Networking and Health Information Exchange

1. Networking and Health Information Exchange Standards Developing Organizations Lecture b This material (Comp 9 Unit 3) 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. This material was updated by Normandale Community College, funded under Award Number 90WT0003. This work is licensed under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/4.0/

2. Standards Developing OrganizationsLearning Objectives • Understand different kinds of standards being developed and for what purpose • Learn about Standards Developing Organizations and the standards they create • Demonstrate how to find, obtain, and use standards that are needed to facilitate networking and health information exchange

3. 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. 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. Significant Relationships • Vienna Agreement • HL7 Pilot Agreement • IEEE Partnership Agreement

6. 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. 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. 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. CEN Standard EN 13606 • An important CEN standard is EN 13606 – Health Informatics – Electronic Health Record communication, published in 5 parts • Reference Model • Archetypes interchange specification • Archetypes and term lists • Security • Interface specification • These standards are being used in the European Union and are becoming ISO standards

10. 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. HL7 Steering Divisions • Domain Experts • Foundation and Technology • Structure and Semantic Design • Technical and Support Services

12. 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. Foundation and Technology • Conformance & Implementation • Infrastructure & Messaging • Implementable Technology Specifications (ITS) • Java • Understand different kinds of standards being developed and for what purpose • Learn about Standards Developing Organizations and the standards they create • Demonstrate how to find, obtain, and use standards that are needed to facilitate networking and health information exchange

14. 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. Technical and Support Services • Education • Electronic Services • Implementation • Marketing Committee

16. 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. HL7 Products • Models • Reference Information Model • Data Types • Common Message Element Type • XML Implementation Technology Specification - Structures

18. 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. 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. 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. HL7 Products • Clinical Context Object Workgroup (CCOW) • Clinical Context Management • Application Protection Package • Manager Protection Package • User Authenticator Package

22. 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 • Continuity of Care Document (CCD) • And growing…

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

24. 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. 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. Standards Developing OrganizationsSummary- Lecture b • Multiple SDOs = competing and overlapping standards • Redundancy in work • Redundancy in people • Limited resources

27. Standards Developing OrganizationsReferences – Lecture b References American Dental Association. (n.d.). Retrieved from American Dental Association website: www.ada.org ANSI - American National Standards Institute. (n.d.). Retrieved from www.ansi.org ANSI Accredited U.S. Technical Advisory Groups (TAGs) to ISO. (n.d.). Retrieved from www.ansi.org/standards_activities/iso_programs/tag_iso.aspx ASCX12 - About ASC X12. (n.d.). Retrieved from ASC X12 website: www.x12.org ASTM International - Welcome to ASTM.org. (n.d.). Retrieved from ASTM International website: www.astm.org CDISC Strength Through Collaboration. (n.d.). Retrieved from Clinical Data Interchange Standards Consortium website: www.cdisc.org DICOM (Digital Imaging and Communications in Medicine). (n.d.). Retrieved from Medical Imaging & Technology Alliance - a division of NEMA website: http://medical.nema.org/ GS1 The global language of business. (n.d.). Retrieved from www.gs1.org Health Level Seven International. (n.d.). Retrieved from HL7 website: www.hl7.org IEEE Advancing Technology for Humanity. (n.d.). Retrieved from IEEE website: www.IEEE.org IHE - Welcome to Integrating the Healthcare Enterprise. (n.d.). Retrieved from IHE International website: www.ihe.net Joint Initiative on SDO Global Health Informatics Standardization. (n.d.). Retrieved from Health Level Seven International website: www.jointinitiativecouncil.org/

28. Standards Developing OrganizationsReferences – Lecture b References MedBiquitous Advancing Healthcare Education Through Collaboration. (n.d.). Retrieved from MedBiquitous Consortium website: www.medbiq.org National Council for Prescription Drug Programs . (n.d.). Retrieved from www.ncpdp.org National Institute of Standards and Technology. (n.d.). Retrieved from U.S. Department of Commerce website: www.nist.gov National Quality Forum. (n.d.). Retrieved from The National Quality Forum website: www.qualityforum.org OASIS - Advancing open standards for the information society. (n.d.). Retrieved from OASIS website: www.oasis-open.org OMG. (n.d.). Retrieved from Object Management Group, Inc. website: www.omg.org openEHR - Welcome to openEHR. (n.d.). Retrieved from openEHR website: www.openehr.org TC 215 Health Informatics. (n.d.). Retrieved 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 from CEN (ComitéEuropéen de Normalisation) website: www.cen.eu/cen/Sectors/TechnicalCommitteesWorkshops/CENTechnicalCommittees/Pages/default.aspx?param=6232&title=CEN/TC%20251 The Internet Engineering Task Force (IETF). (n.d.). Retrieved from Internet Society website: www.ietf.org U.S. National Library of Medicine - National Institutes of Health. (n.d.). Retrieved from U.S. National Library of Medicine website: www.nlm.nih.gov W3C. (n.d.). Retrieved from W3C website: http://www.w3.org/ Welcome to IHTSDO. (n.d.). Retrieved from International Health Terminology Standards Development Organisation website: www.ihtsdo.org World Health Organization. (n.d.). Retrieved from WHO website: www.who.int

29. Standards Developing OrganizationsLecture b This material 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. This material was updated by Normandale Community College, funded under Award Number 90WT0003.