ISO Liaison Report

1. ISO Liaison Report Hidenori Shinoda 11/29/2007 RSNA, Chicago

2. Recent Meeting for ISO/TC215 • The last joint working groups meeting was held between August 26 and 29, 2007 in Brisbane, Australia. • Shinoda attended the meeting for architecture breakout of WG2. • A drafted document on IHE Global Standards Adoption - Part 1 Process was reviewed. It would be submitted to the secretariat for the ballot to be approved.

3. SDO harmonization meeting • A meeting for SDO harmonization was held on Sunday, August 26. Shinoda did not attend the meeting, but items listed below were discussed; • New WG was established as WG9:Joint Initiative on SDO Global Health Informatics Standardization. • The WG was formed to address and resolve issues of gaps, overlaps, and counter-productive standard efforts by ISO, CEN, and HL7. • Co-Chairs（ISO：Don Newsham, HL7：Charles Jaffe, CEN：Melvin Reynolds） • ISO serves as the host of the WG and Australia will be in charge of the secretariat. • They would collect work items which are worked on by each SDO. • They decided that they would call IEEE, DICOM, IHE, etc. to participate to the WG. *I attached a copy of their presentation.

4. WADO standard is now circulated for evaluation. • Each ISO/TC215 member countries are requested to evaluate WADO standard. • Evaluation items are below; • Recommended action (Withdraw, Revise/Amend, Confirm, Confirm with correction of errors * , Abstain, or Abstain with survey replies) • Has this International Standard been adopted or is it intended to be adopted in the future as a national standard or other publication? (Reply only if the answer to Question 2 is "Yes") • Is the national publication identical to the International Standard or was it modified? • Is this International Standard used in your country without national adoption or are products used in your country based on this standard?  • Is this International Standard, or its national adoption, referenced in regulations in your country? • Due date will be March 17, 2008.

5. Joint Initiative on SDO Global Health Informatics StandardizationJoint Working Group (WG9) Meeting #1

6. Welcome / Introductions / Agenda • Charter update (Including ISO Ballot) • Working Group Structure • Work Program Overview / Summary / Harmonization needs • Current Work Program Updates • 13606, Data Types, Care Information Models, Other • Working Group Processes • Next JWG Meetings

7. Joint Initiative – Charter Update • CEN, HL7, ISO Charter Approval Status • Approved in all three • Additional SDO participation already under discussion • Joint Initiative Purpose / Scope The Joint Initiative on SDO Global Health Informatics Standardization is formed to enable common, timely health informatics standards by addressing and resolving issues of gaps, overlaps, and counter-productive standardization efforts through: • An agreed upon and used decision process for international standardization needs. • Coordinated standards strategies and plans. • An integrated work program • Focused, specific resolution of overlapping or counteracting standards within existing work programs.

8. Joint Working Group Structure • Overview • Hosted by ISO TC215 (within ISO as WG9) • Secretariat (Australia) • A planning, process determination and coordinating working group • Purpose: • To provide the discussion, liaison, advisory and communication forum for achieving the goals of the Joint Initiative on SDO Global Health Informatics Standardization

9. Joint Working Group Structure • Scope • Develop an integrated work program amongst the participating SDO’s • Collection, summarization, awareness building, coordinating • Identifying, defining and documenting gaps, overlaps issues and tasks to be addressed • Developing, testing and using a decision process • Developing common processes for harmonization activity • Not • Developing standards, changing SDO accredited processes, changing SDO accountability and mandates

10. Joint Working Group Structure • Participation • Open, all Convenors, Committee chairs from all SDO’s particularly requested to be ongoing and regular JWG members • Process for Co-Chairs • HL7 and CEN have identified their co-Chairs • Charles Jaffe • Melvin Reynolds • ISO proceeding with normal processes for co-Chair / Convenor • Recommendation from WG to Plenary, member vote at plenary, Joint Initiative Council also has input

11. Common Terminology Services Common Glossary HI Conceptual Framework for Pt findings and problems in terminology App of Clinical Risk Mgmt to Hlth S/W Guidance on Risk Eval and Mgmt in deployment of Hlth S/W Secure Archiving of EHR – Pt 2 Guidelines HC Info Privilege Mgmt and Access Control Audit Trails for EHR Pseudonymisation Functional and Structural Roles ISO / CEN /HL7 Work Programs (current) • EHR Architecture (13606) – Parts 1,2,3 • Provider Identification • Identification of Subjects of Care • Document Registry Framework • Harmonized Data Types for Information Interchange • Messages and Communications – WARM • HL7v2.5 Messaging • Clinical Document Arch(R2) • IHE Global Stnds Adoption, Part 1 Process • Genomic Sequence Variation Markup Lang • Exchange of Info Between HC systems – Development of Messages

12. P-o-C Medical Device Comm Framework / overview P-o-C Medical Device Comm Nomenclature – ECG P-o-C Medical Device Comm Implantable Device, Cardiac P-o-C Medical Device Comm App Profiles MIB Elements P-o-C Medical Device Comm App Profiles Access Control P-o-C Medical Device Comm App Profiles Polling P-o-C Medical Device Comm App Profiles Asynch P-o-C Medical Device Comm Analyt Inst. P-o-C test Standard Comm protocol ECG ISO / CEN /HL7 Work Programs (current) • Info Security Mgmt using 17799 • Public Key Infrastructure Pt 1,2,3 • Patient Health Card Pt 8,6,5 (links, admin, identification) • Pharmacovigilance Indivual Case Safety Rpt • Pharmacovigilance Structure and Vocab for Lab Test Units • Identification of Medicinal products (4 parts) • Business Req’s for Reporting of Pharmacist Services • Functional Characteristics for Prescriber Support Systems • Application of Risk Mgmt for IT –Networks w/Med Devices • P-o-C Medical Device Comm App profile (Opt Pkg, R-Ctrl) • P-o-C Medical Device Comm App gateway HL7v2

13. ISO / CEN /HL7 Work Programs (current) • Requirements for EHR Ref Arch • Req’s and Specs for Hlth Summary Record (elements) • Req’s and Specs for Hlth Summary Record (info) • EHR Standards Map • EHR System Functional Model

14. Info Security Mgmt using 17799 Security for Communication Pt 1,2,3 (concepts/term, objects, channels) Measures for pt safety of health s/w Overview of hlth professional cards in CEN countries Audit Trails for EHR App of Clinical risk mgmt to health s/w Guidance of risk eval and mgmt in deployment of health s/w ISO / CEN /HL7 Work Programs (current) • EHR Architecture (13606) – Parts 2,3,5 • Patient Health Card Pt 5, 6,7,8 (identification, admin, med data, linkage) • HI Service Architecture (Pt 1, 2, 3)(Enterprise, Info, Comp) • Data Types • Categorical Structure-terminologies of anatomy • Categorical structure– systems of concepts med devices • Systems of concepts – continuity of care • Clinical knowledge resources – metadata • Syntax for content of med classification systems

15. ISO / CEN /HL7 Work Programs (current) • P-o-C Medical Device Comm Framework / overview • P-o-C Medical Device Comm App profile (Opt Pkg, R-Ctrl) • P-o-C Medical Device Comm App profile (baseline) • P-o-C Medical Device Comm App profile (polling mode) • P-o-C Medical Device Comm Med Waveform encoding

16. Structured Product Labeling CDA structure for Anatomic Path Report Real time location tracking Document architecture / CDA for reporting (non-clinical) Basic imaging reports in CDA and DICOM Administrations for medicinal substances – terminology Care provision – Allergy and Intolerances Role based access permission catalog Orders and Obs- Lab result reporting to EHR Clinical Doc Arch – R2 Periodontal, basic imaging, anatomic path, consult notes, infection reports, history & physican reports ISO / CEN /HL7 Work Programs (current) • HL7 artifacts knowledge base • E-Learning CD Intro HL7 • Web Strategy Overview • Wrappers release 2 • E-learning business plan • HL7 V3 Substantive Changes • Specs / Use of info constraint templates • Master File / Registry Infra • Transmission Infra • Message Control Act infra • Message control Query infra • New Impl Tech Spec Guide • New Impl Tech Spec • Transport Spec – ebXML • Transport Spec Removable media

17. Imp Tech Spec for v3 Structure Imp Tech Spec Data Types Common Message Element types Development Framework ISO / CEN /HL7 Work Programs (current) • V2.5.1 • Orders and Obs Lab to Ambulatory EHR • Accounting and Billing • Claims and Reimbursement • Shared Messages • Data Types – abstract specs • ISO Data Types • Clinical Statement Pattern • Common Observations • Observation request • Composite Order • Orders & Reqs Pattern • Real Time location tracking • Allergy / Intolerance • Immunization • Public hlth Case Mgmt • Public hlth Outbreak Mgmt • Scheduling • Imp Guide Using Snomed CT

18. Current Joint Program – Work Updates • 13606 (Dipak Kalra) • Data Types (Tom Marley, Graham Grieve, Mark Shafarman) • Care Information Models (William Goossens)

19. Joint Working Group – Key Processes Decision Tree (Jeremy Thorpe) Other needed / future process requirements (topics for next meetings)

20. Joint Working Group – Next Meetings JWG at CEN (Dublin, Tuesday October 2, 5-9pm) JWG at HL7 (?) / HIMSS Feb07 JWG at ISO (Sweden May 29) JWG at HL7 (Sept 08)

21. Key Actions

22. Joint Initiative on SDO Global Health Informatics StandardizationJoint Working Group (WG9) Meeting #1