NURSING INFORMATICS (LEC AND LAB) | Sir Jameson M.

Leonardo
Transes by: MJ SABADO | BSN 2E | BulS.U - College of Nursing

(Committee on Data Standards for Patient

Safety, 2004).
Chapter 7: Standards, Development,
Harmonization and Interoperability
Accredited Standards Committee
Keywords X12/Insurance
● Application Programming Interface ● Accredited Standards Committee (ASC)
● Health Information Exchange X12N has developed a broad range of
● Interoperability electronic data interchange (EDI) standards
● Knowledge representation to facilitate electronic business transactions.
● Standards Institute of Electrical and Electronic
● Terminology Engineers.

Introduction Institute of Electrical and Electronic Engineers

● The ability to communicate in a way that (IEEE)
ensures the message is received and the ● The Institute of Electrical and Electronic
content is understood is dependent on Engineers (IEEE) has developed a series of
standards. standards known collectively as P1073
● Data standards are intended to reduce Medical Information Bus (MIB), which
ambiguity in communication so that the support real-time, continuous, and
actions taken based on data are consistent comprehensive capture and communication
with the actual meaning of that data. The of data from bedside medical devices such
healthcare transformation that is underway as those found in intensive care units,
requires data capture and sharing and operating rooms, and emergency
advanced clinical processes, which will departments.
enable improved health outcomes.
National Electrical Manufacturers Association
Standard Categories ● The National Electrical Manufacturers
Association (NEMA), in collaboration with
● Four broad areas are identified to the American College of Radiologists (ACR)
categorize health data standards and others, formed DICOM (Digital Imaging
(Department of Health and Human and Communications in Medicine) to
Services, 2010). Transport standards are develop a generic digital format and a
used to establish a common, predictable, transfer protocol for biomedical images and
secure communication protocol between image-related information.
systems.
World Wide Web Consortium
Transport Standards ● The World Wide Web Consortium (W3C) is
● Transport standards primarily address the the main international standards
format of messages that are exchanged organization for development of the World
between computer systems, document Wide Web (abbreviated WWW or W3). W3C
architecture, clinical templates, the user also publishes XML (Extensible Markup
interface, and patient data linkage Language), which is a set of rules for

Mary Joy O. Sabado | BSN 2E

NURSING INFORMATICS (LEC AND LAB) | Sir Jameson M. Leonardo
Transes by: MJ SABADO | BSN 2E | BulS.U - College of Nursing

encoding documents in machine-readable International Classification of Nursing

format. Practice, Logical Observation Identifiers
Names and Codes (LOINC), North
Communication Protocols American Nursing Diagnosis Association,
Nursing Interventions Classification
● In telecommunications, a protocol is a
(NIC), Nursing Outcome Classification
system of digital rules for data exchange
(NOC), Nursing Management Minimum
within or between computers. When data
Data Set, Nursing Minimum Data Set,
are exchanged through a computer network,
Omaha System, Patient Care Data Set
the rules system is called a network
(retired), Perioperative Nursing Data Set,
protocol.
and SNOMED-CT.
- Pang intervention or pang-nursing outcome.
Vocabulary Standards
● A fundamental requirement for effective RxNorm
communication is the ability to represent
concepts in an unambiguous fashion
RxNorm.
between both the sender and the receiver of
● RxNorm is a standardized nomenclature for
the message.
clinical drugs and drug delivery devices
produced by the National Library of
Current Procedural Terminology Medicine (NLM).
● The Current Procedural Terminology (CPT)
code set, maintained by the American Unified Medical Language System.
Medical Association (AMA), accurately ● The Unified Medical Language System
describes medical, surgical, and diagnostic (UMLS) consists of a large biomedical
services. thesaurus that identifies relationships
between concepts across multiple
vocabularies, including their meanings,
International Statistical Classification of
concept names, and relationships.
Diseases and Related Health Problems: Tenth
Revision
Content Standards
● The International Statistical Classification of
● Content Standards are related to the data
Diseases and Related Health Problems:
content within information exchanges.
Tenth Revision (ICD-10) is the most recent
Information content standards define the
revision of the ICD classification system for
structure and content organization of the
mortality and morbidity, which is used
electronic message’s or document’s
worldwide.
information content. They can also define a
“package” of content standards (messages
Nursing and Other Domain-Specific
or documents).
Terminologies.
American Society for Testing and Materials.
● The American Nurses Association (ANA)
● The American Society for Testing and
has recognized the following nursing
Materials (ASTM) is one of the largest
terminologies that support nursing practice:
SDOs in the world and publishes standards
ABC Codes, Clinical Care Classification,
covering all sectors in the economy.
Mary Joy O. Sabado | BSN 2E
NURSING INFORMATICS (LEC AND LAB) | Sir Jameson M. Leonardo
Transes by: MJ SABADO | BSN 2E | BulS.U - College of Nursing

Clinical Data Interchange Standards National Uniform Claim Committee

Consortium. Recommended Data Set for a Noninstitutional
● The Clinical Data Interchange Standards Claim.
Consortium (CDISC) is a global, ● Organized in 1995, the scope of the
multidisciplinary consortium that has National Uniform Claim Committee (NUCC)
established standards to support the was to develop, promote, and maintain a
acquisition, exchange, submission, and standard data set for use in noninstitutional
archive of clinical research data and claims and encounter information.
metadata.
Security Standards
Health Level Seven.
● HIPAA Security Standards for the
● Health Level Seven (HL7) is an SDO that
Protection of Electronic Health
develops standards in multiple categories
Information at 45 CFR Part 160 and Part
including transport and content. HL7
164, Subparts A and C.
standards focus on facilitating the exchange
of data to support clinical practice both
● The HIPAA Security Rule was developed to
within and across institutions.
protect electronic health information and
implement reasonable and appropriate
SNOMED International.
administrative safeguards that establish the
● SNOMED International is a not-for-profit
foundation for a covered entity’s security
organization that owns, administers, and
program (CMS, 2007).
develops SNOMED-CT, the global common
language for health terms. SNOMED-CT
ISO/IEC 27002:2013 Standard.
has been developed collaboratively to
● ISO/IEC 27002:2013 provides guidelines for
ensure it meets the diverse needs and
organizational information security
expectations of the worldwide medical
standards and information security
profession and healthcare community.
management practices including the
selection, implementation, and management
LOINC. Logical Observation Identifiers Names
of controls taking into consideration the
and Codes
organization’s information security risk
● (LOINC) is a database and universal
environment(s).
standard for identifying medical laboratory
observations. It was developed and is
It is designed to be used by organizations that
maintained by the Regenstrief Institute.
intend to:
● Select controls within the process of
implementing an Information Security
National Council for Prescription Drug
Programs.
Management System based on ISO/IEC 27001;
● The National Council for Prescription Drug
● Implement commonly accepted information
Programs (NCPDP) develops both content
security controls; and
and transport standards for information
● Develop their own information security
processing in the pharmacy services sector
management guidelines.
of the healthcare industry.

Mary Joy O. Sabado | BSN 2E

NURSING INFORMATICS (LEC AND LAB) | Sir Jameson M. Leonardo
Transes by: MJ SABADO | BSN 2E | BulS.U - College of Nursing

STANDARDS COORDINATION AND standards to address specific use cases,

HARMONIZATION filling the gaps between standards, and their
● It has become clear to both public and implementations.
private sector standards development
efforts that no one entity has the resources
to create an exhaustive set of health data
standards that will meet all needs.

The American National Standards Institute

(ANSI)
● Serves as the U.S. coordinating body for
voluntary standards activity. Standards are
submitted to ANSI by member SDOs and
are approved as American National
Standards through a consensus ● To better differentiate those products that
methodology developed by ANSI. European can deliver robust integration capabilities in
Technical Committee for Standardization production systems, IHE has implemented a
conformity assessment program with
● In 1990, Technical Committee (TC) 251 on formalized, rigorous, and independent
medical informatics was established by the testing and validation of IHE profiles and
European Committee for Standardization specifications as implemented in specific
(CEN). CEN/TC 251 works to develop a versions of products going to market (IHE,
wide variety of standards in the area of 2018).
healthcare data management and
interchange.
International Organization for Standardization
Committee (HITAC) was established in 2017 in ● The International Organization for
accordance with provisions of the U.S. Federal Standardization (ISO) develops,
Advisory Committee Act, and was enacted by the harmonizes, and publishes standards
21st Century Cures Office of the National internationally.
Coordinator for Health IT (ONC) (2018).
Implementation Guides Standards, while a
necessary part of the interoperability ecosystem,
are not sufficient alone to fulfill the needs of data
sharing. Simply using a standard does not
necessarily guarantee health information exchange
within or among organizations and systems.

Integrating the Healthcare Enterprise

● Integrating the Healthcare Enterprise (IHE)

is an international standards profiling
organization that provides a detailed
framework for implementing multiple
Mary Joy O. Sabado | BSN 2E
NURSING INFORMATICS (LEC AND LAB) | Sir Jameson M. Leonardo
Transes by: MJ SABADO | BSN 2E | BulS.U - College of Nursing

Object Management Group CommonWell offers interoperability services

to its 80 members and more than 11,000
● While the organizations described thus far
provider sites.
are made up of volunteer-based SDOs, the
Object Management Group (OMG) is
21st Century Cures Act
representative of a different approach to
● The 21st Century Cures Act, signed
standards development.
December 13, 2016 by President Obama,
promotes and funds the acceleration of
Innovation and Interoperability research into preventing and curing serious
illnesses; accelerates drug and medical
Testing and Certification device development; addresses the opioid
● To accelerate the development, use, abuse crisis; and focuses on improving
maintenance, and adoption of mental health service delivery.
interoperability standards across the
industry, and to spur innovation, the ONC APIs and HL7 FHIR
has developed tools to facilitate the entire ● Through its proposed rule based on the 21st
standards life cycle and maximize reuse of Century Cures Act, the ONC (HHS, 2019)
concepts and components, including tools calls for health IT developers to publish
and repositories for browsing, selecting, and APIs and allow health information from such
implementing appropriate standards. technology to be accessed, exchanged, and
used without special effort through their use.
● Both the structure and the function for
health information exchange efforts at The Role of the Consumer
independent and governmental or ● The CARIN Alliance is an organization that
regional/state levels. is working to advance the ability for
consumers and their caregivers to easily
The eHealth Exchange get, use, and share their digital health
● In 2009, the first production exchange information when, where, and how they
began between the Social Security want it, and specifically via open APIs
Administration and Med Virginia, followed (CARIN Alliance, 2019).
by the Veterans Health Administration and
Kaiser Permanente. This was the beginning The Business Imperative For Health Data
of what is now known as the eHealth Standards
Exchange. ● The importance of data standards to
enhancing the quality and efficiency of
By a diverse group of representatives from across healthcare delivery and improving health
healthcare to connect existing and future outcomes is being recognized by national
data-sharing networks to each other, and international leadership. Understanding
the business imperative of defining and
CommonWell Health Alliance using health data standards is critical for
● Launched in 2013, CommonWell Health driving the implementation of these
Alliance services include patient enrollment, standards into applications and real-world
record location, patient identification & systems.
linking, and data query & retrieval. Today,

Mary Joy O. Sabado | BSN 2E

NURSING INFORMATICS (LEC AND LAB) | Sir Jameson M. Leonardo
Transes by: MJ SABADO | BSN 2E | BulS.U - College of Nursing

The report (Soderlund, Kent, Lawyer, & Larsson,

2012) outlined four key success factors:

1. Clinician engagement: The greatest

improvement comes when clinicians are
responsible not only for collecting and
interpreting data but also leading
improvement efforts.

2. National infrastructure: It looked for

common standards for tracking diagnoses,
treatments, outcomes, and costs at the
patient level; a limited number of shared IT
platforms; and a common legal framework
regulating the use of patient data.

3. High-quality data: The most effective way

to collect relevant data is through disease
registries to promote more effective and
cost-efficient care.

4. Outcome-based incentives: Data-driven

incentive measures should spur changes in
the way clinicians practice, payers
reimburse, and suppliers of drugs and
medical devices develop and deliver
products and services.

● HIMSS published a Call to Action (2017)

to encourage a comprehensive integrated
approach to care that can recognize and
build upon the many mature,
consensus-based standards and profiles
already in place, while allowing innovation
to pilot and incorporate new and emerging
standards

Mary Joy O. Sabado | BSN 2E