PD233: Design of

Biomedical Devices and

Systems
(Lecture-16)

Dr. Manish Arora

CPDM, IISc
Course Website:
http://cpdm.iisc.ac.in/utsaah/courses/
• Digital Healthcare
• NDHB
• Ayushman Bharat
• PM-JAY
• Wellness Centres
 Digital Health
Digital health is the application of software or hardware, often using
mobile smartphone or sensor technologies to improve patient or
population health and health care delivery.

Web-based analysis Electronics Health Records

Clinical Decision Support Systems
Electronic Prescribing Systems
E-mail
Mobile phones and applications
Text messages
Wearable devices
Clinic or remote monitoring sensors
Telemedicine

Chen et al., "Characteristics of Digital Health Studies Registered in ClinicalTrials.gov". JAMA Internal Medicine. 179 (6): 838–840.
Challenges in Digital Healthcare
• Technology acceptance by healthcare professionals
• Interoperability and Portability
• Privacy
• Cyber-Security
• Largescale Data Handling & Analysis
 Interoperability and Portability
• DICOM (1) – Digital Imaging and Communication is
Medicine Standard
• Started in 1980s for easy exchange of medical images

• HL7- FIHR (2)

• Build on web-standard technologies (XML,JSON etc.)

(1) https://www.dicomstandard.org/
(2) https://www.hl7.org/fhir/
FIHR – Fast Healthcare Interoperability Resources
FHIR Patient Record Example
Privacy and Cyber-Security
National Digital Health Blueprint
• Final Version Release on
9th Nov 2019
• Framework created to
allow implementation of
National Health Stack
proposed by NITI Aayog

Eco-system not a system

Building Blocks of NDHB
Recommended Standards by NDHB
• Consent Management
Purpose Recommended Standard
ISO/TS 17975:2015 Health Informatics ‐ Principles and data
Consent Management requirements for consent in the collection, Use or Disclosure
of personal health information
Electronic Consent Framework (Technology Specifications
Consent Framework
v1.1) with its subsequent revision(s) published by MeitY.

• Content and Interoperability

• Technical interoperability
• Semantic and syntactic interoperability
Content and Interoperability
Standards
Purpose Recommended Standard
Structured Clinical Information FHIR Release 4 (subject to section 3.4.2)
Exchange (with any future errata(s))
Still Image: JPEG
Document/ Scan: PDF A‐2
Still Images / Documents Audio: MP3 / OGG
Audio / Video Video: MP4 / MOV
(embedded as binary content in relevant FHIR
resource)

Diagnostic Images (Radiology

DICOM PS3.0‐2015c
including CT, MRI, PET, Nuclear
(embedded as binary content in relevant FHIR
Medicine / US / Pathology),
resource)
Waveforms (e.g. ECG)

SNOMED CT
Terminology/ Vocabulary (for all clinical terminology requirements in health
records)
WHO ICD‐10
(for statistical classification of diseases and related
health problems)
Coding System
LOINC
(for observation, measurement, test‐panels, test items
and units)
Recommended Standards by NDHB
• Privacy and Security
Purpose Recommended Standards
Security Digital Certificate, TLS / SSL, SHA‐256, AES‐256
ISO 22600:2014 Health informatics ‐ Privilege Management and
Access Control
Access Control (Part 1 through 3)

• Additional requirements
Record once created cannot be deleted or modified without follow
Immutability
due process.
Any record created may be ‘amended’ with new version numbe
Versioning same records with any changes (previous records to be mar
inactive) with only highest version considered active.
Non‐Repudiation All created records must be traceable to its creator unambiguously
All creation, amendments, access of records should be audit logge
Audit Log
manner that it is verifiable and reliable
Patient should be able to access/view own health records anyt
Patient Control
and control access by others.

EHR Standards for India 2016 should be incorporated.

Recommended Standards by NDHB
• Patient Safety and Data Quality
• Quality in healthcare services and safety of
electrical‐medical equipment are of utmost importance in
the NDHB.
• Electrical‐medical equipment used in the NDHE should be
safe for the patient and para‐medical personnel and against
safety hazards like electric shock,harmful radiation,
excessive temperature, implosion, mechanical instability
and fire.
• Bureau of Indian Standard has published 38 standards in
this area. These standards are either an adoption or
technical equivalent of the related IEC standard. The work
on some additional standards is ongoing in IEC/TC 62.
 NDHB Action Plan:
Year 1 Year 2 Year 4 Year 5
Year 3
(Planning & stabilizing (Pre‐requisite (Analytics & (Sustenance &
(Execution)
NDHM) infrastructure) Innovation) Research)
Approval of National
Digital Health Mission (NDHM) Designing and establishing
and its Unique Health Establishing Health Implementation
operationalization. Identifier(UHID) , Information of artificial intelligence
directories of Exchange enabled clinical decision
Design and development of health professionals & (HIE) support systems
federated enterprise health institutions Design,
architecture, adopting Agile develop and Designing and developing
IndEA Framework. Design and implement launch health analytics platform
federated health cloud & Common
Design of core building blocks secure network Applications Design and develop
Ensuring continuum
of NDHB (to be infrastructure. Establish anonymization
of
identified) and defining the health app methodology for health
care
standard interfaces Enhancing of legacy store data analytics
Continued Research
systems to conform to NDHB Design and Establish Security and
Sustenance of
Assessment of legacy Principles, and implement Privacy
operations
systems for conformity with interoperable it building plan Operations Centre (SOC),
NDHB. Establish the Network Operations
Implementation of repository of Centre (NOC) and Privacy
Design and notification of a plan for adoption of health standards, Operations Centre (POC)
NDHM Security & Privacy informatics API’s,
Policies standards including metadata Design and notification of
Electronic Health Record and data Framework for value‐added
Design and development of (EHR) for citizen with family dictionaries services
consent management folders
framework