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International Standards For Health Care

W. Ed Hammond, Ph.D.President, AMIA

Vice-chair, Technical Steering Committee, HL7Co-chair, Vocabulary Technical Committee, HL7

Co-chair, EHR SIG, HL7Convenor, ISO TC 215, WG2

Professor, Community & Family Medicine, Duke University

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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

JISCUNI

SIIELOT

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

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MAJOR INTERNATIONAL STANDARDS MAJOR INTERNATIONAL STANDARDS BODIESBODIES

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Who are the International Players in Health Who are the International Players in Health Care Standards?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

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Why do we want ISO 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

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Key IssuesKey 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?

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TC 215 ...In the beginning …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

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PurposePurpose

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

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ISO/TC 215 - ScopeISO/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;

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MembershipMembership

• 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

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TC 215 - Health InformaticsTC 215 - Health InformaticsHas 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)

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ISO/TC215 Business PlanISO/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

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ISO/TC 215 Business PlanISO/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.

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WG1: Health RecordsWG1: 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

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WG2: Messaging and Communication WG2: Messaging and Communication ArchitectureArchitecture

• 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

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WG2: Messaging and CommunicationWG2: Messaging and CommunicationMedical Device CommunicationsMedical 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.

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WG2: Messaging and CommunicationsWG2: Messaging and CommunicationsMethodologyMethodology

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

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WG3 - TerminologyWG3 - 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

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WG4 - SecurityWG4 - 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 InfrastructurePublic Key Infrastructure

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WG5: Smart CardsWG5: 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

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Ad Hoc Groups

• EHR• ePharmacy• Consumer Interests• Mobile Communications

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CENCEN

• 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.

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European Committee for StandardizationEuropean Committee for StandardizationCEN - TC251CEN - TC251

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

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CEN - TC 251CEN - TC 251

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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 InternationalDICOM International

•42 members world-wide

•Industry (26)

•Professional societies

•Gov. organizations

•Multiple Liaisons

•20 working groups

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HL7 International AffiliatesHL7 International AffiliatesHL7 International AffiliatesHL7 International Affiliates

• HL7 JapanHL7 Japan• HL7 KoreaHL7 Korea• HL7 LithuaniaHL7 Lithuania• HL7 New ZealandHL7 New Zealand• HL7 South AfricaHL7 South Africa• HL7 Switzerland HL7 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

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Making World Standards

CEN

DICOM

IEEE

HL7

ISOTC 215

Vienna Agreement

ISO-IEEE Pilot

ISO/HL7 Pilot

ISO/DICOM Proposal (being considered)