International Standards For Health Care

1. 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

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

3. MAJOR INTERNATIONAL STANDARDS BODIES

4. 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

5. 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

6. 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?

7. 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

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

9. 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;

10. Membership • Participating National Member Bodies • Australia Austria Belgium Canada • Denmark Finland France Germany • Ireland Italy JapanKorea • NetherlandsNew Zealand Norway • Russia South Africa Spain • Sweden TurkeyUKUSA • Observing National Member Bodies • ArgentinaChina Czech Republic • Ecuador Hungary India • Israel Mongolia Poland • Portugal Singapore Switzerland • Thailand Viet Nam Yugoslavia • Zimbabwe

11. 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)

12. 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

13. 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.

14. 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

15. 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

16. WG2: Messaging and CommunicationMedical 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.

17. WG2: Messaging and CommunicationsMethodology • Single Messaging Development Framework • CHICS • Data Types • RIM • Related messaging models

18. 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

19. 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

20. 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

21. Ad Hoc Groups • EHR • ePharmacy • Consumer Interests • Mobile Communications

22. 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.

23. European Committee for StandardizationCEN - TC251 • 19 Member Countries • 14 Affiliate Countries • 6 Associate Countries • Convenor - Gunnar Klein - Sweden

24. CEN - TC 251

25. DICOM International 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 • 42 members world-wide • Industry (26) • Professional societies • Gov. organizations • Multiple Liaisons • 20 working groups

26. HL7 Japan HL7 Korea HL7 Lithuania HL7 New Zealand HL7 South Africa HL7 Switzerland HL7 Taiwan HL7 The Netherlands HL7 Turkey HL7 United Kingdom HL7 Argentina HL7 Australia HL7 Brazil HL7 Canada HL7 China HL7 Czech Republic HL7 Denmark HL7 Finland HL7 Germany HL7 India HL7 International Affiliates

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