standards strategy –what/why/where

22nd November 200722nd November 2007 Prof. Stephen Kay, University of SalfordProf. Stephen Kay, University of Salford

Standards Strategy –Standards Strategy –what/why/wherewhat/why/where

ISO/CEN/BSIISO/CEN/BSI

&&

HL7HL7Prof. 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

Why?Why? RealismRealism ResponseResponse

Where? (including How? & When?)Where? (including How? & When?) ProducerProducer Product Product ProcessProcess ProgressProgress


WG1 Agenda…WG1 Agenda…

WelcomeWelcome Roll callRoll call

• 4 SDOs4 SDOs OrientationOrientation

• Standards Strategy: An oxymoron?Standards Strategy: An oxymoron?• Harmonisation and/or dominationHarmonisation and/or domination

Current ActivityCurrent Activity ResolutionsResolutions


Welcome… a CV of TLAsWelcome… a CV of TLAs 1987 1987

IEEE P1157 Medix IEEE P1157 Medix (until 1991)(until 1991) 1990 1990

BSI IST/35BSI IST/35 (BCS rep.)(BCS rep.) CEN TC251 WG 1 & 3CEN TC251 WG 1 & 3

• 1996 ENV 13606-1 1996 ENV 13606-1 (PT leader)(PT leader) 19981998

ISO TC215 WG 1 & 2ISO TC215 WG 1 & 2 2002 2002

HL7 Organisation MemberHL7 Organisation Member NHS ‘ISB’NHS ‘ISB’

20062006 CEN WG I CEN WG I (Convenor)(Convenor)


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.”


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…


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)

• Meetings approx 600 delegatesMeetings approx 600 delegates ISO TC 215ISO TC 215

• 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


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

• 20 Technical committees20 Technical committees 35 subcommittees”35 subcommittees”


Roll Call…Roll Call…

All four have a focus on semantic All four have a focus on semantic interoperability of health informationinteroperability of health information

BUT…BUT… Very different in structure Very different in structure

(5-4-9-100+)(5-4-9-100+)

Very different in cultureVery different in culture


Organisational CultureOrganisational Culture

‘‘The way we do things around here’The way we do things around here’ IST/IST/3535; TC ; TC 251251; TC ; TC 215215 and HL7 and HL7

• Autonomy (or lack of it) impacts style and Autonomy (or lack of it) impacts style and processprocess

• Externals impact pace of change and constrain Externals impact pace of change and constrain freedom to act…freedom to act…

Strategy Strategy • None to speak ofNone to speak of• If any… has been initiated by visionaries and If any… has been initiated by visionaries and

then it has reverted to local, silo solutionsthen it has reverted to local, silo solutions


No Strategy -> WHY? -> StrategyNo Strategy -> WHY? -> Strategy

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


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


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


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


Current Activity:Current Activity:International SDO relations … !International SDO relations … !

September 26, 2006 CEN/TC 251, report of the chair


ISO/TC215

WG 2

WG 3

WG 4

WG 5

WG 6WG 1

Sub G 1Sub G 2

WG 7

WG 8

Executive Council

WHERE: CEN/TC251, ISO/TC215, HL7 WHERE: CEN/TC251, ISO/TC215, HL7 HARMONISATIONHARMONISATION

WG 9JWG

Joint Initiative Council (JIC)

HL7 CEN/TC251


Producers: European SDO Producers: European SDO relationshipsrelationships

September 26, 2006 CEN/TC 251, report of the chair


Overall Context for WG1Overall Context for WG1

WGI Information Models

& messagingWGs (1),2,3,4

National Interests

ISO WGs

1,2,6,8

HL7

TC251

Euro Direction

Expert opinions and R&D

OtherESO/SDO


The Central Ideas/The Central Ideas/IssuesIssues

CoordinationCoordination CollaborationCollaboration ConsumptionConsumption

PoliticsPolitics ProcessProcess ProductProduct


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


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


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)


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)


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)


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


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


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)


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


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


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


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


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.


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.


ISO/CEN/HL7 Joint DevelopmentsISO/CEN/HL7 Joint Developments

ISO17113 – Message Development ISO17113 – Message Development Framework – Based on HL7 methodsFramework – Based on HL7 methods

ISO12090 – Harmonized Data Types – ISO12090 – Harmonized Data Types – Under developmentUnder development

Categorisation and Nomenclature of Categorisation and Nomenclature of Medical Devices - RequirementsMedical Devices - Requirements


ISO/IEC/CEN/IEEE Joint ISO/IEC/CEN/IEEE Joint DevelopmentDevelopment

•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


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


Standards Strategy … ChallengeStandards Strategy … Challenge

““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.


Thank You for ListeningThank You for Listening

Questions?Questions?

Prof. Stephen Kay, University of Salford

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