2. Duke University 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

3. Duke University BSI SAI ON IBN BASMP ABNT CSSN DPS ANSI CSNI IRAM INTECO ICONTEC KATS AFNOR SFS EOS INEN DS DZNM MSZT BSN NSAI STIR BIS IDHKSAR KEBS JISC UNI SII ELOT DIN BPS INDECOPI DGSM NSF SNZ NNI SNIMA MOLDST DGN DSM SEE LST AENOR SMIS UNMS PSB SASO GOST-R IPQ FONDONORMA TCVN UNIT SSUAE TSE TTBS TISI SNV SIS SLSI SCC EVS CSM CYS LVS MSA PKN SZS DSTU ASRO

4. Duke University MAJOR INTERNATIONAL STANDARDS BODIES

5. 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

6. 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

7. 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?

8. 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

9. Duke University Purpose Foster international trade Interoperability Improved health Developing country needs Protect consumers Advance global society

10. 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;

11. 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 MongoliaPoland –Portugal SingaporeSwitzerland –Thailand Viet NamYugoslavia –Zimbabwe

12. 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)

13. 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

14. 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.

15. 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

16. 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

17. 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.

18. Duke University WG2: Messaging and Communications Methodology Single Messaging Development Framework CHICS Data Types RIM Related messaging models

19. 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

20. 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

21. 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

22. Duke University Ad Hoc Groups EHR ePharmacy Consumer Interests Mobile Communications

23. 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.

24. Duke University European Committee for Standardization CEN - TC251 19 Member Countries 14 Affiliate Countries 6 Associate Countries Convenor - Gunnar Klein - Sweden

25. Duke University CEN - TC 251

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

27. Duke University HL7 International Affiliates HL7 JapanHL7 Japan HL7 KoreaHL7 Korea HL7 LithuaniaHL7 Lithuania HL7 New ZealandHL7 New Zealand HL7 South AfricaHL7 South Africa HL7 SwitzerlandHL7 Switzerland HL7 TaiwanHL7 Taiwan HL7 The NetherlandsHL7 The Netherlands HL7 TurkeyHL7 Turkey HL7 United KingdomHL7 United Kingdom HL7 ArgentinaHL7 Argentina HL7 AustraliaHL7 Australia HL7 BrazilHL7 Brazil HL7 CanadaHL7 Canada HL7 ChinaHL7 China HL7 Czech RepublicHL7 Czech Republic HL7 DenmarkHL7 Denmark HL7 FinlandHL7 Finland HL7 GermanyHL7 Germany HL7 IndiaHL7 India

28. Duke University Making World Standards CEN DICOM IEEE HL7 ISO TC 215 Vienna Agreement ISO-IEEE Pilot ISO/HL7 Pilot ISO/DICOM Proposal (being considered)