Standards Strategy –what/why/where

1. Prof. Stephen Kay, University of Salford Standards Strategy –what/why/where ISO/CEN/BSI & HL7 Prof. Stephen Kay, University of Salford

2. Standards Strategy: What/Why/WhereInterpreting the Title given • What? (Strategy includes Who?) • Standards Development Organisations (SDOs) • Standards Strategy • Why? • Realism • Response • Where? (including How? & When?) • Producer • Product • Process • Progress Prof. Stephen Kay, University of Salford

3. WG1 Agenda… • Welcome • Roll call • 4 SDOs • Orientation • Standards Strategy: An oxymoron? • Harmonisation and/or domination • Current Activity • Resolutions Prof. Stephen Kay, University of Salford

4. Welcome… a CV of TLAs • 1987 • IEEE P1157 Medix (until 1991) • 1990 • BSI IST/35 (BCS rep.) • CEN TC251 WG 1 & 3 • 1996 ENV 13606-1 (PT leader) • 1998 • ISO TC215 WG 1 & 2 • 2002 • HL7 Organisation Member • NHS ‘ISB’ • 2006 • CEN WG I (Convenor) Prof. Stephen Kay, University of Salford

5. Roll Call…check credentials • BSI/CEN/ISO/HL7 are SDOs. Each is • “a body that is recognized at national, regional or international level, • that has as a principle function, by virtue of its statutes, • the preparation, maintenance and publication of standards • that are made generally available.” Prof. Stephen Kay, University of Salford

6. Roll Call establishes a context… ISO TC215 Worldwide IEEE DICOM CEN TC251 European HL7 (ANSI) Standards Australia European National DIN AFNOR SIS NEN BSI and many more and many more Prof. Stephen Kay, University of Salford

7. Closer look at the 4 SDOs • Health Level 7 • More European involvement in HL7 than in CEN TC251 and ISO TC215 (and increasing in HL7) • Meetings approx 600 delegates • ISO TC 215 • Few European countries participate (unless held in Europe) 100-200 delegates • CEN TC 251 • Nominally represents all EU + some EFTA countries (29) • Meetings approx. 50-80 delegates • BSI IST/35 • Five panels, approx. 35 people active Prof. Stephen Kay, University of Salford

8. BSI IST/35 is an Anomaly… • “Standardisation activity is predominantly in medical devices • Activity mirrors to some extent EU Directives on Medical Devices, Active Implantable Medical Devices and IVD Medical Devices • 1000+ BS EN ISO current standards and drafts • 20 Technical committees • 35 subcommittees” Prof. Stephen Kay, University of Salford

9. Roll Call… All four have a focus on semantic interoperability of health information • BUT… • Very different in structure • (5-4-9-100+) • Very different in culture Prof. Stephen Kay, University of Salford

10. Organisational Culture • ‘The way we do things around here’ • IST/35; TC 251; TC 215 and HL7 • Autonomy (or lack of it) impacts style and process • Externals impact pace of change and constrain freedom to act… • Strategy • None to speak of • If any… has been initiated by visionaries and then it has reverted to local, silo solutions Prof. Stephen Kay, University of Salford

11. No Strategy -> WHY? -> Strategy • Realism • Ironically, a real concern for implementation… • “National Standards, Global Control” • Michael Leavitt, Secretary of US Dept of Health & Human Services. used the catch phrase, in relation to ‘Charter Value Exchanges’ • All SDOs are being criticised for being ineffective by various stakeholders… not least the customer! They require… • Coordination & Collaboration • Single solutions rather than choice • Results sooner than later Prof. Stephen Kay, University of Salford

12. Know Why… but so what? • Response at three levels • External Sticks and carrots • e.g. EU Mandate 403 • Organisationally • Business Plans at the SDO (started a while back but accelerating) • Joint Initiative Council of all 3 SDOs • Communal awareness… • Existing (non-)strategies not working • Need new business models • Global Standards, National Control Prof. Stephen Kay, University of Salford

13. Why? • “We need standards which are implementable, enable interoperability, support global marketing, meet demand side for interoperability and scale of use and meet user side requirements” • Kees Molenaar. Chair CEN/TC 251 Health Informatics Prof. Stephen Kay, University of Salford

14. Where? • Global solutions (for certain problems) • Joint Initiative (all SDOs equal) • Starting point the current 3 SDOs • Created a Charter • Mutual decision process • Coordinated standards through to ISO • Integrated workplan • Resolving conflicts Prof. Stephen Kay, University of Salford

15. Current Activity:International SDO relations … ! Prof. Stephen Kay, University of Salford September 26, 2006 CEN/TC 251, report of the chair

16. WHERE: CEN/TC251, ISO/TC215, HL7 HARMONISATION HL7 CEN/TC251 ISO/TC215 Joint Initiative Council (JIC) Executive Council WG 1 WG 3 WG 6 WG 9 JWG WG 2 WG 4 WG 7 Sub G 1 Sub G 2 WG 8 WG 5 Prof. Stephen Kay, University of Salford

17. Producers: European SDO relationships Prof. Stephen Kay, University of Salford September 26, 2006 CEN/TC 251, report of the chair

18. Euro Direction TC251 ISO WGs 1,2,6,8 HL7 Overall Context for WG1 Other ESO/SDO WGI Information Models & messaging WGs (1),2,3,4 National Interests Expert opinions and R&D Prof. Stephen Kay, University of Salford

19. The Central Ideas/Issues • Coordination • Collaboration • Consumption • Politics • Process • Product Prof. Stephen Kay, University of Salford

20. Product: Topics for collaboration: • Gap Analysis/ existing work • Data Types • Archetypes / templates • 13606 (in particular part 5) / CDA • ICH messages • HISA & SOA (HL7 & OMG) • Identifiers • emergency data set / patient summaries Prof. Stephen Kay, University of Salford

21. Product & Process: Work Plan • Integrated Workplan • New items (easy) • Current Items (not!) • Agreed way forward is known (difficult) • Competitive viewpoints (very difficult) • Integrated Practice • Need to appreciate investment • Need to learn work processes of each other • Need to synchronize SDOs’ ballot cycles Prof. Stephen Kay, University of Salford

22. Process of creating a standard - ISO • Some group of users see the need for standardisation & create a proposal which is presented to a Working Group within the ISO Technical Committee (TC) • May be accepted or rejected • The proposal must be accompanied by at least a draft outline of the standard • A particular country takes lead responsibility • If accepted they create a ‘New Work Item Proposal’ NWIP. This must be supported by at least 5 named experts from different member countries • If the TC agrees, the NWIP is distributed to all member countries for a vote (3 months) Prof. Stephen Kay, University of Salford

23. Process of creating a standard - ISO • The NWIP may be accepted, rejected or there may be requests for change/clarification. • This stage may be repeated. • Once accepted, a ‘Committee Draft’ (CD) is prepared. This is the first complete version of the proposed standard • If acceptable to the TC, the CD goes out for ballot by member countries (3 months) • If not rejected, the task force create a Draft International Standard (DIS) (taking into account comments from CD) • The DIS is distributed for ballot and comments to national bodies (5 months) Prof. Stephen Kay, University of Salford

24. Process of creating a standard - ISO • The task force modifies the document and responds to comments • A Final Draft International Standard (FDIS) is produced. This is distributed to national member bodies for ballot (6 months). • If accepted the standard (possibly with minor changes) goes for publication (6 months) Prof. Stephen Kay, University of Salford

25. start Initial draft NMB NWIP 3 month ballot NMB Committee Draft 3 month ballot NMB Draft International Standard 5 month ballot NMB Final Draft 6 month ballot Publication Min. 6 month Prof. Stephen Kay, University of Salford

26. Balloting • All votes are channelled through the National Member Bodies (not individuals or companies). • A vote on a document may register: • Acceptance – with or without comments • Rejection – must be with comments • Abstention – with or without comments Prof. Stephen Kay, University of Salford

27. Types of ‘standards’ (ISO & CEN) • Technical Report – Informative • ISO TRXXXXX • CEN TRXXXXX • Technical Specification – Replaced ENV in CEN – Normative + Informative • ISO TSXXXXX • CEN TSXXXXX • International Standard • ISOXXXXX • ENXXXXX (CEN) Prof. Stephen Kay, University of Salford

28. Process of creating a standard – HL7 • A Technical Committee within HL7 agree that a standard in a certain domain is required. • The TC or a SIG develops the draft standard which is distributed to all interested HL7 members. • A draft is distributed throughout HL7 international affiliates for comment and ballot (4 months cycle). This cycle may be repeated several times • When acceptable, a ‘Draft Standard for Trial Use’ (DSTU) is created and balloted. Suppliers may now use this ‘pre-standard’ • After a minimum of 1 year, the DSTU (possibly modified) may be balloted to become a full ANSI standard Prof. Stephen Kay, University of Salford

29. Progress: Health Informatics Standards • The SDOs are now working very closely so as to develop GLOBAL STANDARDS • Joint working by ISO, CEN and HL7…+++ • This is being demanded by governments, health care providers and by system suppliers • A common core of experts are represented across the SDO organisations which aids collaboration & fast tracking Prof. Stephen Kay, University of Salford

30. Mechanism 1. HL7 Fast Tracking • HL7 have been requested to submit a number of their standards into ISO so as to become International Standards. • These standards go through the NWIP process and then straight to DIS ballot. If no substantial negative comments then straight to publication. Otherwise to FDIS Prof. Stephen Kay, University of Salford

31. List of HL7 Standards – Fast track • V2.5 Messaging Standard • Clinical Document Architecture R2 • Common Terminology Services R1 • Structured Product Labeling • Individual Case Safety Report • Electronic Submission of Stability Data • Annotated ECG Prof. Stephen Kay, University of Salford

32. Mechanism 2: CEN Fast Tracking • CEN EN13606 – EHR Communication • CEN EN12976 – Health Informatics Service Architecture These are in collaboration with (parts of) HL7. Prof. Stephen Kay, University of Salford

33. Mechanism 3: HL7/CEN/ISO/ICH Joint Developments • The objective is to review six message specifications and to prepare them for formal adoption as EN/ISO standards. • The Electronic Common Technical Document; • The scope of the ICH specification for general purposes; • The EU Module 1 for regional specificities; • The Product Information Management (PIM) Data Exchange Standard; • The latest version of the E2B message for Individual Case Safety Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions; • The Medicinal Product Identifier; • The Controlled Vocabulary Message; • The Application Form. Prof. Stephen Kay, University of Salford

34. ISO/CEN/HL7 Joint Developments • ISO17113 – Message Development Framework – Based on HL7 methods • ISO12090 – Harmonized Data Types – Under development • Categorisation and Nomenclature of Medical Devices - Requirements Prof. Stephen Kay, University of Salford

35. ISO/IEC/CEN/IEEE Joint Development • Success…gold standard • Family of standards • ISO11073 (IEEE1073) Health informatics — Point-of-care medical device communication Prof. Stephen Kay, University of Salford

36. Resolutions • Note that: • Substantive Progress has been made • When? Very fast by SDO standards (but not up to expectations?) • Still turf wars… press releases, ‘not-invented-here’, external hassle • Decision Process/ballots/publication still need to be sorted • Resource urgently required • Strategies… getting there but must do better Prof. Stephen Kay, University of Salford

37. Standards Strategy … Challenge • “When all is said and done, more is said than done.” • Francis Crick on ‘Conscious Computing’ in T. Siegfried’s The Bit and the Pendulum, p145. • If the current emergent strategies are successful in producing relevant products then we should do all we can to make our actions speak louder. Prof. Stephen Kay, University of Salford

38. Prof. Stephen Kay, University of Salford Thank You for Listening Questions? Prof. Stephen Kay, University of Salford