International Standards For Health Care W Ed Hammond

International Standards For Health Care W. Ed Hammond, Ph. D. President, AMIA Vice-chair, Technical Steering Committee, HL 7 Co-chair, Vocabulary Technical Committee, HL 7 Co-chair, EHR SIG, HL 7 Convenor, ISO TC 215, WG 2 Professor, Community & Family Medicine, Duke University

NSAI SIS DS SNV BSI SCC ANSI PKN INTECO IPQ ICONTEC INEN UNIT TTBS ABNT NSF DIN KEBS SSUAE INDECOPI FONDONORMA CSSN SII ELOT DGSM PSB BSN SLSI CSM CYS JISC IDHKSAR KATS BIS DPS GOST-R MOLDST DSM MSZT UNI EOS MSA CSNI EVS LVS DSTU TSE DZNM ON SASO IRAM SEE UNMS SMIS LST IBN AFNOR SNIMA DGN SFS BASMP STIR AENOR NNI TISI BPS SNZ TCVN SAI ASRO SZS 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 HL 7 - 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/TC 215 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/TC 215; 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 Ecuador Israel Portugal Thailand Zimbabwe China Hungary Mongolia Singapore Viet Nam Czech Republic India Poland Switzerland Yugoslavia 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/TC 215 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/TC 215’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

WG 1: 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

WG 2: 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

WG 2: 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

WG 2: Messaging and Communications Methodology • • • Single Messaging Development Framework CHICS Data Types RIM Related messaging models Duke University

WG 3 - 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

WG 4 - 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

WG 5: 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 e. Pharmacy 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 HL 7 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 - TC 251 • • 19 Member Countries 14 Affiliate Countries 6 Associate Countries Convenor - Gunnar Klein - Sweden Duke University

CEN - TC 251 Duke University

DICOM International • 42 members world-wide • Industry (26) • Professional societies • Gov. organizations DICOM develops standards for transmitting images, such as X-rays, digital images, MRI, CT, slides, pictures. Current standard is DICOM 3. 0 -yr. • Multiple Liaisons • 20 working groups Annual update – DICOM Duke University

HL 7 International Affiliates • • • HL 7 Argentina HL 7 Australia HL 7 Brazil HL 7 Canada HL 7 China HL 7 Czech Republic HL 7 Denmark HL 7 Finland HL 7 Germany HL 7 India • • • HL 7 Japan HL 7 Korea HL 7 Lithuania HL 7 New Zealand HL 7 South Africa HL 7 Switzerland HL 7 Taiwan HL 7 The Netherlands HL 7 Turkey HL 7 United Kingdom Duke University

Making World Standards CEN Vienna Agreement ISO-IEEE Pilot IEEE ISO/HL 7 Pilot HL 7 DICOM ISO TC 215 ISO/DICOM Proposal (being considered) Duke University