International Standards For Health Care

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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

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

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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 worlds experts to
  produce best standards?
• To remove barriers to health care in the global
  setting

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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?

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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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Purpose

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

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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

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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

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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)

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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/TC215s objectives, or
• Developing its own standards where neither of the
  above is achievable

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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 TCs work programme
  and in the production of standards, in a manner
  which satisfies the users identified needs.

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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

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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

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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.
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WG2 Messaging and CommunicationsMethodology

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

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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

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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
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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

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Ad Hoc Groups

• EHR
• ePharmacy
• Consumer Interests
• Mobile Communications

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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.

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European Committee for StandardizationCEN - TC251

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

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CEN - TC 251
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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

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HL7 International Affiliates

• 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

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