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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
                                      IBN
                AENOR
 SCC                      AFNOR              CSNI             MOLDST
                                       ON            DSM
                    IPQ     DIN                                         JISC
  ANSI       PKN                   UNI       MSZT         CSSN
                    SNIMA       EOS                 SII          IDHKSAR
                                         ELOT
DGN    INTECO
                 TTBS      SASO       DGSM                KATS         BPS
                                                  BIS
                          MSA      KEBS                       TISI     SNZ
  ICONTEC        ABNT
                                              PSB       BSN
                            SSUAE
      INEN      IRAM                                       TCVN
                                                  SLSI
                                                                     SAI
      UNIT      INDECOPI                    DPS
                                                    ASRO
                                            CSM
             FONDONORMA                                       SZS
                                            CYS
                                                              Duke University
MAJOR INTERNATIONAL STANDARDS
BODIES




                           Duke University
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




                                          Duke University
Why do we want ISO standards?

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




                                         Duke University
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
  standards?
• How will national interests and customs be
  accommodated?
• How do standards requirements differ between
  developing countries and highly developed
  countries?

                                       Duke University
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




                                           Duke University
Purpose

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




                                 Duke University
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
  redundancies
• “… 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;




                                                       Duke University
Membership
• 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


                                               Duke University
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)




                                           Duke University
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




                                                  Duke University
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.




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




                                           Duke University
WG2: Messaging and Communication
Architecture

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




                                          Duke University
 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.




                                      Duke University
WG2: Messaging and Communications
Methodology

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




                                      Duke University
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
      medicine
• Development of a reference terminology model
  for nursing




                                       Duke University
 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

                                         Duke University
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




                                         Duke University
Ad Hoc Groups

•   EHR
•   ePharmacy
•   Consumer Interests
•   Mobile Communications




                            Duke University
CEN

• 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.




                                                Duke University
European Committee for Standardization
CEN - TC251


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




                                       Duke University
CEN - TC 251




               Duke University
        DICOM International
                         DICOM develops
                         standards for
                         transmitting images,
                         such as X-rays, digital
•42 members world-wide   images, MRI, CT, slides,
   •Industry (26)        pictures.
   •Professional
   societies
                         Current standard is
                         DICOM 3.0-yr.
   •Gov. organizations
•Multiple Liaisons       Annual update – DICOM
•20 working groups
                                               Duke University
     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




                                             Duke University
Making World Standards

                Vienna
CEN             Agreement


        ISO-IEEE Pilot
IEEE
        ISO/HL7 Pilot
                                  ISO
                                 TC 215
 HL7

DICOM       ISO/DICOM Proposal
            (being considered)


                                    Duke University

				
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