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

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

MAJOR INTERNATIONAL STANDARDS BODIES

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

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

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?

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

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

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;

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

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)

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

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.

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

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

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.

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

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

Public Key Infrastructure 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

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

Ad Hoc Groups EHR ePharmacy Consumer Interests Mobile Communications

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.

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

CEN - TC 251

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 28

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

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