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
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

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 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 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 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

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 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.

17. WG2: Messaging and Communications Methodology
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. 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

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 Standardization CEN - 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 28

26. 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

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