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07 – Health Data Standards: Transport Data

Development, Harmonization, Transport standards primarily ADDRESS the
& Interoperability format of messages that are EXCHANGED
between computer systems, document
NCM 110: Nursing Informatics
architecture, clinical templates, the user interface,
and patient data linkage (Committee on Data
Objectives Standards for Patient Safety, 2004).
1. Discuss the NEED for health data
standards.
2. Describe the standards development Accredited Standards Committee
process and RELATED organizations. X12 / Insurance
3. Delineate the IMPORTANCE of health
Accredited Standards Committee (ASC) X12N
information exchange and
has developed a BROAD range of electronic
interoperability.
data interchange (EDI) standards to
4. Describe CURRENT health data
FACILITATE electronic business transactions.
standards initiatives.
5. Define the ROLE of the healthcare
consumer in accessing health data.
6. Explore the business imperative of Institute of Electrical and
health data standards Electronic Engineers
The Institute of Electrical and Electronic
Keywords Engineers (IEEE) has developed a SERIES of
standards known collectively as P1073 Medical
• Application Programming Interface Information Bus (MIB), which support REAL-
• Health Information Exchange TIME, CONTINUOUS, and COMPREHENSIVE
• Interoperability capture and communication of data from
• Knowledge representation bedside medical devices such as those found in
• Standards intensive care units, operating rooms, and
• Terminology emergency departments.

Introduction
National Electrical Manufacturers
The ABILITY to communicate in a way that
Association
ensures the message is received and the
content is understood is DEPENDENT on The National Electrical Manufacturers
standards. Association (NEMA), in collaboration with the
American College of Radiologists (ACR) and
DATA STANDARDS are intended to REDUCE
OTHERS, formed DICOM (Digital Imaging and
ambiguity in communication so that the actions
Communications in Medicine) to develop a
taken based on data are consistent with the
generic digital format and a transfer protocol
actual meaning of that data.
for biomedical images and image-related
The healthcare transformation that is underway information.
REQUIRES data capture and sharing and
advanced clinical processes, which will
ENABLE improved health outcomes.
World Wide Web Consortium

Standards Categories The World Wide Web Consortium (W3C) is the

MAIN international standards organization for
FOUR broad areas are identified to categorize development of the World Wide Web
health data standards (Department of Health (abbreviated WWW or W3). W3C also publishes
and Human Services, 2010). Transport XML (Extensible Markup Language), which is a
standards are used to establish a COMMON, SET of rules for encoding documents in
PREDICTABLE, SECURE communication machine-readable format.
protocol between systems.

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In telecommunications, a protocol is a SYSTEM Unified Medical Language System

of digital rules FOR data exchange within or
between computers. When data are exchanged The Unified Medical Language System (UMLS)
through a computer network, the rules system consists of a LARGE biomedical thesaurus that
is called a network protocol. identifies relationships between CONCEPTS
across multiple vocabularies, including their
meanings, concept names, and relationships.
Vocabulary Standards

A FUNDAMENTAL requirement for effective Content Standards

communication is the ABILITY to represent
concepts in an unambiguous fashion Are RELATED to the data content within
BETWEEN both the sender and the receiver of information exchanges. Information content
the message. standards DEFINE the structure and content
organization of the electronic message’s or
document’s information content. They can
Current Procedural Terminology also define a “package” of content standards
(messages or documents).
The Current Procedural Terminology (CPT)
code set, maintained by the American Medical
Association (AMA), ACCURATELY describes American Society for Testing and Materials
medical, surgical, and diagnostic services.
The American Society for Testing and Materials
(ASTM) is one of the LARGEST SDOs in the
International Statistical world and PUBLISHES standards covering
ALL SECTORS in the economy.
Classification of Diseases &
Related Health Problems: 10th
Revision Clinical Data Interchange Standards Consortium
The International Statistical Classification of The Clinical Data Interchange Standards
Diseases and Related Health Problems: Tenth Consortium (CDISC) is a global,
Revision (ICD-10) is the MOST RECENT multidisciplinary consortium that has
revision of the ICD classification system for established standards to support the
mortality and morbidity, which is used ACQUISITION, EXCHANGE, SUBMISSION,
WORLDWIDE. and ARCHIVE of clinical research data and
metadata.

Nursing and Other Domain-Specific

Terminologies Health Level Seven
The American Nurses Association (ANA) has Is an SDO that develops standards in multiple
RECOGNIZED the following nursing categories including transport and content.
terminologies that support nursing practice: HL7 standards FOCUS on facilitating the
ABC Codes, Clinical Care Classification, exchange of data to support clinical practice
International Classification of Nursing Practice, both within and across institutions.
Logical Observation Identifiers Names and
Codes (LOINC), North American Nursing
Diagnosis Association, Nursing Interventions SNOMED International
Classification (NIC), Nursing Outcome
Is a not-for-profit organization that OWNS,
Classification (NOC), Nursing Management
ADMINISTERS, and DEVELOPS SNOMED-CT,
Minimum Data Set, Nursing Minimum Data Set,
the global common language for health terms.
Omaha System, Patient Care Data Set (retired),
Perioperative Nursing Data Set, and SNOMED- SNOMED-CT has been developed
CT. collaboratively to ensure it MEET the diverse
needs and expectations of the worldwide
medical profession and healthcare community.
RxNorm
RxNorm is a STANDARDIZED nomenclature for
clinical drugs and drug delivery devices
produced by the National Library of Medicine
(NLM).

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LOINC • IMPLEMENT commonly accepted

information security controls; and
Logical Observation Identifiers Names and • DEVELOP their own information
Codes is a database and universal standard for security management guideline
IDENTIFYING medical laboratory
observations. It was developed and is
maintained by the Regenstrief Institute. Standards Coordination and Harmonization
It has become CLEAR to both public and private
National Council for Prescription Drug Programs sector standards development efforts that NO
ONE ENTITY has the resources to create an
(NCPDP) develops BOTH content and exhaustive set of health data standards that
transport standards for information will meet ALL needs.
processing in the pharmacy services sector of
the healthcare industry.
American National Standards
Institute
National Uniform Claim Committee Recommended
The American National Standards Institute
Data Set for a Noninstitutional Claim (ANSI) serves as the U.S. COORDINATING
BODY for voluntary standards activity.
ORGANIZED in 1995, the scope of the National Standards are SUBMITTED to ANSI by member
Uniform Claim Committee (NUCC) was to SDOs and are APPROVED as American
DEVELOP, PROMOTE, and MAINTAIN a National Standards through a consensus
standard data set for use in noninstitutional methodology developed by ANSI.
claims and encounter information

European Technical Committee for

Security Standards Standardization
HIPAA Security Standards for the Protection In 1990, Technical Committee (TC) 251 on
of Electronic Health Information at 45 CFR medical informatics was established by the
Part 160 and Part 164, Subparts A and C. European Committee for Standardization
(CEN). CEN/TC 251 works to develop a WIDE
• The HIPAA Security Rule was developed
VARIETY of standards in the area of healthcare
to PROTECT electronic health
data management and interchange.
information and IMPLEMENT
reasonable and appropriate
administrative safeguards that
establish the foundation for a covered Health Information Technology
entity’s security program (CMS, 2007). Advisory Committee
The Health Information Technology Advisory
Committee (HITAC) was established in 2017 in
ISO/IEC 27002:2013 Standard. ISO/IEC
accordance with PROVISIONS of the U.S.
27002:2013 Federal Advisory Committee Act, and was
• Provides guidelines for ENACTED by the 21st Century Cures Office of
the National Coordinator for Health IT (ONC)
organizational information
(2018).
security standards and information
security management practices
including the selection,
implementation, and management of Implementation Guidelines
controls taking into consideration the
Standards, while a necessary part of the
organization’s information security interoperability ecosystem, are NOT sufficient
risk environment(s). ALONE to fulfill the needs of data sharing.
It is designed to be used by organizations Simply using a standard does NOT necessarily
that intend to: guarantee health information exchange within
or among organizations and systems.
• SELECT controls within the process
of implementing an Information
Security Management System
based on ISO/IEC 27001;

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Integrating the Healthcare REPRESENTATIVE of a different approach to

standards development.
Enterprise

Integrating the Healthcare Enterprise (IHE) is an Innovation and Interoperability

international standards profiling organization
that PROVIDES a detailed framework for Testing and Certification
implementing multiple standards to ADDRESS
specific use cases, filling the gaps between
To ACCELERATE the development, use,
standards, and their implementations.
maintenance, and adoption of interoperability
standards across the industry, and to spur
innovation, the ONC has developed TOOLS to
facilitate the entire standards life cycle and
maximize reuse of concepts and components,
including tools and repositories for browsing,
selecting, and implementing appropriate
standards.

Health Information Exchange &

Interoperability

Formal entities have been established to

Conformity Assessment Program provide BOTH the structure and the function for
health information exchange efforts at
To better DIFFERENTIATE those products that independent and governmental or
can deliver robust integration capabilities in regional/state levels.
production systems, IHE has implemented a
conformity assessment program with formalized,
rigorous, and independent TESTING and
VALIDATION of IHE profiles and specifications The eHealth Exchange
as implemented in specific versions of products
In 2009, the FIRST production exchange began
going to market (IHE, 2018).
between the Social Security Administration
and Med Virginia, followed by the Veterans
Health Administration and Kaiser
International Organization for Permanente. This was the BEGINNING of what
Standardization is now known as the eHealth Exchange.
The International Organization for
Standardization (ISO) DEVELOPS, Carequality
HARMONIZES, and PUBLISHES standards
internationally. Another SUBSIDIARY of The Sequoia Project,
Carequality, is a network-to-network trust
framework developed by a diverse group of
representatives from across healthcare to
CONNECT existing and future data-sharing
networks to each other,

Common Well Health Aliance

Launched in 2013, CommonWell Health Alliance
services include patient enrollment, record
location, patient identification & linking, and data
query & retrieval. TODAY, CommonWell offers
interoperability services to its 80 members and
MORE THAN 11,000 provider sites.

Object Management Group 21st Century Cures Act

While the organizations described thus far are The 21st Century Cures Act, signed December
made up of volunteer-based SDOs, the Object 13, 2016 by President Obama, PROMOTES and
Management Group (OMG) is FUNDS the ACCELERATION of research into

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preventing and curing serious illnesses; 4. Outcome-based incentives: Data-

accelerates drug and medical device driven incentive measures should
development; ADDRESSES the opioid abuse SPUR changes in the way clinicians
crisis; and focuses on IMPROVING mental practice, payers reimburse, and
health service delivery. suppliers of drugs and medical
devices develop and deliver products
and services.
APIs and HL7 FHR
HIMSS published a Call to Action (2017) to
Through its PROPOSED RULE based on the encourage a comprehensive integrated
21st Century Cures Act, the ONC (HHS, 2019) approach to CARE that can recognize and
calls for health IT developers to publish APIs build upon the many mature, consensus-
and allow health information from such based standards and profiles already in
technology to be accessed, exchanged, and place, while ALLOWING innovation to
used WITHOUT special effort through their use. PILOT and INCORPORATE new and
emerging standards

The Role of the Consumer

The CARIN Alliance is an ORGANIZATION that
is working to ADVANCE the ability for
consumers and their caregivers to easily get,
use, and share their digital health information
when, where, and how they want it, and
specifically via open APIs (CARIN Alliance,
2019.

The Business Imperative for Health Data

Standards
The IMPORTANCE of data standards to
enhancing the quality and efficiency of
healthcare delivery and improving health
outcomes is being recognized by national and
international leadership.

Understanding the business imperative of

defining and using health data standards is
CRITICAL for driving the implementation of
these standards into applications and real-world
systems.

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.