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					  International Standards For Health Care

                                  W. Ed Hammond, Ph.D.
                                          President, AMIA
           Vice-chair, Technical Steering Committee, HL7
          Co-chair, Vocabulary Technical Committee, HL7
                                  Co-chair, EHR SIG, HL7
                            Convenor, ISO TC 215, WG2
Professor, Community & Family Medicine, Duke University

                                                       Duke University
                                   NNI        SFS                     EVS
                    SIS     NSAI                          UNMS
                                   BASMP          NSF                LVS DSTU
                            DS                            SMIS
                   STIR                SEE    LST
                                 SNV                                 GOST-R
                          BSI                 DZNM         TSE
 SCC                      AFNOR              CSNI             MOLDST
                                       ON            DSM
                    IPQ     DIN                                         JISC
  ANSI       PKN                   UNI       MSZT         CSSN
                    SNIMA       EOS                 SII          IDHKSAR
                 TTBS      SASO       DGSM                KATS         BPS
                          MSA      KEBS                       TISI     SNZ
                                              PSB       BSN
      INEN      IRAM                                       TCVN
      UNIT      INDECOPI                    DPS
             FONDONORMA                                       SZS
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Who are the International Players in Health
Care Standards?

•   ISO - TC 215 Health Informatics
•   CEN - European Standard Development
•   DICOM - Imaging Standard
•   EDIFACT - United Nations Body
•   HL7 - Clinical Messaging Standards
•   IEEE - Medical Device Standards

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Why do we want ISO standards?

• To enable a global market for health care
• To permit highly industrialized countries to
• To minimize effort and combine world’s experts
  to produce best standards?
• To remove barriers to health care in the global

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Key Issues

• Can we work effectively in our country
  standards and at the ISO level, particularly
  when the topics are the same?
• Is there a better way in which we can blend
  these efforts, reducing redundancy?
• Where are the resources to create global
• How will national interests and customs be
• How do standards requirements differ between
  developing countries and highly developed

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TC 215 ...In the beginning …

• Interest in international community, particularly
  ANSI and CEN
• Series of meetings in US and Europe
• Formed in January, 1998
• Secretariat US/ANSI – ASTM
• Convenor – Peter Treseder, Australia

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•   Foster international trade
•   Interoperability
•   Improved health
•   Developing country needs
•   Protect consumers
•   Advance global society

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ISO/TC 215 - Scope

• Standardization in the field of information for health, and
  health information and communications technology (ICT)
  to achieve compatibility and interoperability between
  independent systems. Also, to ensure compatibility of
  data for comparative statistical purposes (eg.,
  classifications), and to reduce duplication of effort and
• “… it is not the intent of the ISO/TC215 to:
   – Standardize the clinical practice of medicine;
   – Define a standardized health care delivery service structure;
   – Standardize medical knowledge, although the
     representation and exchange of knowledge is within the
     scope if ISO/TC215;

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• Participating National Member Bodies
  –   Australia Austria Belgium Canada
  –   Denmark Finland France Germany
  –   Ireland Italy    Japan Korea
  –   Netherlands New Zealand Norway
  –   Russia    South Africa    Spain
  –   Sweden Turkey UK          USA
• Observing National Member Bodies
  –   Argentina   China       Czech Republic
  –   Ecuador     Hungary     India
  –   Israel      Mongolia    Poland
  –   Portugal    Singapore   Switzerland
  –   Thailand    Viet Nam    Yugoslavia
  –   Zimbabwe

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TC 215 - Health Informatics
Has met 7 times
  –   Orlando, Florida (1998)
  –   Berlin, Germany
  –   Tokyo, Japan
  –   Vancouver, Canada
  –   Seoul, Korea
  –   London, England
  –   Pretoria, South Africa
  –   Melbourne, Australia (August 2002)
  –   Oslo, Norway (2003)
  –   Paris, France (2003)

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ISO/TC215 Business Plan

• Objectives
  – To be recognized as a key, global player in the
    development of relevant, timely and useful
    information standards by:
     • Adopting existing standards, or
     • Encouraging other suitable bodies to develop
       standards to fulfill ISO/TC215’s objectives, or
     • Developing its own standards where neither of the
       above is achievable

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ISO/TC 215 Business Plan

• Objectives
   – To produce standards only where there is a demonstrable need
     which is driven by end users and which will be successfully
     delivered in a timely fashion and commensurate with the ISO
     resources required
   – To maximize participation by all national member bodies,
     preferably as “participating” members, and to maximize the
     involvement of those who are expected to be affected by ISO/TC
     215 standards, in both the planning of the TC’s work programme
     and in the production of standards, in a manner which satisfies
     the users’ identified needs.

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WG1: Health Records
• Ownership and access rights to electronic
• Emergency data set
• Country identifier mechanism in health care
• General domain model for health
• Patient identification certification
• Requirements for EHR Architecture

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WG2: Messaging and Communication

• Key Characteristics for Interoperability and
  Compatibility in Messaging and
  Communications Standards
• Interoperability Guidelines for Telehealth - lead
• Trusted End-to-End Information Flows - lead US
• Stakeholders
• High Level Information Flows

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 WG2: Messaging and Communication
 Medical Device Communications

The scope is to advance standards for data
interchange between medical devices and
instruments and between those devices and
service department information systems to
support the exchange of health related data.

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WG2: Messaging and Communications

•   Single Messaging Development Framework
•   Data Types
•   RIM
•   Related messaging models

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WG3 - Terminology

• Foundation of terminology
• Controlled health vocabularies – vocabulary
      structure and high level quality
• Vocabulary on terminologic systems
• Systems of semantic links and concepts in
• Development of a reference terminology model
  for nursing

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 WG4 - Security

Scope: defining standards for technical measures
to ensure the confidentiality, availability and
integrity of health information, and also
accountability for users, as well as guidelines for
security management in healthcare.

 Public Key Infrastructure

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WG5: Smart Cards

• Cards to identify both patients and providers
• Patient data cards intended to convey a
  healthcare data set of medical importance
• Look for technology independent data
  structures leading to interoperability and
  compatibility in the communication of data

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Ad Hoc Groups

•   EHR
•   ePharmacy
•   Consumer Interests
•   Mobile Communications

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• Europe decided in 1990 that many of the issues that
  needed standards for health informatics would best be
  solved on a European scale rather than national. That
  position now seems to be changing with the creation of
  ISO TC 215 and the emergence of HL7 as an international
  standard. CEN has moved to a position of sharing and
  cooperation in the international community.

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European Committee for Standardization
CEN - TC251

•   19 Member Countries
•   14 Affiliate Countries
•   6 Associate Countries
•   Convenor - Gunnar Klein - Sweden

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CEN - TC 251

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        DICOM International
                         DICOM develops
                         standards for
                         transmitting images,
                         such as X-rays, digital
•42 members world-wide   images, MRI, CT, slides,
   •Industry (26)        pictures.
                         Current standard is
                         DICOM 3.0-yr.
   •Gov. organizations
•Multiple Liaisons       Annual update – DICOM
•20 working groups
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     HL7 International Affiliates
•   HL7 Argentina        •   HL7 Japan
•   HL7 Australia        •   HL7 Korea
•   HL7 Brazil           •   HL7 Lithuania
•   HL7 Canada           •   HL7 New Zealand
•   HL7 China            •   HL7 South Africa
•   HL7 Czech Republic   •   HL7 Switzerland
•   HL7 Denmark          •   HL7 Taiwan
•   HL7 Finland          •   HL7 The Netherlands
•   HL7 Germany          •   HL7 Turkey
•   HL7 India            •   HL7 United Kingdom

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Making World Standards

CEN             Agreement

        ISO-IEEE Pilot
        ISO/HL7 Pilot
                                 TC 215

DICOM       ISO/DICOM Proposal
            (being considered)

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