1. 22nd November 2007 Prof. Stephen Kay, University of Salford Standards Strategy – what/why/where ISO/CEN/BSI&HL7 Prof. Stephen Kay, University of Salford

2. 22nd November 2007 Prof. Stephen Kay, University of Salford Standards Strategy: What/Why/Where Interpreting the Title given What? (Strategy includes Who?) What? (Strategy includes Who?) Standards Development Organisations (SDOs) Standards Development Organisations (SDOs) Standards Strategy Standards Strategy Why? Why? Realism Realism Response Response Where? (including How? & When?) Where? (including How? & When?) Producer Producer Product Product Process Process Progress Progress

3. 22nd November 2007 Prof. Stephen Kay, University of Salford WG1 Agenda… Welcome Welcome Roll call Roll call 4 SDOs4 SDOs Orientation Orientation Standards Strategy: An oxymoron?Standards Strategy: An oxymoron? Harmonisation and/or dominationHarmonisation and/or domination Current Activity Current Activity Resolutions Resolutions

4. 22nd November 2007 Prof. Stephen Kay, University of Salford Welcome… a CV of TLAs 1987 1987 IEEE P1157 Medix (until 1991) IEEE P1157 Medix (until 1991) 1990 1990 BSI IST/35(BCS rep.) BSI IST/35(BCS rep.) CEN TC251 WG 1 & 3 CEN TC251 WG 1 & 3 1996 ENV 13606-1 (PT leader)1996 ENV 13606-1 (PT leader) 1998 1998 ISO TC215 WG 1 & 2 ISO TC215 WG 1 & 2 2002 2002 HL7 Organisation Member HL7 Organisation Member NHS ‘ISB’ NHS ‘ISB’ 2006 2006 CEN WG I (Convenor) CEN WG I (Convenor)

5. 22nd November 2007 Prof. Stephen Kay, University of Salford Roll Call…check credentials BSI/CEN/ISO/HL7 are SDOs. Each is BSI/CEN/ISO/HL7 are SDOs. Each is “a body that is recognized at national, regional or international level,“a body that is recognized at national, regional or international level, that has as a principle function, by virtue of its statutes,that has as a principle function, by virtue of its statutes, the preparation, maintenance and publication of standardsthe preparation, maintenance and publication of standards that are made generally available.”that are made generally available.”

6. 22nd November 2007 Prof. Stephen Kay, University of Salford ISO TC215 Worldwide CEN TC251 European BSI NEN DINAFNORSIS European National HL7 (ANSI) Standards Australia IEEE DICOM and many more Roll Call establishes a context…

7. 22nd November 2007 Prof. Stephen Kay, University of Salford Closer look at the 4 SDOs Health Level 7 Health Level 7 More European involvement in HL7 than in CEN TC251 and ISO TC215 (and increasing in HL7)More European involvement in HL7 than in CEN TC251 and ISO TC215 (and increasing in HL7) Meetings approx 600 delegatesMeetings approx 600 delegates ISO TC 215 ISO TC 215 Few European countries participate (unless held in Europe) 100-200 delegatesFew European countries participate (unless held in Europe) 100-200 delegates CEN TC 251 CEN TC 251 Nominally represents all EU + some EFTA countries (29)Nominally represents all EU + some EFTA countries (29) Meetings approx. 50-80 delegatesMeetings approx. 50-80 delegates BSI IST/35 BSI IST/35 Five panels, approx. 35 people activeFive panels, approx. 35 people active

8. 22nd November 2007 Prof. Stephen Kay, University of Salford BSI IST/35 is an Anomaly… “Standardisation activity is predominantly in medical devices “Standardisation activity is predominantly in medical devices Activity mirrors to some extent EU Directives on Medical Devices, Active Implantable Medical Devices and IVD Medical DevicesActivity mirrors to some extent EU Directives on Medical Devices, Active Implantable Medical Devices and IVD Medical Devices 1000+ BS EN ISO current standards and drafts1000+ BS EN ISO current standards and drafts 20 Technical committees20 Technical committees 35 subcommittees” 35 subcommittees”

9. 22nd November 2007 Prof. Stephen Kay, University of Salford Roll Call… All four have a focus on semantic interoperability of health information BUT… BUT… Very different in structure Very different in structure (5-4-9-100+) (5-4-9-100+) Very different in culture Very different in culture

10. 22nd November 2007 Prof. Stephen Kay, University of Salford Organisational Culture ‘The way we do things around here’ ‘The way we do things around here’ IST/35; TC 251; TC 215 and HL7 IST/35; TC 251; TC 215 and HL7 Autonomy (or lack of it) impacts style and processAutonomy (or lack of it) impacts style and process Externals impact pace of change and constrain freedom to act…Externals impact pace of change and constrain freedom to act… Strategy Strategy None to speak ofNone to speak of If any… has been initiated by visionaries and then it has reverted to local, silo solutionsIf any… has been initiated by visionaries and then it has reverted to local, silo solutions

11. 22nd November 2007 Prof. Stephen Kay, University of Salford No Strategy -> WHY? -> Strategy Realism Realism Ironically, a real concern for implementation…Ironically, a real concern for implementation… “National Standards, Global Control”“National Standards, Global Control” Michael Leavitt, Secretary of US Dept of Health & Human Services. used the catch phrase, in relation to ‘Charter Value Exchanges’ 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… All SDOs are being criticised for being ineffective by various stakeholders… not least the customer! They require… Coordination & CollaborationCoordination & Collaboration Single solutions rather than choiceSingle solutions rather than choice Results sooner than laterResults sooner than later

12. 22nd November 2007 Prof. Stephen Kay, University of Salford Know Why… but so what? Response at three levels Response at three levels External Sticks and carrots External Sticks and carrots e.g. EU Mandate 403e.g. EU Mandate 403 Organisationally Organisationally Business Plans at the SDO (started a while back but accelerating)Business Plans at the SDO (started a while back but accelerating) Joint Initiative Council of all 3 SDOsJoint Initiative Council of all 3 SDOs Communal awareness… Communal awareness… Existing (non-)strategies not workingExisting (non-)strategies not working Need new business modelsNeed new business models Global Standards, National ControlGlobal Standards, National Control

13. 22nd November 2007 Prof. Stephen Kay, University of Salford 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” “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 InformaticsKees Molenaar. Chair CEN/TC 251 Health Informatics

14. 22nd November 2007 Prof. Stephen Kay, University of Salford Where? Global solutions (for certain problems) Global solutions (for certain problems) Joint Initiative (all SDOs equal) Joint Initiative (all SDOs equal) Starting point the current 3 SDOs Starting point the current 3 SDOs Created a Charter Created a Charter Mutual decision process Mutual decision process Coordinated standards through to ISO Coordinated standards through to ISO Integrated workplan Integrated workplan Resolving conflicts Resolving conflicts

15. 22nd November 2007 Prof. Stephen Kay, University of Salford Current Activity: International SDO relations … ! September 26, 2006 CEN/TC 251, report of the chair

16. 22nd November 2007 Prof. Stephen Kay, University of Salford ISO/TC215 WG 2 WG 3 WG 4 WG 5 WG 6 WG 1 Sub G 1 Sub G 2 WG 7 WG 8 Executive Council WHERE: CEN/TC251, ISO/TC215, HL7 HARMONISATION WG 9 JWG Joint Initiative Council (JIC) HL7CEN/TC251

17. 22nd November 2007 Prof. Stephen Kay, University of Salford Producers: European SDO relationships September 26, 2006CEN/TC 251, report of the chair

18. 22nd November 2007 Prof. Stephen Kay, University of Salford Overall Context for WG1 WGI Information Models & messaging WGs (1),2,3,4 National Interests ISO WGs 1,2,6,8 HL7 TC251 Euro Direction Expert opinions and R&D Other ESO/SDO

19. 22nd November 2007 Prof. Stephen Kay, University of Salford The Central Ideas/Issues Coordination Coordination Collaboration Collaboration Consumption Consumption Politics Politics Process Process Product Product

20. 22nd November 2007 Prof. Stephen Kay, University of Salford Product: Topics for collaboration: Gap Analysis/ existing workGap Analysis/ existing work Data TypesData Types Archetypes / templatesArchetypes / templates 13606 (in particular part 5) / CDA13606 (in particular part 5) / CDA ICH messagesICH messages HISA & SOA (HL7 & OMG)HISA & SOA (HL7 & OMG) IdentifiersIdentifiers emergency data set / patient summariesemergency data set / patient summaries

21. 22nd November 2007 Prof. Stephen Kay, University of Salford Product & Process: Work Plan Integrated Workplan Integrated Workplan New items (easy)New items (easy) Current Items (not!)Current Items (not!) Agreed way forward is known (difficult) Agreed way forward is known (difficult) Competitive viewpoints (very difficult) Competitive viewpoints (very difficult) Integrated Practice Integrated Practice Need to appreciate investmentNeed to appreciate investment Need to learn work processes of each otherNeed to learn work processes of each other Need to synchronize SDOs’ ballot cyclesNeed to synchronize SDOs’ ballot cycles

22. 22nd November 2007 Prof. Stephen Kay, University of Salford 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) 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 May be accepted or rejected The proposal must be accompanied by at least a draft outline of the standard The proposal must be accompanied by at least a draft outline of the standard A particular country takes lead responsibility 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 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) If the TC agrees, the NWIP is distributed to all member countries for a vote (3 months)

23. 22nd November 2007 Prof. Stephen Kay, University of Salford Process of creating a standard - ISO The NWIP may be accepted, rejected or there may be requests for change/clarification. The NWIP may be accepted, rejected or there may be requests for change/clarification. This stage may be repeated. This stage may be repeated. Once accepted, a ‘Committee Draft’ (CD) is prepared. This is the first complete version of the proposed standard 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 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) 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) The DIS is distributed for ballot and comments to national bodies (5 months)

24. 22nd November 2007 Prof. Stephen Kay, University of Salford Process of creating a standard - ISO The task force modifies the document and responds to comments 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). 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) If accepted the standard (possibly with minor changes) goes for publication (6 months)

25. 22nd November 2007 Prof. Stephen Kay, University of Salford start Initial draft NWIP 3 month ballot Committee Draft 3 month ballot NMB Draft International Standard 5 month ballot NMB Final Draft 6 month ballot NMB Publication Min. 6 month

26. 22nd November 2007 Prof. Stephen Kay, University of Salford Balloting All votes are channelled through the National Member Bodies (not individuals or companies). All votes are channelled through the National Member Bodies (not individuals or companies). A vote on a document may register: A vote on a document may register: Acceptance – with or without commentsAcceptance – with or without comments Rejection – must be with commentsRejection – must be with comments Abstention – with or without commentsAbstention – with or without comments

27. 22nd November 2007 Prof. Stephen Kay, University of Salford Types of ‘standards’ (ISO & CEN) Technical Report – Informative Technical Report – Informative ISO TRXXXXXISO TRXXXXX CEN TRXXXXXCEN TRXXXXX Technical Specification – Replaced ENV in CEN – Normative + Informative Technical Specification – Replaced ENV in CEN – Normative + Informative ISO TSXXXXXISO TSXXXXX CEN TSXXXXXCEN TSXXXXX International Standard International Standard ISOXXXXXISOXXXXX ENXXXXX (CEN)ENXXXXX (CEN)

28. 22nd November 2007 Prof. Stephen Kay, University of Salford Process of creating a standard – HL7 A Technical Committee within HL7 agree that a standard in a certain domain is required. 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. 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 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’ 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 After a minimum of 1 year, the DSTU (possibly modified) may be balloted to become a full ANSI standard

29. 22nd November 2007 Prof. Stephen Kay, University of Salford Progress: Health Informatics Standards The SDOs are now working very closely so as to develop GLOBAL STANDARDS The SDOs are now working very closely so as to develop GLOBAL STANDARDS Joint working by ISO, CEN and HL7…+++ Joint working by ISO, CEN and HL7…+++ This is being demanded by governments, health care providers and by system suppliers 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 A common core of experts are represented across the SDO organisations which aids collaboration & fast tracking

30. 22nd November 2007 Prof. Stephen Kay, University of Salford Mechanism 1. HL7 Fast Tracking HL7 have been requested to submit a number of their standards into ISO so as to become International Standards. 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 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

31. 22nd November 2007 Prof. Stephen Kay, University of Salford List of HL7 Standards – Fast track V2.5 Messaging Standard V2.5 Messaging Standard Clinical Document Architecture R2 Clinical Document Architecture R2 Common Terminology Services R1 Common Terminology Services R1 Structured Product Labeling Structured Product Labeling Individual Case Safety Report Individual Case Safety Report Electronic Submission of Stability Data Electronic Submission of Stability Data Annotated ECG Annotated ECG

32. 22nd November 2007 Prof. Stephen Kay, University of Salford Mechanism 2: CEN Fast Tracking CEN EN13606 – EHR Communication CEN EN13606 – EHR Communication CEN EN12976 – Health Informatics Service Architecture CEN EN12976 – Health Informatics Service Architecture These are in collaboration with (parts of) HL7.

33. 22nd November 2007 Prof. Stephen Kay, University of Salford 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 objective is to review six message specifications and to prepare them for formal adoption as EN/ISO standards. The Electronic Common Technical Document;The Electronic Common Technical Document; The scope of the ICH specification for general purposes; The scope of the ICH specification for general purposes; The EU Module 1 for regional specificities; The EU Module 1 for regional specificities; The Product Information Management (PIM) Data Exchange Standard;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 latest version of the E2B message for Individual Case Safety Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions; The Medicinal Product Identifier;The Medicinal Product Identifier; The Controlled Vocabulary Message;The Controlled Vocabulary Message; The Application Form.The Application Form.

34. 22nd November 2007 Prof. Stephen Kay, University of Salford ISO/CEN/HL7 Joint Developments ISO17113 – Message Development Framework – Based on HL7 methods ISO17113 – Message Development Framework – Based on HL7 methods ISO12090 – Harmonized Data Types – Under development ISO12090 – Harmonized Data Types – Under development Categorisation and Nomenclature of Medical Devices - Requirements Categorisation and Nomenclature of Medical Devices - Requirements

35. 22nd November 2007 Prof. Stephen Kay, University of Salford ISO/IEC/CEN/IEEE Joint Development Success…gold standardSuccess…gold standard Family of standardsFamily of standards ISO11073 (IEEE1073)ISO11073 (IEEE1073) Health informatics — Point-of- care medical device communication

36. 22nd November 2007 Prof. Stephen Kay, University of Salford Resolutions Note that: Note that: Substantive Progress has been madeSubstantive Progress has been made When? Very fast by SDO standards (but not up to expectations?)When? Very fast by SDO standards (but not up to expectations?) Still turf wars… press releases, ‘not-invented- here’, external hassleStill turf wars… press releases, ‘not-invented- here’, external hassle Decision Process/ballots/publication still need to be sortedDecision Process/ballots/publication still need to be sorted Resource urgently requiredResource urgently required Strategies… getting there but must do betterStrategies… getting there but must do better

37. 22nd November 2007 Prof. Stephen Kay, University of Salford Standards Strategy … Challenge “When all is said and done, more is said than done.” “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. 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. If the current emergent strategies are successful in producing relevant products then we should do all we can to make our actions speak louder.

38. 22nd November 2007 Prof. Stephen Kay, University of Salford Thank You for Listening Questions? Prof. Stephen Kay, University of Salford