm of public key cryptography in which

the secret key of a user and the ciphertext are dependent on certain user attributes
such as position, place of residence, type of account, etc. ABE has wide applications
in cloud computing, mobile computing, and the Internet of things. ABE provides
flexible and fine-grained access control of sensitive data. Advantages of ABE are
optimized ciphertext expansion rate and anonymity of receivers.

3.6.4 Privacy Decentralization

There is a rapid increase in reported incidents of security breaches that have compro-
mised the user’s privacy. The decentralization mechanism of Blockchain eliminates
the need for a central authority, thus increasing the user’s privacy. Data privacy can
be reshaped by the following measures:

• Decentralizing data storage and transfer

• Integrating decentralization with innovations such as multiparty computation,
encryption and trusted execution environment.

Blockchain has refueled a growing generation of ideas that has allowed individ-
uals to take their privacy back with the help of decentralization. The decentralized
mechanism of Blockchain addresses several challenges that are faced by centralized
models. Three major challenges are as follows:

• Prevents replicated identities through data verification by all the network users and
through time stamping of transaction records
• Prevents data tampering through hashing algorithms
• Prevents data processing manipulation with a majority consensus achieved through
several mechanisms (proof of work, proof of stake, etc.)
86 M. Swarnkar et al.

3.7 Performance Optimization in Blockchain

Blockchain technology works on three major principles that are decentralization,

security, and scalability. For increasing the performance gains of the system there is
a requirement of improving the performance and scalability of the systems. Some
optimization techniques are sharding, Directed Acyclic Structure (DAG), Scalable
consensus, Side-chain, On-chain and system optimization are currently available.

3.7.1 Sharding

Sharding is a database architecture pattern that divides a large piece of data into
smaller data pieces that are faster and easier to manage. These broken pieces are
later placed on different servers for improving performance and availability. In the
Blockchain, block is fragmented and each node only needs to verify the transaction
in its own shard. There is no need of verifying the transaction outside the shard.
Thus, the transactions can be performed in a parallel fashion with the other nodes
on the network. Parallel mechanism completes the verification task in a faster way,
reduces redundancy calculation performed by the nodes, improves the transaction
speed of the public chain, and minimizes the transaction cost. There are three main-
stream sharding strategies: network sharding, transaction sharding, and state shard-
ing. Creating shards and preventing them from the attackers are crucial tasks for the
developers. Embedment of randomness in the Blockchain structure can prevent the
overfilling of individual fragments by attackers. The key feature of sharding is the
separation of entire storage for accommodating different parts on different shards.
Thus, each node is only responsible to maintain its own fragmented data rather
than storing entire Blockchain structure. In the case of account handing between
two different shards, frequent cross-fragmentation and state change phenomena are
required. Cross-fragmentation does not allow performance gains for state sharding.
This problem requires further studies. Another problem faced in state sharding is
data availability. The solution to this problem is the maintenance of backup by the
node which can help to system to repair and recover data that are not available.
There are various challenges that are faced by sharding such as creation of shards,
assigning shards to the nodes, determining the size of each shard, implementation
of cross-shard trading, high costs, affect on the throughputs and profits of the entire
network, etc. The first project that implemented fragmentation technology using net-
work sharding and consensus mechanism is Zilliqa (Zilliqa, n.d.). It has used 1400
nodes and 6 shards in the test and got a throughput of 2800 TPS.
3 Security, Privacy, Trust Management and Performance … 87

Table 3.3 Comparison between traditional and DAG based blockchain

Property Traditional blockchain DAG based blockchain
Element Block Transaction
Efficiency Low High
Scalability Weak Strong latency
Perpetrate Hard Harder
Data transmission rate Low High
Shadow chain attack Easy Hard
Smart contract development Easy Hard

3.7.2 Directed Acyclic Structure

Directed Acyclic Graph is the second method to design Blockchain systems. DAG
was proposed by Nxt community to store blocks and solving the problem of
Blockchain efficiency. In DAG, performance can be greatly improved by doing the
transaction packaging on different branch chains in a parallel fashion. The concept
of DAG-chain was first proposed in the year 2005 and in the same year DAG network
was upgraded from the block packaging dimension to the transaction-based level.
DAG-chain skips the stage of packing the block and directly broadcasts the trans-
action to the whole network. Thus, efficiency is theoretically improved. Table 3.3
shows the comparison between DAG-based Blockchain and traditional Blockchain.
In DAG, verification of the previous transactions is done by the latter transaction.
This verification method allows the DAG to write transactions asynchronously and
concurrently. This finally forms a topology tree structure and thereby improving
scalability.

3.7.3 Scalable Consensus

New consensus protocols can be adopted to improve efficiency and scalability. The
mining process used in the Proof-of-Work (POW) wastes a large number of resources
and consumes time to reach consensus. These delays are not suitable for commercial
applications. Proof-of-Stake (POS) consensus is an upgrade to POW. The difficulty
of the mining process is reduced in POS consensus by managing the proportion and
time of each node. This shortens the time required to reach the consensus but the
involvement of the mining process still creates problems for commercial applications.
Delegated Proof-of-Stake is another improved version of POS that works on the
concept of voting elections. In DPOS several nodes are selected as representatives to
operate the network and professional network servers are used to ensure security and
performance of the Blockchain network. PBFT Byzantine fault-tolerant algorithm
claims for high performance and good security but the degree of decentralization is
88 M. Swarnkar et al.

weak, fault-tolerance is low, and the node system is closed. Another protocol known
as Ripple consensus protocol that improves speed and scalability works in two stages:
• The first stage involves the scenario of reaching the consensus in the transaction
set.
• The second stage involves the proposal of newly generated blocks and finally
forming the consensual block.

Ripple results in weak security and a centralized structure. Ripple itself controls
a large part of accounting nodes. From all the above consensus protocols, it can be
concluded that extending the protocols might cause some improvements in the perfor-
mance of the network but weakens the degree of network decentralization. Therefore,
the best consensus mechanism can be designed by considering local conditions for
fostering the best results in the future.

3.7.4 Side Chain

The concept of side-chain is introduced to expand the function and performance

of the main chain. This is realized by transferring values from the main chain to
the side chain through bidirectional anchoring. Side-chain works in three phases:
First, a part of bitcoin is locked on the main chain. Second, operate currency on the
side chain. The third and final step, settle on the main chain after the end of the
operation cycle. To solve trust problems in the Blockchain, transaction data can be
easily verified by notary mechanism or block header. Additionally, the hash time
can be used to guarantee the atomicity of transactions. Atomicity is a property of
database management system to mark a transaction either pass or fail by assigning 1
or 0 values to a transaction. If a transaction is successful, value one is assigned and
if a transaction fails, value zero is assigned to a transaction. Locked assets can be
managed by Single custodian, alliance custodian and intelligent contract custodian.
Side-chain is an innovative mechanism to reduce the burden of the main chain by
creating independency between data and code in the side-chain. This phenomenon
is a naturally occurring fragmentation mechanism. Side-chains are greatly useful for
increasing flexibility of the Blockchain and can expand the dimension and applica-
tion range of Blockchain technology. Disadvantages of side-chains include the high
complexity of side-chains and the requirement of enough miners for ensuring safety
parameters within the system. Ethereum requires plasma for building side-chains.
Plasma consists of five core components:

• Incentive layer: This layer calculates the contracts cost-effectively.

• Tree-like arrangement: This arrangement of side-chains can maximize the low-
cost efficiency and the net-settlements of transactions.
• Map-reduce computing framework: It helps in increasing the scalability of side-
chains by reframing the state transitions. Also builds fraudulent proofs of state
transitions in the side-chains and makes them compatible with a tree structure.
3 Security, Privacy, Trust Management and Performance … 89

Plasma Contract
(Decentralized Exchange)

Plasma Contract Plasma Contract

Ethereum Root Chain
(Private Blockchain) (Social Network)

Plasma Contract
(Micropayments)

Fig. 3.7 Rootchain example for ethereum

• Consensus mechanism: This is based on the main chain.

• Bitmap-UTXO commitment: this structure ensures the correctness of state transi-
tions of the main chain and maximizes the cost of large-scale exits.
Figure 3.7 shows an example of Ethereum is the root and trunk of a tree and
side chains based on plasma are branches. Most transactions are handled by these
branches to save space on the main chain and increase processing speed. Each plasma
side-chain is dominated by the main chain. Smart contracts are used for controlling
the participating nodes of the main chain, for confirming activities and reaching to
the consensus.

3.7.5 On Chain

There are some significant ways that are introduced to improve the scalability of
Blockchain networks through on-chain which are as follows:
• Multiple Blocks per Leader: In this approach, multiple blocks are appended to the
Blockchain until another leader is elected. Bitcoin-NG is based on the same trust
model, but breaks bitcoin’s Blockchain operation into leader and transaction seri-
alization for performance improvement. Leader election is performed randomly
and infrequently via proof-of-work. In bitcoin, leader can propose to append only
one block to the Blockchain whereas in Bitcoin-NG time is divided into multiple
epochs and a leader can unilaterally append multiple transactions to the Blockchain
for the duration of its epoch which ends when a new leader is elected.
• Collective Leaders: Many systems employ multiple leaders to collectively and
quickly decide whether the block should be added to the Blockchain or not. This
unanimous decision gives a strong reason to a client about the placement of a
block on the chain. Byzcoin replaces the probabilistic transaction consistency of
a bitcoin with strong consistency thus, improving transaction latency of bitcoin.
90 M. Swarnkar et al.

• Parallel Blockchain Extension: Here, different parts of the Blockchain are grown in
a parallel fashion. This work is accomplished by multiple leaders. Bitcoin performs
a linear process for growing blockchains. A problem is given to the miners, one
who finds the solution adds the bloc to the chain. Boyen et al. (2016) introduced a
framework that parallelizes this process by abandoning the concepts of “blocks”
and “chains” and introduced the concept of cross-validation of transaction. Each
transaction confirms two transactions (its parents) and contains some payload (for
example, cryptocurrency) and proof of work.

3.7.6 System Optimization

Optimization techniques are introduced and implemented to alleviate the bottle-

neck present in the Blockchain network. In a Hyperledger fabric, CPU resources are
left unutilized during the VSSC verification phase. For better resource utilization,
multiple transactions can be processed in the VSSC verification phase. Since encryp-
tion operation requires more involvement of CPU, some routine operations can be
avoided by introducing and maintaining a deserialized identifier cache and its MSP
information. Additional CPU power can be utilized effectively by improving pro-
cess transactions within and across channels. Couch DB can perform batch read/write
operations without additional transaction semantics. Bulk operations are adopted to
reduce lock duration and improve performance. GoLevelDB and CouchDB result
in locking the entire database during the approval and ledger update phases without
snapshot isolation level. There are three simple optimization techniques:

• Addition of a cache to an MSP (Membership Service Provider).

• Parallelization of VSSC (Validation System Chaincode) verification block.
• Creating a batch of (read/write) operations during MVCC (Multi-Version Concur-
rency Control) verification and submitting them.

By optimizing the combination, the overall performance of a single channel envi-

ronment is increased by a factor of 16 (from 140 TPS to 2250 TPS).

3.8 Conclusion

In this chapter, an overview about various security, privacy, trust and optimization
issues on distributed Blockchain system is described. Moreover, this chapter also
described few of the effective solutions given by researchers to resolve each kind of
problem. Blockchain is an interesting modern technology which will grow further in
the near future. Because of its growing popularity and adaptability, applications of
Blockchain will increase and so the issues which are discussed in this chapter. This
will surely give real challenges to Security and Blockchain related researchers in the
coming future.
3 Security, Privacy, Trust Management and Performance … 91

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Chapter 4
Securing Healthcare Data by Using
Blockchain

Meenu Gupta, Rachna Jain, Meet Kumari, and Gaurav Narula

Abstract Healthcare is an important aspect of the development of the nation, and

healthcare data are a key element in curing patient health. Healthcare information
exchange is a very important aspect that benefits patients as well as health service
providers. Due to a large amount of patient data, service providers use many cloud-
based solutions, but insecurity arises in the case of the third-party service provider.
This issue has been addressed by the authors in this chapter. However, existing tech-
niques mainly focus on collecting patients’ records from medical examination. In
the present, IoT is widely used in mobile applications for monitoring patient’s health
and maintaining records. Then, collecting records could be sent to laboratories for
further analysis and diagnosis. But, present techniques are too rigid in exchange of
metadata. Authors tried to develop a method using smart contracts in blockchain
which helps in securing the data over transfer. Each and every aspect of healthcare
has been taken into consideration including the lab results, clinical trials, reimburse-
ments, medical charts, etc. In this chapter, the role of blockchain in making digital
records and transfer of the same in the healthcare system safe and encrypted is
discussed. Different technology used for managing healthcare data is also discussed
in this chapter. Later on, the use of smart contracts in blockchain and migration of
the existing model of healthcare system into blockchain is discussed. Based on the
proposed model, result evaluation is discussed for securing healthcare data using
blockchain.

M. Gupta (B)
Department of CSE, Chandigarh University, Punjab, India
e-mail: [email protected]
R. Jain · G. Narula
Department of CSE, Bharati Vidyapeeth’s College of Engineering, Delhi, India
e-mail: [email protected]
G. Narula
e-mail: [email protected]
M. Kumari
Department of ECE, Chandigarh University, Punjab, India
e-mail: [email protected]

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 93
S. Namasudra and G. C. Deka (eds.), Applications of Blockchain in Healthcare,
Studies in Big Data 83, https://doi.org/10.1007/978-981-15-9547-9_4
94 M. Gupta et al.

Keywords Smart contracts · E-healthcare records · Blockchain · Data exchange ·

Healthcare data · Healthcare service provider

4.1 Introduction

Healthcare is the preservation of health by safety, diagnosis, disease treatment, or

injury. The healthcare industry includes many industries that are essential elements
for delivering healthcare services and goods. Healthcare data are one of the most
important elements of this industry as this data help the healthcare system to construct
a detailed image analysis that examines the whole person, including their phys-
ical, mental and emotional health, while taking into account social factors (Biswas
and Muthukkumarasamy 2017). Managing healthcare data effectively in a classi-
fied manner is very important. Patient data are highly fragmented and substantial,
being a complex system of interconnected entities within heavily regulated bound-
aries. Managing such an enormous amount of data is very difficult (Gordon and
Catalini 2018). Blockchain is a ground-breaking technology that can help over-
come the data processing problems associated with healthcare. Blockchain has been
around for quite a while now. The technology was first brought into the spot-
light through bitcoin (the much-popular cryptocurrency) (Genestier et al. 2017).
Blockchain has previously been used to record transactions such as records, but
with this, its use cannot be restricted. Due to its main features such as decentralized
governance, improved protection, distributed ledgers, consensus, and faster settle-
ment, blockchain technology can be proved very beneficial for the healthcare industry
(Kshetri 2018). Blockchain is a decentralized ledger system that cannot be altered and
can provide data transparency, and for their benefit, no one can change any feature
of the data. The healthcare industry has seen rapid adoption of Electronic Health
Records, which has contributed to major developments in the digitization of health-
care care delivery systems (Kuo and Ohno-Machado 2004). Blockchain is a trusted
interoperability network for certain HERs. Blockchain provides data anonymization
tools and guarantees that the data cannot be manipulated or fabricated (Ahram et al.
2017).
Healthcare has always remained one of the most successful research fields over the
last few decades. It continues to find new and more effective ways of supporting the
population and healthcare sector. Specific parties (practitioners, medical providers,
clinics, nurses, patients, payers, etc.) must arrange, view, and exchange health infor-
mation in a safe and interoperable manner, without any alteration (Ahram et al. 2017).
The provenance of data is also important to prove record authenticity. Blockchain
technology is being applied in different contexts and can address the main healthcare
sector issues. However, it needs to focus on more research to deploy this technology
in real-time applications. Some implementations of this technology in the healthcare
sector follow. MedRec platform provides open record-keeping, authorization, and
data sharing among stakeholders in the healthcare sector. Patients can save their data
and also allow approvals to be issued and revoked on their records. This framework
4 Securing Healthcare Data by Using Blockchain 95

provides complete confidentiality as the records are not stored on the blockchain,
instead of pointing only in this blockchain to the data storage locations, logs, and
permissions. Gem has introduced Gem Health Network using Ethereum blockchain,
in collaboration with Philips Blockchain Lab. This structure is developed to address
operating costs (Shen et al. 2019).
This shared infrastructure offers interoperability between various organizations
that access the same information to improve patient care better. Healthcare platform
Guardtime provides an intermediate partnership between patients and providers in
Estonia. Guardtime blockchain allowed open patient, provider, and payer information
sharing promising secure, accurate, and auditable records. Research organizations
demand the health data of patients. In this sense, the Healthbank has provided patients
with a forum for preserving and exchanging their health data with research organi-
zations that can be used for clinical research and pharmaceuticals. The platform also
supports patients with financial incentives for their blockchain-based data sharing
(BBDS) access control program optimized for their contributions using authoriza-
tion blockchain. Data owners can use a shared data pool to access their EMRs
(Khatoon 2020). This safe and scalable framework recognizes, authenticates, and
authorizes users to use cryptographic keys and digital signatures that gain an advan-
tage over Healthcare Data Gateways (HDG), a mobile application developed over
the blockchain cloud. Quick Healthcare Interoperability Resources: FHIR chain was
developed by the clinical data exchange organization Health Level Seven Interna-
tional (HL7). FHIR is improving performance and interoperability (Khatoon et al.
2019).
The existing systems have certain flaws in its management and security making
it prone to security attacks and making confidential patient data at a very high risk.
Keeping this in mind, authors try to resolve this issue by introducing the concept
of blockchain and smart contract system which uses encryption and decentralized
nodes in its process to provide security. Authors try to develop a system which is
user friendly but also provides high security with public-key encryption to overcome
the existing security flows in the existing systems.
This book chapter focuses on the concepts of decentralization that can be applied
to large-scale data processing using blockchain technology. It can be applied to
large-scale data processing in the medical sector and to streamline tough medical
procedures. The authors demonstrate an innovative approach to the handling of
medical records, giving auditability, interoperability, and accessibility through smart
contracts. In this chapter, a smart contract healthcare system for managing health-
care data and complex streamlining medical procedures has been presented. In the
field of healthcare, authors addressed the state-of-the-art blockchain work and intro-
duced an ethereum cantered solution for healthcare management. The older health-
care system pooled money collectively in the area of medicine and rehabilitation,
which was not consistent with the external network. One of the most important
problems is the exchange of data between different entities requesting data from
healthcare providers such as physicians. This new healthcare system model uses
smart blockchain contracts (Schöner et al. 2017).
96 M. Gupta et al.

The chapter includes every aspect of healthcare facilities. Firstly, smart contracts
are discussed and how they can be used in healthcare management, its benefits over
existing systems. Then, authors proposed a system using Ethereum’s smart contracts
and included medical prescriptions, laboratory data and results, reimbursement,
clinical trials, and various other necessary facilities in the healthcare chain.

4.2 Background

Legacy programs usually only exchange healthcare and medical services internally,
and they are not completely compliant with systems externally. Nonetheless, evidence
shows various benefits from hybridizing these networks for connected internally and
improved medical, calling for interconnections for health informatics researchers
between different organizations (Dennis and Owen 2015). One of the most important
problems is the multi-organizational data sharing that allows other organizations,
like a research or physician center, to have ready access to medical data collected
by a healthcare provider (Mougayar 2020). Blockchain technology redefines data
processing and governance in many healthcare implementations. This is due to its
unparalleled and adaptability segmentation, safe storage, and exchange of healthcare
data. Blockchain technology is at the forefront of dozens of other emerging trends
in the healthcare industry, as shown in Fig. 4.1.
With advances in health-related electronic technology, patient data, cloud data
storage data and security laws, new chances for medical data management and conve-
nience for patients to access and exchange their medical data are opening up (Siyal
et al. 2019). Ensuring data privacy, storing, managing and transactions for their

Fig. 4.1 Blockchain mechanism (Makhdoom et al. 2019)

4 Securing Healthcare Data by Using Blockchain 97

smooth integration is prodigious. This information is valuable to any medical data-

driven organization, especially in medical care where blockchain technology can
solve these critical issues robustly and effectively. Blockchain-based applications
comprising data management, data sharing, data storage, and EHR were addressed
in detail in this section (Hölbl et al. 2018).
Proceedings blockchain-based medical technologies are conceptually divided into
many levels, comprising data sources, blockchain technology, medical care imple-
mentations, and stakeholders (Deshpande et al. 2017). Gordon and Catalini published
a healthcare blockchain analysis where they observed their discussion on how the
blockchain technology would allow patient-centered control over institution-centric
control of data sharing in healthcare (Ratta et al. 2020). They explored how the
blockchain technology changes the medical sector by allowing for digital access
rights, network-wide recognition of patients, managing a vast amount of healthcare
data, and immutability of data (Wu and Lin 2019a).
An MIT Media Lab study addressed the privacy and security aspects of data
processing and information management, outlining all the applications of blockchain
technology. This is the importance of data processing which is stable—in the sense
that it cannot be manipulated (Wu and Lin 2019b). Data protection and privacy
are other dimensions of data security. For instance, the decentralized Enigma is
a privacy-guaranteed computing program and a breakthrough on the blockchain.
Enigma aims to consider developers to create a point to point decentralized appli-
cation without a trusted third party that is ‘privacy by design’. An Enigma is an
extension of the blockchain technology as data storage, and processing data are
not achieved inside the blockchain. Rather the blockchain is an “operating system”
for secure multiparty computations performed by network-participating storage and
computing nodes. Here, information is split between distinct nodes, and various
nodes work together to observe functions without leaking information to the other
nodes. In summary, each party has an insignificant, and no one party has access to
data in its entirety (i.e., seemingly arbitrary) rather a piece of that (Tamazirt et al.
2018).
Blockchain holds the promise of creating the new data contract, a greater degree
of personal data ownership, control, and content delivery, through a network that
enables the society to benefit from data aggregation (Agbo and Mahmoud 2020).

4.2.1 Smart Contract

A smart contract is a computer program or a transaction protocol which is intended

to automatically execute, control, or document legally relevant events and actions
according to the terms of a contract or an agreement. Smart contracts enable valid
transactions to be carried out without third parties. These transactions are permanent
and traceable (Alladi et al. 2020).
Figure 4.2 shows an example of maintaining patient records using smart contracts.
Smart contract proponents argue that many kinds of contractual clauses can be
98 M. Gupta et al.

Fig. 4.2 Role of smart contract in maintaining patient record

made partially or completely self-executing, self-enforcing, or both. The goal of

smart contracts is to provide protection that is superior to traditional contract law
and to reduce certain contract-related transaction costs (Warkentin and Orgeron
2020). Different cryptocurrencies have introduced smart contract forms. In the early
1990s, computer scientist, lawyer, and cryptographer Nick Szabo first proposed smart
contracts which coined the term. In the latest implementations, based on blockchains,
“smart contract” is often used more explicitly in the context of computing the general
intent that takes place on a blockchain or distributed ledger (Al-Jaroodi and Mohamed
2019).
There are various areas of healthcare where smart contracts can be applied for
great benefit.
1. Health insurance
Smart contracts can be used daily in health insurance and could reduce many
inefficiencies in the current system. If patients use smart contracts to buy their
insurance, all details of their policy will be automatically secured in their patient
profile. This is then stored on the blockchain—a safe and secure ledger which is
less prone to hackers than a traditional database. They could also eliminate the
stress involved in having to file lengthy insurance claim forms. If an insurer was to
go through a medical procedure that is covered by the insurance policy, the smart
contract would be automatically triggered. This means that the money from the
insurance company’s account will go straight to the hospital. This automation cuts
out any delays and hassle and allows for correct payments of medical services.
In turn, this would speed up all transactions between parties and ensure the
procedure does not get delayed.
2. Health records
Smart contracts allow records and information to be stored on a digital ledger.
This means if a patient was moving from one hospital to another, they would be
able to do so with ease and without having to fill out numerous forms. Records
can then also be viewed by the patient’s preferred physician on the blockchain
network. Hospitals and healthcare companies rely on a number of databases filled
with patient information. However, these can be too restrictive to allow for the
sharing of potentially life-saving insights around the globe. Without blockchain
and smart contracts, this information may take a long time to reach the recipient
and could potentially be hacked. If health records were kept in a smart contract
and stored on the blockchain, that information would be available to hospitals and
research institutions everywhere. With sufficient adoption, an individual could
4 Securing Healthcare Data by Using Blockchain 99

walk into any hospital in the world for treatment, and if they produce their private
key, the hospital would have access to their information in a heartbeat.
3. Telemedicine
Telemedicine is a medical field that is growing by the day. It allows physicians
and doctors to reach their patients through the use of electronic devices, such
as mobile phones and other IoT devices. It is primarily used for providing care
for the terminally ill. Telemedicine allows doctors to take care of prescription
compliance and collate real-time data measurements of their patients’ conditions.
These modern advancements are helping to increase interoperability and reduce
admin inefficiency while enhancing patient outcomes. However, telemedicine
has downsides as the mechanisms involved are a large target for hackers. If smart
contracts are used, the safety and privacy of a patient’s information and other
important clinical data can be ensured. Smart contracts can be implemented on
a large scale and stored on the blockchain to share and protect the data. They
can also help to maintain data and ensure patients’ private information is stored
securely and in a transparent manner.
Smart contracts combined with blockchain technology represent the future of
healthcare and medicine. They embrace high-level encryption and security that allows
users, patients, and doctors to have trust that their information is safe and attack-proof.
Byzantine fault-tolerant algorithms allowed smart contracts to shape digital
protection through decentralization. Additionally, the programming languages with
varying degrees of Turing-completeness as an integrated function of some blockchain
make it possible to construct custom sophisticated logic (Khezr et al. 2019). Figure 4.3
shows the workflow with smart controlled access in a system.

Fig. 4.3 Workflow with smart controlled access in a system

100 M. Gupta et al.

4.2.2 Migration of Healthcare Chain Code in Blockchain

The Hyperledger Global Forum is the most important annual platform for businesses
implementing blockchain technology in the consortium. At the annual Hyperledger
Forum, hundreds of blockchain enthusiasts come together to share their use cases and
the latest advances in enterprise blockchain technologies (Bell et al. 2017). During
the conference, a paper was presented on the ten critical issues and requirements to be
considered using the Hyperledger Fabric-based Oracle Blockchain Platform (OBP)
based on numerous business blockchain implementation projects. These ventures
span the spectrum of sectors, including financial services, supply chain, healthcare,
and government, and spectrum from custom innovations funded by the Oracle tech-
nology team to ISV technology and SI-led ventures. Those critical issues are as
follows (Kenry and Lim 2016):
• Using SQL for rich smart contract queries
• Save/recover data
• Checkpoint database and pruning/archiving
• Byzantine consensus tolerant of fault
• Governing
• Achievement
• Privacy & privacy protection
• Supporting the internetwork
• Crypto implementations pluggable
• Capacity audit.
Although the original public blockchain relies on a self-sovereign style of
management with complete decentralization and rules governed by consensus algo-
rithms, permitted blockchain is structured differently (Xu et al. 2020). Throughout
the enterprise-permitted blockchain used in private or consortium implementa-
tions, participating companies are mostly concerned with effectively and resiliently
managing their nodes and, at the same time, operating as part of a cross-company
blockchain network (Saberi et al. 2019).
This requires a secure and flexible model of governance and on-chain collab-
orative mechanisms to address the many operational issues at different layers of
the blockchain network—from interoperable connections to storage management,
membership management, chain code distribution, etc. When organizations set up
their blockchain networks, they need to pay special attention to and develop their
networks with a view on many issues (Nir Kshetri 2019). Figure 4.4 shows the
healthcare system using blockchain.
4 Securing Healthcare Data by Using Blockchain 101

Fig. 4.4 Healthcare system using blockchain

4.2.3 Technology Used to Manage Healthcare Data

The technology for implementation of the platform would be a decentralized appli-

cation (DApp) supporting a private blockchain system with a distributed file system
(DFS) at the back end. Ethereum is used to introduce a smart contract framework for
healthcare blockchain. It is an open-source network and currently one of the largest
public blockchain networks with an active community and a large collection of public
DApps (Rejeb 2018). The platform currently uses a consensus proof-of-work (PoW)
algorithm called Ethash, but developers are working to turn it into a proof-of-stake
(PoS) scalability algorithm shortly. Ideally, for the design of distributed applications,
a Delegated Proof-of-Stake (DPoS) or Practical Byzantine Fault Tolerance (PBFT)
consensus algorithm is suitable. The DApp will have the potential to detect irregular-
ities, unwanted data insertions, and missing entities by matching DFS information
with ledger registers (Horst Treiblmaier 2020).
Each phase is labeled with an Audit Timeline. The primary elements of the smart
contracts are events, state variables, functions, and modifiers, and they were written
in the language of a high level known as Solidity. To pay the transaction fee, Remix
and Kovan test networks were used to deploy smart contracts on the test net and test
net ethers. Three stages are involved in the development of smart contracts, which
use Solidity programming to write, compile, and announce (Rodrigo da Rosa Righi
2020). The real-time compiler Solidity creates the bytecode. Ethereum Wallet has
102 M. Gupta et al.

been used to disclose smart Blockchain contracts. Figure 4.4 shows the function of
Ethereum with smart contracts, where for simplification, the mining process is ruled
out. This smart contract is compiled into machine-level bytecode, where each byte
represents an operation and then added as an EVM-1 transaction to the blockchain.
A miner picks it up and confirms Block-1. When a user passes the request through
the Web interface, the EVM-2 queries embeds the Web-based data into Transaction
tx and deploys it to the blockchain. In Block-2, the transaction tx status is changed.
If node 3 decides to test the states stored in the contract, it will need to synchronize
up to at least Block-2 later to observe the changes that tx makes (Crosby et al. 2020).

4.3 Proposed Model

Authors propose a model that uses Ethereum’s smart contracts to construct smart
representations of existing medical records that are stored within individual nodes
on the network. Main focus is building contracts to include metadata, permissions,
and data validity of record ownership. Blockchain transactions of our network hold
cryptographically signed instructions to handle certain properties. State-transition
contract functions execute laws, only through legal transactions that implement data
alteration (Pournader et al. 2019). Such regulations can be designed to implement
any set of rules that govern a specific medical record as long as it can be expressed in
computational form. Such as, a policy can involve the sending of different consent
transactions from both healthcare and patients providers before granting permission
to a third party to access. So, a framework is developed for complex healthcare
workflows that are based on blockchain smart contracts. In the healthcare envi-
ronment, smart contracts were built for specific medical workflows, and then, data
access permission was handled between various entities. A smart stored contract
on blockchain technology could be built, where all the necessary conditions from
handling various permissions to accessing data, as shown in Fig. 4.5. It can be
seen that a variety of stakeholders are interested in this scheme performing distinct
activities. It would help to create stronger physician-patient experiences. The rules
regulating data authorization are integrated into smart contracts (Saberi et al. 2018).
This can also help monitor all actions from their origin to their surrender, with
unique Id. Distinct scenarios have been explained and designed alongside all the
processes embedded, and functions in the smart contracts are well described. There
will be no need for a centralized body to oversee and authorize the project because
it can be handled directly through the smart contract that will greatly reduce the
management process administration costs. To ensure consistency and economic
viability, all healthcare record data is stored in local database storage, and the hash of
data is the data part of the blockchain block joined to the chain (Chang et al. 2019).
The proposed model uses Aadhar card verification combined with smart contracts
in Ethereum blockchain for verification of one’s identity. This identity verification
helps doctors to access the medical history of patients along with any current medi-
cations or treatments ongoing. The Aadhar data transactions are private keys (patient
4 Securing Healthcare Data by Using Blockchain 103

Fig. 4.5 Integrated framework of healthcare system with the existing system
104 M. Gupta et al.

or physician) signed by the owner. The network’s block content reflects data owner-
ship and viewing authorization exchanged by various members of a private peer-to-
peer network. Thus, blockchain technology helps the utilization of smart contracts
that allow automating and monitoring particular state transitions. On an Ethereum
blockchain, one logs patient–provider relationships through smart contracts using
Aadhar card that joins a healthcare record with viewing data retrieval. Permissions
instructions (essentially information pointers) for external server execution to ensure
against manipulation provide a cryptographic hash of the medical record on the
blockchain to ensure data integrity (Pandey and Litoriya 2020). Figure 4.5 shows an
integrated framework for the healthcare system with the existing system.
Providers may attach a new record associated with a specific patient, and patients
can require the sharing of records between providers. In both cases, the party receiving
new information receives an automatic notification and may check the proposed
record before approving or rejecting the data. That keeps the participants updated
and involved in the evolution of their data and helps them decide and give control of
data. This system prioritizes usability by also offering a designated contract based
on Aadhar verification that aggregates references to all a user’s patient–provider
relationships, thus providing a single reference point for checking for any updates
in healthcare history. Also, it uses a public-key cryptography to handle identity
verification and our utilization of a DNS-like implementation that maps the user’s
Ethereum address to an already defined and commonly accepted type of ids such
as name or social security number. A syncing algorithm handles “off-chain” data
exchange between a patient database and a provider database. After referring the
blockchain to validate permissions through our database authentication service, the
data will exchange.
Different medical workflows were planned and implemented through blockchain
smart contract systems, involving unique medical procedures. Those involve
providing simple medical prescriptions for the treatment of chronic diseases and
their protocol for surgical patients as a recovery technique. The aim of developing
these smart medical contracts is to promote the overcoming of administrative inef-
ficiencies for the patients, doctors, and healthcare organizations. This program will
assist in the recovery, review, and management of complex data and procedures in the
healthcare sector (Kleinaki et al. 2018; Namasudra et al. 2017, Namasudra and Roy
2017, 2020a, b, c; Namasudra 2019). Table 4.1 shows the proposed model workflow
for securing healthcare data by using blockchain.
These workflows have been explained as separate entities with data flow in each
of them.
• Issuing and Filling of Medical Prescriptions Process
The key objective is to smooth the process of healthcare prescription handling by
deleting the long waiting period cycle, removing the fraud factor from the network,
and the error rate caused by misinterpretations by the doctor. A doctor prescribes for
the patient and sends it into a smart contract into the patient’s healthcare records.
The pharmacy then accesses this prescription through the Ethereum blockchain smart
contract through the primary doctor and a patient’s permission to do so. After the
4 Securing Healthcare Data by Using Blockchain 105

Table 4.1 Proposed model

S. no. Workflow
workflows
1 Issuing and filling of medical prescriptions process
2 Sharing results data/laboratory test
3 Enabling patients and service providers effective
communication
4 Healthcare reimbursement data flow
5 Smart contracts for clinical trials based on Ethereum
6 Cost estimation method

prescription has been obtained, the pharmacy then issues the drug via smart contracts
along with its expiry date and dosage usage listed on the patient medical records.
Then, the medication is ready for patient selection. Smart contract apps generally
coordinate medicine satisfaction among doctors and drug stores. Doctors spend less
time discussing demands for medication, or simply talking to drug stores during a
patient’s visit (Namasudra 2018).
As shown in Fig. 4.6, data flow for the issuance of a medical prescription involves
patient, primary doctor (PD), and pharmacy. It also contains prescription information,
which includes drug ID, date of expiry, a patient ID, etc.
• Sharing Results Data/Laboratory Test
Here, the primary objective is to exchange information through smart blockchain
contracts by enabling hospitals, physicians, emergency clinics, and various partners
to successfully access and share the therapeutic information of a patient among
various stakeholders, as shown in Fig. 4.7.
Find a case of use in which a patient visits a blood test laboratory. After processing,
the laboratory must insert the causes into the patient records, the patient receives
these updates via Ethereum blockchain, a note that the tests processed provides are

Fig. 4.6 Data flow for

medical prescription
106 M. Gupta et al.

Fig. 4.7 Smart contract for sharing lab results

accessible and can choose whether to allow the laboratory to encrypt the information
and position it on Ethereum blockchain. The patient grants permission to post the
details on the blockchain. The emergency room will be able to access patient details
instantly through Ethereum blockchain whenever he and will have personalized care,
and there is an emergency with the patient (Namasudra et al. 2017).
By allowing medical records to be posted on healthcare blockchain, a medical
prevents having to either bear the test reports on their own or arrange for records
to be faxed to different care providers. He also makes sure all of his healthcare
professionals know available to deliver the best quality treatment.
Laboratories provide each printing and mail/fax regulatory expense for every
test result to singular suppliers. Also, laboratories and patients have access to the
healthcare blockchain, where they can receive installments from protective firms
recommending the transferred information to process claims or from pharmaceu-
tical companies choosing the information to be used in contemplates. Specialists
and emergency departments have access to pool restorative knowledge about their
patients at no expense, reducing authoritative research and expense.
• Enabling Patients and Service Providers Effective Communication
The patient applies to a healthcare condition in this case, as shown in Figs. 4.7
and 4.8. It immediately sends the question through the smart contract network to
the primary doctor. For quality assurance, patient information related to disease is
taken and respond with observations where it is possible. After analyzing the patient
information they refer to the specialist for further treatment. Patient information
about treatment history should be reported on the EHR.
4 Securing Healthcare Data by Using Blockchain 107

Fig. 4.8 Smart contract for

enabling communication
between patient and service
provider

Please notice that a local database holds patient records, and there are unique
rules that can have access to the record to what degree and to what degree the smart
contracts on Ethereum blockchain control those rules, another case in which the
patient applies a particular medical procedure. Accordingly, the strict structure of the
agreement sends this submission to the correct professional. A doctor understands
the demand and response with suggestions, but patients can exchange their thoughts
with the specialist for further treatment. Any patient information regarding treatment
history must be effectively reported on the EHR. Here, a nearby database provides
patient records where there are principles that can approach the record to what extent
the knowledgeable contracts on Ethereum blockchain administer these guidelines
(Namasudra and Deka 2018).
Patients looking for health information on a particular subject receive suggestions
that are far more comprehensive than those given by a Web search. Senior doctors
are finding a new way to monetize without having to overbook their expertise. In
contrast, junior doctors can enter a novel potential customer audience and develop
their brand within their nobility. Payments allow patients to seek Junior Doctors’
recommendations.
• Healthcare Reimbursement Data Flow
The key goal is to speed up the payment process for the healthcare system. In this,
doctors will be able to proceed with care quickly, instead of having to put their
patient’s treatment on hold while waiting for the payer to respond. Automated smart
contract execution will supervise the entire operation. This process is reducing and
removing-human effort to manually review the payment where patients needs to
requests for prior authorization. It also reducing appeals caused by misinterpretation
of manually written prior authorization for medical treatment (Sarkar et al. 2015).
Medical Insurance Company posts its policies via smart blockchain contracts,
which contain the policies used to decide authorization. A manufacturer then lodges a
submission for prior authorization for a specialist consultation, diagnosis, or prescrip-
tion using the blockchain. The payer’s smart contract for a medical policy automat-
ically decides authorization using the patient’s medical details stored by Ethereum
108 M. Gupta et al.

blockchain and the details in the request. Authorization data is then immediately
returned to the supplier. Also, the patient, as well as any laboratories, hospitals,
specialists, and other stakeholders to whom the patient has delegated access, could
check the authorization for insurance in real time. The entire cycle is shown in
Fig. 4.8. The automated prior authorization process will result in considerable cost
savings for payers, which currently spends significant sums on manual analysis and
response to requests.
Doctors will continue with treatment immediately, rather than having to pause
their patient’s care while waiting for the payer’s response. Patients will be spared
concerned about how their insurance will cover the medication their doctor recom-
mends. With details on prior authorization readily accessible, physicians and patients
can work together comfortably with a treatment plan tailored specifically to the
patient’s needs and the correct insurance coverage.
• Smart Contracts for Clinical Trials Based on Ethereum
Allowing medical device and drug manufacturers with a quicker and more cost-
effective alternative to the existing recruitment in clinical trials also entails substan-
tial expenditures in purchasing patient contact information from independent data
suppliers and carrying out extensive pull-marketing campaigns. The primary goal is
to allow users to run clinical trial-related smart contracts on an Ethereum network
leading to secure medicines and improved public interest in medical research. Thus,
in this phase, authors manage metadata via smart contracts, considering protocol
registration, preset study information, screening, and enrollment logs.
A pharmaceutical company is looking for metadata stored on the Ethereum
blockchain to classify possible patients for clinical trial inclusion, as seen in Fig. 4.9.
The organization then sends a letter to read access to their medical records for selected
patients, including any related laboratory test results. The patient permits access, a
pharmaceutical company bill will be processed via smart contracts, awarding the
patient part of the fee paid, and another portion to the laboratories, which recorded
the patient’s correct test results.
Medical devices and drugs and manufacturers can dramatically reduce spending
on data purchases and marketing campaigns by targeted targeting of eligible
consumers, as shown in Fig. 4.10. Patients, meanwhile, will gain access to alter-
native care options, in addition to obtaining compensation for participating in trials.
Laboratories engaged in posting results would have a new way to monetize their
data.
• Cost Estimation Method
In terms of deploying medical blockchain, an assessment of the costs associated with
implementing smart contracts for healthcare needs to be made. The ultimate aim is
to develop a program with all the advantages of blockchain that can offer a feasible
electronic health system. In Ethereum blockchain, all programmable calculations
cost some fees to prevent network misuse and to solve other computer-related issues.
The fee for running all kinds of transactions in the Ethereum blockchain is listed as
gas. Gas refers to the payment or price value provided by the Ethereum blockchain
4 Securing Healthcare Data by Using Blockchain 109

Fig. 4.9 Smart contracts for healthcare reimbursement

Fig. 4.10 Clinical trials smart contracts

platform for a successful transaction or execution of a contract. The exact gas price is
calculated by the miners of the network, who will refuse to process a transaction if the
gas price does not reach their cap. All operations, computations, message calls, smart
contract creation/deployment, and storage on Ethereum virtual machines (EVM),
therefore, require gas to perform all of these tasks. Figure 4.11 presents the smart
contract Metamask extension cost calculation.
To perform transactions on Ethereum virtual machines, if anyone wants to do some
kind of activity on EVM, they need to have a certain amount of gas in their account.
110 M. Gupta et al.

Environment Injected Web 3

Account 0c940..7c074 (2 ether)
Gas Limit 3000000
Value 0

Contract Deployment
$0.00
0
DETAILS DATA
GAS FEE $0.18
Amount-GAS FEE
TOTAL $0.18

Reject Confirm

Fig. 4.11 Calculating smart contract cost Metamask extension

Each transaction has a gas limit, so if there is any unused gas, it will return to the user
account after the transaction has been executed. If a user does not have a valid balance
account, he is unable to perform any sort of operation and is therefore deemed to be
invalid. In EVM Ethers, gas is purchased, and users running the transactions can set
their account gas limit for the particular transaction. But again, whether they want
to authorize the transaction or not, it is on the miner. If a sender opts for a higher
gas price, paying for the gas will cost them a high price, and miners will get great
value for the transactions. A miner then performs the computation to connect the
transaction to a stack. A miner could then broadcast the new block into the network
after the successful execution of transactions.

4.4 Performance Analysis

4.4.1 Experimental Setup

This section discusses the way of securing healthcare data using blockchain are
discussed as follows.

4.4.2 Results and Discussions

The proposed system has many advantages over the existing models that have not
implemented blockchain technology.
4 Securing Healthcare Data by Using Blockchain 111

1. The model is much secure as it uses smart contracts and various encryption
algorithms to achieve that
2. There is no central dependency ensuring that each node participates in data flow,
and the flow path cannot be predicted.
3. Timings of each and every task are reduced by much which will help to provide
the best possible care to a patient.
4. Laboratory data can be directly shared with doctors thus eliminating the paper
trail thus reducing errors.
5. Prescriptions are digitized making admittance of patients easier and simpler.

Feature Existing system Proposed system

Central dependency Yes No
Security Low Moderately high
Smart contract management No Ethereum smart contracts
Reimbursement, lab result High Low
timings
Encryption No Public-key cryptography
User privacy Every doctor can view the Doctor can only view record
record and user cannot with patient’s consent
Error rate Moderate Low
Patient admittance Time taking with long paper Easy as records are digitized
trails

4.5 Conclusions and Future Works

The system thus explained will help in each and every sector of healthcare. The system
proposed by the authors uses smart contracts to provide the security to data over
transfer. The traditional system is much more prone to attacks as the blockchain and
smart contracts are not implemented in it. Thus, in each and every sector from filling
the forms to clinical trials, smart contracts are introduced. These provide encrypted
data thus preventing data loss and making the transfer much more secure. The system
proposed is not centrally dependent, instead uses several nodes of blockchain and
uses smart contract encryption, thus making the data transfer much easier and secure
and much more difficult to attack. This system can be used to replace the traditional
system due to its security and various other benefits.
112 M. Gupta et al.

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Chapter 5
Secure and Decentralized Management
of Health Records

Subramanian Venkatesan, Shubham Sahai, Sandeep Kumar Shukla,

and Jaya Singh

Abstract The electronic Health (eHealth) record transforms the conventional

healthcare domain into a digital healthcare domain that advances the service to
the people. The eHealthcare gained more attention these days due to its benefits
such as ease in transferring the record, available at all times, and effortless search
and access. However, security and user privacy slow down the broader implemen-
tation of eHealthcare in various hospitals and countries. To utilize the effectiveness
of eHealthcare and protect the data against various attacks, this chapter proposes
a blockchain-based electronic health record management system. The encrypted
eHealth records are stored on the cloud or Inter Planetary File System (IPFS) and the
meta-data of the records on the blockchain to ensure data availability, integrity, and
confidentiality. The proposed system provides immutable logging of access informa-
tion for audit and regulatory compliance. In addition, the patient’s redundant account
problem and data inaccessibility during the patient’s unresponsive state are addressed.
The proposed system is implemented by modifying the goethereum implementation
to analyze the overhead and applicability. The implementation results, security, and
overhead analysis substantiate the proposed eHealthcare management system.

Keywords eHealth · Blockchain · Security · IPFS · Cloud

S. Venkatesan (B) · J. Singh

Department of Information Technology, Indian Institute of Information Technology,
Allahabad, India
e-mail: [email protected]
J. Singh
e-mail: [email protected]
S. Sahai · S. K. Shukla
Department of Computer Science and Engineering, Indian Institute of Technology, Kanpur, India
e-mail: [email protected]
S. K. Shukla
e-mail: [email protected]

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 115
S. Namasudra and G. C. Deka (eds.), Applications of Blockchain in Healthcare,
Studies in Big Data 83, https://doi.org/10.1007/978-981-15-9547-9_5
116 S. Venkatesan et al.

5.1 Introduction

The eHealth record management systems have several benefits over the traditional
systems, such as: facilitating fast diagnosis, avoiding repetition of pathological tests,
promoting advanced treatments, and ensuring the availability of the data whenever
required. Overall 84 percent of US hospitals have adopted the electronic health record
system (Henry et al. 2016). However, there are countries with less than 50 percent
adoption of electronic health record systems although percentage will increase in near
future because of broader requirements. In general, eHealth records of the patients are
stored in a centralized storage server and either maintained by the hospital adminis-
tration or outsourced to a trusted third party. The health records stored in a centralized
server could be accessed by various agencies according to their authorization. The
key question to ponder over is how to share these records among various stake-
holders by ensuring integrity and privacy. The drawbacks with traditional electronic
health/medical record management systems are that there is no guarantee for the
integrity, privacy, and availability of the record, and need to trust a third party for
managing the database. It is also not straightforward to connect various hospitals to
share these records each other and connect them seamlessly for the greater good.
The eHealth record management system provides several benefits when compared
to the traditional paper-based record management system; however, security require-
ments such as patient’s record privacy, integrity, and availability minimize the large
utilization. Even though there are models and systems that exist to provide the secu-
rity requirements, unauthorized administrator access, redundant patient’s account,
access of record during patient’s unresponsive state, etc., are not addressed. The
present need of eHealth record management system and unsolved security issues
triggered to develop a secure and decentralized eHealth record management system
using blockchain technology thus enables larger utilization.
In the past decade, it has been seen a range of applications of the blockchain tech-
nology in e-governance and other kinds of data sharing and transaction applications.
It is believed that blockchain solves the problem of data sharing among the right
stakeholders without compromising the privacy of data, maintaining the integrity
of data throughout its life cycle, and availability through redundancy. Therefore,
blockchain-based solution to health record management has a lot of potentials.
In the proposed system, the immutability of blockchain and IPFS/multi-cloud
is utilized to ensure integrity, confidentiality, and availability of the health record.
The proposed system keeps meta-data of the health records that are the message
(record) digest, hospital original or pseudo-identity, and access permissions in the
blockchain and encrypted health record in the cloud/IPFS to ensure the availability.
A user wishes to access the patient record need to get the access permission from the
patient subsequently the proxy re-encrypted record will be provided.
The remaining section of this chapter is organized as follows: Sect. 5.2 discusses
the existing techniques, Sect. 5.3 presents the problem statement, Sect. 5.4 discusses
the background studies, Sect. 5.5 presents the proposed system, Sect. 5.6 analyzes the
5 Secure and Decentralized Management of Health Records 117

security of the proposed system, and Sect. 5.7 discusses the implementation, experi-
mental results, and overhead of the proposed system when compared to existing non-
blockchain-based eHealth record management system. Finally, Sect. 5.8 concludes
the chapter with the directions of future work.

5.2 Literature Review

The Health Insurance Portability and Accountability Act of 1996, known as HIPAA
(HIPPA 1996), and National eHealth Authority known as NeHA (NeHA 2018)
emphasize on the confidentiality and integrity of health information. Conceicao et al.
(2018) indicated the cost issue in the electronic health record management system
that even records are maintained by nonprofit organizations, the maintenance of reli-
able infrastructure in a large scale and control access to them demands significant
resources. Even though there are various existing works present in the literature for
the eHealth record management system, blockchain-based solution is preferred since
it ensures the decentralization, immutability, etc.
In the past decade, several applications of blockchain have been witnessed; it
is also believed that blockchain is one of the best solutions for securing healthcare
data (Namasudra et al. 2020), and researchers implemented in different perspectives.
The promising uses of the blockchain in eHealth record management system include
improving the security and management of patient data, reducing the regulatory
and compliance cost, optimizing the interactions between the hospital and insurance
providers, etc. (Tierion, 2016). Vazirani et al. (2020) analyzed and recommended
blockchain since it supports efficient management of medical records and ensures
interoperability but without compromising security. Azaria et al. (2016) developed a
prototype MedRec, which is a decentralized and modular health record management
system that takes advantage of the Ethereum blockchain for accountability, authen-
tication of stored information, and access. In the prototype, data is stored at a trusted
third party and its meta-information in the blockchain. Even though MedRec uses
blockchain technology, its security depends on the trusted third party.
Yip (2016) discussed the use of blockchain in processing insurance claims in
a positive way. The author suggested to keep insurance claim record on a private
blockchain and provide access only to the organization that exchanges data, and has
it with real-time updated. Therefore, the claims can be processed more quickly and
could mitigate false claims and make sure that the final bill is correct. Shrier et al.
(2016) state that the existing centralized IT systems are vulnerable to hacking and
proposed a solution using blockchain. Kuo et al. (2017) discussed the advantage
of using blockchain for biomedical and healthcare applications. Vian et al. (2016)
discussed the issues in the Medicaid healthcare programs and the use of blockchain
to solve it. Goldwater (2016) addresses the problem of storing the personal health
data gathered from all kinds of new devices and software such as wearables and
mobile on the cloud and proposed a solution that uses blockchain technology as a
base, for bringing greater security to protect the data.
118 S. Venkatesan et al.

Theodouli et al. (2018) proposed a blockchain-based system to facilitate health-

care data sharing. The system ensures record integrity but not confidentiality;
however, it ensures privacy by anonymizing the identity of the patient. A patient
can upload their plain clinical data directly to the cloud with or without having an
account. Since the records are plain, research centers/researchers can use it for anal-
ysis purposes even without the consent of the patient. The drawbacks of the system
are: The patient has no control over record access; the cloud has the complete control
of the record and no guarantee of integrity since the record sharing is managed by
the cloud.
Xia et al. (2017a, b) proposed the blockchain-based eHealth record sharing model
using the cryptographic keys and smart contracts. However, data loss due to third-
party malicious behavior is not considered in the proposal. Dubovitskaya et al.
(2017) have proposed a secure and trustable health record sharing using blockchain.
However, it needs additional overhead in sharing the public key.
Peterson et al. (2016) presented the blockchain-based approach for health infor-
mation exchange networks using Proof of Interoperability (PoI). It follows the Fast
Healthcare Interoperability Resources (FHIR) standard (HL7 2018) for medical data
representation and keeps the URL on the blockchain. It allows privacy-preserving
keyword searches; however, the security is based on a third party.
Khatoo (2020) proposed a smart contract-based healthcare management system
for large-scale data management and to streamline the complex medical procedure.
The model used the social security number to map the Ethereum address of the user.
The major focus of the system is to manage the different permissions to access the
data. However, this model does not considered the issues such as hash conflict, secure
sharing, etc.
Inefficient key sharing, unauthorized creation of records, the conflict between
data and meta-data in networks, and storage failures are the issues not addressed
in the existing works. The proposed eHealth record management system provides
the solutions for those issues using blockchain technology, proxy re-encryption, and
cloud/IPFS.

5.3 Problem Statement

The important security requirements that eHealth record management systems need
to ensure are confidentiality, integrity, and availability (Hasan et al. 2007). The data
modification and unauthorized disclosure are always the issues in the eHealth record
management system since in most cases data is maintained by the third party. The
eHealth records should not be modified by unauthorized users; otherwise, treatment
and analysis may kill the patient and the patient’s record privacy is an important
requirement to avoid the consequent issues, such as neighbor’s activity, knowledge
of regular medication, and misuse.
5 Secure and Decentralized Management of Health Records 119

• Privacy: To ensure the privacy of records, it can be encrypted by the hospital

using the public key of the patients. However, Public Key Infrastructure-based
key sharing is not feasible because of various factors such as cost and a digital
certificate for every patient.
• Integrity and availability: An attack against integrity and availability can be
prevented simply by taking the message digest of health records and hosts in
multiple sites. However, the Byzantine General Problem (BGP) (Lamport et al.
1982) will be a major threat. For example, the insider who generates the message
digest may share different digests to different sites. A distributed system with
distributed consensus is required to overcome the BGP. Also, it is not straightfor-
ward to connect various hospitals to share these records seamlessly for the greater
good.
Hence, the aim is to come up with a system that facilitates distributed storage, effi-
cient key sharing, and decentralized trust. A blockchain is a natural choice satisfying
these requirements, thereby our choice of technology for designing this system.
Attacks that can be addressed by the proposed electronic health/medical record
management system are as follows.
• Unauthorized modification of record: An attacker may modify the record to harm
the patient and treatment.
• Unauthorized record access: An attacker may illegally access and disclose the
record to unauthorized persons.
• Unauthorized creation of record: An attacker may create a false record to harm
the patient.
• Ransomware: The software spread by an attacker may encrypt the health records,
delay or stop the treatment, and claim for ransoms to provide the decryption key.
• Malicious hospital administrator: A compromised administrator can make the
record unusable by creating conflict between the record and meta-data.

5.4 Background Studies

This section discusses the key concepts used in the proposed eHealth record
management system.

5.4.1 Blockchain Types

The blockchain introduced in the Bitcoin is public, which allows any user or organi-
zation to join and contribute. Later, the effectiveness of blockchain and lightweight
applications motivated the researchers to develop different types. The types of
blockchain are as follows.
120 S. Venkatesan et al.

Public or Permissionless: This allows any individual (node) or an organization

to join the network and participate in blockchain activities such as mining, block
validation, and making transaction. No prior authentication or approval required for
a node to join. The consensus protocols used are Proof of Work (PoW), Proof of
Stake (PoS), etc.
Permissioned: It allows only the authenticated or approved users to take part in the
blockchain activities. It uses consensus protocols based on Byzantine Fault Tolerance
(BFT) and crash fault tolerance.

5.4.2 Ethereum

The Ethereum is a blockchain-based platform for decentralized applications. It has

various features including world state and smart contract. The world state is a
mapping between user addresses and account states. This mapping is maintained
in the Merkle Patricia Trie (MPT), and its root is part of the block header. The world
state provides the updated account information of all users in the latest block, thus no
need to traverse the blocks to find the account information of a user. A smart contract
is a self-enforcing agreement embedded in the form of executable code managed by
a blockchain. The code contains a set of rules under which the parties of that smart
contract agree to interact with each other. The agreement will be enforced whenever
the predefined rules are met. It is a part of the blockchain and ensures transparency
and shared ledger, where they are protected from deletion, tampering, and revision.
The drawback of the smart contract is not possible to update once it is hosted on the
blockchain since the hash of the code is used for indexing. Hence, the smart contract
code should be tested in the test network before deploying in the main network. The
proposed system is implemented by modifying the goethereum, an implementation
of Ethereum however not utilized the smart contract.

5.4.3 Proxy Re-encryption

It is used when a party would like to share the received content, which is encrypted
using its public key by another party without disclosing the private key. For example,
Alice received a content encrypted using her public key from Bob. Now, Alice would
like to share the content with Charlie without disclosing her private key as well as
without performing decryption and re-encryption with Charlie’s public key. In this
case, Alice uses the proxy re-encryption to do it. Now, Alice can generate a proxy
re-encryption key using her private key and Charlie’s public key and designate a
proxy to re-encrypt the encrypted content using it. The proxy re-encrypted content
can be shared with Charlie. Charlie can decrypt the proxy re-encrypted content using
his private key. The requirement is achieved without disclosing the content to proxy
and decryption at Alice end (Qin et al. 2016).
5 Secure and Decentralized Management of Health Records 121

5.4.4 Merkle Tree

In cryptography, a Merkle tree or hash tree is a tree, where leaf nodes are a hash of
the data block and non-leaf nodes are a hash of its child nodes. The concept of a hash
tree is named after Ralph Merkle who patented it in 1979 (Merkle Tree 2019). The
sample Merkle tree is shown in Fig. 5.1. The leaf nodes (L 1 and R1 ) of Merkle tree
are hash (h) value of the data blocks (MB1 , MB2 , MB3 …), and non-leaf nodes (L 2
and R2 , L 3 and R3 and Root) are the hash values of its child nodes. The root hash
of the tree will be shared to manage the integrity of the data without keeping the
complete tree.
The hash function used in the Merkle tree is a cryptographic hash function. The
Merkle tree can be used to verify the integrity of the data that is data stored, handled,
and transferred in and between peer network nodes are undamaged and unaltered.
Merkle tree is used in blockchain to store transactions, account balances, etc. The
Practical Algorithm To Retrieve Information Coded In Alphanumeric (PATRICIA)
is also a type of trie, and it was first described in 1968 by Donald R. Morrison (1968).
This is similar to radix tree with radix equal to 2 and has an innovative concept to
store n items in the n nodes. It is very compact that if a node is only one child for
a parent then it gets merged with the parent. The way it is used in cryptocurrency
especially in Ethereum [17] is with the Merkle tree known as Merkle Patricia Trie
(MPT) to ensure the integrity of the data that is transactions, world state, etc.

5.5 Proposed System

The architecture of the proposed blockchain-based eHealth record management

system is shown in Fig. 5.2. The nodes such as hospitals are the part of the blockchain
network and take active participation by doing mining, validation of transactions, etc.
All hospitals maintain the growing blockchain, ensure the liveness of the application
and availability of data. Also, the hospitals are connected with the cloud/IPFS to keep

Fig. 5.1 Merkle tree

122 S. Venkatesan et al.

Fig. 5.2 Architecture of blockchain-based eHealth record management system

the encrypted data and access on-demand. Along with hospitals, government orga-
nizations and insurance agencies can also take part in the blockchain activities and
use the services of the blockchain by accessing the statistics and necessary authentic
data in an authorized way. The system includes the following entities to maintain the
record securely and make it available at all times. All entities except the cloud and
IPFS are part of the blockchain and integrate the blockchain with the cloud/IPFS.
• Patient: A user possessing the unique address, public and private key pair, and
more importantly owner of the record.
• Doctor: A user possessing the unique address, public and private key pair, and
creator of the patient’s record.
• Hospital: A user (or organization) having facility for medical treatment including
doctors, diagnose kits, prepare eHealth records, encrypt, and store it on the third-
party storage. Also, able to access patient records with the consent of the patient
and refer for further treatment.
• Agencies: A user or organization, which uses the eHealth records for statistical
analysis, insurance claim, research, etc.
• Cloud/IPFS: A third-party storage to keep the encrypted record.
5 Secure and Decentralized Management of Health Records 123

Whenever a patient visits the doctor of a hospital for a consultation, it is the

responsibility of the hospital to prepare the patient eHealth record, encrypt using the
patient’s public key, and store it on the cloud/IPFS for seamless service. At the same
time, meta-data of the respective patient record needs to be generated and posted into
the blockchain through a transaction, which will be validated and committed into the
block. The meta-data of the patient’s record along with access information is stored
in the MPT of blockchain. The structure of the patient’s record and blockchain’s
MPT node for the patient and hospital is as follows.
• Record structure {Pid , F id , HR, H HR , D, Did , Dsid , Pcon , H PR }: It includes unique
pseudo-identity of patient (Pid ) and file identity (F id ) of the record that is unique
for the patient, and it sequentially increases by one for every new record, eHealth
record (HR) of a patient, record hash (H HR ), date (D) on which consultation or
treatment is done, doctor identity (Did ), unique disease identity (Dsid ), patient
consent (Pcon ) for the record, and previous record hash (H PR ) of the patient which
will be zero for the very first record. The HR will be encrypted using the patient’s
public key and stored in the cloud/IPFS. The patient personal details like name,
age, parents’ name, address, guardian, etc., are not part of this record. This infor-
mation will be stored separately and linked with the patient pseudo-identity to
maintain privacy.
• Node structure of a patient {Pid , Ppub , H HR , H id , A, HU, O}: It includes unique
patient identity (Pid ) similar to Bitcoin/Ethereum address, public key (Ppub ) of the
patient, which will be used by the hospital to encrypt the record, patient’s latest
record hash (H HR ), hospital identity (H id ) to maintain the meta-information host
identity, access structure (A) to keep the eHealth record access permission data,
last hash update (HU) to maintain the patient’s last hash update block number and
optional (O) field, which is used while records are stored in the IPFS.
• Node structure of a hospital/doctor {H id /Did , H pub }: It includes a unique
hospital/doctor identity (H id /Did ) and public key (H pub ) of the hospital/doctor,
which will be used by the patient to generate proxy re-encryption key.
• Node structure of a disease {DS id , St}: It includes unique disease identity (DS id )
and statistics (St) for the statistical information such as the age and region-wise
count.
The proposed system includes the following three different transactions, respec-
tively, to post the meta-data (hash of the record), and grant or revoke access
permission and key update.
• Record (Pid , F id , H id , H HR , Pcon , sig, t): This transaction is to post the meta-data
of a health record into the blockchain. The meta-data (H HR ) is the cryptographic
hash of the eHealth record to ensure integrity. Any hospital of the blockchain
network can create the transaction and broadcast it to the network. The miners
including the transaction owner take the transaction and validate it. The validation
includes signature (sig) validation, timestamp (t) validation, patient address (Pid ),
and consent (Pcon ) validation. The successful transaction will be committed to the
new block, and the existing meta-data, hospital identity (H id ), and file identity
124 S. Venkatesan et al.

(F id ) will be replaced with the new on the patient’s MPT node if the node exists;
otherwise, a new node will be created and stored.
• GrantRevoke (ty, Pid , H id , F id , sig, t): This transaction will be created and posted
by the patient to grant or revoke permission to hospitals/agencies to access the
records. The transaction includes the type (ty): 1 for grant and 0 for revoke, the data
request hospital’s identity (H id ), patient identity (Pid ), and file (record) identity
(F id ). At first, the transaction signature, identity, and timestamp will be validated
and then committed to the block, if it is valid. The commit is adding the transaction
in the block and updates the access structure (A) of the patient.
• Key (pa |ha , H pub or Ppub , sig, t): This transaction is to update the public key (H pub
or Ppub ) of the transaction owner. If the transaction is valid, then the key will be
updated. The reason for keeping the public key of the hospital and patient in the
blockchain is to reduce the delay in sharing the key. The public key stored in
blockchain for data encryption and proxy re-encryption is different from the key
pair that is used for blockchain account creation since it is advised not to use the
same key for different purposes because in one attack all protection walls will be
compromised.

5.5.1 Record Management

The record management includes indexing, storing, accessing, and sharing of the
patient’s encrypted eHealth record and equivalent meta-data. The hospital has to
prepare the eHealth record of a patient and securely store it in the cloud/IPFS. Since
the patient public key (Ppub ) is available in the blockchain, the hospital can encrypt
the record using the Ppub , obtain C, and store it in the cloud/IPFS. The process of
indexing, storing, and accessing varies for the cloud and IPFS; however, both have
a similar method of sharing.
Cloud: The process flow of indexing and hosting is shown in Fig. 5.3. The
encrypted record (C) along with the previous/preceding record hash (H p ) is stored
in the cloud with index as the patient’s identity (Pid ) and file identity (F id ). The new
file identity is the increment of the previous file identity. The hash of the concate-
nated plain record and previous record hash sent through Record transaction will
be committed in the patient’s MPT node’s record hash attribute. The record can be
accessed by providing the patient and file identity to the cloud. The reason for storing
the preceding record hash along with the succeeding record is to validate the integrity
of preceding records since the meta-data of the records other than the latest record
is not part of the latest block.
IPFS: The index of a record is the hash value of it. The process flow of indexing and
hosting data is shown in Fig. 5.4. The encrypted new record and the previous record
index (H pi ) are hashed to create the IPFS index accordingly encrypted new record
and previous record index are stored. The same index will be placed in the patient’s
MPT node’s optional (O) attribute. Also, the plain record hash will be stored in the
MPT’s hash attribute to validate the integrity of the record. The optional (O) attribute
5 Secure and Decentralized Management of Health Records 125

Fig. 5.3 Data indexing and hosting at cloud

Fig. 5.4 Data indexing and hosting at IPFS

index will be used to locate and access the encrypted health records from the IPFS.
The function h() is the cryptography hash function like SHA 256.
The latest block contains only the latest record index and thus allows accessing
the latest record. A user can fetch preceding records using the index value available
in the accessed records. Similarly, the record’s integrity will be verified using the
meta-data present in the blockchain.

Algorithm 1 (Secure eHealth Record Sharing)

Input: Hospital or Agency Identity (H id ), Patient Identity (Pid )
Output: Valid Plain Health Record (HR)
126 S. Venkatesan et al.

Patient
1: Fetch the H id ’s public key (H pub ) from the blockchain
2: Compute Rk = rekey(H pub , Ppri )
3: Share Rk with proxy/third party
Third party/Patient
4: Fetch C from the IPFS/cloud by providing the patient identity or index
5: Re-encrypt C’ = reenc(C, Rk )
6: Share C’ with Hospital/Agency
Hospital/Agency
7: Decrypt HR = Dec(C’, H pri )
8: Fetch the Pid ’s meta-data (H HR ) from the blockchain
9: if (h(HR)== H HR )
10: return HR
11: else
12: return Invalid
Secure Sharing: The process of a patient sharing the health record with a hospital
or agency is given in algorithm 1. The patient wishes to share the record with any
hospital that has to fetch the respective hospital public key H pub from the blockchain
and generate the proxy re-encryption key RK = rekey(PPri , H Pub ) using his/her private
key Ppri . The proxy (third party) re-encrypts (reenc) the encrypted record C using
re-encryption key Rk and provides C’ to the hospital. The hospital uses its private key
H pri and decrypts the re-encrypted version of the record C’ to get the plain record
HR. Later, the integrity of the record will be verified using the meta-data available
in the blockchain. If it is valid, then hospital uses the record; otherwise reject and
report. Patient can do the re-encryption if the required infrastructure is available.

5.5.2 Process Flow

The process of registration of a patient/hospital, data, and meta-data hosting, and

sharing of the proposed eHealth record management system is shown in Fig. 5.5 with
registration, record generation and hosting, and sharing phase. The system process
flow is as follows:
Step 1: A patient or hospital interested to take part in the proposed system has to
register on the blockchain application by providing the secret passphrase.
The application that runs on the user system provides the unique key pair
5 Secure and Decentralized Management of Health Records 127

Fig. 5.5 Process flow of the proposed eHealth record management system

(Bpub ,Bpri ) and user account address computed using the public key. The
account address that called as the doctor/hospital/patient’s pseudo-identity
is the last 20 characters of the SHA hash function output (h(Bpub )) similar to
Ethereum. The key pairs are derived using the elliptic curve cryptography,
and it is used for the transaction and record consent signature. To ensure that
each patient creates only one account on the blockchain, the blockchain key
pair can be derived from the biometric of the user that is the scalar private
key from the biometric fingerprint. The biometric devices at the hospitals
could also be attacked by parties and would need a high level of protection.
Later, the user-generated record encryption public key (Ppub ) is stored in
the blockchain through Key transaction.
Step 2: On the visit of a patient, a hospital/doctor has to access the patient public
key and previous record file identity from the blockchain and encrypt the
prepared health record. In addition, the meta-data (hash) of the plain record
should be computed and the patient’s consent for the meta-data needs to be
128 S. Venkatesan et al.

taken. Then, the encrypted record has to be hosted on the cloud or IPFS, and
meta-data along with other parameters will be broadcasted to the blockchain
network through a Record transaction. The miners validate and commit to
the block if the transaction is valid.
Step 3: Patients who wish to share the record with the hospital/agency have to
access their public key from the blockchain and generate the re-encryption
key (Rk ) through a rekey function, which takes the private key of the patient
and the public key of the hospital/agency as input.
Step 4: The patient will share the Rk with a third party (proxy) for re-encryption
of the encrypted record. The patient himself/herself can do the proxy re-
encryption provided enough resources. Also, update the access permis-
sion in the blockchain through the GrantRevoke transaction. The grant and
revoke permission can effectively be used for future auditing.
Step 5: Using the respective re-encryption key, proxy, or patient can re-encrypt the
permitted encrypted record and send it to the respective hospital/agency.
Step 6: Hospital decrypts, verifies the integrity of record by accessing the meta-data
from the blockchain, and uses it for further analysis.

5.6 Security Analysis

The proposed system addresses all security issues discussed in the problem statement,
ensure the security and privacy of the patient’s eHealth record, and overcome the
meta-data and record conflict.
Confidentiality: The eHealth records are encrypted using the respective patient’s
public key (Ppub ) and hosted at the cloud or IPFS. Since the private key (Ppri ) is
known only to the patient that is the owner of the record, only authorized users can
access the readable record. The user authorized by a respective patient through a
re-encryption key/grant transaction can access the readable record.
Availability: The eHealth records are encrypted and stored in IPFS or multi-cloud
storage. In the case of one site failure, other sites can provide the data. Hence, the
failure of one node cannot make the record unavailable.
Integrity: Whenever doctors/patients/other agencies request a record from the
cloud or IPFS, they will be provided along with previous record meta-data. For
example, let us assume the records HR1 , HR2 ,…HRn are available for a patient.
Along with records, meta-data H HR:1 , H HR:2 , H HR:3 , … H HR:n are also available.
The meta-data H HR:2 of the second record is computed as h(H HR:1 ||h(HR2 )) using the
SHA hash function. Similarly, the next hashes H HR:3 , H HR:4 , and so on are computed.
While accessing the record, for example, HR10 , the health record HR10 and H HR:9
will be provided to the user. The user will fetch H HR:10 from the public blockchain
and verify the integrity of the record by mapping the H HR:10 and h(H HR:9 ||h(R10 )). If
mapping is successful, then data is not modified and accepted; otherwise reject and
report to the patient. Hence, integrity of the record is achieved.
5 Secure and Decentralized Management of Health Records 129

Logging and Auditing: Since the records are encrypted and stored, without patient
consent and proxy re-encryption, records cannot be accessed and used by any of the
subscribers. Patient grant access to the health record for any of the hospital is stored in
the immutable blockchain. The auditing can be done using the information available
in the blockchain. However, patient grant permission to agencies without posting on
the blockchain cannot be identified and controlled.
There are insider attacks possible since the data and meta-data are in different
networks or environments. The possible attack and the solution by the proposed
system are as follows.
(a) Unauthorized creation and posting of eHealth record: There is a possibility that
malicious intended hospital or agency knowing the patient identity and public
key can host the poison data on the cloud or IPFS and link the hash in blockchain.
This creates uncertainty on the patient’s health record. To overcome this attack,
the proposed system mandates hospital to create blockchain Record transaction
with patient signature (consent of the patient) on the health record hash using
Bpri . The Record transaction validation includes the patient consent validation.
While accessing and using the record, in addition to record integrity verification,
the client signature also verified to confirm the patient consent on the record.
(b) Unauthorized modification of the encrypted record stored at cloud/IPFS by
faulty nodes: The malicious intent user or compromised third party may modify
the encrypted records or meta-data. This will lead to hash conflict, poisoned
records, etc. Since the proposed system uses cloud/IPFS which has distributed
storage, modification of record will not harm because other non-faulty nodes
will provide the true copy of records. It is hard for the attacker to compromise
all storage nodes to achieve the desired attack. However, it is not suggestive to
store the health record in all IPFS nodes since the eHealth records are too big
in size.
(c) The malicious intended hospital may host the meta-data in blockchain but not
in IPFS/cloud and vice versa: The solution to tolerate this fault is MPT node’s
additional attribute HU.

Problem I Malicious intended hospital hosts a record on IPFS/cloud but not the
meta-data on blockchain.

Solution In this case, the problematic record is not part of the patient’s record set.
IPFS: To access the record of a patient, the hash available in the block MPT’s optional
attribute (O) will be used as an index. Thus, record can be accessed; however, the
problematic record will not be usable. Cloud: The patient’s Pid is used to access
the latest record and the record hash is mapped with the meta-data (hash) available
in blockchain. The hash conflict will occur because of a mismatch between data in
storage and meta-data; thus, records cannot be used. However, it is possible to access
the preceding record from the cloud using the same identity and can be verified with
blockchain meta-data (hash). If again conflict occurs, then next preceding record and
so on. At one stage, hashes (record hash and blockchain hash) will be matching and
130 S. Venkatesan et al.

the respective record and preceding records can be used. Hence, the malicious node
behavior will not affect the complete record access and use.

Problem II Malicious intended hospital hosts meta-data into blockchain but not the
record on IPFS or cloud.

Solution In this case, the hash available at the latest block and hash of the latest
record in the cloud will not match. To tolerate the problem, fetch the preceding hash
by directly accessing the block, which has the previous hash update using the HU
attribute, and validate the records. If not matches, continue till it matches. Similarly
for the IPFS, if the record not found for the respective hash index then try with the
preceding hash index.

The above solutions consume more time for record access if malicious behavior
occurs. In case blockchain and IPFS validating nodes verify each other about the
new update, an attack will be identified immediately and prevented. However, this
is computationally heavy and infeasible because miner as well as non-miner has to
verify with IPFS and validate the transaction. Similarly, IPFS nodes have to perform
the task. Hence, in the proposed system only the above two solutions are considered.
(d) Hospital posts incorrect record or not posts the record: Patient can verify the data
availability through blockchain and IPFS/cloud. However, incorrect data cannot
be identified until the patient has medical knowledge or it is cross-verified by
multiple hospitals.
Single account and access of record in an unresponsive state: Ensuring a single
identity for a patient is a complex problem in health care, since a patient may register
multiple times within the same or different hospitals under different accounts. This
causes fragmentation of patient data and affects data sharing and effective use. To
bring a single account, the account address or identity of the patient can be derived
from his/her biometric fingerprint. Even though the patient knowingly or unknow-
ingly tries to create multiple accounts, in blockchain, it will be stored under a single
account. In the proposed system, the key pair is derived using the elliptic curve cryp-
tosystem, where the private key (Bpri ) is a random scalar value and the public key
(Bpub ) is the point multiplication of the private key and elliptic curve base point. The
random scalar value can be derived using the patient’s biometric; thus getting a single
account address or identity for the patient. The key escrow technique will be used
to solve the problem of accessing the record when the patient is in an unresponsive
state.
Statistical Data Privacy: It is very important to maintain the disease/patients statis-
tics and making the information available to the public or governing bodies without
violating the privacy of the patients. The proposed system never discloses the actual
identity of the patient similar to Reen et al. model (2019); however, the malicious
can map the statistics information in the hospital’s Record transaction and the visit
of the known patient to conclude or predict the health report. Also, specialized hospi-
tals increase the chance of prediction. This can be mitigated by posting transactions
continuously and in random order. In case, the hospital broadcasts multiple Record
5 Secure and Decentralized Management of Health Records 131

transactions continuously and randomly then it creates non-determinism and thus

mitigates the attack against the patient’s privacy.

5.7 Performance Analysis

5.7.1 Experimental Setup

The proposed system is implemented by modifying the goethereum tool. The

goethereum (Go-ethereum) is the implementation of Ethereum protocol (Wood,
2014) using the Go language (Golang). The results are from the private network
full node device with the configuration of 4 core 3.30 GHz processor, 8 GB RAM
with Ubuntu 16.04 LTS, and geth version 1.8.2-stable-b8b9f7f4. For the overhead
analysis, the platform used for local storage is MongoDB, the cloud is Amazon
Cloud using MongoDB, and IPFS is INFURA. To compare the smart contract and
core world state MPT-based storage access, a private full node device with the config-
uration of 4 core 3.50 GHz processor, 12 GB RAM with Ubuntu 16.04 LTS and geth
1.9.11-stable version is used.

5.7.2 Results and Discussion

The implementation scenario is the hospital gives the hash of the health record to
the patient, and then the patient creates a transaction by including from and to as
his/her address (from: eth.accounts[0] & to: eth.accounts[0]) and health record hash
concatenated with the previous record hash (H p ). Then broadcast it to the network for
inclusion in the block. The successfully validated transaction will be given transaction
confirmation as shown in Fig. 5.6 and then committed into the block during mining.
In the implementation, the transaction is prepared and submitted by the patient; thus

Fig. 5.6 Output of the modified sendTransaction in goethereum

132 S. Venkatesan et al.

Fig. 5.7 Retrieval of health record hash and public key of a patient

by default, the hash of the record along with other parameters in the transaction is
signed by the patient using his/her Bpri .
Figure 5.7 shows the retrieval of latest health record hash (meta-data) and the
public key of a user from the blockchain by providing the patient’s Ethereum address.
These data can be accessed by any of the nodes in the network.
Figure 5.8 shows the computational time (latency) consumption of goethereum
node for modified sendTransaction validation and data access on the presence of a
different number of participating nodes. The computational time plot HRhAc is for
accessing the health record hash (meta-data) of a patient, and RTr is for the validation
of modified sendTransaction. The experimental result shows that the transaction
validation time is greater than the data access time. This is because of multiple
validations such as signature and account existence. Also, the result in Fig. 5.8
shows that the access to meta-data and validation of the transaction are not heavy
and time-consuming.
Figure 5.9 shows the latency difference of smart contract (SCAcc) and core world
state MPT storage (MPTAcc)-based data access. The data access includes two steps in
the case of core world state MPT storage and three steps in the case of smart contract
storage. In the world state MPT storage-based data access, as the first step, the trie is
traversed and the patient node is located using the patient pseudo-identity/Ethereum
address and as the second step data is accessed. In smart contract storage-based data

18
16
Latency (in milliseconds)

14
12
10
8 RTr
6
Hrhacc
4
2
0
40 80 100 200 500
No. of Nodes

Fig. 5.8 Computational latency for the transaction validation and data access
5 Secure and Decentralized Management of Health Records 133

12

Latency (in milli seconds)

10

6
SCAcc
4
MPTAcc
2

0
20 40 80 100
No. of Nodes

Fig. 5.9 Computational latency for the world state MPT and smart contract storage data access

access, the first step is to traverse the trie and locate the application administrator
node, the second step is to traverse and locate the application user (patient) node in
the smart contract storage, and the third step is accessing the data. Hence, the smart
contract storage-based data access latency is more when compared to the world state
MPT storage-based data access. The existing systems use the smart contract-based
storage, and that needs more latency for data access as shown in Fig. 5.9. Hence, the
proposed eHealth record management system uses the core world state MPT storage
instead of smart contract-based storage.

5.7.3 Overhead Analysis

Table 5.1 shows the parameters and values considered for the overhead evaluation of
the proposed eHealth record management system, which uses the blockchain tech-
nology. The blockchain considered for the analysis is the Ethereum public cryptocur-
rency blockchain since the proposed system uses the Proof of Authority (PoA)-based
Ethereum implementation.
There are four different eHealth record management systems considered for
comparison: A: the eHealth record is kept at the hospital in plain format, B: the
eHealth records are encrypted and kept in the hospital, C: the eHealth records are
encrypted and placed in the hospital as well as in cloud, and D: the eHealth records
encrypted and placed in the hospital, cloud or IPFS and meta-data on the blockchain.
Table 5.2 shows the space, access time, and computational time requirement of all
systems. The given computational time for eHealth record encryption, and hashing
is computed through the OpenSSL since these are not part of the blockchain activ-
ities. Table 5.2 shows that the systems C and D are computationally heavy when
134 S. Venkatesan et al.

Table 5.1 Parameters for evaluation of the proposed model

Parameters Value
Number of patients 500
Total record size 2.5 GB
Avg. patient record size (only text) 50 KB
Encryption algorithm (RSA is considered in place of ECC since no RSA
significance in the systems comparison)
Blockchain size (public Ethereum size (Stat, 2018), it extends) 667.10 GB
Block count (public Ethereum (Stat, 2018), it extends) 6,542,612
Storage size of plain/encrypted records 2.5 GB
Block size considered with respect to Ethereum 33 KB
Avg. hash time of medical record HT
Avg. record encryption time ET
Computation, validation and access time In milli seconds

compared with the systems A and B; however, the systems A and B are not consid-
ered for overhead analysis since it lags in confidentiality and integrity while sharing
the records.
Table 5.3 shows the overhead of the proposed system D over system C for storage
space, access time, and record, and block sharing cost. The proposed blockchain-
based system (D) needs more overhead with respect to space, data sharing, and IPFS
data access.
(i) Storage space: It has storage space overhead of approximately 7 TB; however,
it is not from the beginning of the blockchain application. It increased gradually
from 33 KB to 7 TB in ~ 10 years, and it will further go high. In connection with
Moore’s law [Moore 1965], the year it goes, the cost of memory may reduce.
Hence, it will not affect the cost at a high level. Also, the proposed system
provides faster access to meta-data since the copy of the blockchain is stored
locally in full nodes.
(ii) Access time: It has additional overhead only in IPFS access; however, if the
records are accessed by different nodes then records will be in nearby storage
and will achieve the quick access of record. Also, the efficient cloud data access
techniques (Namasudra et al. 2020a; Namasudra et al. 2020b; Namasudra et al.
2017a; b) will further reduce the access time.
(iii) Sharing cost: The overhead is only ~ 3mbps considering each block size is
33 KB and 10 nodes in the network sharing it. This overhead will not reduce the
functional capability of the system. Also in today’s network, 3mbps bandwidth
is not an overhead.
The Proof of Authority-based block mining and validation is also the additional
overhead. However, this will not delay the record and meta-data access. Even though
proposed system has significant overhead with respect to storage, it achieves reliable
health record sharing, public verifiability, record integrity, and fault tolerance. Also,
Table 5.2 Storage and computational analysis
Model HT ET Blockchain data Blockchain Blockchain Time for Record Time for Record Time for Record
access time transaction validation Size (Storage cost) access from the local access from the IPFS access from the cloud
time database
A NA NA NA NA NA 46.5 NA NA
B 6.0 11.0 NA NA NA 46.5 NA NA
C 6.0 11.0 NA NA NA 46.5 NA 226.7
D 6.0 11.0 2.2 16.5 667.10 GB * 10 nodes 46.5 431.4 226.7
5 Secure and Decentralized Management of Health Records

= 6670.10 GB ~ 7 TB
135
136 S. Venkatesan et al.

Table 5.3 Overhead analysis

Resource C D Overhead
Storage space 2.5 GB ~7 TB ~7 TB
Access time Cloud 226.7 226.7 0
IPFS NA 431.4 204.7
Local storage 46.5 46.5 0
Record and block sharing cost 20Gbps ~3mbps + 20Gbps ~3mbps

blockchain of the proposed system maintains the disease statistics without violating
the privacy of any patient.

5.7.4 Limitations

The proposed model has the following limitations with respect to rural patient
technical knowledge and insider (hospital administrator) malicious behavior.
(i) Patient ignorance and pressure may be used to access the record in an
unauthorized manner.
(ii) The patient may not have enough resources or technical knowledge to do re-
encryption or create transactions even though the interface will be provided.
(iii) Hospital administration may keep the copy of the plain eHealth record without
the knowledge of the patient and access it whenever required without patient
consent.
(iv) Hospital administrators may inject incorrect data.
The limitations (i) and (ii) can be mitigated through awareness. The limitation
(iii) is not going to harm the patient because the respective hospital already knows
the patient details. However, if the respective storage server is compromised or the
hospital shares the data with others then patient privacy is in question. Limitation
(iv) is not possible to mitigate without multiple verifications.

5.8 Conclusions and Future Works

This chapter proposed the eHealth record management system using blockchain to
secure and efficiently share the healthcare data. The health records are encrypted and
stored in the cloud/IPFS to ensure availability and confidentiality. The meta-data of
the health record is stored on the blockchain to ensure the integrity and public verifi-
ability. The proposed system achieves confidentiality, privacy, availability, and fault
tolerance in the presence of inside and outside attackers. Also, it provides services like
5 Secure and Decentralized Management of Health Records 137

statistics generation, and single account for patients. The experimental results, secu-
rity, and overheads analysis prove the applicability of the proposed eHealth record
management system in eHealth care. The future work of this paper is to achieve the
granular access control of the patient’s record.
Key Terms and Definitions
Blockchain: It is a distributed ledger consisting of blocks, which keeps on growing
and cryptographically linked to mitigating the malicious alterations. Also, it spreads
over many users of the network to ensure decentralization and availability.
Cloud: It is an on-demand facility provided by third parties especially for data storage
and computation without direct active management by the client. The encrypted
eHealth records of the proposed record management system are stored in the cloud.
Inter Planetary File System (IPFS): It is a peer-to-peer network for storing and
sharing data in a distributed file system using the Distributed Hash Table (DHT). The
content can be hosted on the IPFS by users using the index (hash of the data); also,
it can be stored in multiple nodes. Any user in the network can access a file using
its content address by approaching any peer in the network that can find and request
the content from a peer that has it.
Cryptographic Hash: It is a function that takes arbitrary size input and produces
a fixed-size output. A small change in a message will change the hash output so
extensively that the new hash value appears uncorrelated with the old hash value.
The properties of the hash function are Pre-Image Resistance, Second Pre-Image
Resistance, and Collision Resistance. This is used for ensuring the eHealth record
integrity.

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Subramanian Venkatesan is Associate Professor in the Department of Information Technology

at Indian Institute of Information Technology, Allahabad, Prayagraj, India. He works in the area
of cybersecurity and blockchain. He is Member of the Network Security and Cryptography Lab,
Indian Institute of Information Technology, Allahabad, Prayagraj, India.

Shubham Sahai is a Ph.D. scholar in Cyber Security Center, Indian Institute of Technology,
Kanpur, and currently working with Prof. Sandeep K. Shukla and Prof. Pramod Subramanyan. His
research interest lies around blockchain, formal methods, and applied cryptography. He has a keen
interest in designing systems that guarantee trust and privacy among users. His peripheral interest
in cryptography revolves around zero-knowledge proofs, oblivious RAMs, and homomorphic
encryption, and he believes that these constructions will play a pivotal role in the development
of a secure, trustworthy, and privacy-preserving digital world.

Sandeep Kumar Shukla is Professor in the Department of Computer Science and Engineering,
Indian Institute of Technology, Kanpur, India. He is an Associate Editor of ACM Transactions
on Cyber-Physical Systems. He is an IEEE fellow and an ACM Distinguished Scientist, and
served as an IEEE Computer Society Distinguished Visitor from 2008 to 2012 and as an ACM
Distinguished Speaker from 2007 to 2014. He was previously the Poonam and Prabhu Goel
Chair Professor in the Deparment of Computer Science and Engineering, Indian Institute of Tech-
nology, Kanpur, India, Editor in Chief of ACM Transactions on Embedded Systems from 2013
to 2020, Associate Editor of IEEE Transactions on Computers, IEEE Transactions on Industrial
Informatics, IEEE Design & Test, IEEE Embedded Systems Letters, and various other journals.
He was Member of the faculty at the Virginia Polytechnic Institute, Arlington, Virginia, between
2002 and 2015, and has also been a visiting scholar at INRIA, France, and the University of
Kaiserslautern, Germany. In 2014, he was named a fellow of the Institute of Electrical and Elec-
tronics Engineers (IEEE) for his contributions to applied probabilistic model checking for system
design. He has authored several books on systems and has edited and co-authored numerous books
with Springer.

Jaya Singh is a Ph.D. student in Network Security and Cryptography Laboratory, Department of
Information Technology, Indian Institute of Information Technology, Allahabad, Prayagraj, India.
Her research interest includes blockchain applications and lightweight authentication techniques.
Chapter 6
IoT-Based Healthcare Monitoring Using
Blockchain

Monireh Vahdati, Kamran Gholizadeh HamlAbadi,

and Ali Mohammad Saghiri

Abstract The Internet of Things (IoT) is used to improve traditional healthcare

systems in different aspects, including monitoring patients’ behaviors. Informa-
tion gathered by sensors in the IoT plays an essential role in healthcare systems.
Because of privacy and security issues, the data must be protected against unautho-
rized changes. On the other hand, Blockchain technology provides a wide range of
mechanisms to protect data against changes. Therefore, IoT-based healthcare moni-
toring using Blockchain constitutes an exciting technological innovation, which may
help mitigate security and privacy concerns related to the gathering of informa-
tion during patient monitoring. In this chapter, the potential applications of IoT–
Blockchain systems are studied, and then monitoring mechanisms in healthcare
systems are analyzed. To this end, a novel architecture based on recently reported
solutions is proposed. The proposed architecture, with the aid of computational power
obtained from the IoT, Blockchain and artificial intelligence, can be used in a wide
range of solutions aimed at managing the coronavirus disease 2019 (COVID-19).
In order to show the potential of the proposed architecture, three case studies are
presented. At the end of this chapter, other applications of the proposed architecture
are summarized, which can be used in pandemic situations.

Keywords Internet of Things · Blockchain technology · Artificial intelligence ·

Healthcare systems · COVID-19

M. Vahdati (B) · K. Gholizadeh HamlAbadi

Young Researchers and Elite Club, Qazvin Branch, Islamic Azad University, Qazvin, Iran
e-mail: [email protected]
K. Gholizadeh HamlAbadi
e-mail: [email protected]
Faculty of Computer and Information Technology Engineering, Qazvin Branch, Islamic Azad
University, Qazvin, Iran
A. M. Saghiri
Computer Engineering and Information Technology Department, Amirkabir University of
Technology (Tehran Polytechnic), 424 Hafez Ave, Tehran, Iran
e-mail: [email protected]

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 141
S. Namasudra and G. C. Deka (eds.), Applications of Blockchain in Healthcare,
Studies in Big Data 83, https://doi.org/10.1007/978-981-15-9547-9_6
142 M. Vahdati et al.

6.1 Introduction

Recently, healthcare systems have been revolutionized by technologies in different

fields, linked to the IoT. Monitoring is one field of healthcare that invests in the IoT
technologies. IoT constitutes a powerful ecosystem, incorporating sensors, actuators
and computational resources in order to organize useful monitoring systems (Saddik
et al. 2020; Saghiri et al. 2020). In the next three paragraphs, problems associated
with the organization of monitoring systems based on IoT are summarized.
Remote monitoring is very common these days for the treatment of patients, and
a key concern with such systems is maintaining security and privacy of vast amounts
of data (Ajerla et al. 2019; Griggs et al. 2018; Mohammed et al. 2014), which
could potentially be transferred. It is therefore crucial to guard against cyberattacks,
which can cause major problems. These problems can lead to delays in patient treat-
ment. Blockchain can be used to solve these problems (Gupta et al. 2020). However,
Blockchain technology requires high bandwidth and extra computational power that
are not appropriate for devices with resource constraints. In addition, the combina-
tion of Blockchain and IoT-based systems has many drawbacks, like low scalability
and long latency for network transactions. Other challenges have also been identi-
fied in (Dwivedi et al. 2019b). An IoT–Blockchain combination may constitute a
strong approach which can considerably smooth the way for new business models
and distributed applications.
According to Jamil et al. (2020), data communication is one of the major problems
encountered by healthcare providers. Given the huge amount of data involved, it is
almost impossible to manage in the local domain, and it has been suggested that
the public domain should be used for this purpose. One problem, which is still
a barrier for both patients and healers, is locating data stored in different places.
Therefore, a unified and holistic healthcare infrastructure is necessary to enable
interoperability and secure sharing of medical data across diverse healthcare areas,
to increase collaborative healthcare services and research. Moreover, other associated
issues (e.g., record sharing, data privacy, security, identity, scalability, data integrity,
and patient enrollment) also present challenges for patients in healthcare ecosystems.
Blockchain technology can overcome such problems. It should be noted, few systems
provide the necessary data integrity and privacy in the clinical healthcare system. In
Jamil et al. (2020), a patient monitoring system based on Blockchain is suggested.
This system, with the introduction of Blockchain technology, not only significantly
enhances the entire manufacturing process but also considers security issues.
Nowadays, sensors are commonly embedded in devices and vehicles which are
connected to the Internet. To simplify the treatment of patients through Remote
Patient-Monitoring (RPM) technology, healthcare experts now use IoT. In recent
years, increasing use of wearable devices and IoT has improved the quality of patient
care outside formal clinical settings. However, there are lots of privacy and security
problems, including concerns about data transfer and transactions, which may result
in delays in treatment progresses. Use of Blockchain technology has been reported
for managing and safeguarding data (Dwivedi et al. 2019b).
6 IoT-Based Healthcare Monitoring Using Blockchain 143

In this chapter, an architecture based on Saghiri et al. (2018) for healthcare moni-
toring is proposed. In addition, some solutions given in ( Abujamra and Randall, 2019;
Jamil et al. 2020; Bublitz et al. 2019; HamlAbadi et al. 2017; Vahdati et al. 2018;
Saghiri et al. 2020) are deployed in this architecture. This architecture solves some
problems associated with security and privacy in IoT, using Blockchain technology.
Because of the distributed and dynamic nature of IoT systems based on Blockchain,
a wide range of management problems should be solved using smart algorithms.
Therefore, the cognitive systems framework has been embedded in the proposed
architecture to better organize the management processes in order to solve problems
in a self-organized manner. Note that all existing algorithms suffer from complex
organization of management algorithms. In other words, the proposed architecture
solves the challenges of complexity in designing management algorithms using a
cognitive systems approach. According to Saghiri (2020b) and Wang et al. (2020),
cognitive systems are used to decrease the complexity of management algorithms in
a wide range of applications. In order to study potential applications of the proposed
architecture, some case studies involving the fight against COVID-19 are studied in
this chapter. The structure of this chapter is as follows: Sect. 6.2 is dedicated to the
literature review. Section 6.3 focuses on background studies. In Sect. 6.4, an archi-
tecture is proposed for healthcare monitoring. In Sect. 6.5, three case studies are
suggested. Discussions and potential applications are given in Sect. 6.6. Section 6.7
is dedicated to performance analysis. Conclusions and future work are given in
Sect. 6.8.

6.2 Literature Review

Blockchain technologies in IoT have been considered in a myriad of papers. In

this part, some of the primary reasons for investigation of the use of Blockchain
and the IoT in healthcare monitoring services are studied (Mettler 2016; Panarello
et al. 2018). Although Blockchain technologies facilitate secure administration and
enable users to find data from a vast array of healthcare information (Dwivedi et al.
2019b), these technologies are still computationally costly and require a high transfer
speed and extra computational power, which is not appropriate for most resource-
constrained IoT devices in smart cites.
In Conoscenti et al. (2016), the use of a Blockchain in IoT is reported. The
authors identify many issues associated with the trustworthiness, obscurity and flex-
ibility of Blockchain frameworks. They find that Blockchain frameworks are secure
but not appropriate for the IoT because of adaptability issues. The author of Kshetri
(2017) has considered how a Blockchain could address some common IoT chal-
lenges. Furthermore, IoT and Blockchain (along with their associated problems)
have been studied by Reyna et al. (2018). In addition, in Huh et al. (2017), novel use
of a Blockchain has been demonstrated, featuring the Ethereum platform. It should
be noted that the security of medical records is critical point when discussing health
144 M. Vahdati et al.

information. This feature is supported by Blockchain technology. Table 6.1 provides

a detailed comparison of existing approaches in healthcare systems.

6.3 Background Studies

6.3.1 Overview of IoT

The idea of connecting everything, anywhere, at any time, loosely describes the
concept of IoT. The notion of the IoT is that it not only provides connectivity but
also assists interaction between the devices to be connected. The speed with which
new devices can be connected to an integrated system is very important, but it also
has several serious dangers in terms of security and privacy (Gupta et al. 2020).
In IoT, cloud computing leads to important features such as efficiency, time saving,
cost effectiveness, pay-per-use, flexibility and scalability (Hassanalieragh et al. 2015;
Namasudra and Roy 2017). Blockchain has an important role in the next generation
of IoT-based applications (Dorri et al. 2017). In addition, in order to improve the
security of data in IoT-based devices, some solutions are given in (Namasudra et al.
2020a, c; Namasudra 2018, 2019; Devi et al. 2020; Namasudra et al. 2017, 2018;
Namasudra and Deka 2018).
Wearable devices in healthcare systems are a kind of smart electronic devices,
which can be worn as an accessory or even embedded in clothes. These kinds
of devices are very simple, user friendly, and connection to them can be done
through wireless communication. Important information which can be provided by
these devices includes blood pressure, blood glucose levels and breathing patterns
(Dwivedi et al. 2019b).
Wearable accessories worn by patients can transmit a myriad of data to a smart-
phone. These data play a crucial role in preventive care and critical care, as reported in
Hang et al. (2019). This technology also permits doctors to treat more patients. RPM
facilitates observation and care of patients beyond the contractual clinical setting .
A key advantage is that IoT promotes patient comfort. Patients can keep in touch
with healthcare practitioners as required. It likewise decreases clinical expenses and
improves the quality of care. Medical services suppliers are now investigating ways
of extending the scope of RPM so that it can serve the majority of patients. The
primary segment of RPM framework could be a uniquely planned checking device
to monitor and transmit key data. Wearable devices and the IoT play a significant
role in RPM and are currently being promoted as part of the creation of smart cities.
Wearable devices continuously gather health information and can send it to emer-
gency clinics or clinical organizations as part of their health interventions, enabling
them to monitor disease results and the progress of treatment (Dwivedi et al. 2019b).
Recently, another related concept called the “cognitive IoT” (Foteinos et al.
2013; Saghiri et al. 2018) has been described. This targets coordination of subjec-
tive advances into IoT-based frameworks in order to guarantee smart administration
Table 6.1 Comparison of existing approaches for health care using Blockchains
References Contribution Advantages Disadvantages
(Dwivedi et al. 2019b) Represents use of a Blockchain to Makes IoT application data and No implementation exists
provide secure management and transactions more secure
analysis of healthcare big data
(Dwivedi et al. 2019a) Represents the Blockchain model for Identifies the key points where the IoT No implementation exists
IoT-based healthcare applications and Blockchains can work well together
Bublitz et al. (2019) A framework based on AI, the IoT and The IoT, Blockchains and AI have great No implementation exists
Blockchains is used to support potential in terms of supporting initiatives
investigation and improvement of integrating health and environmental
pan-Canadian monitoring and data, including the potential to be part of
observation activities that have an a pan-Canadian surveillance system
environmental impact on health
Hang et al. (2019) Represents a Blockchain-based medical Support patients with a comprehensive, Does not evaluate the suggested platform
platform to secure electronic medical unchanging log and simple access to their across a large-scale network
record management medical data over diverse departments
within the clinic
6 IoT-Based Healthcare Monitoring Using Blockchain

Fernández-Caramés and Design of fog computing, Blockchains Helps with the control of diseases; Does not evaluate the suggested platform
Fraga-Lamas (2018) and an IoT-based continuous provides a transparent and trustworthy across a large-scale network
glucose-monitoring system for blood-sugar data source
crowdsourcing mHealth
Attia et al. (2019) Represents a secure Blockchain Provides a secure remote-monitoring IoT Needs to implement more functionality
architecture for healthcare monitoring system; secured IoT architecture can be to get a complete
applications implemented in the healthcare IoT–Blockchain framework dedicated to
application domain health monitoring
(continued)
145
Table 6.1 (continued)
146

References Contribution Advantages Disadvantages

Islam and Shin (2019) Analysis of specific aspects of secure Health data are collected from users’ Does not evaluate the suggested platform
outdoor healthcare monitoring in a wearable sensors with the help of an across a large-scale network
smart city, using Blockchain technology unmanned aerial vehicle (UAV); user
data can be encrypted using the UAV’s
public key
Jaiswal et al. (2018) Demonstration of an IoT cloud-based This architecture is cost-effective, The platform has not been deployed in a
smart healthcare model, which carries scalable, supports interoperability and real healthcare environment
out monitoring patient information, lightweight access
collected by different remote sensors of
medical services materials
Griggs et al. (2018) Proposal of Blockchain-based smart Smart contracts would trigger alarms for No implementation has been reported
contracts to encourage secure patients and healthcare providers as
examination and administration of appropriate, as well as recording details
therapeutic sensors to handle protected about transactions on the Blockchain
health information (PHI) produced by
IoT gadgets
Jamil et al. (2020) Proposal of a platform for observing Provides several benefits to patients, like Lack of extensive testing in various IoT
crucial patient signs, utilizing smart an extensive, immutable history log and frameworks
contracts based on Blockchains global access to medical data from
anywhere at any time
(continued)
M. Vahdati et al.
Table 6.1 (continued)
References Contribution Advantages Disadvantages
Kazmi et al. (2020) Proposal of a healthcare system Their framework monitors patients from No implementation has been reported
utilizing Blockchain-based smart a distance and produces alerts if a crisis
contracts that support patient occurs
enrollment and specialists in a health Smart contracts are used for authorization
center, subsequently expanding user of its devices, constituting a legalized and
cooperation in remote patient secure way of using medical sensors
monitoring
Ahmadi et al. (2020) Exploration of IoT-based Blockchain Improves drug administration throughout No implementation has been reported
advances addressing the issue of fraud the supply chain, making healthcare more
and manhandled drugs within the effective and dependable
pharmaceutical supply chain
Lemieux et al. (2020) Presentation of a prototype Blockchain The project studies potential ethical, No implementation has been reported
solution for private and secure legal, social and cognitive constraints of
individual “Omics” health data self-organized healthcare data
management and sharing management and sharing, and whether
6 IoT-Based Healthcare Monitoring Using Blockchain

such constraints can be addressed

through careful user interface design of a
Blockchain solution
147
148 M. Vahdati et al.

through empowering collaboration and communication between the IoT and humans
(Mezghani et al. 2017).

6.3.2 Overview of Blockchain Technology

The Blockchain network concept is started out as a decentralized, immutable ledger

framework for transactional information management (Lu 2019; Wang et al. 2019b).
This technology is capable of revolutionizing a wide range of domains, from finance
to administration, by promoting security, reliability and transparency, established
via a decentralized and equitable computational model (Jacobsen et al. 2018); Zhang
et al. 2018), with a high level of privacy guaranteed (Liu et al. 2019). Blockchain
technology has recently received much critical attention from academic environment
and industry due to its capabilities (Nelaturu et al. 2020). This technology was initially
created to handle monetary transactions within the context of digital currency, using
a peer-to-peer network (Adler et al. 2018). Blockchain technology includes some
applications in different fields (Cai et al. 2018; Namasudra et al. 2020b).
In Blockchain technology, consensus protocols maintain information consistency
and integrity over all nodes on the network, organized in a distributed fashion. The
purpose of most consensus protocols within the Blockchain is to guarantee that each
distributed copy of shared information is updated correctly throughout the chain.
Basically, the consensus is an agreement that needs each participant’s approval for
the new block to be added to the Blockchain network (Baliga 2017; Wang et al.
2019c). Blockchain technologies use different consensus algorithms, which can be
roughly divided into consensus protocols such as “proof of concept” (PoC), “proof
of work” (PoW), “proof of stake” (PoS), “delegated proof of stake” (DPoS), “proof
of authority” (PoA) and “Byzantine fault-tolerant replication” (Liu et al. 2020).
Design of the next-generation healthcare information systems is a significant
application area for Blockchain technology (Mišić et al. 2019). Blockchain technolo-
gies provide advanced security and privacy properties to IoT-based remote patient-
monitoring systems (Srivastava et al. 2019). Furthermore, Blockchain technology
brings with it fundamental and unique value, such as integrity, timelessness, inter-
operability, irreplaceability, reliability, reduced verification costs, networking and
decentralization in health care (Abujamra and Randall 2019; Gordon and Catalini
2018; Koshechkin et al. 2018; McGhin et al. 2019).
As a summary, Blockchain technologies are computationally costly, requiring
a high transfer speed and extra computational power. But, this technology is able
to solve many serious problems in a wide range of applications including modern
IoT-based healthcare monitoring.
6 IoT-Based Healthcare Monitoring Using Blockchain 149

6.3.3 Smart Contract

The term “smart contract” was first coined by Szabo (1996) as “a set of promises, spec-
ified in digital form, including protocols within which the parties perform on these
promises” (Szabo 1996). Smart contracts could be defined as the computer protocols
that digitally facilitate, verify and exert the contracts created among parties on a
Blockchain. Smart contracts are ordinarily deployed and secured by a Blockchain.
Firstly, the program code of a smart contract is recorded and confirmed on the
Blockchain. Secondly, the execution of a smart contract is implemented among
anonymous, trustless nodes without centralized control or coordination of third-party
specialists. Thirdly, a smart contract, like an intelligent agent, might have its own
cryptocurrencies or other digital assets, and it can transfer them when predefined
conditions are triggered (Stark 2016; Wang et al. 2019a). Recently, smart contracts
have been developed to deploy multiple interactions for Ethereum using “Solidity”
programing language (Nelaturu et al. 2020).
Smart contract technology can solve substantial challenges associated with the
healthcare domain in terms of managing and enforcing contracts without the inter-
ference of a third party in order to improve interoperability and privacy in healthcare
processes. A smart contract in a Blockchain can provide a safe way to create a signif-
icant connection between a patient’s medical data and useful medical guidelines.
This system reduces the costs of healthcare services and increases their accessibility
(Kormiltsyn et al. 2019). In Fig. 6.1, the main objective, i.e., to share patient infor-
mation through Blockchain smart contracts among hospitals, laboratories, doctors,
patients, insurance companies, pharmacies and consultants is presented.

6.3.4 Algorithms and Tools for Medical Blockchain

Depending on how Blockchain technology is to be used in the medical domain,

different algorithms and tools are used to define solutions. Algorithms and tools can
be studied from two perspectives, and these perspectives are explained in the next
two paragraphs.
Financial: From a financial perspective, several cryptocurrencies, such as Dent-
coin (2020), are reported to facilitate financial transactions in medical domains.
Since the amounts of money and number of transactions in healthcare systems
are increasing, and digital money can be used to decrease the number of contacts
and interactions among users, cryptocurrencies are likely to play an essential role
in medical Blockchains. During the COVID-19 pandemic, this approach has been
followed in several countries, such as China (Chamola et al. 2020). On the other hand,
Initial Coin Offering (ICO) techniques may be used to decrease paperwork and diffi-
culties associated with collecting money for medical problems in different fields.
It is worth noting that utilizing cryptocurrencies that are customized for medical
150 M. Vahdati et al.

Fig. 6.1 Smart contract for health care

problems may help define better treatment plans using gamification techniques as a
means of incentivizing those people who follow the guidelines defined by doctors.
Technical: From a technical perspective, many tools and algorithms are reported
in the literature to solve different types of problems. Blockchain technology facilitates
three activities, as described below:
• Patients’ medical records can be transferred with a high degree of security and
privacy.
• Management of the medicine supply chain can be done with a high level of
accuracy.
• Healthcare researchers can study patient records, and genetic codes can be
analyzed in accordance with legal routines.
From a technical point of view, some challenges can be solved by a Blockchain-
based algorithm very efficiently. Moreover, such an algorithm could be integrated
with other solutions. For example, in Azaria et al. (2016), secure access controls in
healthcare systems are designated. Blockchain can also be used to secure data sharing,
as reported in Xia et al. (2017). Medical records can be stored in Blockchain with a
6 IoT-Based Healthcare Monitoring Using Blockchain 151

high degree of security, such as one algorithm reported in Dubovitskaya et al. (2018).
Recently reported studies focusing on the abovementioned activities are discussed
below:
• In BurstIQ 2020, a platform is reported that manages patient data considering
safety and security issues handled by Blockchain technology. This platform
includes information about patients’ health and healthcare activities.
• In SimplyVital Health 2020, a system is reported to establish decentralized tech-
nologies for healthcare industries. It helps healthcare experts to access patient
information quickly. This company recently cooperated with genomics and
precision medicine company Shivom in order to organize a global healthcare
Blockchain alliance to protect DNA sequencing data.
• In Coral Health 2020, the author presents a Blockchain-based system to accel-
erate the care control process in relation to administrative processes and health
outcomes. Many actors, such as doctors, scientists, laboratory technicians and
public health authorities, can be connected to each other using a Blockchain
based network very quickly. To ensure accuracy of the data and treatment process,
this company implements smart contracts between patients and healthcare
professionals.
• In Medicalchain 2018, the system utilizes a Blockchain to store health records,
addressing integrity and truth issues. This company also supports patient
consultations with doctors using “MedTokens”.
• In chronicled 2020, the author proposes a Blockchain in order to demonstrate a
solution to help pharma companies track medicine deliveries and also provide a
detailed review of drug shipments.
• The Center for Disease Control and Prevention (CDC) works on diseases in
a supply-chain-based manner utilizing Blockchain technology (CDC 2020).
Blockchain technology can consider timestamps, peer-to-peer health reporting
and data processing in a real-time fashion. These capabilities can be used in
pandemic situations.
• The EncrypGen (GENE-CHAIN 2020) is a Blockchain-based platform that
focuses on the security and privacy of genetic information. This platform facili-
tates activities such as searching, sharing, saving, buying, and selling of genetic
information.
• In XMED Chain 2018, XMED Chain (XMC) is reported. This platform focuses
on artificial intelligence and big data technologies. This platform can provide
a sustainable, patient-oriented and intelligent ecosystem solution, which can be
organized to build a more efficient global healthcare system.
In this part, firstly two aspects of algorithms and tools in medical Blockchain
are considered. The position of Blockchain-based algorithms in healthcare systems
is then analyzed. Finally, the solutions presented by various companies in different
domains are summarized.
152 M. Vahdati et al.

6.3.5 IoT Sensors for Monitoring Drugs

IoT sensors play an important role in healthcare systems. The IoT supports a wide
range of body sensors, including pulse rate, blood oxygen level, distance traveled,
maximal oxygen consumption, body temperature, blood pressure, blood glucose
level, EEG, ECG and calories burned. These sensors can be used either in wearable
devices or body implants. Information gathered by these sensors may be used to
different purposes such as fall detection, diabetes control, sleep monitoring and hearth
attack detection. In contracts to traditional sensing elements, the IoT sensors are cheap
and also small enough to be used in a wide range of devices. A type of IoT sensors that
enables online drug monitoring has revolutionized healthcare monitoring systems.
In healthcare systems, drug monitoring plays an important role in different fields
for different actors in healthcare systems. Drug monitoring activity refers to measure-
ment of medication levels in the blood, and this can be done using IoT sensors in an
online fashion. In the literature, many algorithms based on drug monitoring using IoT
sensors are given to design modern IoT-based treatments. The overdose and under-
dose of a drug may lead to hurtful situation for patents. A small change in insulin
and glucose in the blood of patient leads to many problems. In Al-Odat et al. (2018)
and Gia et al. (2017), some solutions based on IoT-based blood monitoring systems
such as insulin and glucose are given for diabetic patients. In Othman (2019), an
IoT-based system for medication dose calculator for children is presented.

6.4 The Proposed Architecture

In this section, a novel architecture for IoT-based healthcare monitoring using

Blockchain technology is proposed. This architecture is obtained from recently
reported solutions given in (HamlAbadi et al. 2017; Saghiri et al. 2020, 2018; Vahdati
et al. 2018), and (Abujamra and Randall 2019; Jamil et al. 2020; Bublitz et al. 2019).
An overview of the proposed architecture is given in Fig. 6.2. In this figure, dashed
boxes refer to areas outside the proposed architecture. Users of this architecture can
be patients, nurses, and doctors. IoT sensors and other devices act as sensing elements
in the architecture to support functionalities of the network layer. Three main layers
are identified in this architecture: (1) the network layer, (2) the IoT/Blockchain/AI
services layer, and (3) application layers. Descriptions of these layers are given in
the next three subsections.

6.4.1 Network Layer

This layer provides the interconnection backbone for transferring data among many
entities, such as doctors, patients, laboratories, ambulances, hospitals, and smart
6 IoT-Based Healthcare Monitoring Using Blockchain 153

Fig. 6.2 Proposed architecture for IoT-based healthcare monitoring using Blockchain

homes. Some scenarios demonstrating the functionalities of this layer are given as
follows. IoT sensors enable online health monitoring, and the network layer directly
transmits data to IoT/Blockchain/AI services layer. A connected home can monitor
the daily activities of individuals which has the capability of monitoring human health
through simple wireless measuring scales. Health centers in particular hospitals and
clinics have benefited from new technologies integrating the IoT into health care,
which play a vital part in improving the quality of medical care, bringing comfort
154 M. Vahdati et al.

for patients and improving the management level of healing centers. In medical
emergencies, smart ambulance sensors such as heart rate sensors, blood pressure
and ECGs will determine the status of crucial parameters, and the status of these
parameters can be sent to the hospital’s database at the same time as activity signals.
Upon receiving data on the state of critical parameters, hospital specialists can then
act accordingly. The network layer components are as follows:

1. Routing management unit: The routing management unit sets up a communi-

cation pathway from a source IoT device to a destination. The solution given in
the Ramezan and Leung (2018) can be used in this unit.
2. Security management unit: The security management unit protects the data, a
large number of devices, and interconnected systems.
3. Adaptive protocol management unit: Messaging protocols are a critical compo-
nent in an IoT device, responsible for collecting data or sending commands, and
they are used to transmit device messages from IoT devices to the IoT messaging
hub. This unit adaptively manages the messaging protocols.
4. Connection management unit: The network communication system requires
massive IoT capability, such as Wi-Fi, 2G/3G/4G, 5G, and 6G.
5. Gateway management unit: Gateway management is widely used to promote
communication among smart devices.

6.4.2 IoT/Blockchain/AI Services Layer

A primary challenge arising during the design of this layer is the complexity of the
management processes, involving three elements: IoT, Blockchain and AI. In order to
resolve this challenge, a framework for the Cognitive Internet of Things (CIoT) based
on a Blockchain is utilized. This framework was proposed in Saghiri et al. (2018),
HamlAbadi et al. (2017), and Vahdati et al. (2018). This framework suggests three
layers, with the following descriptions, to organize management processes (Fig. 6.2):
1. Requirement layer: In this layer, the goals and behaviors of the system are
determined using a language called Cognitive Specification Language (CSL).
In Saghiri et al. 2018; HamlAbadi et al. 2017; Vahdati et al. 2018, the authors
suggest use CSL, but it seems that any formal language (HTML) and informal
language (English) can be used to determine the goals and behaviors of the system
because cognitive engines can be used to extract goals and behaviors based on
machine learning and natural language-processing (NLP) engines.
2. Cognitive process layer: In this layer, cognitive processes are organized. Each
cognitive process may be designated to manage several tasks. In this layer, the
designer develops one or more cognitive engines, and each cognitive engine has
responsibility for managing certain cognitive processes. The cognitive process
layer takes goals from the requirement layer and executes appropriate algorithms
using sensors and actuators provided by the things’ management layer. Some
essential cognitive processes are given below:
6 IoT-Based Healthcare Monitoring Using Blockchain 155

• Cognitive process for managing sensors and actuators.

• Cognitive process for managing ontologies to facilitate communication among
entities in healthcare systems.
• Cognitive process for sharing learning models to facilitate learning in
healthcare systems.
• Cognitive process for authentication, identity management and privacy
protection.
• Cognitive process for managing smart contracts (triggering, execution and
recovery).
• Cognitive process for continually monitoring all entities involved in a
healthcare system (doctors, patients, nurses, prescriptions, drugs, diets, and
ambulances).
• Cognitive process for predicting dangerous and unsafe states (such as
pandemic situations and drug interactions).
• Cognitive process for insurance management (Vahdati et al. 2018).
• Cognitive process for securing patients’ data records.
• Cognitive process for analyzing consensus algorithms.
• Cognitive process for intrusion detection.
• Cognitive process for processing and communication related to
virtual/augmented reality devices in the thing’s management layer.
• Cognitive process for managing digital twin of the system. Digital twin can
be used to resolve complexities in the management algorithms.
• Cognitive process for specific applications. Some application-specific cogni-
tive processes are considered in Sect. 6.5 in relation to combating COVID-19.
3. Things management layer: In this layer, Blockchain technology is used to manage
information related to the IoT. This layer has several units, as described below:
• Blockchain unit: This unit manages the required information in multiple
Blockchains. In this unit, several Blockchains for different types of data
related to patient, drugs, DNA, and insurance are considered. In addition to
healthcare-related data, information about microservices is stored in a separate
Blockchain in the system.
• Peer-to-peer communication unit: This unit manages peer-to-peer commu-
nication among different entities in the system. It plays an important role
in managing thing-to-thing communications in Decentralized Autonomous
Organization (DAO).
• Smart contract unit: This unit manages issues related to smart contracts based
on cognitive engines. In this unit, cognitive smart contract can be designated.
• Payment unit: This unit manages financial transactions among entities in the
system.
156 M. Vahdati et al.

6.4.3 Application Layer

In this layer, DAO can be implemented based on distributed application logics. This
layer also provides RESTful APIs to cooperate with other systems. The APIs can be
used in internal parts of this architecture.

6.5 Case Study

In this section, to apply the proposed architecture in different case studies, three
algorithms, namely path recommendation for pandemic situations, health insurance
recommendation, and fighting COVID-19 pandemic have been suggested. It should
be noted that a wide range of AI and Blockchain-based solutions are given in the
(Ebadi et al. 2020; Hussain et al. 2020, p. 19; Kassani et al. 2020) to combat COVID-
19. To implement these algorithms, different smart contracts in the cognitive engine
must be provided. Table 6.2 presents descriptions of the smart contracts used for the
proposed algorithms. Five Blockchains are included in the cognitive engines (see
Table 6.3), and different microservices are used for the proposed algorithms. These
services are available on a Blockchain platform. Table 6.4 presents a description of
seven services. Three services viz path services, health insurance services and drug
services are provided in this section.

6.5.1 Path Recommendation for Pandemic Situations

In Algorithm 1, when a user wants to go to a particular destination, his information

and location are sensed by the sensors and saved in Blockchain-users-positions. Once
a destination location is confirmed by a user, the user’s commands are transmitted
to the cognitive engine. In this case study, a user may send a command using his
voice or a terminal, e.g., “Please recommend a safe path to travel from source X to
destination Y.” In the cognitive engine, the corresponding microservices are called
to interpret the commands in order to draw out the goals of the system for the
user. According to the goals, that is, finding a safe path for the user, three smart
contracts (e.g., the user-medical-records-contract, geographic-information-system-
contract and mass-surveillance-system-contract) can be fetched from the contracts-
Blockchain, and the corresponding recommendation microservice can be called.
After this, the system can recommend an appropriate path for the user, and user road
information is calculated based on the three smart contracts. Furthermore, the final
distance for the user is computed by the systems. The user is then shown the path
process for their destination. It should be noted that according to the goals determined
by the user, the smart contracts are fetched based on the user’s medical records and
Table 6.2 Smart contracts used in cognitive engines
Smart contract Contract actors Description
User-medical-records-contract Among users and some actors in the healthcare This contract collates user information and provides
system the patient’s medical records
Geographic-information-system-contract Among users and some government actors This contract collates user information and indicates
the position of the user. This concept is reported in
(Mashamba-Thompson and Crayton 2020)
Mass-surveillance-system-contract Among users and some actors in the healthcare This contract collates user information and indicates
system patterns of movement. This concept is borrowed from
(Torky and Hassanien 2020)
Doctor prescription-contract Among users, healthcare providers and health This contract collates user information and provides a
centers doctor’s prescription
User allergy information-contract Among patients, healthcare providers and health This contract relays information about patients’
centers allergies to different drugs and indicates patterns of
consumption
User DNA information-contract Among users, healthcare providers and health This contract collates information from users and
6 IoT-Based Healthcare Monitoring Using Blockchain

centers health dossiers and conveys DNA information

(continued)
157
Table 6.2 (continued)
158

Smart contract Contract actors Description

Clinical test-contract Among users, healthcare providers and health This contract collates information from users and
centers health dossiers and returns test results such as
molecular, serological (Chamola et al. 2020) and
antibody (Eisenstadt et al. 2020) checks
Clinic/hospital/pharmacy information-contract Among users and health centers This contract collates information from medical
centers and then indicates the services that are
available to users
Drug information-contract Among users, healthcare providers and drug This contract collates information from healthcare
stores providers and drug stores and conveys this to users
Medical diagnosis and screening-contract Among users, healthcare providers and drug This contract collates information relating to medical
stores diagnoses and screening (such as testing kits, face
scanners, medical imaging and voice detection
systems) and sends diagnosis results to users
(Chamola et al. 2020)
Tracing-contract Among users and some government actors This contract connects individuals with each other and
indicates patterns of movement and communication to
government(Chamola et al. 2020)
M. Vahdati et al.
6 IoT-Based Healthcare Monitoring Using Blockchain 159

Table 6.3 Blockchains used in cognitive engines

Blockchain names Description
User-positions-Blockchain This Blockchain is used to maintain the positions of users
Contracts-Blockchain This Blockchain is used to maintain the contracts
User-medical-records-Blockchain This Blockchain is used to maintain users’ medical records
Communications-Blockchain This Blockchain is used to maintain communication among
users
Microservices-Blockchain This Blockchain is used to maintain the microservices

Table 6.4 Microservices used in cognitive engines

Microservices Description
Infection-info-service This service provides information about the COVID-19
pandemic
RS-service The RS-service uses cognitive recommender systems to
recommend items for users (HamlAbadi et al. 2017)
Fake news-service This service tracks fake news published on Web sites, Twitter
and other social networks and indicates which information is
valid (Chamola et al. 2020)
Curative investigate-service This service tracks relevant research for users, e.g., drugs and
development of vaccines for different diseases such as
COVID-19 (Chamola et al. 2020)
Medical-supply-chain-service This service uses medical supply-chain information in order to
track drug production (Chamola et al. 2020)
Donate-service This service tracks individuals and organizations which provide
donations (Chamola et al. 2020)
Global-economy-services In order to suggest appropriate solutions, this service considers
the effects of the COVID-19 pandemic on the global economy
such as the automotive industry and tourism industry, etc.
(Chamola et al. 2020)

path information. The user can finally take the safest route to his destination, i.e., in
the case of the COVID-19 pandemic, a low-risk route.
160 M. Vahdati et al.

Algorithm 1: Cognitive engine for path recommendation

Input: User commands; user information collected by the sensors
Output: A safe path recommendation sent to the user
Notations:
User-Medical-Records-Contract: A smart contract as described in Table 6.2
Geographic-Information-System-Contract: A smart contract as described in Table 6.2
Mass-Surveillance-System-Contract: A smart contract as described in Table 6.2
Contracts-Blockchain: A Blockchain as described in Table 6.3
Users-Positions-Blockchain: A Blockchain as described in Table 6.3
Users-Medical-Records-Blockchain: A Blockchain as described in Table 6.3
Communications-Blockchain: A Blockchain as described in Table 6.3
RS-Service: A service provided for cognitive engines, as described in Table 6.4
Infection-Info-Service: A service provided for cognitive engines, as described in Table 6.4
01: Begin
02: Receive the user’s commands; // Command can be “P lease recommend a safe path to travel from X
starting point to Y destination.”
03: Interpret the commands according to the goals of the system;
04: For each smart contract required by the cognitive engine, do
05 Fetch smart contracts from the contracts-Blockchain;
06: End
07: Call RS-Service; // Provides a list of path recommendations;
08: Calculate a safe path using smart contracts and information from the Blockchains;
// All contracts, services and Blockchains introduced in the notations are used in this syntax;
09: Compute the final distance for user;
10: Execute path recommendation process using the user-selected destination.
End

6.5.2 Health Insurance Recommendation

In health insurance recommendations, each user has an identifier, and his/her infor-
mation is saved in the Blockchain. The system goals are determined based on the
user’s commands with considering user’s environmental information collected by
IoT sensors. The goals of the systems can be set automatically by the system or
manually by the user and is obtained by the cognitive engine. The system’s output
can recommend an appropriate insurance package to the user.
6 IoT-Based Healthcare Monitoring Using Blockchain 161

In the cognitive engine, the corresponding microservices are called to interpret the
commands in order to draw out the goal of recommending an appropriate insurance
package for the customer. In accordance with this goal, an algorithm including three
phases is executed. These phases are explained as follows. In the first phase, different
smart contracts can be fetched. These smart contracts include the following:
• A smart contract for users’ medical records: This smart contract can be used to
produce a suitable insurance package for users, as described in Table 6.2.
• A smart contract for a doctor’s prescription: This smart contract can be used to
produce an insurance package according to an individual’s medical prescription,
as described in Table 6.2.
• A smart contract for user’s DNA information: This smart contract can be used to
produce an insurance package according to an individual’s DNA information, as
described in Table 6.2.
• A smart contract for user allergy information: This smart contract can be used to
produce an insurance package according to an individual’s allergy information,
e.g., an allergy to drugs, a seasonal allergy or other allergies, as described in
Table 6.2.
• A smart contract for clinical test needs: This smart contract can be used to produce
an insurance package according to an individual’s clinical test results, as described
in Table 6.2.
• A smart contract for clinical/hospital/pharmacy information: This smart
contract can be used to produce an insurance package according to clin-
ical/hospital/pharmacy information, locations, and services, as described in
Table 6.2.
• A smart contract for drug information: This smart contract can be used to produce
an insurance package according to an individual’s medication details, as described
in Table 6.2.
• A smart contract for medical diagnosis and screening: This smart contract can
be used to produce an insurance package according to an individual’s medical
diagnosis and screening, as described in Table 6.2.
In the second phase, the corresponding microservices can be called. These smart
contracts include the following:
• RS-Service: This service provides users with a list of insurance recommendations
from the cognitive engines, as described in Table 6.4.
• Infection-Info-Service: This service provides information for cognitive engines
as described in Table 6.4. This service may take into consideration the COVID-19
pandemic in order to create an appropriate package.
• Medical-Supply-Chain-Service: This service provides information for cognitive
engines as described in Table 6.4. Calling this service is used to track medication
information to create an appropriate package with high accuracy.
162 M. Vahdati et al.

• Donate-Service: This service provides information for cognitive engines as

described in Table 6.4. This service can track people’s needs and then consider
charitable services for these types of people.
• Global-Economy-Services: This service provides information for cognitive
engines as described in Table 6.4. Calling this service is used to track industrial
needs and then consider supportive services for each type of industry.

In the third phase, the best insurance package can be provided using smart
contracts. During this phase, information can be provided from the Blockchains, and
relevant discounts can be calculated for insurance packages. Finally, the requisite
payment is processed, and the user’s account is updated to reflect the transaction.

6.5.3 Fighting COVID-19 Pandemic

In Algorithm 2, the system goals are determined by the user’s commands with partic-
ular attention to user’s environmental information collected by IoT sensors. The goals
of the system can be set automatically by the system or manually by the user and is
obtained by the cognitive engine. System output can be represented on a dashboard.
This dashboard utilizes data that can be used to mitigate the impact of the COVID-19
outbreak through predicting, tracking, detecting and managing the pandemic.
In the cognitive engine, user commands can be organized into a system for
managing COVID-19. According to the system’s goals, all smart contracts (as
described in Table 6.2) can be fetched. In addition, all corresponding services (as
described in Table 6.4) can be called to interpret the commands in order to draw out
the goals. Then, suitable dashboards will be handled by the system for managing
COVID-19 outbreak. Based on the cognitive engine, six dashboards will be repre-
sented to the user as described follows; 1) virus modeling and analysis, 2) predic-
tion of future outbreaks, 3) virus outbreak estimation, 4) risk prediction, 5) medical
development, and 6) COVID-19 test certificate. Furthermore, based on appropriate
information like user’s DNA and information relating to pharmaceutical services,
different treatments can be developed (e.g., drugs and vaccines). This information
can be used to organize an appropriate panel. Eventually, the proposed algorithms will
facilitate verification of COVID-19 antibody testing, vaccines, and then will issue a
valid certificate for them. These certificates will be registered in the Blockchain in
a transparent and immutable manner (Eisenstadt et al. 2020). A panel on the dash-
board is dedicated to show the certificates. The Blockchain-based functionalities of
the proposed architecture will be useful for equitable COVID-19 vaccine distribution.
6 IoT-Based Healthcare Monitoring Using Blockchain 163

Algorithm 2: Cognitive engine for fighting the COVID-19 pandemic

Input: User commands;
Output: Dashboards for managing the impact of the COVID-19 outbreak; // Several dashboards including
predictions, tracking, detection and management of COVID-19 will be shown to the user.
01: Begin
02: Take the user’s commands; // Command can be “P lease organize a system to manage COVID-19.”
03: Interpret the commands in accordance with the goals of the system;
04: For each smart contract required by the cognitive engine,
05: Fetch smart contracts from the contracts-Blockchain; // Fetch all smart contracts as described in
Table 6.2;
06: End
07: For each service required by the cognitive engine,
08: Call a service list from the service-Blockchain; // Call all services as described in Table 6.4;
09: End
10: Call path recommendation from cognitive engine; // Provides a list of path recommendations;
11: Organize dashboards for virus modeling and analysis; // Organize a panel to represent virus modeling and
analysis;
12: Organize dashboards for prediction of future outbreaks of the virus; // Organize a panel to represent
predictions of future virus outbreaks;
13: Organize dashboards for virus outbreak estimation; // Organize a panel to represent predictions of future
virus outbreaks;
14: Organize dashboards for risk prediction; // Organize a panel to represent risk prediction;
15: Organize dashboards for medical developments; // Organize a panel to represent medical developments
such as vaccines and drugs;
16: Organize dashboards for COVID-19 test certificates; // Issue a valid COVID-19 test certificate such as an
antibody test/vaccination, and organize a panel to represent this test certification.
17: End

6.6 Discussion and Potential Applications

In this subsection, potentials of the proposed architecture to solve many of the prob-
lems caused by COVID-19 are studied. To start with, a short description of this disease
is given, and potential applications for the proposed architecture are presented.
COVID-19 is an infectious disease caused by the coronavirus. In this disease,
common symptoms include fever, coughing, shortness of breath, muscle pain, sputum
production, a sore throat, indigestion, and redness of the eyes. The time between
exposure to the disease and the onset of symptoms is 2–14 days. Humans may prevent
this disease by keeping a certain amount of distance among themselves (Mehta et al.
2020; Schwartz et al. 2020).The proposed architecture will handle the following
potential applications:
1. Smart social distance determination: The proposed architecture can determine
social distances, taking into consideration high-risk humans. It seems that deter-
mining a fixed distance for all humans may not be rational because of variations
in medical status from person to person. This application can be implemented
using proposed architecture. Because of access to users’ medical records, IoT
sensors can gather information about the environment in an selective fashion. For
example, for a person with high allergy, sensors focus on allergen entities. The
solution given in Devi et al. (2020) may be used to design an adaptive distance
determination.
164 M. Vahdati et al.

2. Population control using gamification: The proposed architecture can be used

along with gamification to change the behavior of individuals, using the concept
of reinforcement learning , and mechanism design. The proposed architecture can
extract the movement pattern, behavior for each person. A gamification mech-
anism utilizing cryptocurrencies and tokens (rewards and punishment) may be
applied to encourage people to change their behavior. The proposed architecture
can support the mentioned mechanism entirely through the use of smart contracts
and Blockchain. Governments may use this solution in their countries.
3. Online parameter prediction: Application will enable prediction of the number
of infected and cured cases in online fashion. The proposed architecture, with the
aid of the IoT and AI, can predict several parameters in the system, both online
and offline.
4. Pattern mining for healthcare purposes: The proposed architecture can be used
to determine safe and useful lifestyles for humans using a large amount of data
gathered from medical records. This information may be used to obtain valuable
knowledge about finding a proper diet and establishing habits to keep infection
rates low.
5. Genetic-based analyses: The proposed architecture may be used to store and
handle genetic information relating to humans. Analysis of this information may
be used to predict pandemic situations and also detect those people who are
resistant to some diseases, by considering certain genetic features. In this archi-
tecture, DNA information may be stored in the Blockchain, and then users can
share their keys with relevant experts using smart contracts based on privacy
protected mechanisms.

6.7 Performance Analysis

In the previous section, an architecture for IoT-based healthcare monitoring using

Blockchain was proposed. This architecture is generalized, and it can be used to
design a wide range of algorithms in the healthcare systems. The performance of this
architecture is characterized by the following (Saghiri 2020a):
• Reliability: The proposed architecture can manage data with a high degree of
reliability because of the capabilities of Blockchain technology.
• Decentralization: The proposed architecture can be used to design algorithms
that can avoid monopolies, using certain concepts in Blockchain technology, such
as consensus algorithms.
• Scalability: The proposed design can support scalability using some hybrid
techniques in the fusion of Blockchains and IoT systems.
• User anonymity: The proposed architecture can provide anonymity for users via
peer-to-peer and Blockchain technologies.
• Security and privacy: Blockchain technology ensures that users’ data are
protected, and confidentiality is maintained.
6 IoT-Based Healthcare Monitoring Using Blockchain 165

• Portability: Some parts of the system such as the database and back-end are
based on Blockchains, and designers may organize a portable application such as
DAOs using the proposed architecture, considering this feature.

6.8 Conclusions and Future Works

In this chapter, a novel architecture for modern healthcare systems has been proposed.
This architecture is an extension to a recently reported framework for cognitive
IoT based on Blockchain considering healthcare monitoring issues. In comparison
with existing solutions for healthcare monitoring systems, a main advantage of the
proposed architecture is to utilize cognitive computing to organize management
processes in IoT-based Blockchain systems. To show the potential of the proposed
architecture, some case studies aimed at combating COVID-19 have been presented.
In presented case studies, the suggested solutions are able to manage impact of
COVID-19 outbreak. In future work, designing gamification algorithms to change
human behaviors in relation to infection rates may be considered. As another direction
in the future work, digital twin technology may be deployed by the cognitive engines
of the proposed architecture. Digital twin technology may also be used to design
personalized medicine in healthcare systems.

Acknowledgements Last but not least, I am dedicating this chapter to my late father Mohammad
Vahdati gone forever away from our loving eyes and who left a void never to be filled ever. Though
your life was short, I will make sure your memory lives on as long as I shall live. I love you all and
miss you all beyond words.

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Chapter 7
Healthify: A Blockchain-Based
Distributed Application for Health care

Pratima Sharma, Rajni Jindal, and Malaya Dutta Borah

Abstract Blockchain technology has received significant popularity, with a growing

interest in various domains, including data processing, financial services, informa-
tion security, and IoT to the healthcare and medical research industries. There has
also been a tremendous trend in using blockchain technologies to provide efficient
data protection in health care. However, through secure and efficient data storage,
blockchain turns traditional healthcare approaches into a more robust means of effec-
tive treatment and cure. In this chapter, we examine both current and latest innova-
tions in the healthcare sector through the application of blockchain as a platform. We
propose a secure distributed application called Healthify, a wide-range healthcare
data protection approach focused on distributed ledger technology where medical
data is encoded to provide a safer environment. The objective of this approach is to
provide a practical application that offers a permanent database and offers simple
accessibility to the gadgets. The application’s basis is specified by the smart contract,
which provides rules and regulations for the users. Also, the architecture of the
distributed application promotes the delivery of secure healthcare services within
the medical system.

Keywords Blockchain · Distributed application · Smart contract · Health care ·

Security

P. Sharma (B) · R. Jindal

Department of CSE, Delhi Technological University, Delhi, India
e-mail: [email protected]
R. Jindal
e-mail: [email protected]
M. D. Borah
Department of CSE, National Institute of Technology Silchar, Silchar, Assam, India
e-mail: [email protected]

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 171
S. Namasudra and G. C. Deka (eds.), Applications of Blockchain in Healthcare,
Studies in Big Data 83, https://doi.org/10.1007/978-981-15-9547-9_7
172 P. Sharma et al.

7.1 Introduction

Blockchain technology offers a transparent, shared, and digitized ledger that

Nakamoto (2008) initially proposed. It is commonly used in transactions of cryp-
tocurrencies, such as Bitcoin (Nakamoto 2008) and Ether (Wood 2014), while it has
developed as a primary technology for more innovations in various scenarios. All the
entities are identical and offer shared resources without a single failing point, thereby
eliminating the possibility of central point bottlenecks. The ledger includes several
transactions, which significantly increases where each block holds a preceding block
hash, a nonce, a time value, and some exchanges. Nodes only approve the block if
all the transactions therein are legitimate. Once a block is linked to the chain of
blocks, it should not be modified under certain security assumptions. In the health-
care sector, blockchain can be applied to create secure and efficient technical systems
to improve the coordination and quality of care and thus, improves the well-being of
individuals and society. The healthcare system is an information-intensive medical
environment where large amounts of data are routinely generated, obtained, and
disseminated. Due to the sensitiveness of data and restricting factors, such as protec-
tion and privacy, storing and distributing this vast volume of data is crucial, as well
as significantly challenging (Griebel et al. 2015). Secure data management is essen-
tial for diagnosis in the healthcare sector and clinical settings, as well as for inte-
grated clinical decision-making. The practice of data management is necessary to
allow healthcare practitioners to store and share their patients’ clinical data to the
concerned authority for rapid follow-up. In health care, protection of secure infor-
mation has been innovated in the last decade through a large number of platforms,
software and communication technologies. All of them concentrate to secure health-
care records, tracking illnesses and developing chronic disease prevention strate-
gies worldwide. Jamoom et al. (2016) have first translated the health records of
paper into electronic health records (EHRs). EHRs must be regularly distributed and
exchanged by various healthcare centers, doctors, nurses, healthcare professionals,
health insurance companies, pharmacy manufacturers, and administration to provide
a realistic way of a person’s health background to give proper and prompt treatment.
In the case of a conventional client–server data management healthcare system,
each hospital/healthcare center maintains its own database of medical records of
sick person; the delivery of EHRs becomes a slow and costly task. Treatment of an
infected person lagged if an ill person travels from one hospital to another. Also, most
of the time, a sick person is required to perform multiple medical tests and cardiology
treatments. Web-based health information monitoring methods (Bahga and Madisetti
2013; Fernández-Cardeñosa et al. 2012; Zangara et al. 2014) have been presented to
solve the accessibility, data usage, single failure point, and security issues that exist
in the client–server architecture. Patient medical information from various hospi-
tals is saved in remote online storage, making it readily available to patients and
healthcare professionals. Nevertheless, this requires doctors and healthcare centers
to encode complex and personal health information of patients before storing on the
7 Healthify: A Blockchain-Based Distributed Application … 173

cloud environment (Namasudra 2018). However, cloud environment also faces data
security issues (Namasudra 2019).
This chapter designs an application that focused on blockchain and protects health
data. In this architecture, users can upload and publish health data periodically.
Doctors, patients, or health analyzers can access the data at anytime and anywhere.
There is a large amount of medical information with the exponential growth of
the hospital’s report. It is not sufficient to document full user information in the
blockchain, as the resource requirements are extremely high for each node on the
blockchain. Considering each blockchain node’s limited storage capacity, an Inter-
Planetary File System (IPFS) supports to share document for high integrity and
durability data storage. There is no single repository in IPFS, and the information is
circulated and collected in various IPFS nodes throughout the Internet. Hence, IPFS
has no single failure point. Without replication, a large volume of data can effectively
spread in IPFS (Nizamuddin et al. 2018). The document stored on the IPFS frame-
work has one distinct hash sequence. In the proposed architecture, complete user
health information is uploaded on the IPFS file framework. Within IPFS, the only
hash sequence of medical information is saved in blockchain to check the validity
of the data and to map the entire data. Healthcare architecture thus promotes the
collection of large-scale health data and has excellent usability. The contributions of
the chapter are given below:
1. This chapter proposes a blockchain-based distributed application for the protec-
tion of large-scale healthcare data, called Healthify. In Healthify application,
clients are allowed to publish healthcare information and access treatments from
doctors. In the meantime, doctors are capable of reading information from users
and upload diagnosis.
2. Healthify distinguishes data publishing transactions from access control transac-
tions. The healthcare information is encoded and processed in IPFS, which may
effectively decrease the overhead of processing while maintaining the protection
of healthcare data.
3. Healthify supports integrity checking and enhances security of the healthcare
data.

7.2 Related Works

This section discusses problems relating to conventional health data monitoring

systems and blockchain-based smart healthcare systems.

7.2.1 Traditional System to Monitor Healthcare Data

Collection of healthcare data is crucial to provide: better treatment, reliable detec-

tion of illnesses, health records for studying and producing successful medications,
174 P. Sharma et al.

and an appropriate prevention strategy. Today, hospitals and healthcare providers are
commonly using EHRs to monitor the medical data of patients using a client–server
architecture (Rind et al. 1997; Schoenberg and Safran 2000; Uckert et al. 2002;
Grant et al. 2006; Gritzalis and Lambrinoudakis 2004; Bonacina et al. 2007; Ibraimi
et al. 2009). But the hospitals are the primary data guardians in this form of data
management system for health care. This thing makes it hard for medical practi-
tioners to give a specific diagnosis or treatment of illness whenever necessary. It is
also tough for sick persons to have a clear understanding of the health records, as their
prescription data mostly found in multiple health centers. Over the past few years,
researchers and organizations have created several cloud-based medical information
management methods (Fernández-Cardeñosa et al. 2012; Bahga and Madisetti 2013;
Zangara et al. 2014) to enable a patient to monitor their medical data from different
organizations. In these schemes, however, a patient maintains essential health infor-
mation in a concentrated cloud-based repository that struggles from a single failure
point and makes the plan vulnerable to mistakes, cyberthreats, and leakage of data.
As a consequence, the present cloud-based and client server-based health informa-
tion monitoring methods are suffering from device vulnerability problems, lack of
transparency, protection, and security, as noted above.

7.2.2 Blockchain-Based Smart Healthcare System

Blockchain is the recent developments in computer technology. Blockchain tech-

nology offers transparent, shared, and digitized ledger. All the entities participating
offer shared resources without a single failing point, thereby eliminating the possi-
bility of central point bottlenecks. Many study results have employed the technology
to fix the weaknesses in the existing EHR. Many research publications (Saravanan
et al. 2017; Liang et al. 2017; Patel 2018; Juneja and Marefat 2018; Griggs et al.
2018) utilized blockchain to solve the privacy and security issues of health documents
by maintaining cloud information hash within the blockchain. Nevertheless, in these
works, the device is prone to a single failure point due to the cloud server. However, the
solution does not address the privacy issue of the health records of patients when they
contained in a centralized cloud repository. Several studies suggest that blockchain
is used to maintain health information in a shared database to solve the single failing
point issue. Most of these studies either introduce new data encoding/decoding tech-
niques (Wang and Song 2018; Zhang and Poslad 2018; Badr et al. 2018), or a more
modern digital signature method (Guo et al. 2018), or a protected scheme of informa-
tion transmission (Zhang et al. 2016; Brogan et al. 2018), or keys generator method
(Hussein et al. 2018) used by the blockchain for health information. Few studies
(Azaria et al. 2016; Dagher et al. 2018; Li et al. 2018; Fan et al. 2018; Dey et al.
2017) have suggested medical information schemes that use blockchain to exchange
patient medical records between various health centers. In Azaria et al. (2016), writers
proposed a blockchain-based information exchange system, MedRec, that interacts
7 Healthify: A Blockchain-Based Distributed Application … 175

with the existing physician data storage solutions and allows for scalability. The appli-
cation enables the physicians to share on the blockchain medical records of patients.
The authors use patient information as a reward for miners, keeping the security of
patient information at greater liability. The authors of Dagher et al. (2018) and Li
et al. (2018) proposed a smart contract-based system for accessing health information
using Ethereum.
The authors of Fan et al. (2018) recommend MedBlock, a blockchain-based health
information delivery scheme that provides efficient accessibility and extraction of
EHRs for an authenticated network. These work (Azaria et al. 2016; Dagher et al.
2018; Li et al. 2018; Fan et al. 2018) do not permit a sick person to transfer data
on their health problems and activities to the blockchain network that would help
healthcare professionals strengthen their treatment and follow-up. On the other hand,
the writers of Dey et al. (2017), Yue et al. (2016) suggest the need for blockchain
for sharing patient information. However, it only allows medical practitioners to
access the health records of patients and does not allow the professionals to dissem-
inate the medical data of patients to the network (treatments, outcomes of labs, and
medication). The authors (Uddin et al. 2018) suggest a medical data network to
exchange health information between different health centers and patients through
blockchain. This study permits both hospitals and physicians to upload patient health
records on the blockchain network, giving a full overview of a patient’s records.
Shen et al. (2019) introduce a system to use blockchain and peer-to-peer networks
such as MedChain to exchange medical data. This system was designed to produce
healthcare data via medical inspection and collect patient data from IoT sensors and
other mobile applications. Zhang et al. (2017) addressed how blockchain-based smart
contracts can resolve various healthcare concerns. They introduced some initial steps
to incorporate blockchain technology for specific healthcare use cases and pointed
to numerous obstacles in adopting blockchain technology. They also elaborated that
creating blockchain-based applications will more effectively tackle healthcare issues.

7.3 Problem Statements

Blockchain is an evolving technological innovation that can offer solutions to real-

world problems, including health care perceived as one of the fundamental human
rights concerns. Over the past few years, blockchain technology has acquired good
faith as a modern, secure distributed network in the form of distributed ledger
to conduct and store records of transactions. However, according to the health-
care perspective, the stakeholders are more interested in exploring and analyzing
blockchain as a tool, instead of concentrating on the healthcare problems that
blockchain may tackle. Therefore, this section outlined the significant healthcare
challenges that this technology can solve and then explores potential solutions via
the proposed application in further sections. Various entities are associated, including
patient, doctor, and healthcare professionals. Blockchain can promote the interoper-
ability of patient’s updated electronic medical records on a timely basis, along with
176 P. Sharma et al.

many other advantages like medical data security, patient identity safety, and care
management. The critical healthcare problems that blockchain technology can tackle
are described below.
• Ensuring security: Ensuring data protection in health care is one of the crit-
ical issues when sharing information among different stakeholders, such as
doctors, research and development units, health agencies, government sectors,
and information given to their caregivers.
• Ensuring the integrity of health records: Improving or preserving the high
degree of data integrity is essential in health care, as these documents indicate
medication, laboratory check, and significant procedure. Record errors may lead
to misdiagnosis and insufficient treatment. These errors can be generated during
record exchange, sharing, and storage in electronic systems.
• Centralized health records: Health information is exceptionally susceptible and
must be protected appropriately. A centralized cloud-based healthcare solution
reveals customer privacy to commercial benefit. For example, consumers only
enable authorized healthcare professionals to access their health data. Still, cloud
providers may release customized EHRs from users for scientific research, medi-
cation advertising, and so on, without the customer’s consent. Where there is a
diagnostic conflict, the patient can assume that the main EHRs saved in the cloud
altered as third-party mistrust.
• Limited access to health records: In terms of the sharing of information on health
care, there is restricted access to health records to ensure security; however, this
often creates obstacles in investigating the study of different conditions and the
results of such medications.
• Interoperability of healthcare information and requests: Interoperability prob-
lems occur when it comes to accessing, sharing, and storing healthcare applica-
tions and data. It first involves confidence building between various stakeholders
and maintaining safe access and transactions. It is assumed that the blockchain is
capable of overcoming these challenges. This chapter also analyzes and explains
how the proposed architecture handles and provides a solution for each identified
problem in the analysis section.

7.4 Background Studies

This section provides an outline of blockchain technology and explains basic terms
and related technologies.
7 Healthify: A Blockchain-Based Distributed Application … 177

7.4.1 Overview of Blockchain

Blockchain is a distributed ledger system, operated on a peer-to-peer network by

various peers (Rabah 2017; Hölbl et al. 2018; Namasudra et al. 2020). This innova-
tion works without any centralized data storage management or central administrator
(McGhin et al. 2019). Information is widely distributed across multiple nodes, and
data consistency is retained by redundancy and encryption (Esposito et al. 2018;
Engelhardt 2017). The idea of blockchain came into existence through a white paper,
written by Nakamoto (Zyskind and Nathan 2015). The key concept was to create a
trustless (Nakamoto 2008) program that uses peer-to-peer distributed ledger tech-
nology to solve the double-spending problem through a mathematical confirmation
of the chronological order of transactions (Curran 2018). Blockchain refers to a
chain of blocks where each block preserves a collection of data (Khatoon et al.
2019; Academy 2019). Each block plays a crucial role in communicating with the
previous block, and the following block, as soon as it is a part of the chain (Yli-
Huumo et al. 2016). Block’s principal function is to register, verify, and transmit
the transactions among other blocks (James 2018). This means that it is difficult
to delete or modify a block in the chain because that will change any subsequent
block (Beck et al. 2017; Erik et al. 2018). Therefore, the blockchain framework is
a distributed information system (Meng et al. 2018; Gipp et al. 2016) that includes
details about all the previous transactions and depends on a pre-selected protocol.
It defines how the transactions are handled, validated, and the working of the entire
network and its members (Mehdi and Ravaud 2017). Also, this network is generally
termed a distributed database, because it is saved on each node running in each of
the networks (Suveen et al. 2017; Ahram et al. 2017). Using hash from the previous
block record (Ovais 2017), a transaction group in blockchain networks is merged
into blocks of transactions linked in the chain. Hence, the primary security feature
of blockchain networks is enforced as a property of immutability (Arati 2017). As
far as the block lies down the chain (the older it is), the more protected are the data
contained in it from adjustments (Saberi et al. 2019). When an intruder attempts to
change some of the keys, the local register will automatically cease to be valid as the
hash values inside the next headers of the blocks will be entirely different depending
on the hash function mechanism (Chris 2018; Florian 2017).

7.4.2 Smart Contract

Smart contracts are coding functions stored on a ledger. Users can specifically call or
establish smart contracts to activate any action (e.g., modifying a smart contract vari-
able through a transaction that could trigger a confirmation response to the contract).
When smart contract methods are called, each entity in the network runs the code,
verifying the output against other nodes through the consensus algorithm. Subse-
quently, the smart function call (arguments) may be added to the blockchain as a
178 P. Sharma et al.

verification transaction. However, it is necessary to remember that the code cannot be

changed once a smart contract is added to the blockchain, due to blockchain’s inherent
immutability property. This immutability property means conventional methods
cannot be used to update code. Additionally, approaches to updating smart contracts
include using intermediate smart contracts that keep the address of the most up-to-
date smart contracts. Intermediate smart contracts that delegate calls pose security
risks and therefore need to be carefully coded, and public lists are requiring users to
check regularly to ensure they have the most up-to-date smart contract address.

7.5 Proposed Work

This section presents the architecture of the proposed application for secure health-
care data management. The architecture contains the main components, such as a
smart contract, IPFS storage, and distributed application, as shown in Fig. 7.1. A
blockchain-based smart contract is designed to check the authenticity of the users
and maintain the integrity of the healthcare data. The smart contract consists of
various functions that are deployed on the blockchain network. Smart contract execu-
tion triggers automatically whenever the user initiates a request to upload/access the
healthcare data to check the user’s authenticity. The healthcare data is stored in the
form of blocks in the peer-to-peer IPFS storage network. The application is imple-
mented to guarantee that anybody, including the users themselves, cannot manipulate
the transactions of users. The application has three types of user transactions: data
transactions, data access transactions, and validation transactions. Data transactions
are used to upload healthcare data, data access transactions are used for accessing
data, and validation transactions are handled to safeguard data integrity.

Fig. 7.1 Architecture of blockchain-based distributed application for healthcare

7 Healthify: A Blockchain-Based Distributed Application … 179

Figure 7.1 presents a layered architecture of the application. It describes all the
entities of the application in different layers showing how the data flows through
them and the functionalities of each layer.
Data Collection Layer The first layer, data collection layer, consisted of different
users, and the user interface of the Healthify using which the users interact with
the application. Firstly, users register on the platform using a distributed application
(Dapp), and his/her details are stored on the Ethereum network using the smart
contract. The user receives a unique address using which the user interacts on the
Dapp. Through the application portal, users may collect their health data. The users
may upload the data manually or can set a time after which the data will upload. The
user sends data on the Dapp, where it accumulates the healthcare data in the form of
files, and the user can also visualize the data and registered doctors list.
Data Processing Layer The second layer is the data processing layer. The Healthify
will utilize the Ethereum platform for implementation, and the blockchain user
utilizes the platform’s functionalities. The users authorize by their public addresses
and digital signatures, and they are generated using their private keys, which ensure
the authority. User access manages using the public–private keys of each user, and
the users can access the data only according to their provided access and authority.
Storage Layer The last layer is the storage layer, which consists of smart contract
and IPFS storage. The smart contract provides a primary application backend that
governs all tasks and authorities of the user. The smart contract is responsible for
creating a record, checking integrity, transferring data, and funds between users. The
smart contract uses an authentication process to ensure the accessibility of security
service. It can check to see if users’ transactions are valid and legitimate. A smart
contract manages the authenticity of the users by checking if the legit user is using the
application. The IPFS storage layer is the layer where the individual healthcare data
are stored, and the user has received a unique hash of the file. The data is encrypted
using the Advanced Encryption Standard (AES) algorithm before uploading it to
the IPFS storage node. The IPFS is a peer-to-peer network and security procedures
to store and share information in a decentralized manner. IPFS utilizes information
addressing to locate each document in a global namespace that uniquely connects
all computing devices. In contrast to a central server, IPFS is developed through
a distributed client–operator scheme, which holds a percentage of the aggregate
information, generating a robust document processing and exchanging system. The
unique file hash is stored on the Ethereum network (smart contract) to maintain the
user’s record.

7.5.1 Threat Model

This work assumes that a protected connection exists between the system and the
user node. Doctor nodes follow the criteria strictly and honestly give the diagnoses.
180 P. Sharma et al.

User and medical professional private keys are protected in storage. The shared IPFS
servers used for saving data use encryption to collect data from users and doctors
safely and stably. It is believed that hospitals or a person who is not part of the
network could be a malicious attacker. Intruders may imitate a customer identifi-
cation, generate malicious blocks or transactions, interfere with interaction, reject
operations, remove or alter transaction information. The network’s critical threat
groups may be divided into four categories: threats to availability, threats to confi-
dentiality, threats to authentication, access control, and threats to integrity. Threats to
availability create problems for a ledger user to view their data, while confidentiality
threats create security-related issues for a user’s healthcare data. Threats to authen-
tication involve the imitation of a client to obtain entry to his records. Threats to
integrity create problems for application users to access correct healthcare data. The
discussion and explanation describe how the proposed architecture handles them in
the analysis section.

7.5.2 Smart Contract Modeling

A smart contract is defined as a digital contract or a computerized protocol used

for the transaction to implement contract terms. It minimizes the need for interme-
diate trust between transacting sides and the existence of accidental or false events.
The smart contract runs on every node in the network independently and automat-
ically (Sharma et al. 2019). It depends on the information to be included in the
initiating operations. The smart contract supports user registration, authentication,
integrity checking functions, and it is published on the blockchain afterward. The
smart contract offers various features to recognize legitimate customers effectively,
efficiently, and securely. The smart contract is a safe and effective programmable
asset that runs as scheduled. The blockchain also publishes all tasks conducted
using the smart contract. The smart contract supports the following characteristics:
(1) allowing the registration of the users, (2) allowing the uploading of healthcare
data, (3) allowing the access of the stored healthcare data, (4) allowing the integrity
checking of healthcare data.
In a proposed architecture, the smart contract consists of various functions, as
shown in Fig. 7.2 for each entity: (1) controller functions: to register a new user;
(2) user node functions: to upload, access, and verify the validity of the data on
request. The functions are in such a way that Healthify users can execute and get
access to storage services. Figure 7.2 shows all smart contract functions deployed
in Healthify for different users. This section presents sample algorithms for the
registration process, sharing data, file uploading, and integrity checking services.
Algorithm 1 represents the function to register the user on the application. The
conditional statements check if the user is already registered as a patient (or doctor) or
not; if yes, then the function reverts with an error message written after the condition.
If the task is completed, it emits an event PatientAdded showing the address of the
7 Healthify: A Blockchain-Based Distributed Application … 181

Fig. 7.2 Smart contract functions

currently registered user. Similarly, the same function is designed for other users of
the application.

1. Algorithm to Register a User (addPatient())

Input: Registered user address
Output: Successful registration of a user
1. if (isDoc[msg.sender] == false)
2. Print “Address is Doctor”;
3. end
4. if (isPatient[msg.sender] == false)
5. Print “Address is already Patient”;
6. end
7. isPatient[msg.sender] == true;
8. allPatients.push(msg.sender);
9. emit PatientAdded(msg.sender);

Algorithm 2 represents the file uploading function. This function is called when
the user is uploading the health data on the blockchain. This function stores the IPFS
hash of the encrypted file on the smart contract. The conditional statements check if
the function is called by a valid user only.

2. Algorithm to Upload File (addFile (_fileHash))

Input: File Hash
Output: Successful uploading
(continued)
182 P. Sharma et al.

(continued)
2. Algorithm to Upload File (addFile (_fileHash))
1. if (isPatient[msg.sender] == true)
2. Print “Address is not Patient”;
3. end
4. PatientData[msg.sender].push(_fileHash);

Algorithm 3 function is called when the user wants to share (or send) the data to any
authorized user. It shows the sample function for registered patients. This function
also deducts the doctor’s fee from the patient account and reverts if the user has
insufficient token balance. Similarly, the function is called by the doctor/diagnostic
center to send a prescription/report to the patient. Once the prescription/report is
sent, the user receives the fee which is stored in the contract.

3. Algorithm to Share File (sendFile(address_doc, _fileHash, _amount))

Input: Registered user address, File hash, Token Amount
Output: Successful Sharing of File
1. if (isPatient[msg.sender] == true)
2. Print “You are not Patient”;
3. end
4. if (isDoc[_doc] == true)
5. Print “Invalid Doctor”;
6. end
7. if (_amount == docFee[_doc])
8. Print “Insufficient fee”;
9. end
10. token.approveContract(address, msg.sender, _amount);
11. token.transferFrom(msg.sender, address, _amount);
12. docPatientList[_doc.push(msg.sender);
13. docPatient[_doc][msg.sender] = true;
14. docData[_doc][msg.sender].push(_fileHash);

Algorithm 4 function is called by different users to check the integrity of the

files stored on the IPFS storage. IPFS storage shared the unique hash for each saved
record. This unique hash of file is used to test the validity of the files. The smart
contract to audit integrity may use the stored metadata of the files. The file hash
value was registered when the file was uploaded. The user will request to access
stored healthcare data to the blockchain network and then automatically execute
the smart contract function. Then, after checking the user’s status, a smart contract
will request a file hash from the network. After this, the smart contract selects the
requested file to check the integrity by recalculating the hash and compares the new
hash with the previously stored hash. If they are equal, the data integrity is safe,
otherwise not. In the end, the network will return the result to the user.
7 Healthify: A Blockchain-Based Distributed Application … 183

4. Algorithm to Check Integrity (checkIntegrity(file, user))

Input: File Details
Output: Checking of integrity
1. var reader = new FileReader();
2. var r = bcrypt.hash(reader.result, salt, function(err, hash){
3. if(err)
4. Print “err”;
5. end
6. else
7. this.setState({bcryptHash: hash});
8. end
9. reader.readAsDataURL(f);
10. varinst = this.props.state.contract;
11. inst.methods.isUnique(this.state.bcryptHash.toString()).call().then(function(res){
12. if(res == true)
13. Print “Integrity completed”;
14. return true;
15. end
16. else
17. return false;}
18. End

7.5.3 Conceptual Scenario

This section presents a model that shows how the user interacts with the Healthify
application and all processes functionalities. Firstly, users register on the platform
using a Dapp, and his/her details are stored on the Ethereum network using a smart
contract. The user receives a unique address using which the user interacts on the
Dapp. Whenever a user wants, the user can send the data to the IPFS file storage, and
in return, the user receives a unique hash corresponding to the stored file. This unique
file hash is stored on the Ethereum network as well (smart contract) to maintain a
record of the user. If a user wants to send his data to another user, the user can transfer
the file (not actual file but only the file hash) along with the fee in the form of tokens.
Once the user receives the hash of the file, she/he views the file content and can send
the response to the user accordingly.
The application basically would consist of four separate users. They will engage
in delivering improved healthcare services through the joint use of self-monitoring
and specialist consultation. The shared relationship occurs as the patient will be given
the option to send the data to the doctor for review, provide feedback, and then act
on his advice. The model of interaction for each user is described below.

Patient Patient satisfaction is an important aspect of the medical sector and the
lifeline for any health-related enterprise or initiative. Personal well-being is a concern
for most of us, and that is why the need for the hour is to find the most effective ways
184 P. Sharma et al.

to improve health conditions. A distributed application is one of those tools used by

one in three health-conscious individuals and ailing patients. Therefore, this work
introduces the Healthify application to provide instant medical services to users.
Figure 7.3a represents the stepwise overall flow of the patient in the application.

Step 1: Initially, the patient must register with the application by providing various
personal information, including his name, age, sex, etc., and data is stored on a

Fig. 7.3 a Flow diagram of patient. b The flow diagram of doctor. c The flow diagram of diagnostic
center. d The flow diagram of healthcare analyzer
7 Healthify: A Blockchain-Based Distributed Application … 185

Fig. 7.3 (continued)

smart contract. The registration phase is compulsory until the user can use the
functionalities of the software. The user then logs on using his/her specific address.
Step 2: Upon logging into the application, the user has a few choices on the
portal. The user can upload the health data using the portal options. Before the data
uploading process, data is encrypted using the AES algorithm to provide a more
secure environment. After encryption, information is divided into multiple shards
and stored in the distributed platform supplied by the IPFS. In response, the user
receives a unique hash corresponding to the uploaded file, which is further utilized
by the user for sharing the file to the doctors or for accessing the file. The data file
186 P. Sharma et al.

for healthcare is created from the consumer’s data over a given period. After this file
is submitted to the application, it will allow the applicant to continue obtaining the
diagnosis/prescription from the application’s registered doctors.
Step 3: The user selects the doctor from the registered doctor list and sends the
individual stored health data unique hash to the doctor. When sending the request,
the selected doctor’s fees deducted from the patient account and save on a smart
contract. The smart contract automatically transfers the stored tokens in the doctor’s
account once the patient receives the prescription.

Doctor The work of a doctor is essential to every medical care process, and we
include the provision in our proposal to obtain input from doctors. The patient should
be able to report to the selected doctor. But this feature must depend entirely on
the customer’s decision whether she/he follows the doctor’s feedback. Interaction
between the patients and the doctors was a significant obstacle due to the hectic
schedules and availability of physicians. It is a little inconvenient for patients to call
the doctors anytime of the day, given the fact that real-time contact is highly needed
for treatments and cures. The medical apps, fortunately, provide instant solutions
to this issue. Medical applications are provided between healthcare providers and
patients to address this challenge in the industry. Doctors are actively using digital
technologies to ease their day-to-day processes and provide their patients with effec-
tive, enhanced, and improved care solutions. Therefore, the proposed application
provides the interaction between the patients and the doctors to combat the issues
mentioned above. Figure 7.3b represents the stepwise overall flow of the registered
doctor.

Step 1: The doctor registers on the application using the same procedure and then
uses his unique credentials to sign in to the application.
Step 2: When the doctor is logged in, she/he should be able to view a patient’s data
via a user interface, which allows him/her to pick the patients. After the patient’s
selection, the data should be available for the review by the doctors, except that
after reviewing the patient’s information, the doctor should be able to add his/her
suggestions or input. Remember that the data used for monitoring will not be editable
by either the patient or the physician. Doctors are allowed to view the files using the
file hash shared by the patients.
Step 3: Once the doctor uploads the prescriptions, the prescription sends to the
patients in the same manner, and the doctor receives his fee in the form of tokens,
especially design for the proposed application. After posting the doctor’s comments,
the user/patient will be able to see that once after signing in to their account.

Diagnostic Center One of the most tedious tasks for everyone is receiving medical
records from test centers. Adding to that was the pain of taking these reports to doctors
or having immediate consultation about the same. Mobile apps make electronic
monitoring of their health records simple for patients. Patients may check the reports
directly from the centers, and the same can be exchanged immediately with the
doctors. Therefore, no more trouble picking up files from centers or carrying them to
hospitals. Thus, the proposed application allows diagnostic centers to register at the
7 Healthify: A Blockchain-Based Distributed Application … 187

portal and provide quick services to the users in a more secure manner. Figure 7.3c
represents the overall flow of the registered diagnostic center.
Step 1: The diagnostic center starts with the registration process and obtains
unique credentials.
Step 2: After logging into the system, the diagnostic may store the generated
reports to the IPFS storage and obtained the unique hash of the file.
Step 3: The diagnostic shares the stored report hash to the registered patients by
checking the details stored on the smart contract. The diagnostic center also allows
to check the integrity of the shared document and ensures security.
Healthcare Analyzer Healthcare experts include a wide range of specialists and
practitioners who provide some form of healthcare service, including primary care
practitioners such as nurses, doctors, surgeons, physical therapists, medical labora-
tories, healthcare researchers, scientists, and social workers. They mostly work in
hospitals, healthcare centers, and other service delivery points, but often in academic
training, science, and management. Health analysts play a key and essential role in
enhancing the quality of health care. Based on the primary healthcare model, they
provide critical services that promote wellness, prevent diseases, and provide health-
care services to patients, families, and communities. Thus, the proposed application
included the interface for healthcare analyzers to provide a medium for improving
the quality of health care. Figure 7.3d shows the stepwise overall flow of healthcare
analyzers.
Step 1: The healthcare analyzer starts with the registration process and obtains
unique credentials.
Step 2: After the registration process, healthcare analyzer may utilize healthcare
data to improve the quality of healthcare services, tools, medications, and diagnostic
methods.

7.6 Performance Analysis

In this section, we are dealing with validating Healthify efficiency and viability. The
section is further split into two subparts. The first subsection presented the imple-
mentation and deployment setting of the application. In the second part, we analyze
the application’s performance by using the processing time required for uploading
different sized files on IPFS, the computation time needed for the completion of the
transactions, and the cost incurred for the deployment of the smart contract.

7.6.1 Experimental Setup

The proposed architecture implements a decentralized application that supports a

blockchain network with a decentralized file system (IPFS). Ethereum framework
188 P. Sharma et al.

has been used to develop smart contracts for healthcare blockchain. This is an open-
source platform and presently one of the largest public blockchain networks with
an active community and a large collection of public Dapp. The Dapp can detect
discrepancies, unauthorized access to the data, and missing objects. Ganache tool
is used to setting up Healthify blockchain network to deploy contracts, develop
Dapp, and run tests. It provides the environment to perform all the actions on the
main chain. Ganache also provides ten default user accounts, each with a hundred
Ether. The proposed application experimental setup consists of two parts, distributed
application setup and a smart contract deployment. Thus, the implementation settings
are described in two tables, respectively, to explain each part. Table 7.1 describes the
development environment of a distributed application. The user interface is designed
using React Native as it has excellent compatibility with the Ethereum client. Node
JS is used to connect with the backend, i.e., connection with Ethereum and IPFS.
The deployment settings of smart contracts are described in Table 7.2. Smart
contracts are developed in Solidity language, which is the primary smart contract
language for Ethereum. These are designed by using online compiler remix.ethereum.
The key elements of the smart contracts are functions, events, state variables, and
modifiers and are written in the Solidity programming language. The remix test
network is used to deploy smart contracts on the testnet, and Ethers are utilized to
pay the transaction fee. Three stages are involved in the creation of smart contracts,
which use Solidity programming to write, compile, and announce. The real-time
compiler Solidity creates the bytecode. Ethereum wallet is used to announce smart
contracts to the blockchain.

Table 7.1 Development

Component Description
environment for the proposed
application RAM 4 GB
Operating system Windows 10
Server Apache Tomcat
Frontend React native
Backend Node JS
Host Infura
Encryption AES
Data storage InterPlanetary File System

Table 7.2 Development

Component Description
environment for the
blockchain smart contract RAM 4 GB
Operating system Windows 10
Ethereum 2.0
IDE Remix Ethereum
Programming language Solidity
7 Healthify: A Blockchain-Based Distributed Application … 189

7.6.2 Performance Evaluation

This section presents the actual results of the work to assess the output of the proposed
application. Several experimental tests were performed using various parameters.
The processing time would include the time to send a transaction query to access
the health document and the amount of time it takes for the upload process until the
user receives an acknowledgment. For this test, we used different sized health files
and noted the time for each file uploading process, as shown in Table 7.3. These are
approximate times, and these solely depend on the number of peers and the Internet
connection speed at the moment.
The proposed architecture is also evaluated for computation time required for
data storage, data access, and validation transactions. The computation time is the
average time taken by the proposed application to execute the series of transactions
requested by the users. As shown in Fig. 7.4, the Healthify application calculated
the computation time for a series of hundred transactions. A total of five hundred
transactions are initiated by different users to analyze the computation time of the
proposed application for different types of transactions.

Table 7.3 Time required for

File size (x) Time (in s)
uploading different sized files
x < 1 MB ~0.02
1 MB < x < 10 MB ~0.1–~2
10 MB < x < 100 MB ~2–~15
100 MB < x ~15<

Computation Time

400-500
No. of Transactions

300-400

200-300

100-200

0-100

0 20 40 60 80 100 120 140

Computation Time in Sec
Validation Transactions Data Access Transactions Data Storage Transactions

Fig. 7.4 Computation time required for completion of transactions

190 P. Sharma et al.

Table 7.4 Deployment cost of contracts

Contract Cost (ETH) Cost (Dollar)
Health token 0.0408706 $10.94
Health care 0.0715839 $19.16
Total cost 0.1124545 $30.1

Table 7.5 Gas used in calling/sending functions of smart contract

Function Gas (ETH) Gas (Dollar)
Register patient 0.002535 $0.68
Register doctor 0.003149 $0.84
Initial transferring of coins (minting 1000 coins) 0.001997 $0.53
Patient adding file 0.003214 $0.86
Patient sending file to doctor 0.007091 $1.9
Doctor sending file to patient 0.006174 $1.65

There is a requirement to estimate costs associated with deploying smart contracts

for healthcare in terms of executing blockchain. In Ethereum blockchain, all
programmable calculations cost some fees to prevent network misuse and to solve
other computational-related issues. The fee is listed as gas in Ethereum blockchain
to run all kinds of transactions. Gas refers to the payment or price value provided
by the Ethereum blockchain platform for a successful transaction or execution of
a contract as shown in Table 7.4. The exact gas price is calculated by the miners
of the network, who may decline to handle a transaction if the price of gas does
not reach their mark. All functions, computations, message calls, smart contract
creation/deployment, and storage on Ethereum Virtual Machine (EVM), therefore,
require gas to execute all of these operations, as shown in Table 7.5. When a user has
no legitimate balance account, she/he is unable to carry out any form of operation
and is thus deemed invalid. In EVM, Ethers (ETH) are used to buy gas, and users
running the transactions can set their account gas limit for the particular transaction.

7.7 Security Analysis

A threat model is constructed to ensure the accurate determination of the attack

surface for the proposed application. Several threats are outlined in Sect. 7.5. This
section explains how the designed architecture addresses the identified threats. Asso-
ciated mitigation processes are driven to ensure security. The risks are categorized
into four categories:
1. Threats to availability: Healthify users may easily access health data by using
the unique credentials that reduce the chances of fake requests and prevent the
7 Healthify: A Blockchain-Based Distributed Application … 191

system. Users are allowed to access the stored files by using unique hash obtained
at the time of the uploading process. The unique sequence of hash mapping with
document provides a secure and efficient environment. Users can securely access
the data anytime, anywhere, by using the gadgets.
2. Threats to confidentiality: Healthify used the AES algorithm to encrypt the health
data, thus preventing secrecy. It utilizes the IPFS for storing health data. There-
fore, due to the immutability feature of decentralized storage and mapping of
data to the hash, the attackers cannot access data and prevent confidentiality.
3. Threats to authentication and access control: In essence, the proposed application
provides the registration portal through which users may obtain the credentials
and access the application portal services according to the role assigned.
4. Threat to integrity: In the attack on data manipulation, an intruder attempts to
change or erase a specific user’s information. The application’s data cannot be
changed because of the blockchain’s immutability feature. If the intruder attempts
to alter or remove any information, the network may detect the violation using
the application’s integrity check function and notifies the users.

7.8 Discussion

This section discussed the potential solutions provided by the distributed applica-
tion for the secure management of broad-scale health data. It also presents a useful
comparison between the existing approaches and proposed application and highlights
the assessment findings.

7.8.1 Mapping of Challenges and Solutions

This section presents the analysis of identified problem statements in Sect. 7.3. All
the defined problem statements are analyzed along with the potential solutions deliv-
ered by the proposed application. Table 7.6 represents the solutions provided by the
proposed application.

7.8.2 Comparison

This section performs the proposed platform’s comparative analysis with some of
the latest platforms examined in the related work. A comparison survey is conducted
to illustrate the built platform’s performance and flexibility, and the findings of the
assessment are summarized in Table 7.7.
192 P. Sharma et al.

Table 7.6 Mapping of problem statements and solutions

Challenges Potential Healthify solution
Ensuring security The proposed application utilizes a decentralized
storage network. It is a peer-to-peer network that
distributes workloads among several nodes and
improves security. It also used the encryption
algorithm to provide a more secure environment
Ensuring integrity of health records The Healthify application utilized the integrity
checking mechanism by using smart contract
functionality, thus ensuring integrity features
Limited access to healthcare data The proposed application incorporated the
registration process that restricts access to healthcare
records. Each user assigned a unique address, and
the stored data is mapped to the designated address
that provides the access control method
Interoperability of healthcare information It stores the healthcare data by dividing it into
multiple shards and sharing the unique file hash to
the user. Therefore, it provides safe interoperability
of healthcare data with the help of a unique file hash
Deficient architecture Healthify utilizes a distributed blockchain-based
structure for maintaining healthcare records.
Therefore, no single point of failure

Table 7.7 Comparative analysis of the proposed application with the existing studies
Author Cryptocurrency Mining Smart Blockchain Integrity File Access
used required contract platform checking storage policy
Azaria No Yes No Permissioned Yes Database Yes
et al. gatekeeper
(2016)
Dagher No Yes Yes Permissioned Yes EHR DB Yes
et al.
(2018)
Li et al. No Yes Yes Consortium Yes Cloud Yes
(2018) storage
Fan et al. No No No Permissioned Yes Blockchain Yes
(2018) as storage
Dey et al. No Yes Yes Permissioned No IPFS Yes
(2017)
Yue et al. No No No Permissionless Yes Blockchain Yes
(2016) cloud
Uddin Yes Yes Yes Customized Yes Blockchain Yes
et al. blockchain cloud
(2018)
Shen et al. No No No Permissioned Yes Healthcare Yes
(2019) database
Proposed Yes (tokens) Yes Yes Permissioned Yes IPFS Yes
application
7 Healthify: A Blockchain-Based Distributed Application … 193

For this analysis, the characteristics mentioned above play a crucial role in
comparing the existing frameworks. It also represents the overall blockchain plat-
form’s success and shows the importance of our proposed approach. As shown in
Table 7.7, the proposed system offers a more appropriate environment for storing
healthcare data as compared with the existing works for the following reasons:
(1) Users may use the distributed application anywhere anytime by using smart-
phones, (2) utilized the decentralized storage (IPFS) for securely saving users files
instead of static databases, (3) designed tokens for providing services to the users.
It also prevents the malicious activities, (4) designed smart contract to store user-
related/token-related information during the communication between the users, (5)
the health data of each individual can only be accessed by him/herself.

7.9 Conclusions and Future Works

This chapter introduced a distributed application for secure authentication and access
control of broad-scale health data. We have implemented the application to guar-
antee that the medical data of patients is secured to prevent diagnostic conflicts.
We designed a smart contract for authentication, access control, file sharing, and
token management process to obtain secure and flexible healthcare data manage-
ment. Furthermore, users can validate the integrity of documents to ensure security
and privacy at anytime. The results, performance evaluation, security analysis, and
comparison study show that our plan fulfilled the safety and storage requirements.
The proposed application could easily be extended by providing more services to
users in the healthcare domain.
Key Terms and Definitions
Healthcare Data Healthcare data is a digital version of a patient’s paper medical
history that provides information to approved healthcare practitioners instantly and
securely. They include patient medical and may store information outside traditional
clinical data obtained at a provider’s office, such as diagnoses, medicines, treatment
options, reactions, and test results.
Distributed Application (Dapp) A Dapp is an independently managed open-source
application that operates its data and stores records cryptographically in a distributed
blockchain (e.g., via a smart contract) to avoid single points of failure. To monetize
the Dapp, it uses a new or cryptographic token. The tokens are required to use the
services provided by the application.
InterPlanetary File System (IPFS) The IPFS is a decentralized, peer-to-peer file
network designed to link all computer nodes to the same file system. There is no
single repository in IPFS, and the information is circulated and collected in various
IPFS nodes throughout the Internet. Hence, IPFS has no single failure point. Without
replication, vast volumes of data can effectively spread in IPFS. The document stored
on the IPFS framework has one distinct hash sequence.
194 P. Sharma et al.

Advanced Encryption Standard (AES) The more popular and widely adopted
symmetric encryption algorithm. AES is a cryptographic cipher that uses a block
length of 128 bits and key lengths of 128, 192, or 256 bits. AES is based on a
design principle known as a substitution–permutation network and is efficient in
both software and hardware. It is essential for computer security, cybersecurity, and
electronic data protection.

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Pratima Sharma is a Research Scholar, Department of Computer Science and Engineering at

Delhi Technological University, India. Prior to this, she worked as an Assistant Professor, at Inder-
prastha Engineering College, Ghaziabad, for nearly three years. She received the M.Tech. and
B.Tech. degrees in Computer Science and Engineering from Guru Gobind Singh Indraprastha
University, Delhi, India, in 2013 and 2015, respectively. She developed HoneyDos application for
preventing the system from malicious packets and denial-of-service attack using support vector
machine technique during the postgraduation degree.
Her research and publication interests include blockchain technology, honeypot, network secu-
rity, information security, and data mining. She has presented papers at international/national
conferences, published articles, and papers in various journals.

Rajni Jindal is working as Professor and Head at the Computer Engineering Department, Delhi
Technological University, Delhi. She received her M.E. from Delhi College of Engineering. She
completed her Ph.D. (Computer Engineering) from Faculty of Technology, Delhi University,
Delhi. She also worked as Professor (IT), Dean (Research and Collaboration) at Indira Gandhi
Delhi Technical University for women, Delhi, for 3 years. She possesses a work experience of
around 29 years in research and academics.
Her research interests include database systems, data mining, operating systems, and compiler
design. She has authored around 100 research papers and articles for various national and inter-
national journals/conferences and five books. She is a senior member of IEEE and a life member
of CSI.

Malaya Dutta Borah is an Assistant Professor in the Department of Computer Science and Engi-
neering at the National Institute of Technology (NIT) Silchar, Assam, India. Before joining NIT
Silchar, she worked at Assam Engineering College, Delhi Technological University, Inderprastha
Engineering College.
She has received her Engineering Degree (B.Tech.) in Computer Science and Engineering,
Master of Engineering (with distinction) in Computer Technology and Applications, and Ph.D. in
Computer Science and Engineering. She has authored/co-authored around 30 research papers in
national/international journals/conferences. She is actively involved in research works in the field
of data mining, blockchain technology, cloud computing, ICT, and e-governance. As of now, she
has organized three international conferences (Springer and IEEE) in India as Organizing Chair,
198 P. Sharma et al.

Finance Chair, and member. She is an editorial board member of the International Journal of Infor-
mation Systems and Social Change, IGI-Global, and reviewer for various journals and interna-
tional conferences. She is the associate member of CSI (India) and IEEE. Online Profile: https://
cs.nits.ac.in/malaya/.
Chapter 8
Blockchain in Pharmaceutical Sector

Meet Kumari, Meenu Gupta, and Chetanya Ved

Abstract The pharmaceutical research and development is a composite process that

grabs lots of years in drug discovery, drug development and regulatory approval in
the supply chain in the pharmaceutical sector. But due to the drugs counterfeiting,
such as hidden, uncontrolled and outdated information of drug regulatory authority
and manufacturers over drugs supply leads to producing, marketing and consuming
counterfeit drugs. For this, blockchain is the fittest in these scenarios where data
security and privacy protection is the priority. It confirms the security of drugs on
the market with high trust and quality of health care for the population and recipes
by using modern authentic digital devices. In this chapter, it has been discussed that
how blockchain technology concerning the supply chain in the pharmaceutical sector
helps to add visibility, traceability and privacy to the medicines and drugs system.
Here, it has been discussed that how blockchain technology in the supply chain in the
pharmaceutical sector helps to add visibility, traceability and privacy to the medicines
and drugs system. Also, it has been explained how the drug usability, its effect on
patient and data recorded to the blockchain database and the authorized blockchain
used for these statistics to store the transactions in the pharmaceutical sector. Also,
the drug usability, its effect on the patient, data recorded to the blockchain database
and authorized blockchain used for these statistics to store the transactions for the
future has been explained. Further, its future applications, challenges and solutions
to guard people’s life are discussed.

Keywords Blockchain · Counterfeiting · Drug · Pharmaceutical · Supply chain ·

Telemedicine

M. Kumari (B)
Department of ECE, Chandigarh University, Punjab, India
e-mail: [email protected]
M. Gupta
Department of CSE, Chandigarh University, Punjab, India
e-mail: [email protected]
C. Ved
Department of Information Technology, Bharati Vidyapeeth’s College of Engineering, Delhi, India
e-mail: [email protected]

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 199
S. Namasudra and G. C. Deka (eds.), Applications of Blockchain in Healthcare,
Studies in Big Data 83, https://doi.org/10.1007/978-981-15-9547-9_8
200 M. Kumari et al.

8.1 Introduction

8.1.1 Brief Detail of Blockchain

The development of digital technology such as blockchain is considered as one

of the modern, promising and economical in the modern world. Blockchain is a
distributed ledger system having widespread flexibility, and various economic sectors
sought ways of integrating its capabilities into their functional operational (Siyal et al.
2019; Segara et al. 2019). Although most of the motive has been on the economical
services industry, the latest work in the pharmaceutical industry also started using
this paradigm. The pharmaceutical research and development is a composite process
that grabs lots of years in drug discovery, drug development and regulatory approval
in the supply chain in the pharmaceutical sector (Makhdoom et al. 2019; Aleksic
2019). But due to the drugs counterfeiting such as hidden, uncontrolled and outdated
information of drug regulatory authority and manufacturers over drugs supply leads
to producing, marketing and consuming counterfeit drugs (Deshpande et al. 2017b;
Lamb and Curtin 2019). For this, blockchain is the fittest in these scenarios where data
security and privacy protection is the priority. The presence of blockchain technology
into the pharmaceutical sector allows tracking all levels of production of drugs along
with their quality (Nofer et al. 2017; Qian et al. 2018). It confirms the security of
drugs and recipes by using modern authentic digital devices. This consequences a
reduction in counterfeit drugs on the market with high trust and quality of health care
for the population (Ratta et al. 2020)
The blockchain has emerged as innovative technology and gained remarkable
attention, with various applications, ranging from financial services, data manage-
ment, food science and IoT to biomedical research (Deshpande et al. 2017a; Qin
2017). Thus, there has been a significant attentiveness in utilizing blockchain tech-
nology in the next-generation passive optical network for transparent, high speed,
less costly, energy-efficient and secure networks. By utilizing the six major elements
of blockchain technology such as decentralized, transparent, open-source, autonomy,
immutable and anonymity, these issues can be overcome in the pharmaceutical sector
(Seliem and Elgazzar 2019; Chen and Huang 2018). Blockchain is a heterogeneous
ledger technology having the potential to interrupt many industries. It is a distributed
ledger to maintain and track a tamper-proof and permanent record of the decentral-
ized network. Blockchain can be public, private and it depends on the capability to
be a customer or node (Crosby et al. 2016; Zheng et al. 2018; Dinh et al. 2018).
Figure 8.1 shows the basic architecture of the blockchain.
Blockchain technology has various applications such as power, food, agriculture
and supply chain. Among lots of activities likely to be transferred by blockchain
technology, the supply chain deserves important attention (Dinh et al. 2018; Kshetri
2018). The current supply chain is complex consists of geographically disjointed enti-
ties, multi-echelon, etc. For this, globalization consists of regulatory policies, human
behavior and varied culture in the supply chain to make it impossible to find and
manage information in the network (Siyal et al. 2019; Chen and Huang 2018; Hussein
8 Blockchain in Pharmaceutical Sector 201

Blockchain Block
Node 1

Blockchain Blockchain
Node 2 Node 3
Block Block

Fig. 8.1 Architecture of blockchain (Nofer et al. 2017; Mohanta et al. 2019)

et al. 2019). Inefficient transactions, poorly performing supply chains, pilferage and
fraud supply chains lead to trust shortage thus the need for good information sharing,
traceability and verifiability (Saberi et al. 2019; Xu et al. 2016).

8.1.2 Problem in the Pharmaceutical Industry

As in pharmaceutical industry drugs counterfeiting like uncontrolled, hidden and

outdated information of drug regulatory manufacturers and authority over drugs
supply provide to producing, marketing and consuming counterfeit drugs. Hence,
blockchain is the most advantageous in these scenarios for data security and privacy
in the pharmaceutical industry. It helps in drug security confirmation in the market
with trust and quality of health care for the people and recipes by using modern
authentic digital devices (Namasudra et al. 2020c).

8.1.3 Existing Solutions of the Problem

in the Pharmaceutical Industry

In 1976, a research paper was published on “New Directions in Cryptography,” which

discusses the distributed ledger concept. Then, one more paper got published on “Hot
to TimeStamp a Digital Document” to laid out the concept of the advancement of
cryptography and to timestamp the data. Then, another “Electronic cash” concept
contributed toward the innovation of blockchain technology (Hasselgren et al. 2020;
Kleinaki et al. 2018). Satoshi Nakamoto is the inventor of blockchain technology who
published a paper on “Bitcoin: A Peer-to-Peer Electronic Cash System” in 2008. This
202 M. Kumari et al.

paper provides the concept of the electronic payment system based on cryptography,
and it also provides the solution to the two times money spending where no one
can spend money more than one. After an open-source bitcoin implemented, the
system was released within a few months. The first bitcoin network was begun in
2009 (Sarmah 2018; Albanese et al. 2020). Bitcoin holds the lion share, the most
famous market cryptocurrency among the others such as Dogecoin, Litecoin, etc.
(Sarmah 2018; Alladi et al. 2019a). Schöner, Manuela M, et al. presented a blockchain
technology-based solution for enhancing the supply chain privacy and security for
the pharmaceutical industry means supply chain security (Schöner et al. 2017).
Kshetri, Nir reported the effect of blockchain is examined on supply chain manage-
ment by considering the concept of speed, risk reduction, cost, quality and flexibility.
The case studies in this paper show transparency and accountability of supply chain
management and various ways to achieve the above supply chain goals (Kshetri 2018;
Abou Jaoude and George Saade 2019). Clauson, Kevin A et al. presented the various
challenges, issues and opportunities associated with using blockchain technology
in health care for the deployment of health supply chain in pharmaceutical supply,
Internet of healthy things (IoHT), public health sectors and medical devices has been
discussed. The results show that critical challenges in the health supply chain can be
omitted by the development of blockchain technology in health care (Clauson et al.
2018; Tamazirt et al. 2018).
Again, in (Jain and Mishra 2018), the introduction of blockchain technology,
uses in different applications and future scope in supply chain in the next gener-
ations has been presented. Further, the authors discussed the security and trust of
blockchain with its challenges and solutions against counterfeit malpractices for
supply chain. Also, the role of blockchain in improving business relationships to
know the truth about this technology has been discussed. Chang, Yanling et al.
discussed the blockchain technology is introduced in supply chain management for
sustainability and its applications. Then, its major advantages are described to main-
tain sustainability dimensions along with various challenges while implementation
of blockchain technology in a sustainable supply chain (Chang et al. 2019). Also, in
(Wu and Lin 2019), the decision-making process, corrective and preventative action
(CAPA), out of specification (OOS), out of trend (OOT) and the action of the working
group have been recalled in blockchain technology in the pharmaceutical field. This
helps in shortening time, protecting and transparency.
Chang, Yanling et al. provided the use of blockchain technology to provide critical
synthesis has been presented. Again, the taxonomy of pilot initiatives in the pharma-
ceutical industry for the wide applications of blockchain technology in the private
field has been provided. The efforts, implications and open challenge of blockchain
technology for governmental agencies and the existing gaps among governmental
agencies, the private sector and the public sector are also identified (Chang et al.
2019). Also, Jameela and Nader proposed and reviewed various industrial applica-
tion fields for using blockchain technologies. It also explores the benefits, opportu-
nities and open challenges of blockchain technology in different industrial applica-
tions has been presented. It also identifies the basic requirements that support the
applications of blockchain for various industrial applications that has been revised
8 Blockchain in Pharmaceutical Sector 203

by Al-Jaroodi and Mohamed (2019). Workman, J. P. presented the various merits

and demerits of blockchain technology in the biomedical domain. It was explored
how multiple challenges in medical such as data ownership, accessibility and cost
can be inscribed by blockchain, equally important or not. The clear merits and
demerits of blockchain technology identify the open area’s innovation for biomed-
ical entrepreneurs, academics and executives (Workman 2008). Further, Jovic, A.
et al. analyzed the medical signal has been analyzed based on Web systems, and they
describe the own design of software architecture. Here, the applications, medical
education, home care, visualization capabilities, signal repositories, signal analysis
circumstances and data mining have been examined of biomedical signals. Also, the
various open challenges, such as frontend workflow, frontend interactions, backend
interactions, data analysis integration, reporting libraries, programming language
challenges and data privacy, have been discussed (Jovic et al. 2018).
In (Namasudra et al. 2017, 2020a, b; Namasudra and Roy 2017; Namasudra
2018, 2019; Namasudra and Deka 2018; Sarkar et al. 2015), authors discussed about
managing of data using DNA-based cloud environment. The cloud-based environ-
ment helps in managing data and improves healthcare-related functionality such as
virtual medication, telemedices and care plans. Service, C., and Via, P. MeDShare
proposed a MeDShare system that presents the healthcare information issue sharing
with medical big data guardians in a faithless environment. The proposed technique
was based on blockchain technology and provides data control, auditing and prove-
nance for medical shared data among entities of big data in cloud repositories, Nozari
and Szmelter (2020). MeDShare helps in monitoring access information entities for
malicious use in a data guardian system. It helps in data sharing and transitions
in substances having tasks performed on the proposed method. It shows that the
proposed system, along with cloud service and data guardians, provides data prove-
nance, control and auditing, which helps in medical institutions and various research
institutions with less risk factor of data privacy (Service and Via 2017). Hussein, A. F.
et al. presented a blockchain technology-based managing technique to provide inter-
pretation enhancement concerning medical fields. Here, two blockchain methods
have been used for constructing base and blockchain algorithm utilized to produce
a secure series for a hash key. It shows that it helps in handling various kinds of
data types as well as biomedical images and text. Again, it shows a latency up to
750 ms indicating its use in hospitals and clinics at 400 requests/second (Hussein
et al. 2019). Similarly, Mamoshina, P. et al. represented a review of the blockchain
and artificial intelligence-based on next-generation innovative solutions to encourage
the research in the healthcare domain with the latest tools for controlling and profiting
from data utilized personally has been provided for regular health monitoring (Jain
et al. 2020). Here, the novel concepts have been discussed to evaluate and appraise
personal records with relationship value and time combinations of data. It is shown
that how blockchain-based decentralized technological personal data provides new
techniques for healthcare maker development, discover of the drug as well as preven-
tative medical care. The combined deep learning and blockchain technologies help
in resolving the open challenges accepted by personal data such as medical records
and regulators (Mamoshina et al. 2018). Pournader, Mehrdokht et al. presented the
204 M. Kumari et al.

latest academic and industrial frontiers in blockchain technology in the supply chain
transport management and logistics system. The systematic review and co-citation
analysis contain four main clusters, namely traceability/transparency, trust, trade
and technology, which have been presented (Rejeb 2018). The applied inductive
method in reasoning and the emerging themes along with various applications of
blockchain technology for supply chains, transport and logistics have been applied.
It is concluded that future-based blockchain technology’s main themes and its appli-
cations (Pournader et al. 2019). It is observed that there are very few existing reviews
that focus on the role of blockchain in pharmaceutical industries and its applications.
Specifically, in this chapter, the detailed review of the role of blockchain in pharma-
ceutical industries to create visibility, traceability and privacy to the medicines and
drugs system among people has been presented (Si et al. 2019; Mistry et al. 2020).

8.1.4 Motivation and Proposed Scheme

Thus, in this chapter, blockchain technology in the pharmaceutical sector has been
explained in detail. Here, it has been discussed that how the blockchain technology
in the supply chain for the pharmaceutical sector helps to add visibility, traceability
and privacy to the medicines and drugs system (Mougayar 2020; Horst Treiblmaier
2020). Firstly, it has been explained how the drug usability, its impact on patients’
health and data recorded to the blockchain database for the future purpose. Secondary,
the authorized blockchain used for these statistics to store the transactions has been
discussed. Also, its future applications, challenges and solutions to guard people’s
life are discussed (Khezr et al. 2019; Rejeb 2018; Sengupta et al. 2020). Here, the
introduction about blockchain technology, its background and its role in pharma-
ceutical industries have been introduced in Sect. 8.1. In Sect. 8.2, telemedicine in
blockchain for pharmaceutical sectors and its advantages as well as disadvantages
has been described. Section 8.3 describes the pharmaceutical drug discovery process.
Section 8.4 presents the blockchain-based supply chain in pharmaceutical industries
that incorporating the supply chain process to manage and detect fake drug using
blockchain technology. Sections 8.5 and 8.6 present the applications, challenges
and future research opportunities, respectively. Finally, the conclusion is drawn in
Sect. 8.7.

8.2 Telemedicine

In the previous ten years, telemedicine has emerged as a healthcare communication

technology for better understanding the utilization of information to send healthcare
services at a distance. As technological communication restrictions have been defeat
and costs have reduced, clinicians from a huge range of specialisms have observed the
potential for enlarging health care and enhancing its cost-effectiveness and quality
8 Blockchain in Pharmaceutical Sector 205

(Norris 2001). Also, some of the examples are given as follows which are significant
to tackle technology (Hjelm 2005).
1. Access extension: The enlarging healthcare access to communities as well as
individuals who have restricted, erratic or no access to medical services has
encouraged telemedicine developers from recent times. Beneficiaries consist of
patients who reside in rural areas with limited healthcare professionals for care
and residents who live in periodically cut-off areas form general transport by
worst weather (Tachakraet al. 2003).
2. Traveler’s health care: Public members who live within fixed access to medical
services at first level may see themselves contradict their travels (Dhillon and
Forducey 2006).
3. Military applications: These applications in perception are comparable
providing health care for patients and travelers from general access to first-level
medical facilities. Since the circumstances are different, and the conventional
disease incidence to emergency conditions is normally opposite civilian life
(Dhillon and Forducey 2006). Major advantages of telemedicine are as follows:
• It has enhanced information access.
• Enhanced services access and improving care delivery.
• Enhanced professional education.
• Screening programmers quality control.
• Minimize healthcare costs.

The disadvantages of telemedicine are as follows:

• A failure relationship between patient and health professional.
• A failure relationship among health professionals.
• Quality of health information issues.
• Bureaucratic and organizational difficulties.

8.3 Pharmaceutical Drug Discovery

Pharmaceutical industries are continually trying to enhance the quality of medicine

by inventing new medicines for distinct diseases. These medicines are required to
move by a long process to ensure the patent’s protection, efficiency, safety, approval
and validity from the regulatory authorities as this process consists of many years
with significant steps from discovery or pre-clinical to commercialization. As a result,
such a long process is unsafe for drug recall because of a lack of privacy and security
(MacDonald 2017).
This challenge can be overcome by using blockchain technology within the phar-
maceutical process. Security and privacy can be reserved by using blockchain tech-
nology. The private blockchain type can be used to ensure the all pharmaceutical
process to preserve the patient security with the help of smart contract that provides
transparency, traceability and integrity (Crosby et al. 2016). Moreover, counterfeit
206 M. Kumari et al.

Table 8.1 Current open issues within the modern pharmaceutical industries (Bell et al. 2017)
S. No Issues Working in pharmaceutical industries
1 Data exchange The healthcare data must be passed between medical providers and
necessary third patients insure and parties with high protection
2 Interoperability These should be a single standard for medical data exchange
3 Device tracking The medical tracking device allows for the swift curing of devices,
protection of fraud analysis and repurchasing
4 Drug tracking Drug tracking from the supply chain for patients allows for the
protection of counterfeit drugs

drugs are the world problem with general consumers and public risks. Thus, many
researchers are working on pharmacy surveillance blockchain system which will
improve the transparency, traceability and integrity of counterfeit drugs (Chang et al.
2019; Khezr et al. 2019).
The supply chain and smart contract with distributed ledgers motive for providing
interoperability and developing a traceable and transparent system in the pharma-
ceutical sector. To increase the tracing and tracking ability in the pharmaceutical
supply chain, there is a requirement of integrating the smart contract-based system
with the distributed ledgers (Khezr et al. 2019). The smart contract will play the role
of getting digital signatures recorded in digital signature-based distributed ledger
with an increment of each phase in the supply chain, which is incorporated with a
transaction-based distributed ledger (Valentina et al. 2020; Rosa Righi and Alberti
2020). At each incremental phase in the supply chain, the smart contract also gets
updated with the next phase. To maintain transparency and security of supplies, this
system will provide this capability to every node to cross-verify its previous digital
signatures and transactions at any point. It will be going to maintain trustability
between the trustable organization and non-trustable organizations will improve the
transparency, traceability and integrity of counterfeit drugs (Chang et al. 2019; Khezr
et al. 2019) (Table 8.1).
All the above challenges in pharmaceutical industries can be overcome by
blockchain technology as follows (Bell et al. 2017; Kosba et al. 2016).
1. Blockchain can help to reduce the increasing risk of unapproved and counter-
feit drugs. With the help of blockchain technology, the healthcare device can
track drugs and identify pills with integrated smart GPS and chain of custody
mechanism (Agbo and Mahmoud 2020).
2. In healthcare clinical trials, blockchain can minimize fraudulent results and data
removal, which is not significant for the researcher’s bias.
3. It allows for an immutable log to be kept the trail subject consent.
8 Blockchain in Pharmaceutical Sector 207

8.3.1 IP Management and Clinical Trial

Intellectual property management (IPM) plays a significant role in various sectors

of society. As the utilization of blockchain technology in public health, it is a highly
sensitive area means the how IPM is utilized in the pharmaceutical industry (Wipo
1957; Andanda 2013; Stoimenova et al. 2013; Awan et al. 2009).

8.4 Supply Chain Process to Manage and Detect Fake Drug

Using Blockchain Technology

The pharmaceutical drug chain starts with the development process of a drug as the
pharmaceutical drug development process is a complex process that takes an average
of fifteen years, starting from the discovery of drugs to regulatory approval. For this,
the pharmaceutical industrial process is structured into three phases, wherein the first
phase lots of test phases proceeded by industries to the various test phases and at
last market access is granted. It starts with discovery followed by pre-clinical testing
and finally filed for patent protection. As shown in Fig. 8.2, firstly, the clinical test
starts with primary healthy human testing, followed by testing in a larger community
of patients for safety and efficacy. These trails are done in three phases, such as
phase 1, phase 2 and phase 3. In these phases, the efficacy, effeteness and safety are
tested. Moreover, each phase is ended up with a proceeded decision, termination or
suspended testing. After clinical trial completion, the firms may file for marketing
approval. Here, the critical decision goes to the market to control the pharmaceutical
organizations (We et al. 2017) (Fig. 8.3).
For this, the new drug is regulated by a government agency to control the phar-
maceutical industry by exercised trusted regulatory control. Then, pharmaceutical
industrial negotiate pricing after successful authorization of markets with other stake-
holders, e.g., payers. The added value is processed by the pharmaceutical innovator
and reviewed by the efficient and quality institute (Tamazirt et al. 2018). When
the drug is up-scaled for distribution and manufacturing, the consumers’ safety and
quality are the main issue (Di Francesco Maesa and Mori 2020). Supply chain privacy
is one of the main aspects that won attention to the drug supply chain security imple-
mented. Then, after successful implementation of act verification of the drug, legit-
imacy is done to enhance the detection of illegal medicines. At last, by packing and
selling the drugs in a country with minimum price, the various opportunities occur in
pharmaceutical companies (Deshpande et al. 2017; Radanović and Likić 2018). The
blockchain technology can have an opportunity to increase security, trust and trans-
parency with users being able to track drugs in pharmaceutical industries through
supply chain management. With the help of blockchain, only trusted patties can be
delivered by scanned code bar to see the product history for ensuring verification,
tracking, notification and identification in case of the illegitimate drug found (Bell
et al. 2017; Radanović and Likić 2018) (Fig. 8.4).
208 M. Kumari et al.

Fig. 8.2 Smart contract-based supply chain management system

Supply chain management in the pharmaceutical industries is tough and complex,

with medicines changing ownership from wholesalers, distributors, ownership and
repackages. There is no transparency for the manufacturing plant by the supply chain
to track the authenticity of drugs. Moreover, the counterfeit drug problem includes
implementing returns and recalls processing. This further loses finance and recall
processing, as well as trust among users (Kshetri 2018; Radanović and Likić 2018).
The supply chain allows for business, government agenesis, consumers and author-
ities to manage the risks in a document and responsive way. Traceability focuses
mainly on upstream supply networks, the origin of raw components and tracking
the source. Its scope extends to downstream capabilities, tracing materials with
multi-layer distribution networks by the end users (Kleinaki et al. 2018). Presently,
the sellers and buyers have no efficient and reliable way to validate the details
of services and products. This is due to the lack of transparency and traceability.
Surprisingly, governments, consumers and companies are enhancing demands more
8 Blockchain in Pharmaceutical Sector 209

Phase 3
Volunteer
paƟent, validity,
Approval 3.5 years

Drug
Development
Process
Pre-clinical Phase 2
Research and Volunteer
animal test, paƟent, safety,
paƟent 2 years
protecƟon, 6
years

Phase 1
Healthy, safety,
1.5 years

Fig. 8.3 Blockchain in pharmaceutical industries (Schöner et al. 2017)

Fig. 8.4 Process of smart contract-based supply chain management

210 M. Kumari et al.

transparency from brands, producers and manufacturers throughout the whole supply
chain (Hussein et al. 2019). For this, blockchain technology tracking capabilities will
provide a full audit trail for every touchpoint of transaction data in the supply chain.
This will help in improving the traceability of the supply chain among government,
customers and businesses with the authenticity of products for sustainable supply
chain (Chang et al. 2019; Dorri and Dorri 2017).

8.4.1 Detecting and Managing Fake Drug

The working steps of blockchain in pharmaceutical industries are as follows for

detecting and managing fake drugs:
1. Step-1: Firstly, a block is generated on the invention of the new medicine, which
consists of protection for a long process of various clinical trials. Further, this
information is stored in a digital ledger in the form of block transactions.
2. Step-2: After that, when the trial of clinical is tested and got successful, then
the patent is sent to the manufacturing plant for further test prototype and mass
production. Here, each product has its own defined identity, which is integrated
with a block or transaction in the blockchain.
3. Step-3: As mass production is finished with packaging, then the medicine is
collected from a warehouse for the next distribution near the future. This step
contains the information like time, expiry date, lot number and barcode included
in the blockchain.
4. Step-4: Then, the transportation information is included in blockchain for
time out from warehouse IN to warehouse OUT, authorized agent, way of
transportation and information.
5. Step-5: The third-party heterogeneous network is accountable for distributing
medical supplies and drugs to healthcare retailers or providers. A warehouse OUT
is used for all distribution linked endpoints. Moreover, a separate transaction is
integrated into blockchain.
6. Step-6: In this step, care providers like hospitals or clinics provide sensitive
information, such as batch number, expired date, lot number and product owner,
to verify and prevent counterfeit drugs.
7. Step-7: At last, the patients are motivated to find verification throughout the entire
process as blockchain supply chain technology provides the real and transparent
information for verification (Fig. 8.5).

8.4.2 Advantages of Supply Chain Process Using Blockchain

1. Transparency: This system aims to provide transparency by integrating two

distributed ledgers so that it keeps track of signatures as well as the transactions.
8 Blockchain in Pharmaceutical Sector 211

Patients
7

Healthcare
providers/
Retailers
Warehouse
6
Out

Transpiration 5

Warehouse In 4

Manufacturing 3
Plant

Pharmaceutical 2
Clinical Research

Fig. 8.5 Steps of working blockchain technology in pharmaceutical industries (Khezr et al. 2019)

2. Traceability: Cross-verification and validation are easy at every step of trans-

actions. So that if any counterfeiting or damage gets occurred, it will be
traceable.
3. Security: The concept of blockchain enhances the security level of various
applications. Decentralization also improves other factors which makes this
technology more adaptable in real world.
4. Trustability: Distributed ledger maintains the trustability between non-trustable
and trustable organizations.
With fully private blockchains, write permissions are given only to members of
an organization but read permissions can still be public or restricted to some or
all participants of the network, thus providing a greater level of privacy. This way,
keeping patients’ medical records, modifying balances, reverting transactions and
changing the blockchain rules can be easily achieved by a company or a health
organization running their private blockchain. Furthermore, because the validators
of a private blockchain are known, there is no risk from 51% attacks. Although the
incidence is lower in the developed world, it is estimated that counterfeit drugs cost
the European Union pharmaceutical industry around e10.2 billion or 4.4% of sales
each year and result in a direct loss of around 40,000 jobs (Wajsman et al. 2016).
Additionally, there has been a 400% increase in the number of counterfeit drugs
from 2005 to 2010 in Europe alone. Blockchain systems could be used to record
212 M. Kumari et al.

the movement of pharmaceuticals and for their authentication throughout the supply
chain. Every manufactured item could be marked by a unique code, and blockchain
could be used to check the authenticity of the code and the product (Schöner et al.
2017).
Further, the supply chain consists of distinct partners: carriers, forwarders, pre-
wholesale providers, wholesalers, etc. The quality management is significant to the
pharmaceutical sector. Here, each supply chain participant has an important role
in providing quality, efficient and safe medicine in public and provides a result of
therapy responsibility. Securing and protecting the pharmaceutical supply channel
need constant vigilance in collection with channel partners such as distributor, manu-
facturer and pharmacy with state and regulatory agencies. But the medicinal product
quality affected by adequate control lack over various activities that happen during
the process of distribution. Thus, to maintain the real medicinal product quality, each
activity consisted of their distribution should be bearded as per the good manufac-
turing practice (GMP), good distribution practice (GDP) and good storage practice
(GSP) principles (Stoimenova et al. 2013; Di Francesco Maesa and Mori 2020;
Biswas and Muthukkumarasamy 2016).

8.5 Potential Applications Related to Blockchain

Technology in the Pharmaceutical Sector

The applications of blockchain technology in pharmaceutical industries are as

follows:
• The implementation of blockchain technology pharmaceutical industries helps in a
healthcare organization. The most obvious strength is managing patient data in the
form of electronic health records. This will helps in storing patient data securely
and can be distributed among many hospitals, institutes, insurance providers, etc.,
without full access to scattered patient databases (Schöner et al. 2017; Alladiet
et al. 2019b).
• It allows patients to manage data structurally and available to researchers, such
as exchanging determined cryptocurrency fees. This data record helps in making
tamper-proof entries to empowers patients (Farhad Ameri et al. 2020).
• Also, there is no need to carry data papers having the medical history and diagnosis
process results. It saves time and money, as well. This will further improve the
smart pharmaceutical industries’ management system (Pournader et al. 2019;
Radanović and Likić 2018).
• The large data pool of patient can be used to guide the public health policies for
the population to permit easier allocation at palaces when they needed. Also, the
national public health in the USA is investigating the way the blockchain may be
used to share the medical data between pharmaceutical organizations (Tamazirt
et al. 2018). In the case of a pandemic, sensitive patient information can be shared
with lots of pharmaceutical industries on time.
8 Blockchain in Pharmaceutical Sector 213

• The blockchain technology can secure the private data move fast and timely
(Radanović and Likić 2018; Eklund 2019).
• The education of medical is an important field for showing the benefit of
blockchain technology in the pharmaceutical field. This technology can be used
to track and store the medical education data among students in the form of
records on the digital ledger for continue growing, achieving, an article written,
rate and share the performance of every procedure performed (Clauson et al. 2018;
Radanović and Likić 2018).

8.6 Challenges and Future Research Opportunities

Blockchain technology is regarded as the prominent technology for providing

systemic, economic, same access service, improved longevity, etc. It is a very
promising technology in the pharmaceutical sector with different application
fields like healthcare management and automated medical adjustment. Health care
performs data exchanging, precision medicine, drug counterfeiting, as well as longi-
tudinal medical healthcare records. Blockchain technology in the pharmaceutical
sector solves the issues of reliability of looking at lacking data, data dredging, etc.,
in the various clinical trials and resolves the healthcare-related problems of patients
(Seliem and Elgazzar 2019; Albanese et al. 2020).
As the blockchain technology is beneficial in healthcare industries; however, lots
of open challenges and issues related to technical and non-technical face the devel-
opment and adaption of blockchain in pharmaceutical industries. There are some
of the key heightened challenges of using blockchain technology in pharmaceutical
industries are discussed as follows (Wu and Lin 2019; Radanović and Likić 2018).
Table 8.2 shows the challenges and issues occurred in blockchain technology for
healthcare industries.
1. Security: It is one of the main concerns of using blockchain technology in phar-
maceutical industries. It happens due to the availability of blockchain appli-
cations over the Internet, which may be vulnerable for lots of cyber-attacks
such as stealing, denial-of-service (DoS) and spy attempts, which can affect
the blockchain services. One of the attacks that compromise a cryptocurrency
system is the 51% attack, which is also known as majority attack (Jovic et al.
2018; Eklund 2019). This attack permits to reject transactions and allows for own

Table 8.2 Major challenges

S. No Challenges and issues
and issues
1 Security
2 Integration
3 Scalability
4 Privacy
5 Technical
214 M. Kumari et al.

coins to spend many times, which is also known as double spend. This attack
is more resistant to bitcoin having more cryptocurrencies with communities of
miners. Thus, security plays an important part in protecting from such attacks.
Unfortunately, the blockchain technology and its models increase the vulner-
ability while operating on multiple platforms (Radanović and Likić 2018; Nir
Kshetri 2019).
2. Integration: As the blockchain solutions are integrated with multiple distributed
applications to enable the addition of new applications used within the pharma-
ceutical industries. This leads to challenges due to security and interoperability
issues. The example of this challenge are smooth and secure integrated legacy
applications, different operating environment and platforms need incorporation to
operate blockchain-based solutions in pharmaceutical industries (Kleinaki et al.
2018). Moreover, the integration process becomes more complex due to the pres-
ence of different environments, methodologies and programming languages in
integrated pharmaceutical organizations. Further, the integration must be secure,
consistent, reliable and available for opening new doors for tomorrow phar-
maceutical industrial sectors (Jain and Mishra 2018; Al-Jaroodi and Mohamed
2019).
3. Scalability: As the current pharmaceutical industries require blockchain tech-
nology to generate a large number of transactions to link and process, which may
easily reduce the performance of the healthcare system (Hussein et al. 2019).
Moreover, the bigger the blockchain size in pharmaceutical industries slower will
be the process. Scaling becomes a major issue when the no. of entries involved
increases in transitions performed. These issues create the operational and busi-
ness issues to pharmaceutical industries applications (Al-Jaroodi and Mohamed
2019; Saberi et al. 2018).
4. Privacy: In a public blockchain, some pharmaceutical industries participants can
verify and view the transitions, contribution, etc., in the blockchain process while
others cannot. However, all participants are restricted to the strict agreement on
authorization policies. Also, in the private blockchain transition process, the oper-
ation and control are done by a single entry with its own rule and regulation (Siyal
et al. 2019) as the different blockchain types are used in variable applications.
In a public blockchain, all pharmaceutical industry participants are difficult to
maintain who can see all the transition process. While in private pharmaceutical
industries, participants have high degree of security and privacy needed, which
is generally considered as insecure (Al-Jaroodi and Mohamed 2019; Moin et al.
2019).
5. Technological challenges: The lack of technical and technological knowledge
of blockchain technology is a serious challenge for the adoption of blockchain
technology in pharmaceutical industries (Saberi et al. 2019). It requires a certain
degree of literacy of complex and simple blockchain. Thus, efforts are neces-
sary for improving user experience and developing blockchain protocols (Chang
et al. 2019; Moin et al. 2019; Namasudra et al. 2017b, 2020b; Namasudra 2018;
Namasudra and Deka 2018; Sarkar et al. 2015) (Fig. 8.6).
8 Blockchain in Pharmaceutical Sector 215

Fig. 8.6 Challenges and

issues in blockchain
technology in
pharmaceutical industries Integration
(Chang et al. 2019; Jain et al.
2020; Namasudra et al.
2017a, 2020a; Namasudra
and Roy 2017; Namasudra
2019) Security Scalability
Challeng
es and
Issues

Technolo
gical
Privacy
challenges

Further, blockchain technology can solve the various problems presents in phar-
maceutical industries. A trusted owner can enable novel healthcare solutions, and the
right machine can enable the novel business model to lead new dynamic healthcare
stakeholders like providers and patients (Mohanta 2019; Schöner et al. 2017).

8.7 Conclusion

Blockchain is the most important technological innovation in recent years. It is a revo-

lutionary concept that can be successfully applied to bring transparency, security and
flexibility among the users. Due to this, blockchain technology has become a game-
changer for lots of pharmaceutical industries. This technology has opened new doors
to the next future new possibilities with economic empowerment. Although it has lots
of challenges in pharmaceutical industries, such as security, professional preparation,
scalability, privacy and integration, and the future of blockchain technology looks
promising solutions for the pharmaceutical sector. It has been described that using
blockchain in the biomedical domain will benefit a vast amount of patients, health-
care providers, healthcare entities, medical practitioners, pharmaceutical researchers
and research and development specialists to dispense a large amount of information
significantly. Blockchain recommendations in the pharmaceutical field have guar-
anteed security excellent privacy protection. It will surely open innovative research
avenues for the next future advanced pharmaceutical research. This would help in the
sharing of safe, scalable acquisition, secure, etc., clinical data in developing potential
methods for the treatment of diseases. The transparent and decentralized feature of
216 M. Kumari et al.

blockchain would restrict medical data from being stolen or changed. Consequently,
the blockchain-based biomedical domain system will grab patients more in their
excellent health care to ultimately enhance the quality of human life.

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Meet Kumari is an Assistant Professor (ECE-UIE) at the Department of Electronics and Commu-
nication Engineering at Chandigarh University, Punjab, India. She has done her graduation and
postgraduation from Guru Nanak Dev University, Regional Campus (GNDU RC) Gurdaspur and
GNDU RC Jalandhar, respectively, Punjab, India. Currently, she is pursuing a Ph.D. from Punjabi
University Patiala, Punjab, India. She has published around 10 research papers in different journals
(SCOPUS) and conferences. Her areas of interest are the next generation of wireless communica-
tion networks. Her areas of interest are wireless communication, optical communication and deep
learning.

Meenu Gupta is an Assistant Professor (CSE-UIE) at the Department of Computer Science Engi-
neering at Chandigarh University, Punjab, India. She has done her Ph.D. from Ansal University,
Gurugram, in Computer Science in the year 2020. She received an M.Tech degree in the year 2010
from MDU University, Rohtak, with a specialization in Computer Science and Engineering. She
was awarded an honors degree in B.Tech (Information Technology) in 2006 from NC College
of Engineering, Kurukshetra University. She also received an award of Best Project Display in
2006. She completed many certifications like a rational seed, Vb.Net, DBMS by oracle, DBA
from Microsoft and CDC from Govt. consultancy. She also certified faculty of MTA and MOS.
Her research interests are cloud computing, blockchain, big data, IoT, deep learning and machine
learning. A total of 12+ years of academic/research experience with more than 30+ publications
in various national, international conferences cum international journals (Scopus/ESCI/SCI) of
high repute. She is a lifetime member of educational society like ISTE and IAENG. She hosted a
session chair at the IEEE conference, the year 2017. She guided the thesis of M.Tech students and
handled the project of B.Tech (CSE). She published four subject books named, Web Development
Using core Java, Theory of Automata & Computation, Analysis & Design Algorithm and Visual
Basic C++. She also contributes to writing book chapters of reputed book calls (i.e., Springer-
Scopus, Elsevier, Taylor & Francis, DeGruter, Apple Academia, etc.). She also worked on patent
filing and submitted two patents for further recommendation. She attended many workshops
and seminars along with she did a research fellowship program from IITD. She also attended
FDP programs of reputed College/University/Organizations such as Infosys, C-DAC, IIITD, ISTE
sponsored, CSI sponsored and UGC sponsored. In her teaching scenario, she worked as an event
coordinator, workshop/seminar/conference coordinator, exam evaluation coordinator, training and
placement coordinator, etc. She also organized a five-day FDP and worked as a co-convener. She
organized industrial visits in Infosys (Chandigarh), Network Bulls, Wipro, TCS, IAON, etc. She
received many appreciation letters for conducting events.

Chetanya Ved is a student currently pursuing B.Tech in Information Technology from Bharati
Vidyapeeth’s College of Engineering, New Delhi, India. He has been part of various conferences
and events related to Information Technology. Organized and founded various events in college
society which is associated with IEEE. Attended Delhi Section Congress in IIITD which is orga-
nized by IEEE of Delhi Section in October 2019. He has been a student member of IEEE for
1 year. He has been instructor and mentor of several workshops of society which is associated
with IEEE. He has completed his higher secondary education from N.C Jindal Public School, New
Delhi, India, in 2016.
Chapter 9
Accelerating Life Sciences Research
with Blockchain

Wendy Marie Charles

Abstract As life sciences research becomes increasingly focused on patient-

centered technologies that allow for remote participation and greater access,
distributed ledger technologies (“blockchain”) are being developed to address these
needs. Blockchain-based applications range from basic functions, such as securing
electronic data with audit trails, to honoring research participants’ informed consent
for secondary uses of their data, and to the advanced features of aggregating data
on a single platform for sophisticated machine learning, and hundreds of examples
in between. There are many questions, however, about the best uses of blockchain
and implementation strategies for life sciences research. This chapter introduces uses
of blockchain for life sciences research and offers ethical, regulatory, and practical
considerations for implementation. Recommendations are pertinent for blockchain
developers, researchers, and life sciences organizations considering blockchain
solutions for their research.

Keywords Blockchain · Life sciences research · Governance · Ethics · Consent ·

Regulatory compliance

9.1 Introduction

While life sciences research involves increasing volumes of data and a greater need
for real-world evidence (U.S. Food and Drug Administration 2019c), current research
data collection and storage systems face limited capabilities to meet emerging tech-
nological needs (Efanov and Roschin 2018). As examples, there are few cost-
effective methods to integrate data silos or easily aggregate data from multiple
sources (Angeletti et al. 2017a). Further, most electronic data capture systems for life
sciences research are not designed to give research participants access to their data
or honor specific terms of their preferences for future uses of their data (Benchoufi

W. M. Charles (B)
Life Sciences Division, BurstIQ, Denver, CO, USA
e-mail: [email protected]

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 221
S. Namasudra and G. C. Deka (eds.), Applications of Blockchain in Healthcare,
Studies in Big Data 83, https://doi.org/10.1007/978-981-15-9547-9_9
222 W. M. Charles

et al. 2018). Blockchain and other distributed ledger technologies (referred to collec-
tively as “blockchain”) offer capabilities that could solve many obstacles of life
sciences research in a secure and systematic manner (Hughes et al. 2019). Most
notably, blockchain offers opportunities to accelerate research innovation in ways
not possible with current data technologies.
At this early stage of blockchain development for life sciences research,
blockchain developers and operators often express lack of familiarity with research
infrastructure and related data and technology standards (Kakavand et al. 2017).
Similarly, research organizations may be cautious to implement new technologies
due to uncertainties about best practices and an unpredictable regulatory climate
(De Filippi and Hassan 2016). This chapter explains blockchain uses and considera-
tions to developers and life sciences research stakeholders to help them understand
blockchain features that advance research capabilities.

9.1.1 Overview of Life Sciences Research

Life sciences research is conducted to determine the effectiveness of new treat-

ments or understanding of the physiology and manifestations of the disease. Research
studies are directed by detailed protocols carefully designed to answer specific scien-
tific questions. These protocols specify aims/objectives, inclusion criteria, methods
for data collection, safety monitoring, and statistical analyses (Friedman et al. 2015).
Because data are now customarily collected and processed electronically (with
decreasing uses of paper-based processes), blockchain is aiding the life sciences
industry in processing data. The following section briefly summarizes a few different
types of life sciences research with comparisons of trial features (Refer to Table 9.1
for trial types and characteristics, with the presentation style inspired by Park et al.
2020.).

9.1.1.1 Clinical Trials

A clinical trial is “a prospective study comparing the effects and value of interven-
tion(s) in human beings” while conducted in a clinical or medical setting (Friedman
et al. 2015, p. 2). While there are many clinical trial designs, these types of trials
study a person’s health by applying an intervention with varying combinations of
procedures, diagnostic methods, prevention strategies, therapeutic drugs, devices,
biologics, or treatment regimens (Friedman et al. 2015). The outcome of an inter-
vention is referred to as “efficacy” to recognize that the outcome was studied under
tightly controlled circumstances—the ideal setting (Angeletti et al. 2018; Friedman
et al. 2015).
When conducting studies with the intention of developing new drugs or devices,
pharmaceutical, and device trials involve highly controlled study designs and rigid
protocols. All stakeholders must follow the rules of the applicable regulatory agency
9 Accelerating Life Sciences Research with Blockchain 223

Table 9.1 A comparison of basic research trial types and their primary characteristics
Clinical trial Pragmatic trial Participatory trial
Expertise needed for Expert Expert Public
trial design
Objective Clinical assessment Decision-making, policy Information delivery,
development study planning
Outcome Efficacy Effectiveness Effectiveness
Protocol type Structured and rigid Structured and Structured to fluid
explanatory and interpretable
Enrollment target Selective within Representative of Representative of
patient population patient population patients, caregivers,
and providers
Data collection Very controlled Moderately controlled Loosely controlled
prospective prospective or prospective
retrospective
Research environment Clinical Community Community
Electronic assessment Medical grade Medical grade to Consumer grade
tools consumer grade

to ensure solid scientific outcomes and ethical protections of the human participants
(Charles et al. 2019; Turner 2010).
For both safety and data integrity, study participants typically visit a clinical or
medical facility for testing and checkups. The frequency and distance of these study
visits become burdensome for research participants (Angeletti et al. 2017b) as well
as logistically challenging and expensive to conduct (Steinhubl et al. 2019). There is
increasing interest in alternative study designs to facilitate more practical methods
of data collection.

9.1.1.2 Pragmatic (Real-World Evidence) Trials

Within the past several years, there has been greater emphasis on studies that reflect
“real-world” healthcare and management. These studies are referred to as “pragmatic
trials” or “real-world evidence trials” because they are designed to evaluate interven-
tions in settings that more closely represent patients’ or communities’ typical health
experiences (Thorpe et al. 2009). For example, this type of research may assess the
outcomes of patients who have received the standard of care by collecting information
from their medical records. Other methods of data collection may involve patient-
completed surveys, questionnaires, or healthcare applications designed to collect
patient-reported outcomes (Park et al. 2020). Any patient/participant involvement
in data collection is designed to minimize the burdens and maintain engagement
(Schultz et al. 2019). The interventions’ outcomes are referred to as “effectiveness”
because it is believed that the outcome reflects real-world behavior and typical clinical
practice (Ethier et al. 2017).
224 W. M. Charles

A current example of a large pragmatic study originated from a research partner-

ship between Johnson & Johnson and Apple called the HEARTLINE study (Datta
2019). The goal of this study is to determine if the Apple watch could assist with diag-
nosing atrial fibrillation. Any member of the public who meets structured cardiology
criteria and owns an Apple watch can enroll. Volunteers answer survey questions on
their phone and allow information to be transmitted from their Apple watches. As of
March 2019, this pragmatic study enrolled 180,000 people (Datta 2019).
There is increasing interest in pragmatic studies because they are typically
conducted at much lower cost than a clinical trial and do not require as much as
much burden on the research participants (Ethier et al. 2017). Regulatory agencies,
such as the US Food and Drug Administration (FDA), have expressed strong support
for pragmatic trials because these trials not only reflect typical patient behavior, but
can include patients who are unable to visit clinical research sites—often due to the
distance (Dorsey 2017; U.S. Food and Drug Administration 2018).
While promising, pragmatic trials can be hindered by the same limitations that
accompany real-world treatments. There is unpredictable patient compliance with
treatment, clinicians demonstrate variety in the “standard of care,” there may be
heterogeneity in patient populations, and patients may have many co-morbidities
that confound the relationships between interventions and outcomes (Ethier et al.
2017; Park et al. 2020).

9.1.1.3 Participatory Trials

Scientists in many research fields are also exploring the creative and innovative oppor-
tunities afforded by participatory trials. A participatory trial, sometimes referred to
as a “crowdsourcing trial,” reaches out to large group of volunteers in the public
or patient communities to help answer research questions in a real-world setting.
In many circumstances, researchers post-enrollment information via social media
or reach out to participatory sites, such as Amazon Turks (Park et al. 2020). The
looser eligibility criteria and enrollment processes allow researchers to collect a
large volume of data quickly and inexpensively. Further, “citizen science” members
of the public may also be asked to provide feedback about data collection methods
or to suggest endpoints that may be more meaningful to the patient group being
studied (Park et al. 2020). The primary drawback of studies that lack close oversight,
however, is that data tend to be less reliable and may unintentionally collect complex
unstructured information (Park et al. 2020).
As a current participatory trial, the Eunice Kennedy Shriver National Institute
of Child Health and Human Development is currently sponsoring a crowdsourced
application-based data collection method to obtain current real-world information
about pregnancy management and complications (PregSource: Crowdsourcing to
understand pregnancy 2020). All adult pregnant women are eligible to participate.
There is a click-through informed consent process that collects minimal personal
information. Using an application, participants are asked to answer questions about
9 Accelerating Life Sciences Research with Blockchain 225

weight, health conditions and treatments, and emotions throughout their pregnancies.
Up to 100,000 pregnant women are invited to participate.

9.1.2 Overview of Blockchain Protocols and Algorithms

As blockchain technology is increasingly used for life sciences research, there

is a need to determine the best blockchain protocols and algorithms to support
the intended research uses. The selection of the most suitable platform should be
examined from many perspectives: performance, functionality, security, scalability,
interoperability, and usability of smart contracts (Smetanin et al. 2020).
Performance is often measured among three types of metrics: (1) system node
metrics (details about memory and storage), (2) blockchain metrics (number and
speed for producing blocks), and (3) peer-to-peer (P2P) metrics (number of peers
and nature of P2P traffic) (Smetanin et al. 2020). Blockchain platform characteristics
are discussed below by type of platform, consensus mechanisms, and considerations
for whether data should be stored on the blockchain (“on-chain”) or in a separate
storage location (“off-chain”).

9.1.2.1 Permissioning and Consensus

A comprehensive overview of the types of blockchain protocols or consensus mech-

anisms is outside the scope of this chapter. Pertinent concepts will be briefly intro-
duced as they apply to life sciences research. While early descriptions of blockchains
described public/permissionless and private/permissioned terminology, this binary
classification is largely considered obsolete. Privacy and permissioning are no longer
mutually exclusive because the technology has evolved to allow permissioning on
some public blockchains. For example, Ethereum Private and Enterprise Ethereum
offer private zones but still use the Ethereum codebase and can connect with the
Ethereum platform (About Enterprise Ethereum Alliance 2020; Private Ethereum
networks 2019). For simplicity, the following types of networks will be referred to as
public, private, consortium, and hybrid. Further, with the consideration that there are
currently more than 66 consensus protocols employed in various platforms (Shahaab
et al. 2019), the reader is encouraged to examine detailed reviews on this topic (e.g.,
Ray et al. 2020; Shahaab et al. 2019; Shetty et al. 2019).
The first types of blockchain platforms created were “public” chains, such as
Bitcoin, Ethereum or Monero, to promote trustless and transparent cryptocurrency
transactions. In a public blockchain, anyone can join and participate in the consensus
process to verify the validity of information and approve blocks (Calvaresi et al.
2019). Permissionless platforms require storage distribution across many nodes to
strengthen the security and integrity of the entry (Jung and Pfister 2020). Because of
the large number of nodes in the distributed network, there are no single points of
failure and the platform is generally resilient to security attacks (Zhang et al. 2019).
226 W. M. Charles

The most common type of consensus mechanism for public blockchains involves
proof of work. This mechanism relies on “mining,” where all nodes compete to find
a “nonce,” a random number that requires intensive computing capability to find in
order to create a block (Calvaresi et al. 2019).
For life sciences research, the transparent nature of public chains is not suitable for
the proprietary or private information processed and stored. Further, data processing
could be slow and computationally intensive, creating performance limitations for
the volume, and speed required. The need for financial incentives to create blocks or
the cost of data mining may also be cost-prohibitive (Lopez et al. 2019). Last, due to
the need to have some centralized governance of data and decision-making for life
sciences research, a public infrastructure is generally not appropriate (Wong et al.
2019).
In contrast to public blockchains, platforms with a governance structure requiring
permission to join, post, or view information are referred to as “private” blockchains
[Note that there is some controversy as to whether the network and governance
features of permissioned platforms meet the definition of “blockchains” (Lopez et al.
2019)]. These private networks are synchronized and distributed, but their networks
are usually restricted to nodes that are known and invested in the network, such as life
sciences research sponsors, healthcare organizations, or academic institutions who
are willing to make an investment in the governance and privacy (Essén and Ekholm
2020). The governance structure allows for planning and decision-making about
preventing or managing nodes’ collusion, malicious actions, or failures (Calvaresi
et al. 2019). As a final consideration, these private networks are supported by the
organizations within the governance structure and therefore do not require mining
or incentives for block storage and maintenance (Choudhury et al. 2019).
Common private blockchain platform structures include Hyperledger Fabric,
Ethereum Private, R3 Corda, and MultiChain (Calvaresi et al. 2019). In addition,
private blockchain companies dedicated to healthcare or life sciences research include
BurstIQ, Carechain, ConsenSys Health, Hashed Health, and Patientory, among others
(Essén and Ekholm 2020). Due to the investment and control required for blockchain
governance, private blockchains often utilize “proof of stake” or modifications of this
consensus structure to validate and store transactions in a manner that does not require
intensive computing (Zhuang et al. 2018).
A “consortium” blockchain model is thought of as a semi-decentralized network
where multiple organizations provide support and decision-making for blockchain
operations. Because of the need for permissioning across separate legal entities, a
consortium model may include infrastructure from private blockchain models and/or
hybrid models (Ray et al. 2020).
A “hybrid” model combines the best features from public and private platforms or
may offer a private network that connects to a public blockchain. The public platform
could store metadata and proof of transactions for data integrity and immutability,
while the private platform could store confidential information (Benchoufi et al. 2019;
Sato and Himura 2018). As an example, ConsenSys adds a private network module,
Hyperledger Besu, to the public Ethereum platform for private enterprise blockchain
solutions (Enterprise Ethereum: 5 reasons why Enterprise Ethereum is so much more
9 Accelerating Life Sciences Research with Blockchain 227

than a distributed ledger technology 2020). For life sciences research, TrialChain is
a private ledger that synchronizes hashes with the public Ethereum blockchain (Dai
et al. 2018; Wong et al. 2019). These companies seem to have created a successful
balance of public/private capabilities with the added benefit that the public platform
allows anyone to verify hash integrity (Calvaresi et al. 2019).

9.1.2.2 On-Chain Versus Off-Chain

Because life sciences research may require data processing for millions of data points
across an extensive network of users, it is also necessary to determine the most
scalable mechanisms for storage. Life sciences research information, for example,
may contain radiological images, scans of documents, and genomic data that may
exceed the size capabilities of a traditional blockchain ledger (Zhang et al. 2018).
Not only does volume and size of data create possible reductions in performance but
can potentially increase storage costs. Therefore, the blockchain storage structure
merits careful consideration and planning.
When storing data on-chain, data points and their metadata are stored in program-
ming code on the ledger in a manner reminiscent of eXtensible Markup Language
(XML code). In some cases, data files, such as an Excel spreadsheet, can also be
stored on the blockchain for security if they do not exceed the ledger’s capabili-
ties. As an example, BurstIQ is a proprietary platform that stores data—including
protected health information (PHI) and personally identifiable information (PII)—
on-chain to enable very flexible data representations and access permissions (Pennec
2018; Srivastava et al. 2019). Because the platform stores data subject to privacy
regulations and research regulations, BurstIQ sought and obtained SOC 2 Type II
certification to demonstrate compliance with the Health Insurance Portability and
Accountability Act (HIPAA) and the General Data Protection Regulation (GDPR)
(Build your impossible: the most advanced blockchain platform on the market, period
2020).
As drawbacks of on-chain storage, there are some files that may be too large
to store on-chain. Further, some organizations find the security programming to
be complicated and cumbersome (Lin et al. 2020). Also, with recognition that a
blockchain ledger is continually growing, the process of chain management requires
forethought and planning otherwise performance may degrade (Zhang et al. 2018).
When designing on-chain storage, scalability and speed can be maintained by creating
a network of separate chains and forks. Additionally, a hybrid approach could be
designed where most data are stored on-chain, but data larger than a certain size
could be stored off-chain in a database or data lake while only hashes of those large
transactions are maintained on-chain (Jung and Pfister 2020).
In contract, some platforms store all private data off-chain where only a represen-
tative hash and metadata are stored on-chain. In this manner, the platform does not
store PHI or PII and so privacy regulations may not apply to the blockchain itself.
The length of the ledger may also remain more manageable, preserving desired
228 W. M. Charles

performance. However, Košťál et al. (2019) recommend against storing data off-
chain because data then lose the security of the blockchain and distributed networks.
The authors point out that data or files stored in an off-chain database or data lake
are not protected, and anyone with access to that storage can modify or delete the
files. There may be a hash on the blockchain that reflects that a file was modified or
deleted, but the hash cannot restore the data.

9.2 Blockchain Capabilities that Facilitate Research

There are certain challenges inherent in all types of research, such as the risks of data
fabrication/manipulation and misconduct (Thornton 2017), interoperability chal-
lenges between data systems and silos (Kendzierskyj and Jahankhani 2019), and
lack of flexibility with patient and researcher access controls (Sukhija et al. 2019).
These issues can be addressed, in part, by blockchain, but blockchain can also unlock
the potential capabilities in data to accelerate the future of life sciences research.

9.2.1 Accelerating Study Preparation

9.2.1.1 Drug Development

When conducting drug development research, the pharmaceutical industry faces

stringent regulatory requirements, which often differ across geographic locations
(Treshock et al. 2018). Further, this industry faces exorbitant drug development costs.
The cost of creating molecular compounds through to FDA approval is estimated to
take up to 13 years (Burki 2019) and to cost up to US$3 billion (Mak and Pichika
2019). A key consideration for cost is the need for a company to absorb the cost of
development for drugs that fail at various stages of development. A report published
by the U.S. Government Accountability office (2019) specified that of 100 molecular
compound candidates studied in Phase 1 clinical trials, approximately 63 would
advance to Phase II, with 19 advancing to Phase III and only 10 may receive FDA
approval.
Therefore, pharmaceutical companies such as Pfizer (Beckstrom 2019) are
increasingly looking to blockchain technologies to accelerate drug development
and lower costs, while still meeting compliance. In a 2018, survey of life sciences
company executives conducted by IBM, nearly 70% of executives stated they planned
to implement one or more blockchain projects by 2020 (Treshock et al. 2018).
The following subsections describe some blockchain drug development projects in
progress.
9 Accelerating Life Sciences Research with Blockchain 229

Use of Data Mining

Rather than conducting lengthy and costly clinical trials, pharmaceutical compa-
nies are increasingly employing blockchain technologies to perform data mining of
enormous data sets of electronic records, conduct meta-analyses, longitudinal data
analyses, and subgroup analyses to identify new trends that signal new drug develop-
ment or marketing opportunities (Choudhury et al. 2019). As a Federal example, the
US Department of Health and Human Services Innovation, Design, Entrepreneurship
and Action Laboratory, together with the FDA Office of Hematology and Oncology
Products (Khozin et al. 2017) initiated the Information Exchange and Data Trans-
formation (INFORMED) project to provide infrastructure for big data analyses. A
blockchain, powered by IBM Watson Health, provides a decentralized mechanism
for stakeholders within the pharmaceutical industry to share data (Khozin et al. 2018).
This project also serves as a sandbox for sharing resources across companies and
generating new ideas (Khozin et al. 2018).
The FDA is also using the blockchain capabilities within INFORMED to aggre-
gate data that had been submitted from new drug applications or biologic licensing
applications (Dorsey 2017). The FDA has been aggregating these data for predic-
tive analytics used to inform internal decisions and create processes to streamline
data curation and standardization. Findings believed to influence public health deci-
sions or drug development strategies are shared through publications and workshops
(Dorsey 2017).
The INFORMED project has also partnered with the FDA’s Office of Surveillance
and Epidemiology to create a blockchain framework for secure transmission of safety
information to the FDA (Dorsey 2017). After transitioning from a PDF-based system
to a secure digital submission system, the FDA has realized significant efficiencies
and streamlined the ability to detect and validate drug safety signals (Khozin et al.
2018).
Consistent with the FDA’s data aggregation efforts, pharmaceutical companies are
using blockchain to aggregate and parse enormous data sets. This enables companies
to learn about real-world uses of their drugs in clinical practice to request regulatory
approval for new indications instead of conducting additional costly and lengthy
clinical trials (Loftus 2019). Data may come from electronic health records or other
research studies with strict confidentiality protections (Leon-Sanz 2019). For new
studies where randomization may not be feasible or ethical, existing real-world
health data can serve as a control group. As a result from aggregating and real-
world data about drugs, the FDA has already approved new drug labeling indications
for leukemia, breast cancer, and bladder cancer (Loftus 2019).

Federated Learning

For blockchain initiatives to succeed within the pharmaceutical industry, it is neces-

sary for a community of companies to agree to share data or drug development strate-
gies in a secure environment. Recently, 10 pharmaceutical companies agreed upon
230 W. M. Charles

strategies to advance discoveries about promising molecular compounds without

compromising intellectual property (Burki 2019). Pharmaceutical companies such
as Janssen, AstraZeneca, GlaxoSmithKline, Novartis, and others agreed to collec-
tively provide data on 10 million molecular compounds, 100 million dose–responses,
and more than a billion assays toward a public–private blockchain-based consor-
tium called machine learning ledger orchestration for drug discovery (MELLODDY)
(Burki 2019). To protect proprietary information, MELLODDY data are stored within
each company’s secure infrastructure in decentralized locations. Using a blockchain
designed by OWKIN to create “federated learning” (Burki 2019), a machine learning
algorithm is then pushed to encrypted data to improve the accuracy of the algorithm
(U.S. Government Accountability Office 2019). This information is also integrated
with the collective body of clinical evidence to identify candidates for drug develop-
ment (Porsdam Mann et al. 2020). With this design, each company’s drug discovery
data remain confidential, while the federated approach allows companies to target
their research and development more effectively (Burki 2019).
Another blockchain-facilitated federated learning program is ModelChain. This
blockchain technology was developed to facilitate quality improvement and accel-
erate research initiatives based on decentralized predictive modeling (Kuo et al.
2019). Similar to MELLODDY, different institutions contribute data to a shared
algorithm without storing data in a central location. This technology has already
been used to improve predictive analytics for anesthesia (Kuo et al. 2019).
OpenMined uses blockchain to support federated learning by creating an anony-
mous and secure data space to train machine learning algorithms (Inbaraj and
Chaitanya 2020). This site allows “miners” to be rewarded by supplying data
and training models. OpenMined applies encrypted computation and homomorphic
encryption to maintain data security (Inbaraj and Chaitanya 2020).

9.2.1.2 Protocol Design and Integrity

Because a research protocol directs methods for ethical and objective data collection,
it is typically written by teams of experts and maintained under strict confidentiality
(Benchoufi et al. 2018). However, patient involvement in the research design could
improve the research participants’ experience, add financial value (up to fivefold
return on investment), and reduce the time necessary to conduct trials (Levitan et al.
2018). Blockchain is currently enabling patient participation in protocol design while
maintaining confidentiality of proprietary information. As examples, Transparency
Life Sciences (Vuturo 2020) uses a blockchain-based crowdsourcing application to
design protocols. After a team of scientists designs, a project with specific aims
(without revealing proprietary information), patients, advocacy groups, caregivers,
and healthcare providers then provide direct input about methodology to improve
patient-centric approaches. The scientists review the feedback and include sugges-
tions that would benefit the target patient population (Park et al. 2020). Similarly,
CORUS (Park et al. 2020) is a crowdsourcing blockchain platform that allows for
protocol development collaboration between scientists and the general public, but
9 Accelerating Life Sciences Research with Blockchain 231

could even be used without the help of experts. Members of the community can
design research, offer feedback about an expert-designed study, or even join a study.
After a protocol is designed, there is great risk of protocol manipulation, such
as modifying the hypotheses to fit the collected data (Park et al. 2020). However,
blockchain can maintain protocol versioning and traceability to ensure scientific
integrity (Benchoufi et al. 2019; Benchoufi and Ravaud 2017). Before a study
begins, the critical study documents, such as the protocol, consent form(s), case
report form(s), data-sharing plan, and analytic code could be time-stamped by the
blockchain, reducing the risk of unauthorized revisions (Benchoufi and Ravaud 2017;
Porsdam Mann et al. 2020).

9.2.2 Data Collection

Blockchain-based processes can facilitate data collection with security and integrity.
In this section, we will review the emerging roles of blockchain to enhance and
facilitate study recruitment, crowdsourcing, consent management, and electronic
data capture.

9.2.2.1 Participant Recruitment

To conduct a study with sufficient strategic endpoints and statistical power, there is
need for a well-structured enrollment and recruitment plan. According to the 2019
survey conducted by the Center for Information and Study on Clinical Research
Participation (2020), 85% of participants stated they would be willing to partici-
pate in a research, but recruiting and selecting participants is a complex process.
Enrollment criteria typically include age, gender, diagnosis, stage of disease, current
medications, or other medical conditions (Weng et al. 2010). Unfortunately, failure
to enroll enough participants in a timely manner is the primary cause for delays in
trials (U.S. Government Accountability Office 2019), and the majority of clinical
trials do not meet their recruitment goals on time (Vining et al. 2014; Zhuang et al.
2019). Further, inconsistent recruitment may result in an unrepresentative sample,
which compromises the generalizability and interpretability of the studies’ results
(Vining et al. 2014).
Blockchain is currently being used to bring together researchers and prospective
participants in new and unique ways. Using a private Ethereum blockchain, Zhuang
et al. (2019) created a system by which research participants can provide details
about their health and study interests on the blockchain. When new eligibility criteria
are entered by researchers into smart contracts, prospective participants can see the
study opportunities in a guided interface or receive automated alerts. Only when a
prospective participant agrees to learn more about a study, a smart contract is triggered
to share that person’s information with the sponsor or investigators recruiting for
the study. Machine learning can be applied to recruitment information to optimize
232 W. M. Charles

recruitment strategies, including the necessary number of research participants (U.S.

Government Accountability Office 2019).
With a blockchain-based participatory trial, Park et al. (2020) demonstrated how
smart contracts can increase the rate of enrollment. When comparing the average
number of subjects enrolled per month (0.92) in 151 traditional clinical trials in the
UK (Walters et al. 2017), Park’s team enrolled an average of 142.8 participants per
month (Park et al. 2020)—a higher rate than other web-based trials (93.6 per month;
Lane et al. 2015). While there are stark differences between eligibility criteria for
in-person clinical trials and participatory trials, the prospect of blockchain-based
participatory trials merits consideration for studies that could collect information
remotely.
While these strategies seem to increase research participant matching and control,
it should be noted that eligibility criteria are not always written in a manner that could
be programmed with logical statements into smart contracts. In an analysis performed
by Weng et al. (2010) of 452 eligibility criteria across 19 protocols, the authors
found that nearly half of the eligibility criteria involved complex clinical concepts
that required clinical interpretation and judgment. The authors provided the following
examples of criteria that could not be mapped into computer code as currently written:
“evidence of significant chronic or acute inflammation outside the lung such as
connective tissue disease, panniculitis, or acute infection,” “elevated sodium,” or
“neurological illness” (Weng et al. 2010, p. 11). Therefore, smart contracts may
improve some aspects of recruitment, but cannot address all eligibility criteria in
traditional clinical trials.

9.2.2.2 Crowdsourcing

As noted with the descriptions of pragmatic and participatory trials, data can be
collected quickly and in large volumes using crowdsourcing strategies. This approach
is increasingly popular within disease communities and improves participant engage-
ment in their health (Avdoshin and Pesotskaya 2019). To conduct crowdsourcing
research in an ethical manner, it is important to carefully control access privi-
leges, ensure data provenance, and manage participants’ privacy and confidentiality
(Sukhija et al. 2019).
Blockchain is introduced for crowdsourcing studies—not only for offering faster
enrollment, as noted above—but for enhancing privacy and confidentiality on a
public-access study platform. In some trials, the platform provides tamper-resistant
secure zones for protecting private information contributed by individual partici-
pants (Sukhija et al. 2019) or transparency for public review and accountability when
not private (Fernández-Caramés et al. 2019). Further, smart contracts can automate
payments to participants for engagement (Curbera et al. 2019).
Blockchain-based crowdsourcing platforms include TrialChain, where project
creators post-study opportunities and instructions and users can select and immedi-
ately participate in a trial (Wong et al. 2019). The platform TraneAi uses blockchain
for crowdsourcing to complete trial data tasks, such as tagging training data for
9 Accelerating Life Sciences Research with Blockchain 233

machine learning (Inbaraj and Chaitanya 2020). CrowdBC encourages crowd-

sourcing data solutions for big data (Li et al. 2019). To maintain privacy on the
CrowdBC platform, users can select a pseudonym instead of revealing their true iden-
tities. Further, users are asked to make a deposit prior to participation to reduce the
possibilities of Sybil attacks, distributed denial of service attacks, and false reporting
(Li et al. 2019). Another platform, SecBCS, offers crowdsourced problem-solving
where crowdsourcing tasks and results are stored on-chain with privacy-preserving
data encryption and smart contracts delivering incentives (Lin et al. 2020). Finally,
for an FDA-regulated study, a crowdsourcing method was employed by Project Data
Sphere to inspire members of the public to provide statistical analyses in a data
challenge to create a prognostic model for prostate cancer (Dorsey 2017).
Regardless of the data security and efficiencies offered by crowdsourced
blockchain platforms, the data remain vulnerable to inaccuracies—sometimes due to
mischief (Li et al. 2019)—and there are few practical mechanisms to ensure validity
and reliability of data collected. Accordingly, a blockchain-based crowdsourcing
platform may be valuable for data challenges where proposed solutions are refereed
but is not recommended for data collection that would influence treatment decisions.

9.2.2.3 Patient/Participant Consent

A cornerstone of ethical participation in research involves informed consent, a

process codified in international research regulations (Kaye et al. 2015), by which
interested participants learn details about a proposed trial and make autonomous deci-
sions to participate (Lorell et al. 2015). Because documentation of informed consent
is typically required for studies involving more than minimal risk, blockchain has
been introduced as a method to secure consent documentation (Jung and Pfister
2020). Because this concept is such an expansive topic, it has been broken into
separate discussions about consent integrity and dynamic consent.

Consent Integrity

Because uses of paper or electronic consent forms are the primary methods of docu-
menting a person’s agreement to participate in research, this documentation must be
carefully protected to ensure the integrity of the process. Unfortunately, a review of
FDA records found failures of consent process in 53% of the cases studied (Porsdam
Mann et al. 2020). Falsified consent forms are listed among the most common types
of research misconduct (Bell et al. 2018). Therefore, the tamper-resistant nature of
a blockchain promotes greater trust and integrity of the consent documentation.
Some blockchain platforms have emerged to organize and secure these legal docu-
ments digitally (Benchoufi et al. 2018; Jung and Pfister 2020). A blockchain platform
prototype designed by Angeletti et al. (2017a) allows a research organization to store
consent forms off-chain in a private space and create a hash on the blockchain to
verify the integrity and authenticity of the form. A time-stamped consent form could
234 W. M. Charles

offer evidence that a research participant provided consent prior to randomization

(Benchoufi et al. 2019). These forms are then transparent and traceable so that regula-
tory authorities could also review the consent documentation and the corresponding
audit log to ensure that all regulatory requirements were met (Bell et al. 2018).
After securing a consent form with blockchain, smart contracts could be executed
to facilitate subsequent actions for that person’s participation. For example, a smart
contract could interact with an interactive voice response system to order drugs
supplies or obtain electronic health records (Andrianov and Kaganov 2018). Smart
contracts could also be used to prevent progression to the next step in the protocol
until certain conditions are met, such as participant review of an amended consent
form (Porsdam Mann et al. 2020). Further, data access could be restricted after
participant study withdrawal or until the data are monitored and verified (Benchoufi
et al. 2018).

Dynamic Consent for Secondary Research

The regulations pertaining to ethical protections for human research participation

specify that informed consent must be an ongoing process between a researcher
and participant (Kaye et al. 2015). Research participants should be provided with
new information about their participation, when pertinent, or when research condi-
tions may no longer represent a participant’s preferences (Custers 2016). Therefore,
“dynamic consent” is a participant-centered approach to grant research participants
more control over their data and participation (Leon-Sanz 2019). The term “dynamic”
reflects that participants’ choices may change. A dynamic consent strategy—typi-
cally used to permit future uses of data or specimens—allows research participants to
engage as often or infrequently as they desire and specify different options for future
research. This concept is similar to, but less flexible than, the Revised Common
Rule’s new option for “broad consent” where a person can provide consent for a
specified type of future research, and a person’s refusal to agree to certain types of
research cannot be overridden by a waiver of informed consent issued by an Institu-
tional Review Board (45 CFR § 46.116(d) and (e), 2013). Because of the complexity
involved in managing participants’ changing research choices, some organizations
have elected not to offer dynamic consent.
Blockchain offers many capabilities that could automate processes within
dynamic consent. First, a web-based user interface may allow a participant to interact
directly with a blockchain-based consent management system, which greatly reduces
burdens on data administrators (Albanese et al. 2020; Porsdam Mann et al. 2020). If a
participant changes his or her research preferences, the participant’s activity is added
to the ledger for authenticity and transparency to researchers authorized to access
the system. Further, any changes to consent preferences can create or append smart
contracts so that the participant’s information is not available in researcher queries
if the person has not provided consent for that type of research. Rahimzadeh (2020)
adds that blockchain-based dynamic and transparent consent processes may confer
9 Accelerating Life Sciences Research with Blockchain 235

much-needed trust among marginalized groups that have historically been cautious
about participating in research.

Problems with Consent Mechanisms

While blockchain may offer many positive advances to ensure integrity and flexibility
of informed consent, there are certain obstacles that blockchain cannot overcome.
For example, after a researcher receives data based on a participant’s consent for a
particular type of research, there is no way to control how the researcher actually
uses the information. Taylor and Whitton (2020) note that research plans may drift
or researchers may share data with collaborators for research not consistent with
the participant’s original preferences. Further, there are not currently mechanisms—
short of an organizational audit—to monitor or enforce a researchers’ adherence to
the participant’s wishes, and such violations are unlikely to be detected (Shabani
2019).
As an additional limitation, when participants are given access to a web-based
consent platform, it is difficult, if not impossible, to verify the identity of the user
logging into the web-based system. Usernames and passwords can be easily shared
and sometimes compromised. Therefore, Chen et al. (2020) recommend adding
biometric identification, such as finger-drawn signatures, that adds an authentication
token to the blockchain. This token could be stored with the electronically signed
document. Even if the correct participant accesses the system, it is difficult to verify
that the participant has the competence or capacity to understand the ramifications
of their choices (Leon-Sanz 2019). It is also necessary to consider how legal consent
authority transfers from parents to their children when the children reach the age of
majority and parental permission is no longer valid (Rahimzadeh 2020). To address
the expiration of parental permission, smart contracts can be designed to provide
alerts to the researchers to contact the child-turned-adult for informed consent, to
request a waiver of informed consent from the IRB, or to discontinue future uses of
the child-turned-adult’s data and/or specimens.

9.2.2.4 Electronic Data Capture and System Interoperability

Life sciences research organizations use several different electronic systems to plan,
manage, execute, and report research activities (Albanese et al. 2020). These systems
are critical for maintaining timelines and budgets. However, there are still many
obstacles for disparate systems to readily exchange information—especially across
different companies, such as vendors (Zhang et al. 2018). Life sciences organizations
have been exploring blockchain to enable secure interoperability between electronic
data capture systems and electronic health record systems (Paramesh and Shabna
2020).
Remote electronic data capture systems are increasingly used in life sciences
research to allow for remote participation or collect real-time information. Remote
236 W. M. Charles

participation is valuable when considering that 70% of eligible research participants

live further than a 2-h drive from a research center (Angeletti et al. 2018). In a post-
COVID research climate, research organizations are adding remote data collection
methods to reduce the number of visits and hence unnecessary infectious exposure
(Li et al. 2020). Irrespective of distance, the FDA has noted that these electronic
remote devices are necessary to further empower research participants and provide
information about their health experiences outside of the clinic or research center
(Dorsey 2017). A primary drawback, however, of using remote data capture is the
lack of interoperability between traditional research platforms and electronic data
capture systems.
Blockchain is emerging as an encouraging and cost-effective method of enabling
interoperability between disparate data systems. For examples, blockchain can
enhance the electronic data infrastructure to optimize transfer and management of
remote Internet of things (IoT) devices (Košťál et al. 2019). Košťál et al. (2019) note
that IoT devices can be connected in a blockchain environment with awareness of
some potential scalability constraints. Typically, remote IoT devices are connected
to the blockchain using application programming interfaces with remote procedure
calls (Zhuang et al. 2018). Zhuang et al. (2018) point out that this process can also
typically connect electronic health record systems to blockchains. When an IoT
device or other system is unable to send data using a secure Hypertext Transfer
Protocol (HTTPS) request, middleware can be added as an optional node for trans-
mission (Košťál et al. 2019). Because of the increased potential for using blockchain
and other innovative digital tools for interoperable data collection in life sciences
research, the FDA explicitly described blockchain’s capabilities in the Technology
Modernization Action Plan (U.S. Food and Drug Administration 2019a).
While blockchain is gaining interest and traction to address interoperability in life
sciences research, there are still some remaining obstacles. Connecting devices and
systems to a blockchain require sufficient internet bandwidth, which may not always
be available to research participants (Internet/broadband fact sheet, 2019). Also,
for real-time data capture, the IoT device must be on—and online—which could
drain battery and is not always practical (Košťál et al. 2019). Last, there is minimal
interoperability between blockchain platforms to exchange information (Siyal et al.
2019).

9.2.3 Data Storage

After data are collected for a research study, they must be stored in a secure envi-
ronment to protect the confidentiality of participants’ information. With life sciences
research trials, there is need for researcher access, monitoring, and validating data
after collection (Albanese et al. 2020). Because so many research stakeholders may
need data access, it is necessary to ensure the right balance of confidentiality and
access to ensure appropriate study oversight.
9 Accelerating Life Sciences Research with Blockchain 237

Blockchain-based research storage surpasses the current capabilities of many

database systems (Essén and Ekholm 2020). Data replication across nodes protects
against ransomware, data corruptions, and system failures (Casino et al. 2019). Data
stored on a blockchain are often cryptographically encrypted for greater security
and can be stored with the metadata for the audit trail or other contextual informa-
tion (Kaye et al. 2015). Last, homomorphic encryption offers additional confiden-
tially enhancing capabilities for analyses. With homomorphic encryption, data can
be processed and analyzed while encrypted (Lin et al. 2018). The encrypted output
can be later decrypted by authorized parties to reveal the results.
While several blockchain-based systems have been created to store life sciences
research information, only a few examples will be described in this chapter. With
the platform enigma, blockchain technologies are utilized to manage research data
access (Porsdam Mann et al. 2020). When research data are collected, data points
are encrypted with ownership keys held by individual research participants and the
lead investigator. Data are stored off-chain while only the signature hash is stored on-
chain. To perform queries, access is permitted only to those who hold the appropriate
keys. An additional blockchain-based research trial system designed by Banga and
Juneja (2018) allows all research stakeholders to participate in the same network.
Each stakeholder organization maintains its own node and runs smart contracts that
update only their own instance of the ledger. Private channels exist to share data
among stakeholders.
While blockchain storage is traceable and verifiable, blockchain cannot prevent
human data transcription or measurement errors; nor can blockchain prevent manip-
ulation during data entry (Wong et al. 2019). Any data errors or mistakes are carried
forward in the blockchain. Wong et al. (2019) recommend that data should be added
to the blockchain in the most raw form available and captured as early as possible
before human handling.

9.2.4 Data Sharing

9.2.4.1 Research Participant Data Sharing

With increased importance for patients to have access to their own health informa-
tion, blockchain can be used as a tool to give patients and research participants the
opportunity to access and share their own health data (Ballantyne 2020). Dr. Sean
Khozin, recent Director of US FDA’s Oncology Center of Excellence, commented
that the FDA would also like to empower patients to access and exchange their health
information (Dorsey 2017).
While there are many blockchain technology capabilities that enable
patients/research participants to access and share their own healthcare information,
the circumstances are different for the life sciences research industry due to company
ownership of data collected during a sponsored research study. Unlike healthcare
238 W. M. Charles

information, there is no requirement for life sciences organizations to share partici-

pants’ research data with them. The U.S. Government Accountability Office (2019)
acknowledges that there are no economic incentives for life sciences organizations to
share research data with participants and there may be protocol blinding or intellectual
property constraints that make it infeasible to share data. Curating patient requests for
their health information may also be expensive with uncertainty about geographic
privacy laws (U.S. Government Accountability Office 2018). It is hoped that the
ease of blockchain-based access controls will encourage life sciences organizations
to share more health information with research participants in the future.
To increase the likelihood that patients will share more health information with
researchers, patients can be incentivized to share their data using blockchain-based
reward systems. Ballantyne (2020) points out that patients’ health data are very
valuable and are commonly sold or traded; therefore, patients should be given an
opportunity to participate in this marketplace. A blockchain-based prototype created
by Park et al. (2020) provides cryptocurrency rewards for providing data to be used
for research. Participants receive immediate payment for active participation and/or
data sharing to researchers. Another example is LunaCoin, which incentives patients
to anonymously share their DNA and general health data information (Shabani 2019).
Similarly, Shivom encourages patients to monetize their health data by sharing with
pharmaceutical companies (Shabani 2019).

9.2.4.2 Collaborative Research

Among researchers, data sharing is necessary to enhance reproducibility and to

perform secondary analyses (Benchoufi and Ravaud 2017). In fact, researchers who
receive research funding from the National Institutes of Health (2018) are required
to create a data-sharing plan and provide the anonymized data set upon request.
However, researchers are hesitant to share data with consideration that they lose
control of the data they had worked so hard to collect. There may also be burden-
some or bureaucratic processes for transferring data (Shabani 2019), especially when
transferring limited data sets, which contain dates and geocodes still considered PHI
under HIPAA (Charles et al. 2019).
Blockchain-based mechanisms can greatly facilitate data sharing in a more effi-
cient and secure manner. Smart contracts can automate facets of verifying participant
consent for data sharing as well as prevent unauthorized data access. As examples of
blockchain-based research data-sharing platforms, the FDA has tested decentralized
approaches to data sharing and plans to apply a data exchange at scale (Dorsey 2017).
This change would allow information to be shared more readily between the FDA
and industry, as well as between clinical investigators and research participants. In
addition, BlockTrial is a blockchain designed to share clinical trials data (Maslove
et al. 2018). Using a private Ethereum infrastructure, participants and researchers
serve as nodes. When authorized, smart contracts execute to grant researchers access
to specified off-chain data storage (Maslove et al. 2018). Last, in a blockchain-based
research data-sharing platform described by Choudhury et al. (2019), a smart contract
9 Accelerating Life Sciences Research with Blockchain 239

not only verifies whether access is appropriate, but also releases de-identified data
in Statistical Analysis Software (SAS) format.

9.2.4.3 Monitoring and Auditing

During and after a research study, data are continuously reviewed for adverse events,
deaths, and circumstances surrounding participant withdrawal from a study (Williams
2006). The study sponsor or the investigator is also expected to monitor data for
quality and ensure that the investigator and study team are closely adhering to study
requirements and local instructions (Williams 2006). Most sponsors design a moni-
toring plan based on perceived risk in the study and conduct a combination of on-site
and remote monitoring visits.
Because study monitoring and auditing are expensive and time-consuming, orga-
nizations are evaluating blockchain to address common problems in life sciences
research (Beckstrom 2019). Instead of providing monitoring in a centralized manner
where few individuals have access to data corrections or monitoring reports, a
blockchain-based system could ensure that monitoring information is available in
real time to study stakeholders, as appropriate, to allow for risk assessments and
corrective actions in a timely manner (Shabani 2019). In a similar manner, informa-
tion about adverse events is normally processed and distributed in a manual manner,
resulting in human errors. Wong et al. (2019) proposed a blockchain-based safety
system where smart contracts execute to alert the study’s medical monitor and can
aggregate data for the data safety monitoring board. The authors note that automation
of adverse event processing and alerts could improve study safety.

9.3 Planning and Considerations for Adding Blockchain

to a Study

As blockchain provides an increasing role in life sciences research, research organi-

zation is advised to carefully plan their blockchain-based data management systems
for complying with expected data standards and regulatory requirements.

9.3.1 Data Standards

When organizations use blockchain for collecting or processing data for life sciences
research studies, the sponsors must determine which semantic (variable/data naming)
standards would best to allow for robust data exchange or would be required for
submission to a regulatory agency (Ethier et al. 2017; U.S. Food and Drug Adminis-
tration 2014). Semantic data standards should be built into the data dictionary early
240 W. M. Charles

in the design process for electronic case report forms, data management systems,
and statistical analyses plans (U.S. Food and Drug Administration 2014).
As the most common example, the Clinical Data Interchange Standards Consor-
tium (CDISC) together with the National Cancer Institute has developed structured
data terminology, referred to as Common Data Elements for clinical research (U.S.
Food and Drug Administration 2020a). This type of terminology also called a “vocab-
ulary” is necessary to standardize study data to allow for semantic interoperability
with electronic health records or clinical research data (U.S. Food and Drug Admin-
istration 2014). Table 9.2 displays data standards associated with different types of
clinical data. While this nomenclature is required for data submission to the US
FDA, Japanese Pharmaceuticals and Medical Devices Agency, and other interna-
tional regulatory agencies, use of data standards is considered a best practice for
other types of research to enable meaningful data exchange.
Standard data structures are also necessary to support data normalization (data
derivations, transformation, and extraction of original data) and statistical anal-
yses (Ethier et al. 2017). As examples, the CDISC Analysis Data Model (ADaM

Table 9.2 Data standards associated with different types of clinical data
Nature of data Data standard
General clinical data Clinical Data Interchange Standards
Consortium (CDISC) Terminology
Adverse events Medical Dictionary for Regulatory Activities
(MedDRA)
Medications WHO Drug Dictionary or WHO Drug Global
Laboratory test name Logical Observation Identifiers Names and
Codes (LOINC)
Substances, including active ingredients, Unique Ingredient Identifiers (UNII)
active moieties, inactive ingredients
Pharmacological class Medication Reference Terminology (MED-RT)
Indication and usage Systematized Nomenclature of
Medicine—Clinical Terms (SNOMED CT)
Product labeling submissions Structured Product Labeling (SPL)
Postmarketing safety reporting—Adverse Individual Case Safety Report (ICSR)
events for medical devices
Countries (e.g., USA) and their Principal Geopolitical Entities, Names, and Codes
subdivisions (e.g., Maryland) (GENC)
Drug establishment registration and drug Unified Codes for Unit of Measures (UCUM)
listing, structured product labeling, content of
labeling
Tabulations data CDISC Study Data Tabulation Model (SDTM)
or Standard Exchange for Nonclinical Data
(SEND)
U.S. Food and Drug Administration (2020b)
9 Accelerating Life Sciences Research with Blockchain 241

2020) provides standards for subject-level analyses data set structures and anal-
yses methods, and the CDISC Operational Data Model (ODM) is a platform-neutral
XML format that facilitates metadata for contextualizing, exchanging, and archiving
clinical research data (Ethier et al. 2017).
To provide clearer standards for implementation and use of blockchain uses in
life sciences, IEEE created a new working group and subgroups among a wide
range of industry experts (IEEE Standards Association 2020). The Life Sciences
Research subgroup is designing standards for appropriate life sciences data sharing
and oversight. We expect that standards will continue to develop and become more
nuanced as blockchain becomes a more pervasive presence in life sciences research.

9.3.2 Regulatory Compliance

When blockchain technologies are used for clinical research, the technologies must
meet the requirements of research laws, statutes, and regulations. The nature of
research requirements depends on whether the research involves human partici-
pants, PHI or PII, and whether the research involves support by, or submission to, a
regulatory agency (Charles et al. 2019).
In particular, when a blockchain platform manages electronic records that are
“created, modified, maintained, archived, retrieved, or transmitted, under any records
requirements set forth in agency regulations” (21 CFR § 11.1(b), 2018), there are
many requirements that must be met by the blockchain developer, sponsors, and/or
research sites to ensure data integrity and confidentiality (U.S. Food and Drug Admin-
istration 2007, 2019b). Further, each sponsor and research site should ensure that
their standard operating procedures (SOPs) reflect their data integrity requirements,
as appropriate. A listing of these requirements is outside the scope of this article but
a detailed regulatory assessment for blockchain uses in research is available in my
earlier work (Charles et al. 2019).
When a blockchain—or more likely, the smart contracts—are “intended to be used
for one or more medical purposes that perform these purposes without being part of
a hardware medical device,” the software may be regulated as Software as a Medical
Device (SaMD) (Software as a Medical Device Working Group 2017, p. 11). Whether
SaMD is regulated by the FDA Center for Devices and Radiological Health depends
on the software’s intended functions and the risks posed by the software if there are
errors or system failures (U.S. Food and Drug Administration 2017). In most cases,
the blockchain will not be considered SaMD under the exception, “software functions
that are solely intended to transfer, store, convert formats, and display medical device
data or medical imaging data, unless the software function is intended to interpret
or analyze clinical laboratory test or other device data, results, and findings, are
not devices and are not subject to FDA laws and regulations applicable to devices”
(“21st Century Cures Act” 2016, Sec. 3060). Software and blockchain developers
should not immediately assume that their products are not regulated. In 2019, the
FDA reviewed and cleared several standalone AI algorithms as SaMD (Wu 2020).
242 W. M. Charles

Writing complex smart contracts that are accurate and reliable without error is
unlikely (Abdullah and Jones 2019). Smart contract code is vulnerable to mistakes;
therefore, code should be transparent and explainable. When using smart contracts
with regulated life sciences data, the code must be validated “to ensure accuracy, reli-
ability, consistent intended performance, and the ability to discern invalid or altered
records” (21 CFR § 11.10(a), 2018). Both the regulatory authorities in the USA and
European Commission have created guidance documents about validation processes
(EudraLex: The rules governing medicinal products in the European Union, Volume
4: Good manufacturing practice: medicinal products for human and veterinary use;
Annex 11: computerized systems 2011; U.S. Food and Drug Administration 2002).
The privacy regulations are likely to have the largest impact on blockchain strate-
gies used for life sciences data because research typically requires the collection
of PHI involving a covered entity (defined as a healthcare provider, health plan,
or clearinghouse; 45 CFR § 160.103, 2013). When an individual or organization
receives, generates, maintains, processes, or transmits PHI for a covered entity, that
individual or organization is considered a business associate (45 CFR § 160.103,
2013). Business associates must follow all the same HIPAA Privacy and Security
Rule requirements as covered entities (Department of Health and Human Services
2009). Data management companies that store or process PHI for covered entities are
explicitly listed as business associates that must comply with the HIPAA regulations
(Office for Civil Rights 2002). Therefore, blockchain companies should evaluate the
type of data and nature of activities to determine if the HIPAA Privacy and Security
Rules apply to their services.
Similarly, if citizens of the European Union are targeted for enrollment in research
and their PII is managed by a blockchain, GDPR may apply (“General Data Protec-
tion Regulation” 2016). The GDPR grants citizens more protections for the privacy
of their PII, including the right to have their data deleted at their request, also referred
to as the “right to be forgotten.” This right has caused concern about the prospects of
using an “immutable” blockchain to process data in the European Union (Evangelatos
et al. 2020). However, clinical and public health research data are classified in GDPR
in special categories for exemptions (Hasselgren et al. 2020). The European Commis-
sion recognizes that research data cannot be removed from the audit trail without
jeopardizing regulatory requirements for complete records and cannot be removed
from a data set without changing statistical outcomes. Hence, the immutability of a
blockchain’s ledger should involve careful planning and documentation for compli-
ance strategies with the right to be forgotten, but life sciences research is typically
exempt from that provision.

9.4 Future Directions

While blockchain has achieved significant progress in life sciences research, there
remain opportunities for improvement.
9 Accelerating Life Sciences Research with Blockchain 243

9.4.1 Digital Identity

As blockchain enables aggregation of disparate data sets and interoperability of elec-

tronic systems, there are not currently reasonable methods to link data for individuals
across data sets. Zhang et al. (2018) noted that healthcare organizations often use
demographic data to match individuals to other records, but not all patients have
(or are willing to provide) their social security numbers or other sensitive pieces
of identification. Compounding this issue, names may be stored in many different
formats or spellings, and different patients may share similar names and other demo-
graphics. However, in research data sets, individuals are typically represented by ID
numbers instead of information that could readily identify them, which also removes
information that could link data across data sets. Some organizations are exploring
the use of identity standards or identity management systems to manage research
participants’ identities (Jung and Pfister 2020), but this creates a challenging balance
between data value and privacy.

9.4.2 Security

Electronic health records systems have been increasingly targeted for breaches and
ransomware (Koczkodaj et al. 2019) and research participants are concerned about
unauthorized access to their private information. In a 2019 survey conducted by the
Center for Information and Study on Clinical Research Participation (2020), 65%
of potential research participants stated that confidentiality protections were “very
important” considerations for their participation in research. While blockchain-based
systems are highly tamper-resistant, these systems are not be immune from hacking
efforts. Saad et al. (2019) describe three major areas where blockchains are targeted:
mathematical/cryptographic techniques for creating the ledger, architecture distribu-
tions, and application contexts. Most of the known types of attacks are designed to
attack cryptocurrency, but general risk principles of domain name system attacks,
consensus delays, and distributed denial of service attacks apply to all types of
distributed ledgers (Xu 2016).
If research participants will interact with a blockchain, the primary security
concern involves their sometimes poor discretion when presented with phishing
attacks and key management (Radhakrishnan et al. 2019). Participants may be
unable to recover their public/private key pair due to accidental loss or may not
be able to retrieve it during an emergency or health decline (Verde et al. 2019). If
a blockchain-based user interface allows access to the system using a password,
weak passwords can be easy to guess with a dictionary attack and when passwords
are reused (Takemiya and Vanieiev 2018). Therefore, any approach to blockchain
security should not be focused on the technology but also consider education, data
governance, and risk monitoring (Ballantyne 2020).
244 W. M. Charles

9.4.3 Slow Adoption

Adding a blockchain solution will require some degree of cultural change within a life
sciences organization (De Filippi and Hassan 2016; Zhang et al. 2018). Hindering this
effort, many proposed blockchain technologies are new and have not achieved suffi-
cient large-scale implementation to demonstrate value (Porsdam Mann et al. 2020).
To educate stakeholders and overcome misperceptions about blockchain, Porsdam
Mann et al. (2020) recommend creation of partnerships among health and technology
divisions. These partnerships should create a dialogue that is open and supportive
with a focus on the central role that blockchain would serve in the life sciences
research. A patient advocate could provide insight about patient-centric features that
could promote patient engagement. This partnership must be ongoing due to the
organization’s need to develop and revise policies, workflows, risk assessments, and
monitoring (Kaye et al. 2015).

9.5 Conclusions

Blockchain is not just a new technology, but a new approach to data collection
and governance in life sciences research. Rather than implement blockchain to
address current operational challenge, life sciences organizations should explore
how blockchain could facilitate advances and breakthroughs in research. Blockchain
will require active collaborations among stakeholders to determine data governance,
new models of data ownership, and a new level of data transparency and control to
research participants. This is a significant undertaking, but I expect that the investment
will be well worth the effort.
Key Terminology and Definitions
Blockchain: A distributed digital ledger of cryptographically signed transactions
that are grouped into blocks. Each block is cryptographically linked to the previous
one (making it tamper evident) after validation and undergoing a consensus decision.
As new blocks are added, older blocks become more difficult to modify (creating
tamper resistance). New blocks are replicated across copies of the ledger within the
network, and any conflicts are resolved automatically using established rules.
Consensus mechanism: A fault-tolerant mechanism used in blockchain systems to
achieve the necessary agreement on a single data value or a single state of the network
among distributed nodes or multi-agent systems.
Hashing: A method of applying a cryptographic hash function to data, which calcu-
lates a relatively unique output (called a message digest, or just digest) for an input
of nearly any size (e.g., a file, text, or image). It allows individuals to independently
take input data, hash that data, and derive the same result—proving that there was
9 Accelerating Life Sciences Research with Blockchain 245

no change in the data. Even the smallest change to the input (e.g., changing a single
bit, such as adding a comma) will result in a completely different output digest.
Homomorphic encryption: A form of encryption allowing one to perform calcula-
tions on encrypted data without decrypting it first. The result of the computation is
on an encrypted form, when decrypted the output is the same as if the operations had
been performed on the unencrypted data.
Institutional Review Board (IRB)/Ethical Review Board (ERB): Any board,
committee, or other group formally designated by an institution to review biomed-
ical research involving humans as subjects, to approve the initiation of, and conduct
periodic review of such research.
Participatory trial: A trial design where a large group of volunteers from the general
public or who individuals who self-identify with a particular health condition can
self-enroll in a less structured study to understand the effectiveness of an approach
in a real-world setting. There is some overlap with a pragmatic trial.
Private identifiable information (PII): Personal data that are related to an identified
or identifiable natural person. In the content of research, PII could allow the identity
of a research participant to be ascertained by the clinical investigator or members of
the research team.
Pragmatic trial (also referred to as “real-world evidence trial”) A structured research
design that collects health information and patient-reported outcomes to establish the
external validity of interventions in settings that more closely represent patients’ or
communities’ typical health experiences and outcomes. There is some overlap with
a participatory trial.
Protected health information (PHI): Individually identifiable health information
transmitted or held by a covered entity or its business associate, in any form or
medium, whether electronic, on paper, or oral.
Secondary research: Research with materials originally obtained for non-research
purposes or for research other than the current research proposal. The exemption
can only be used when there is broad consent from the subjects for the storage,
maintenance, and secondary research use of their identifiable materials.
Smart contract: A collection of code deployed using cryptographically signed trans-
actions on the blockchain network. The smart contract is executed by nodes within
the blockchain network; all nodes must derive the same results for the execution, and
the results of execution are recorded on the blockchain.
246 W. M. Charles

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6371378/
Chapter 10
Challenges and Future Work Directions
in Healthcare Data Management Using
Blockchain Technology

Denis A. Pustokhin, Irina V. Pustokhina, and K. Shankar

Abstract In recent times, blockchain becomes a hot research topic and several
research works have been made to investigate the applications of the blockchain to
non-financial use cases. Healthcare is an important industry in which blockchain is
anticipated to have substantial impacts. Exploration of this domain is certainly new
and increasing rapidly in present times. Therefore, healthcare informatics research
communities and physicians are struggling to retain pace with research progress in
this area. This survey offers a detailed review of the ongoing study in the application
of blockchain technologies in the healthcare sector. This survey elaborates on several
research works involving the applicability of blockchain in healthcare, but there is an
absence of enough prototype implementation and studies to describe the efficiency
of these presented use cases. The survey additionally highlights the existing devel-
opments of blockchain applications in the medical domain, benefits, challenges, and
future scope.

Keywords Blockchain · Healthcare · Bitcoin · Electronic health record (EHR) ·

Security

D. A. Pustokhin
Department of Logistics, State University of Management, Moscow, Russia
e-mail: [email protected]
I. V. Pustokhina
Department of Entrepreneurship and Logistics, Plekhanov Russian University of Economics,
117997 Moscow, Russia
e-mail: [email protected]
K. Shankar (B)
Department of Computer Applications, Alagappa University, Karaikudi, India
e-mail: [email protected]

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 253
S. Namasudra and G. C. Deka (eds.), Applications of Blockchain in Healthcare,
Studies in Big Data 83, https://doi.org/10.1007/978-981-15-9547-9_10
254 D. A. Pustokhin et al.

10.1 Introduction

In recent decades, blockchain has attained maximum attention as a distributed ledger

method which refers to the Bitcoin white paper (Hussien et al. 2019). Based on
the model for Bitcoin, the major component of blockchain is applied for making
feasible interchanges of digital or transactions from participants involved in a
distributed network with no requirement of central management and valid third party
(Namasudra et al. 2020c). Any transaction of exchanging transaction among the
people and organizations always depends upon a Trusted Third Party (TTP), namely
bank, as an intermediary or mediator. But, the confidence of TTP is not adoptable
for massive situations. Sometimes, the TTP may be a fraud, and collect the amount
without returning to the user; hence, a TTP challenges a model potentially due to
the single point of failure. Moreover, TTP makes transaction fees for any transaction
that takes place from ATM, cash withdraw from the bank, and so on. The main aim
of Bitcoin is to resolve the demerits involved in the confidence of TTP in digital
transactions.
After few years of publishing a white paper on Bitcoin, the Bitcoin cryptocur-
rency has been executed as open-source that is applicable to change the code and
enhance the performance where it tends to produce new generations of blockchain
methodologies. Initially, the executions of blockchain-based cryptocurrencies, like
Bitcoin (Namasudra et al. 2020d), enclose the first generation named as a blockchain
1.0. Alternate blockchain 1.0 models are Monero, Dash and Litecoin, etc. Then, the
second generation blockchain method which is referred to as blockchain 2.0 that
depends upon the establishment of intelligent features as well as modern contracts.
Followed by, smart features are defined as electronic properties or assets with owner-
ship could be managed using a blockchain relied environment whereas the modern
contracts are referred to as software programs that are applied for encoding the proce-
dures of controlling the smart properties (Agbo et al. 2019). Figure 10.1 shows the
structural design of the bitcoin, which comprises header, transaction counter and
transaction.
Some of the instances of blockchain 2.0 cryptocurrencies are Ethereum, Ethereum
Classic, NEO, and QTUM. Besides, the 3rd generation of blockchain method called
as blockchain 3.0 is used for non-financial applications of blockchain. These models
are applied for adopting it to the domains like economical sector, and alternate
companies can be benefited by applying the interesting properties of the blockchain.
Finally, blockchain is assumed as a typical framework that has identified various
sectors in diverse organizations like identity control, dispute resolution, supply chain
management, financial and medical, contract organization, and so forth (Peters et al.
2017).
Using the progressive blockchain development several firms, clinical sectors and
many other applications have implied many use cases that are found for blockchain.
Figure 10.2 shows the sample scenario of with and without using blockchain in
the healthcare sector. Hence, blockchain is one of the novel methods with massive
propaganda in media and grey publications like opinion pieces, commentaries, blog
10 Challenges and Future Work Directions in Healthcare Data … 255

Fig. 10.1 Architecture of bitcoin

Fig. 10.2 Healthcare scenario without and with blockchain

posts, interviews and so on, and there are unwanted data, rumors and irregularities
regarding the valid component of blockchain in medical application. Developers and
practitioners have tried to learn the particular function or utilize cases of blockchain
in the medical industry; and the recognized utilize cases are what blockchain-based
medical functions were deployed.
256 D. A. Pustokhin et al.

This survey intends to offer a brief survey of existing research works carried out on
the function of blockchain technologies in the healthcare sector. These surveys elab-
orate several research works involving the applicability of blockchain in healthcare,
but it is an absence of enough prototype implementation and learned for describing
the efficiency of this presented employ case. A survey additionally highlights the
existing developments of blockchain applications in the medical domain, benefits,
challenges, and future scope.
The remaining section of the chapter are organized as follows. Section 10.2
explains the different application areas of blockchain in healthcare. Section 10.3
discusses the healthcare data management in blockchain. Then, Sect. 10.4 listed out
the significant merits of blockchain in healthcare industry. Next, the challenges exist
in the blockchain in healthcare is provided in Sect. 10.5 and the future works is listed
out in Sect. 10.6. Finally, the chapter is concluded in Sect. 10.7.

10.2 Blockchain in Healthcare Applications

The lifecycle of electronic health records (EHRs) is depicted in Fig. 10.3. Blockchain
method is mainly to approve the traceability and immutability of the patient’s clin-
ical data without placing the medicinal details on the blockchain; however, it is
recorded as metadata and patient’s consent. The maximum and sensitive medical
data have been saved in single nodes of the network, whereas the smart implications
are recorded on-chain. The latter method is applied in cloud-based service for tempo-
rary storage as well as data exchange (Namasudra and Roy 2017). FHIR chain is a
blockchain-dependent method used for data interchange which encapsulates HL7

Fig. 10.3 Schematic diagram of EHR cycle

10 Challenges and Future Work Directions in Healthcare Data … 257

Fast Healthcare Interoperability Resources (FHIR) for healthcare data. Effective on-
chain consent supervision as well as enforcement of management policy represented
by consent would enhance and serve data exchange for secured data transmission.
Optimal treatment management could be accomplished by linking patients, several
medical providers, health insurances, and pharmacies provide a specific kind of
data (Mohanty et al. 2020). The major limitation involved in developing connected
health is the absence of interoperability. A module which depends upon the permis-
sion blockchain platform, and defined the FHIR combination with a system can
report the interoperability problem. The evidence of interoperability is based on the
assurance of FHIR protocol that needs validation for the messages forwarded to
the blockchain which is finally transformed into the required format. Then, visible
implementation of modern contracts would activate rapid, independent, standard,
and bias-free computations reimbursements and claims. Furthermore, it is essential
to assure the problems involved in healthcare data management. Magyar in (Magyar
et al. 2017) developed few strategies of HIPAA regulation, which recommends a list
of cryptographic devices that are highly used to assure data privacy and security.
Traceability, data authenticity, and interoperability among the data sources would
activate a probability of developing and supervising the whole medical data.
Blockchain-relied use cases in supply-chain are developing, with the help of trace-
ability and immutability features of blockchain to overcome limitations involved
in healthcare, protecting clinical devices, optimizing the performance of medical
IoT tools, and maximizing the common health supply chain, assuring control over
returned drugs to pharmacies. Recently, the capability of a blockchain to offer the
advantages of SCM and traceability of pharmaceuticals is shown. Issues of phar-
maceutical supply-chain, validation of transportation, and memory conditions have
maximum significance where medications have minimum efficiency. To apply smart
contracts developed on Ethereum blockchain for compliance validation depends upon
the sensor details (Sivaram et al. 2020).

10.2.1 Medical Research and Its Reproducibility

Medical trials are carried out to determine newly presented models and medicines.
Organization among various centers activates the aggregation of maximum hetero-
geneous data within a limited period and compared the medical trials processed in
a medical institution (Namasudra and Deka 2018a). Furthermore, the contribution
of various centers makes autonomous estimation. Therefore, these trials are highly
difficult with respect to coordination. Under the application of blockchain model
facilitates control over multicenter medical trials, enhances transparency, traceability
of the consents in clinical trials, supremacy, and scalability of medical trials’ data, and
improvises patient contribution and refers to the proper treatment. Under the obser-
vation of data exchange, the threats involved can be predicted to gain maximum
knowledge regarding a patient, by integrating anonymized datasets with the same
258 D. A. Pustokhin et al.

patient data and evaluate the threats that reduce the patient’s security (Pustokhina
et al. 2020).

10.3 A Review on Blockchain Healthcare Applications

The legacy method exclusively distributes healthcare resources within the medicinal
field and is completely incompatible with the exterior system (Kathiresan et al.
2020). However, facts show various advantages with these integrated networks for
interrelated and betterment in medicinal sectors, intercom calls involving several
firms for healthcare information studies. Multi-organizational data exchange is the
most crucial problem that requests the medicinal data received by a health care
contributor could openly accessible to other firms like doctors or laboratory (Elhoseny
et al. 2019). Blockchain technique specifies process and control over the data to make
it flexible, secure, forms new segmentation as well as share the data with services in
various healthcare management, as shown in Fig. 10.4. This technique is prominence
for various recent developing process (Raj et al. 2020).
With progress in digital data allied to healthcare, cloud storage and patient infor-
mation safety policies (Namasudra et al. 2020a), innovative chances are available
for healthcare organization and easily accessible to patient data and use its data.
Assuring transactions, storing, data security (Devi et al. 2020) and controlling its
smooth integration is highly important to every data-driven firm, mainly in health-
care where blockchain technique has the possible to determine such crucial prob-
lems in a vigorous and effectual method. In this segment, blockchain-based appli-
cation comprises EHR, data storage, data management and data sharing, explained
elaborately. Developing blockchain technology in healthcare innovations, consists
of stakeholders, blockchain technology, healthcare applications, and data sources,
which are theoretically separated into numerous levels.
(Gordon and Catalini 2018) posted an analysis on medicinal blockchain. In
their research, they evaluate the working of blockchain transformation technique
in the healthcare area by permitting data immutability, handling a large volume of
healthcare data, patient identification across the network and digital access rights. It
employed on medicinal record utilizing the Hyperledger fabric blockchain sector to

Fig. 10.4 Healthcare data management in blockchain

10 Challenges and Future Work Directions in Healthcare Data … 259

send medicinal information to the hyper ledger blockchain network. They gathered
these medicinal records with the help of smart phones and other IoT gadgets and
aims to assure the healthcare data are recorded to the Blockchain.
(Vazirani et al. 2019) considered blockchain is the method to handle the medicinal
data effectively. They involved many research types and have discussed the possibility
of profits and drawbacks of the blockchain technique without submission of any
evidence. It is finalized that the blockchain is more suitable for healthcare records
management on the cloud network whereas controlling safety and confidentiality
of information. (Rouhani et al. 2018) emerged with a method for addressing the
restriction of authorization. They have utilized a sample of Hyperledger domain to
control and manage healthcare data by the patient. (Wu and Tsai 2018) have surveyed
literature of healthcare management systems and discovered 2 programs for offering
network security. They planned to use a distributed system and creating policies for
medical data management (Namasudra and Deka 2018, a).
Shen et al. (2019) recommend a system to share healthcare data by blockchain
and peer to peer networks called as MedChain. It has calculated these mechanisms
to medicinal information generation through medicinal inspection and information
gathered from IoT sensing gadgets and other mobile phone applications. It described
several problems of the medicinal management mechanism and explained the method
of solving with the help of blockchain technique. It has introduced the existing
investigate techniques on healthcare sector by distributed ledger method with an
essential function for developing into the effective method as well as recommended
IoMT deliverance utilizing network protocols. Vora et al. (2018) proposed neglecting
of patient data like name, address and so on automatically and provide the blockchain
method to manage the health record digitally. The ultimate aim of the research is to
monitor the efficiency of the system to view the working of the proposed framework
which manages the requirements of patient, physicians and others.
Zhang et al. (2018) have promoted blockchain importance related to system for
healthcare and blockchain working technique gives valuable healthcare plan. Jamil
et al. (2019) studied the problems about drug rules and the process of standard-
izing drugs utilizing blockchain. They have displayed the challenges to discover
obscured drugs and projected blockchain as a method for identifying counterfeits.
Lee and Yang (2018) employed on the fingernail investigation management method
by blockchain and microscopy sensing devices. Human nails are highly peculiar and
replicate the physiological personality of the individuals. They have used microscope
sensing devices for capturing images of the nails and utilized in image pre-processing
method to obtain a clearer image. A deep neural network used to monitor the feature
extraction technique. Blockchain technique was utilized in order to secure user infor-
mation and gives privacy and security so some modification in the scheme is tracked
and recorded through the ledger. (Agbo et al. 2019) tested standardized survey of
existing studies of blockchain applications. They have selected sixty-five research
for addressing their doubts. It represents that blockchain can have potential tech-
niques for various healthcare use cases that comprise managing electronic health-
care records, biomedical research, drugs supply chain. On the other hand, they have
also determined the statement that still there is necessity to build extra thoughtful of
260 D. A. Pustokhin et al.

blockchain method. Modernization has been decreased slowly in medical sector due
to incompetency and serious policy.
Azaria et al. (2016) proposed these policy problems resulting in bad performance
in the EMR mechanism. They have planned blockchain based solution called MedRec
to manage a large number of medicinal data in EMR process. They have established
a typical and novel technique to access medical record, which offers reasonable
inspection access log method. MedRec allows both patients and doctors for sharing
the medicinal information between third parties utilizing distributed ledger tech-
nique. It provides motivation for researchers and other health persons who take
part in the data mining. MedRec allows vagueness of data and data accessibilities
to the miners as a bonus to involve in the network. (Zhang et al. 2017) reviewed
regarding blockchain and smart contracts functioning of blockchain based smart
contracts has the capacity to deal with various medicinal problems. In their research
they hold various primary step to approve blockchain technique and address the
various difficulties in blockchain implementation. They have explained that evolu-
tion of blockchain based applications could point medical problems in good effective
manner.
Kumar et al. (2018) introduced diverse blockchain apps for medical sector. They
have focused problems and challenges in adopting blockchain technique and discov-
ered smart contract for blockchain based medicinal methods. There are numerous
benefits to the distributed ledger system as reviewed with identity management, elim-
inating third parties, sensitive information handling, and protection to the personal
data. In the case other diverse centralized networks, the functions of the network
carry on even when separate nodes fail. It raises trust as the reliability of the agent.
Information security is also helped by insufficiency in intermediaries. Since, it is
an opportunity for safety violations in the present practice of 3rd parties collecting
personal information. The 3rd parties might develop into excess by utilizing the
blockchain, efficiently maximizing the safety of the user.
Blockchain and Ethereum as safe domain to handle every sensible data. It
describes blockchain is distributed system for solving business issues and has large
capacity. During the blockchain transaction, encryption protects the data and every
transaction is associated with earlier transactions or a proof (Namasudra et al. 2020b).
A blockchain transaction is verified on the nodes utilizing programs. It could not
possible for individual to do a transaction. At last, blockchains are transparent that
allow all user at any time to follow the transactions. Smart contract is a safe method
which supports to avoid intrusion by other parties. Ethereum is a distributed network
operating smart contracts. These facilitate developers for building markets to the
movements of funds based on commands specified in the earlier period. The most
important characteristics of Blockchain are Payment, Immutability, fast transmission,
Decentralization, and confirmation within no time.
(Liang et al. 2017) utilized the cloud services state and decide the cloud proof as
a data unit to locate the activity of the user rapidly and to collect data source. By
fixing the original information into blockchain activities, it creates and executes
ProvChain, as well as design for the grouping and confirmation of cloud data
provenance. On examining the efficiency of the simulation outcomes portrayed that
10 Challenges and Future Work Directions in Healthcare Data … 261

ProvChain provides safety features for cloud storage software, containing low over-
head reliability, consumer privacy, and deceptive provenance. (Mackey et al. 2019)
reviewed blockchain working is broadly discovered in the medical field by various
business stakeholders to develop the business function. It could support in optimizing
patient results, reducing the cost and standardization of the entire method. They have
carried out research from diverse physicians on blockchain conceptualization and
exploitation of blockchain framework in the medicinal organization.

10.4 Potential Benefits of Blockchain in the Healthcare

Industry

The blockchain offers several advantages for medical researchers, health care
suppliers, and individuals. It will explore and adapted medicine for creating a single
saved location to all health information, track adapted information in concurrent
and a group of information access authorizations at a granular level. The health
researchers require inclusive datasets for different kinds of diseases, accelerate
biomedical detection, way the progress of drugs rapidly, and create individual treat-
ment devices according to genetics, lifecycle, and atmosphere. By incorporating
the patients of various ethnic and socio-economic surroundings and from several
geographic regions, the allocated information method of Blockchain will give a large
series of datasets. It gives correct data to longitudinal learns as blockchain gathers
health information above the person life span.
The health care blockchain would widen the gathering of health information from
the set of people presently under-served with the medicinal community or not usually
contained in science. A distributed information surroundings of blockchain generates
that it simple to make audiences to be concerned and to the normal public for making
outcomes further reflective. The healthcare blockchain would possibly support the
growth of novel breed of “smart” health care supplier apps which will circumvent
the most recent medicinal explore and grow customized cure ways.

10.5 Challenges

The blockchain gives a reliable solution for particular healthcare function challenges
namely safety, confidentiality, integrity, disturbing, interoperability, accessibility,
and concurrent updates of medical information, mainly if executed perfectly. But,
blockchain has limitations and restrictions. Although the benefits of blockchain tech-
nology, growth, and use in healthcare functions assumed severe research challenges
that need extra research. The challenges caused by blockchain technology are listed
as follows.
(1) Security.
262 D. A. Pustokhin et al.

Structural design and the working of blockchain skills have numerous particular
safety vulnerabilities. The blockchain protection vulnerabilities are frequently
connected to issues through the traditional consensus system utilized for veri-
fying and confirming transactions. Consensus system techniques are inca-
pable of preventing these security threats in the shared blockchain mecha-
nism. For conquering these safety threats, the propose of consensus systems
have minimum importance. Specifically, a protocol with counter evaluates
that will avoid these attacks must be given inside a perfect result. Security
bugs permit malicious software performance for implementing decentralized
functions according to grow blockchain.
(2) Privacy.
Present secure transmission structural designs of EHR disregard users or
patients’ privacy, like the replacing method useful every information without
the authorization of owners or noise in the data requester review. But, when
alive HER functions depend on a blockchain, after that the requester requires
specific patient information for providing personalised services. The key chal-
lenge of keeping the confidentiality of patient information is by offering a struc-
ture that utilizes cryptographic systems to information confidentiality and relia-
bility on a blockchain-based EHR. Some identical structures, shortcomings must
be addressed in preserving patient’s confidential information. Initially, patients
must allocate their information through the ease of utilization as employing
blockchain-based structures in HER needs maximum calculation power and get
substantial time for completing all the tasks. Secondly, further a novel node to
the blockchain network that novel patients require, it needs various steps for
verifying the honest patient.
(3) Latency and throughput restrictions.
In the case of transaction latency, a blockchain gets time to process transactions.
For instance, the bitcoin blockchains latency needs 10 min for verifying some
transactions in the network. Although the detail that 5 or 6 blocks should be
further to increase the chain previous to verification, the approval is to wait
around 1 h to verify all transactions. In contrast, the majority of usual database
methods only need a couple of seconds for confirming a transaction.
(4) Blockchain size.
If all devices conduct transactions like IoT-RPM and EHR, blockchains are
always enhancing and need to utilize stronger miners. A usual resource-
constraint IoMT tool is unable to handle the tiny size of blockchains. So,
compression systems in the blockchain with alternative manners like mini-
blockchains must be studied.
(5) Computing power limitations.
IoMT mechanism information collected with blockchain is regular calcula-
tion restricted, such that cryptographic systems cannot be utilized. Several
health-related functions, cryptosystems in resource-constraint tools that manage
sensor and actuator security has very restricted calculation resources concerning
memory as well as processing power. Specifically, it deals with recent and
protected public-key cryptography methods. A majority of blockchains employ
10 Challenges and Future Work Directions in Healthcare Data … 263

public-key cryptosystems on the support of ECC has effectiveness and safety

problems, so generating the chosen of the suitable cryptography is challenging.
Cryptosystems in blockchains must be aware of the post-quantum calculating
threat and appear to energy-efficient quantum-safe techniques for keeping
information protected to a long time.
(6) Storage requirements.
A blockchain needs to save record entire transactions in the network that is issue
to restrictive nodes that transmit information to the network. The blockchain
makes sure that the saved and distributed EHR information is not influenced,
unforgeable, and confirmable other than is efficiently undergo from saving
conditions of large-scale shared EHR data.
(7) Scalability.
A blockchain method proposes another challenge in scalability and enhancing
overhead or calculation resources in IoMT tools due to the enhanced amount
of method applicants. The challenge can cause calculation necessities to the
whole blockchain infrastructure. During this condition became an enhancing
complex problem when various smart tools or sensors are projected as these
tools’ calculation abilities are less than the average computer. An IoT tool
in the blockchain network is calculation difficult and occupies a higher over-
head bandwidth resultant information delays and important processing power.
A device can shortcoming the calculation power needed for utilizing blockchain
abilities, thus probably cause tools to run at suboptimal or potentially extreme
speeds, so avoiding them from still running their original or blockchain software
concurrently.
(8) Interoperability and Standardisation.
The shortage of data gathering, replace and examination formations cause
an absence of interoperability in healthcare functions. The predefining HER
method is controlled through centralized local databases and offline structural
design, whilst cloud-based blockchain skill is decentralized (Namasudra et al.
2017). Therefore, traveling healthcare schemes to these ways and executing
blockchain tool is initially need a capable EHR method able to assist collab-
oration and interoperability among medical as well as scientific communities.
Several technical challenges must be addressed to EHR’s transferred informa-
tion to the blockchain tools. The alive healthcare ledger (database) is not shared
that cannot be combined or grow for a large scale.

10.6 Future Directions

Additional research directions cooperative secret information for illegal parties in

healthcare functions has diminished the level of patient reliability to the HER method.
So, public belief could not be continued when the privacy of receptive health data
is revealed. While the current HER methods are significantly possible and suitable,
patients are always disturbed with the security and privacy of their health data.
264 D. A. Pustokhin et al.

Thus, it is a plan for offering the growth and application of a platform to distribute
EHRs among different health care organizations in Malaysia utilizing blockchain
and regarding safety and confidentiality protocols to manage patient information. A
blockchain transaction in the HER method is determined as the procedure with that
patient information is updated, generated, removed, or transmitted among the several
nodes of a related network.
When the platform allows the simple identification of the specific node which
visits the supplier and the visit frequency, so allowing the gathering of confiden-
tial patient data namely names, disease, and present address. In addition, correctly
arrange the gathered data and defining the linked in a blockchain network are prob-
lems that have to be addressed. For conducting private and secret transactions, plan
for projecting a structure utilizing the concept of cryptographic protocols like trusted
implementation surroundings and non-interactive safe multi-party calculation that
allows private calculation of encrypted transactions previous to being accessible into
the blockchain.

10.7 Conclusion

Healthcare is an important industry in that blockchain is anticipated to contain

substantial impacts. Using the progressive blockchain development several firms,
clinical sectors, and many other applications have implied many use cases that are
found for blockchain. Developers and practitioners have tried to learn the partic-
ular function or utilize cases of blockchain in the medical industry; and the recog-
nized utilize cases are what blockchain-based medical functions were deployed.
This survey has reviewed the available functions of blockchain technologies in the
healthcare sector. The survey also discussed the existing developments of blockchain
applications in the medical domain, benefits, challenges, and future scope.

Acknowledgement The work of K. Shankar was supported by RUSA–Phase 2.0 grant sanc-
tioned vide Letter No. F. 24-51/2014-U, Policy (TNMulti-Gen), Dept. of Edn. Govt. of India,
Dt. 09.10.2018.

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Denis A. Pustokhin received the Ph.D. degree in logistics and supply chain management from
the State University of Management, Moscow, Russia. He is currently an Associate Professor with
the State University of Management. He has published more than 30 conferences and journal arti-
cles. His research interests include enterprise logistics planning, artificial intelligence, big data, the
Internet of Things, and reverse logistics network design.

Irina V. Pustokhina received the M.B.A. degree in logistics and supply chain management and
the Ph.D. degree in logistics and supply chain management from the State University of Manage-
ment, Moscow, Russia. She is currently an Associate Professor with the Plekhanov Russian
University of Economics, Moscow. She has published more than 40 conferences and journal arti-
cles. Her research interests include supply chain management, regional logistics development,
sustainable urban development, city logistics, intelligent logistics systems, big data technology
and applications, information management, and the Internet of Things.
10 Challenges and Future Work Directions in Healthcare Data … 267

K. Shankar (Member, IEEE) is currently a Postdoctoral Fellow with Department of Computer

Applications, Alagappa University, Karaikudi, India. He has authored/coauthored over 52 ISI
Journal articles (with total Impact Factor 150+ ) and more than 100 Scopus Indexed Articles. He
has guest-edited several special issues at many journals published by SAGE, TechScience, Inder-
science and MDPI. He has served as Guest Editor and Associate Editor in SCI, Scopus indexed
journals like Elsevier, Springer, IGI, Wiley & MDPI. He has served as chair (program, publi-
cations, Technical committee and track) on several International conferences. He has delivered
several invited and keynote talks, and reviewed the technology leading articles for journals like
Scientific Reports – Nature, the IEEE Transactions on Neural Networks and Learning Systems,
IEEE Journal of Biomedical and Health Informatics, IEEE Transactions on Reliability, the IEEE
Access and the IEEE Internet of Things. He has authored/edited Conference Proceedings, Book
Chapters, and 2 books published by Springer. He has been a part of various seminars, paper
presentations, research paper reviews, and convener and a session chair of the several confer-
ences. He displayed vast success in continuously acquiring new knowledge and applying innova-
tive pedagogies and has always aimed to be an effective educator and have a global outlook. His
current research interests include Healthcare applications, Secret Image Sharing Scheme, Digital
Image Security, Cryptography, Internet of Things, and Optimization algorithms.