22nd November 2007 22nd November 2007 Prof. Stephen Kay, University of S Prof. Stephen Kay, University of S alford alford Standards Strategy Standards Strategy –what/why/where –what/why/where ISO/CEN/BSI ISO/CEN/BSI & & HL7 HL7 Prof. Stephen Kay, University of Salford
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22nd November 2007 Prof. Stephen Kay, University of Salford Standards Strategy – what/why/where ISO/CEN/BSI&HL7 Prof. Stephen Kay, University of Salford.
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22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Standards Strategy: What/Why/WhereStandards Strategy: What/Why/WhereInterpreting the Title givenInterpreting the Title given
What? (Strategy includes Who?)What? (Strategy includes Who?) Standards Development Organisations (SDOs)Standards Development Organisations (SDOs) Standards StrategyStandards Strategy
HL7 Organisation MemberHL7 Organisation Member NHS ‘ISB’NHS ‘ISB’
20062006 CEN WG I CEN WG I (Convenor)(Convenor)
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Roll Call…check credentialsRoll Call…check credentials
BSI/CEN/ISO/HL7 are SDOs. Each isBSI/CEN/ISO/HL7 are SDOs. Each is• ““a body that is recognized at national, a body that is recognized at national,
regional or international level, regional or international level, • that has as a principle function, by that has as a principle function, by
virtue of its statutes, virtue of its statutes, • the preparation, maintenance and the preparation, maintenance and
publication of standards publication of standards • that are made generally available.”that are made generally available.”
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
ISO TC215 Worldwide
CEN TC251 European
BSI NEN DIN AFNOR SISEuropeanNational
HL7 (ANSI)
Standards Australia
IEEE
DICOM
and many moreand many more
Roll Call establishes a context…
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Closer look at the 4 SDOsCloser look at the 4 SDOs Health Level 7Health Level 7
• More European involvement in HL7 than in CEN TC251 More European involvement in HL7 than in CEN TC251 and ISO TC215 (and increasing in HL7)and ISO TC215 (and increasing in HL7)
• Few European countries participate (unless held in Few European countries participate (unless held in Europe) 100-200 delegatesEurope) 100-200 delegates
CEN TC 251CEN 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/35BSI IST/35• Five panels, approx. 35 people activeFive panels, approx. 35 people active
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
BSI IST/35 is an Anomaly…BSI IST/35 is an Anomaly…
““Standardisation activity is Standardisation activity is predominantly in medical devicespredominantly in medical devices• Activity mirrors to some extent EU Activity mirrors to some extent EU
Directives on Medical Devices, Active Directives on Medical Devices, Active Implantable Medical Devices and IVD Implantable Medical Devices and IVD Medical DevicesMedical Devices
• 1000+ BS EN ISO current standards 1000+ BS EN ISO current standards and draftsand drafts
RealismRealism• 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 & Michael Leavitt, Secretary of US Dept of Health & Human Services. used the catch phrase, in relation to Human Services. used the catch phrase, in relation to ‘Charter Value Exchanges’‘Charter Value Exchanges’
All SDOs are being criticised for being All SDOs are being criticised for being ineffective by various stakeholders… not ineffective by various stakeholders… not least the customer! They require…least the customer! They require…• Coordination & CollaborationCoordination & Collaboration• Single solutions rather than choiceSingle solutions rather than choice• Results sooner than laterResults sooner than later
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Know Why… but so what?Know Why… but so what? Response at three levelsResponse at three levels External Sticks and carrotsExternal Sticks and carrots
• e.g. EU Mandate 403e.g. EU Mandate 403 OrganisationallyOrganisationally
• Business Plans at the SDO (started a while Business Plans at the SDO (started a while back but accelerating)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
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Why?Why? ““We need standards which are We need standards which are
implementable, enable implementable, enable interoperability, support global interoperability, support global marketing, meet demand side for marketing, meet demand side for interoperability and scale of use and interoperability and scale of use and meet user side requirements”meet user side requirements”
• Kees Molenaar. Chair CEN/TC 251 Health Kees Molenaar. Chair CEN/TC 251 Health InformaticsInformatics
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Where?Where?
Global solutions (for certain Global solutions (for certain problems)problems)
Joint Initiative (all SDOs equal)Joint Initiative (all SDOs equal) Starting point the current 3 SDOsStarting point the current 3 SDOs
Created a CharterCreated a Charter Mutual decision processMutual decision process Coordinated standards through to ISOCoordinated standards through to ISO Integrated workplanIntegrated workplan Resolving conflictsResolving conflicts
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Product: Topics for collaboration:Product: Topics for collaboration:•Gap Analysis/ existing workGap Analysis/ existing work•Data TypesData Types•Archetypes / templatesArchetypes / templates•13606 (in particular part 5) / CDA 13606 (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
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Product & Process: Work PlanProduct & Process: Work Plan
Integrated WorkplanIntegrated 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 PracticeIntegrated Practice• Need to appreciate investmentNeed to appreciate investment• Need to learn work processes of each other Need to learn work processes of each other • Need to synchronize SDOs’ ballot cyclesNeed to synchronize SDOs’ ballot cycles
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Process of creating a standard - ISOProcess of creating a standard - ISO Some group of users see the need for Some group of users see the need for
standardisation & create a proposal which is standardisation & create a proposal which is presented to a Working Group within the ISO presented to a Working Group within the ISO Technical Committee (TC)Technical Committee (TC)
May be accepted or rejectedMay be accepted or rejected The proposal must be accompanied by at least a The proposal must be accompanied by at least a
draft outline of the standarddraft outline of the standard A particular country takes lead responsibilityA particular country takes lead responsibility If accepted they create a ‘New Work Item If accepted they create a ‘New Work Item
Proposal’ NWIP. This must be supported by at Proposal’ NWIP. This must be supported by at least 5 named experts from different member least 5 named experts from different member countriescountries
If the TC agrees, the NWIP is distributed to all If the TC agrees, the NWIP is distributed to all member countries for a vote (3 months)member countries for a vote (3 months)
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Process of creating a standard - ISOProcess of creating a standard - ISO The NWIP may be accepted, rejected or there may The NWIP may be accepted, rejected or there may
be requests for change/clarification.be requests for change/clarification. This stage may be repeated.This stage may be repeated. Once accepted, a ‘Committee Draft’ (CD) is Once accepted, a ‘Committee Draft’ (CD) is
prepared. This is the first complete version of the prepared. This is the first complete version of the proposed standardproposed standard
If acceptable to the TC, the CD goes out for ballot If acceptable to the TC, the CD goes out for ballot by member countries (3 months)by member countries (3 months)
If not rejected, the task force create a Draft If not rejected, the task force create a Draft International Standard (DIS) (taking into account International Standard (DIS) (taking into account comments from CD)comments from CD)
The DIS is distributed for ballot and comments to The DIS is distributed for ballot and comments to national bodies (5 months)national bodies (5 months)
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Process of creating a standard - Process of creating a standard - ISOISO
The task force modifies the document and The task force modifies the document and responds to commentsresponds to comments
A Final Draft International Standard (FDIS) is A Final Draft International Standard (FDIS) is produced. This is distributed to national member produced. This is distributed to national member bodies for ballot (6 months).bodies for ballot (6 months).
If accepted the standard (possibly with minor If accepted the standard (possibly with minor changes) goes for publication (6 months)changes) goes for publication (6 months)
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
start Initial draft
NWIP 3 month ballot
Committee Draft 3 month ballotNMB
Draft InternationalStandard
5 month ballotNMB
NMB
Final Draft 6 month ballotNMB
Publication Min. 6 month
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
BallotingBalloting
All votes are channelled through the All votes are channelled through the National Member Bodies (not National Member Bodies (not individuals or companies).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
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Types of ‘standards’ (ISO & CEN)Types of ‘standards’ (ISO & CEN) Technical Report – InformativeTechnical Report – Informative
• ISO TRXXXXXISO TRXXXXX• CEN TRXXXXXCEN TRXXXXX
Technical Specification – Replaced ENV in Technical Specification – Replaced ENV in CEN – Normative + InformativeCEN – Normative + Informative• ISO TSXXXXXISO TSXXXXX• CEN TSXXXXXCEN TSXXXXX
International StandardInternational Standard• ISOXXXXXISOXXXXX• ENXXXXX (CEN)ENXXXXX (CEN)
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Process of creating a standard – HL7Process of creating a standard – HL7 A Technical Committee within HL7 agree that a A Technical Committee within HL7 agree that a
standard in a certain domain is required. standard in a certain domain is required. The TC or a SIG develops the draft standard which The TC or a SIG develops the draft standard which
is distributed to all interested HL7 members.is distributed to all interested HL7 members. A draft is distributed throughout HL7 international A draft is distributed throughout HL7 international
affiliates for comment and ballot (4 months cycle). affiliates for comment and ballot (4 months cycle). This cycle may be repeated several timesThis cycle may be repeated several times
When acceptable, a ‘Draft Standard for Trial Use’ When acceptable, a ‘Draft Standard for Trial Use’ (DSTU) is created and balloted. Suppliers may now (DSTU) is created and balloted. Suppliers may now use this ‘pre-standard’use this ‘pre-standard’
After a minimum of 1 year, the DSTU (possibly After a minimum of 1 year, the DSTU (possibly modified) may be balloted to become a full ANSI modified) may be balloted to become a full ANSI standardstandard
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Progress: Health Informatics Progress: Health Informatics StandardsStandards
The SDOs are now working very closely so The SDOs are now working very closely so as to develop GLOBAL STANDARDSas to develop GLOBAL STANDARDS
Joint working by ISO, CEN and HL7…+++Joint working by ISO, CEN and HL7…+++ This is being demanded by governments, This is being demanded by governments,
health care providers and by system health care providers and by system supplierssuppliers
A common core of experts are represented A common core of experts are represented across the SDO organisations which aids across the SDO organisations which aids collaboration & fast trackingcollaboration & fast tracking
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Mechanism 1. Mechanism 1. HL7 Fast Tracking HL7 Fast Tracking
HL7 have been requested to submit a HL7 have been requested to submit a number of their standards into ISO so number of their standards into ISO so as to become International as to become International Standards.Standards.
These standards go through the These standards go through the NWIP process and then straight to NWIP process and then straight to DIS ballot. If no substantial negative DIS ballot. If no substantial negative comments then straight to comments then straight to publication. Otherwise to FDISpublication. Otherwise to FDIS
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
List of HL7 Standards – Fast List of HL7 Standards – Fast tracktrack
V2.5 Messaging StandardV2.5 Messaging Standard Clinical Document Architecture R2Clinical Document Architecture R2 Common Terminology Services R1Common Terminology Services R1 Structured Product LabelingStructured Product Labeling Individual Case Safety ReportIndividual Case Safety Report Electronic Submission of Stability DataElectronic Submission of Stability Data Annotated ECGAnnotated ECG
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Mechanism 2: Mechanism 2: CEN Fast Tracking CEN Fast Tracking
CEN EN13606 – EHR CommunicationCEN EN13606 – EHR Communication CEN EN12976 – Health Informatics CEN EN12976 – Health Informatics
Service Architecture Service Architecture
These are in collaboration with (parts These are in collaboration with (parts of) HL7.of) HL7.
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
Mechanism 3: Mechanism 3: HL7/CEN/ISO/ICH Joint DevelopmentsHL7/CEN/ISO/ICH Joint Developments The objective is to The objective is to reviewreview six message specifications and to six message specifications and to
prepare them for formal adoption prepare them for formal adoption as EN/ISO standards. 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 The latest version of the E2B message for Individual Case Safety
Reports (ICSRs) and Suspected Unexpected Serious Adverse Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions;Reactions;
• The Medicinal Product Identifier;The Medicinal Product Identifier;• The Controlled Vocabulary Message;The Controlled Vocabulary Message;• The Application Form.The Application Form.
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
•Success…gold standardSuccess…gold standard•Family of standardsFamily of standards• ISO11073 (IEEE1073) ISO11073 (IEEE1073)
Health informatics Health informatics — — Point-of-Point-of-care medical device care medical device communicationcommunication
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
ResolutionsResolutions
Note that:Note that:• Substantive Progress has been madeSubstantive Progress has been made• When? Very fast by SDO standards (but not up When? Very fast by SDO standards (but not up
to expectations?)to expectations?)• Still turf wars… press releases, ‘not-invented-Still turf wars… press releases, ‘not-invented-
here’, external hasslehere’, external hassle• Decision Process/ballots/publication still need Decision Process/ballots/publication still need
to be sortedto be sorted• Resource urgently requiredResource urgently required• Strategies… getting there but must do betterStrategies… getting there but must do better
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford
““When all is said and done, more is When all is said and done, more is said than done.”said than done.”
Francis Crick on ‘Conscious Computing’ in T. Francis Crick on ‘Conscious Computing’ in T. Siegfried’s The Bit and the Pendulum, p145.Siegfried’s The Bit and the Pendulum, p145.
If the current emergent strategies If the current emergent strategies are successful in producing relevant are successful in producing relevant products then we should do all we products then we should do all we can to make our actions speak can to make our actions speak louder.louder.
22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford