09 - Networking and Health Information Exchange - Unit 3 - National and International Standards Developing Organizations - Lecture B

Networking and Health
Information Exchange
National and International Standards
Developing Organizations
Lecture b
This material Comp9_Unit3b was developed by Duke University, funded by the Department of Health and Human Services,
Office of the National Coordinator for Health Information Technology under Award Number IU24OC000024.
Learning Objectives
2
1. Explain why standards related to networking
and health information exchange are important
in the current environment (Lecture a)
2. Standards development (Lecture a)
a. How standards are developed
b. Who develops them
c. How standards are accredited
d. How standards are selected

Health IT Workforce Curriculum
Version 3.0/Spring 2012
Networking and Health Information Exchange
National and International Standards Developing Organizations
Lecture b
Learning Objectives
3. Understand different kinds of standards being
developed and for what purpose (Lectures a, b)
4. Learn about Standards Developing
Organizations and the standards they create
(Lectures b, c)
5. Demonstrate how to find, obtain, and use
standards that are needed to facilitate
networking and health information exchange
(Lectures b, c)

3
Lecture b
ISO TC 215 Healthcare
Informatics
Standards have national priority
Members are nations
Established in 1998
Products include Technical Reports,
Technical Specifications, and International
Standards

4
Lecture b
Work Groups of TC 215
WG1 Data Structure
WG2 Data Interchange
WG3 Semantic Content
WG4 Security
WG6 Pharmacy and Medicines Business
WG7 Medical Devices
WG8 Business requirements for Electronic
Health Records
WG9 SDO Harmonization

5
Lecture b
Significant Relationships
Vienna Agreement
HL7 Pilot Agreement
IEEE Partnership Agreement

6
Lecture b
Harmonization of International
Standards
Creation of Joint Initiative Council in 2007
Founding members
ISO TC 215
CEN TC 251
HL7 International
Later members include
CDISC
IHTSDO
GS1
Operates as a council of equals and was formed
to create a single standard for a single business use

7
Lecture b
CEN TC 251
Workgroup within European Union
Goal is to achieve compatibility and
interoperability between independent systems
and to enable modularity in EHR systems

8
Lecture b
CEN TC 251 Work Groups
WG I Information Models
WG II Terminology and knowledge
representation
WG III Safety and Quality
WG IV Technology for Interoperability

9
Lecture b
CEN Standard EN 13606
An important CEN standard is EN 13606 Health
Informatics Electronic Health Record communication,
published in 5 parts
1. Reference Model
2. Archetypes interchange specification
3. Archetypes and term lists
4. Security
5. Interface specification
These standards are being used in the European Union
and are becoming ISO standards

10
Lecture b
Health Level 7 International
Formed in 1987 as a U.S. SDO; invited
international affiliates in the early 1990s
Now HL7 International with over 40
international country members
Is an ANSI accredited SDO

11
Networking and Health Information Exchange(
Lecture b
HL7 Steering Divisions
Domain Experts
Foundation and Technology
Structure and Semantic Design
Technical and Support Services

12
Lecture b
Domain Experts
Anatomic Pathology
Anesthesiology
Attachments
Child Health
Clinical Interoperability
Council
Community Based
Health Services
Emergency Care
Government Projects
Health Care Devices
Imaging Integration
Laboratory
Patient Care
Patient Safety
Public Health Emergency
Response (PHER)
Pharmacy
Regulated Clinical
Research Information
Management (RCRIM)

13
Lecture b
Foundation and Technology
Conformance &
Implementation
Infrastructure &
Messaging
Implementable
Technology
Specifications (ITS)
Java
Modeling & Methodology
Security
Service Oriented
Architecture (SOA)
Templates
Vocabulary
14
Lecture b
Structure and Semantic Design
Arden Syntax
Clinical Context
Object Workgroup
(CCOW)
Clinical Decision
Support
Clinical Statement
Electronic Health
Record (EHR)
Financial
Management

Genomics
Orders &
Observations
Patient Administration
Personnel
Management
Scheduling &
Logistics
Structured
Documents

15
Lecture b
Technical and Support Services
Education
Electronic Services
Implementation
Marketing Committee

16
Lecture b
HL7 Products
Messaging Standards
Version 2.x (current is 2.7 published 12/07)
XML Encoding Rules for v2 Messages
Version 3.0 (2008 Normative Edition in
publication)
Infrastructure
Master file structure infrastructure
Role-Based Access Control

17
Lecture b
HL7 Products
Models
Reference Information Model
Data Types
Common Message Element Type
XML Implementation Technology Specification
- Structures

18
Lecture b
HL7 Products
Application
Electronic Health Record
Functional EHR-S Standard
Interactions for EHR-S and Functional PHR-S
Profiles
EHR Behavioral Health Functional Model
EHR Child Health Functional Model
Scheduling
Notifiable Condition Report
Personnel Management
Genomics - Pedigree

19
Lecture b
HL7 Products
Documents
Clinical Document Architecture (CDA)
Continuity of Care Document (CCD)
Decision Support
Arden Syntax
Virtual Medical Record
GELLO: Common Expression Language
Infobutton

20
Lecture b
HL7 Products
Regulated Studies
Structured Product Labeling (SPL)
Annotated ECG
Individual Case Safety Report (ICSR)
Drug Stability Study
Regulated Product Submission
Common Product Model (CPM)
Periodic Reporting of Clinical Trials Laboratory
Results

21
Lecture b
HL7 Products
Clinical Context Object Workgroup
(CCOW)
Clinical Context Management
Application Protection Package
Manager Protection Package
User Authenticator Package

22
Lecture b
Implementation Guides
HL7 Claims Attachments
Secure HL7 Transactions Using Internet Mail
HL7 Security Service Framework
CDA R2
Common Audit Message
Standard Guide for Implementing HL7 EDI
Communication Security
HL7 Version 2.x Messaging Profiling Specification
And growing

23
Lecture b
HL7 Standards Named in HHS
Final Rule
HL7 v2.5.1 Implementation Guide:
Electronic Laboratory Results Reporting to
Public Health
Clinical Document Architecture (CDA)
Messaging Standard v2.5.1
Messaging Standard v2.3.1

24
Lecture b
CDISC Standards
Study Data Tabulation Model (SDTM)
Recommended for FDA regulatory submissions
Analysis Data Model (ADaM)
Complements SDTM submission by detailing statistical analysis
performed on clinical trials results
Operational Data Model (ODM)
Clinical Data Acquisition Standards Harmonization
(CDASH)
Laboratory Data Model (LAB)
CDISC Terminology

25
Lecture b
GS1 Key Standards
Barcodes
eCom electronic business messaging
standards for automatic transmission of data
GDSN Global Data Synchronization allow
business partners to have consistent item data
in their systems at the same time
EPCglobal use RFID technology to track items
in real time
26
Lecture b
Summary- Lecture b
Multiple SDOs = competing and
overlapping standards
Redundancy in work
Redundancy in people
Limited resources

27
Lecture b
References Lecture a
References
Additional resources for information contained in this lecture
TC 215 Health Informatics. (n.d.). Retrieved January 10, 2012, from ISO (International Organization for
Standardization) website: www.iso.org/iso/iso_technical_committee?commid=54960
Technical Committees, Workshops and other bodies. (n.d.). Retrieved January 10, 2012, from CEN (Comit
Europen de Normalisation) website:
www.cen.eu/cen/Sectors/TechnicalCommitteesWorkshops/CENTechnicalCommittees/Pages/default.aspx?param=
6232&title=CEN/TC%20251
Health Level Seven International. (n.d.). Retrieved January 10, 2012, from HL7 website: www.hl7.org
DICOM (Digital Imaging and Communications in Medicine). (n.d.). Retrieved January 10, 2012, from Medical
Imaging & Technology Alliance - a division of NEMA website: http://medical.nema.org/
IEEE Advancing Technology for Humanity. (n.d.). Retrieved January 10, 2012, from IEEE website: www.IEEE.org
CDISC Strength Through Collaboration. (n.d.). Retrieved January 10, 2012, from Clinical Data Interchange
Standards Consortium website: www.cdisc.org
GS1 The global language of business. (n.d.). Retrieved January 10, 2012, from www.gs1.org
Welcome to IHTSDO. (n.d.). Retrieved January 10, 2012, from International Health Terminology Standards
Development Organisation website: www.ihtsdo.org
Joint Initiative on SDO Global Health Informatics Standardization. (n.d.). Retrieved January 10, 2012, from Health
Level Seven International website: www.jointinitiativecouncil.org/
World Health Organization. (n.d.). Retrieved January 10, 2012, from WHO website: www.who.int
OMG. (n.d.). Retrieved January 10, 2012, from Object Management Group, Inc. website: www.omg.org

28
Lecture a
References Lecture a
References
IHE - Welcome to Integrating the Healthcare Enterprise. (n.d.). Retrieved January 10, 2012, from IHE International
website: www.ihe.net
openEHR - Welcome to openEHR. (n.d.). Retrieved January 10, 2012, from openEHR website: www.openehr.org
OASIS - Advancing open standards for the information society. (n.d.). Retrieved January 10, 2012, from OASIS
website: www.oasis-open.org
W3C. (n.d.). Retrieved January 10, 2012, from W3C website: http://www.w3.org/
The Internet Engineering Task Force (IETF). (n.d.). Retrieved January 10, 2012, from Internet Society website:
www.ietf.org
ASTM International - Welcome to ASTM.org. (n.d.). Retrieved January 10, 2012, from ASTM International website:
www.astm.org
ASCX12 - About ASC X12. (n.d.). Retrieved January 10, 2012, from ASC X12 website: www.x12.org
National Council for Prescription Drug Programs . (n.d.). Retrieved January 10, 2012, from www.ncpdp.org
MedBiquitous Advancing Healthcare Education Through Collaboration. (n.d.). Retrieved January 10, 2012, from
MedBiquitous Consortium website: www.medbiq.org
American Dental Association. (n.d.). Retrieved January 10, 2012, from American Dental Association website:
www.ada.org
ANSI - American National Standards Institute. (n.d.). Retrieved January 10, 2012, from www.ansi.org
National Institute of Standards and Technology. (n.d.). Retrieved January 10, 2012, from U.S. Department of
Commerce website: www.nist.gov

29
Lecture a
References Lecture b
References
National Quality Forum. (n.d.). Retrieved January 10, 2012, from The National Quality Forum website:
www.qualityforum.org
U.S. National Library of Medicine - National Institutes of Health. (n.d.). Retrieved January 10, 2012, from U.S.
National Library of Medicine website: www.nlm.nih.gov
ANSI Accredited U.S. Technical Advisory Groups (TAGs) to ISO. (n.d.). Retrieved January 10, 2012, from
www.ansi.org/standards_activities/iso_programs/tag_iso.aspx

30
Lecture a

09 - Networking and Health Information Exchange - Unit 3 - National and International Standards Developing Organizations - Lecture B

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09 - Networking and Health Information Exchange - Unit 3 - National and International Standards Developing Organizations - Lecture B

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