About

Scope

Standardization in the field of health informatics, to facilitate capture, interchange and use of health-related data, information, and knowledge to support and enable all aspects of the health system.

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Sustainable Development Goals

This committee contributes with 264 standards to the following Sustainable Development Goals:

1
No Poverty
2
Zero Hunger
3
Good Health and Well-being
4
Quality Education
5
Gender Equality
8
Decent Work and Economic Growth
9
Industry, Innovation and Infrastructure
10
Reduced Inequalities
11
Sustainable Cities and Communities
12
Responsible Consumption and Production
13
Climate Action
16
Peace, Justice and Strong Institutions
236

Published ISO standards *

of which 224 under the direct responsibility of ISO/TC 215

66

ISO standards under development *

of which 64 under the direct responsibility of ISO/TC 215

35
Participating members
32
Observing members

* number includes updates

Reference Title Type
ISO/TC 215/SC 1 Genomics Informatics Subcommittee
ISO/TC 215/CAG 1   Executive council, harmonization and operations Working group
ISO/TC 215/CAG 02   Advisory group Working group
ISO/TC 215/JWG 1   Joint ISO/TC 215 - ISO/TC 249 WG: Traditional Chinese Medicine (Informatics) Working group
ISO/TC 215/JWG 7   Joint ISO/TC 215 - IEC/SC 62A WG: Safe, effective and secure health software and health IT systems, including those incorporating medical devices Working group
ISO/TC 215/TF 1   Task Force on Quantities and Units to be used in e-health Working group
ISO/TC 215/TF 3   Outreach & Communications Working group
ISO/TC 215/TF 5   AI technologies in health informatics Working group
ISO/TC 215/TF 6   Process and quality improvement Working group
ISO/TC 215/TF 7   Telehealth and Virtual Care (TVC) Standards Working group
ISO/TC 215/WG 1   Architecture, Frameworks and Models Working group
ISO/TC 215/WG 2   Systems and Device Interoperability Working group
ISO/TC 215/WG 3   Semantic content Working group
ISO/TC 215/WG 4   Security, Safety and Privacy Working group
ISO/TC 215/WG 6   Pharmacy and medicines business Working group
ISO/TC 215/WG 10   Traditional Medicine Working group
ISO/TC 215/WG 11   Personalized digital health Working group

 

Joint working groups under the responsibility of another committee
Reference Title
ISO/IEC JTC 1/SC 42/JWG 3 Joint Working Group ISO/IEC JTC1/SC42 - ISO/TC 215 WG : AI enabled health informatics
ISO/TC 249/JWG 1 Joint ISO/TC 249 - ISO/TC 215 WG: Informatics
Liaison Committees to ISO/TC 215

The committees below can access the documents of ISO/TC 215:

Reference Title ISO/IEC
IEC/SC 62A Common aspects of medical equipment, software, and systems IEC
IEC/SyC AAL Active Assisted Living IEC
IEC/TC 62 Medical equipment, software, and systems IEC
IEC/TC 106 Methods for the assessment of electric, magnetic and electromagnetic fields associated with human exposure IEC
ISO/IEC JTC 1 Information technology ISO/IEC
ISO/IEC JTC 1/SC 6 Telecommunications and information exchange between systems ISO/IEC
ISO/IEC JTC 1/SC 7 Software and systems engineering ISO/IEC
ISO/IEC JTC 1/SC 17 Cards and security devices for personal identification ISO/IEC
ISO/IEC JTC 1/SC 24 Computer graphics, image processing and environmental data representation ISO/IEC
ISO/IEC JTC 1/SC 27 Information security, cybersecurity and privacy protection ISO/IEC
ISO/IEC JTC 1/SC 29 Coding of audio, picture, multimedia and hypermedia information ISO/IEC
ISO/IEC JTC 1/SC 32 Data management and interchange ISO/IEC
ISO/IEC JTC 1/SC 36 Information technology for learning, education and training ISO/IEC
ISO/IEC JTC 1/SC 41 Internet of things and digital twin ISO/IEC
ISO/IEC JTC 1/SC 42 Artificial intelligence ISO/IEC
ISO/IEC JTC 1/SC 43 Brain-computer interfaces ISO/IEC
ISO/TC 12 Quantities and units ISO
ISO/TC 37 Language and terminology ISO
ISO/TC 46 Information and documentation ISO
ISO/TC 84 Devices for administration of medicinal products and catheters ISO
ISO/TC 106 Dentistry ISO
ISO/TC 106/SC 3 Terminology ISO
ISO/TC 121 Anaesthetic and respiratory equipment ISO
ISO/TC 145 Graphical symbols ISO
ISO/TC 154 Processes, data elements and documents in commerce, industry and administration ISO
ISO/TC 170 Surgical instruments ISO
ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices ISO
ISO/TC 212 Medical laboratories and in vitro diagnostic systems ISO
ISO/TC 249 Traditional Chinese medicine ISO
ISO/TC 276 Biotechnology ISO
ISO/TC 307 Blockchain and distributed ledger technologies ISO
ISO/TC 314 Ageing societies ISO

 

Liaison Committees from ISO/TC 215

ISO/TC 215 can access the documents of the committees below:

Reference Title ISO/IEC
IEC/SC 62A Common aspects of medical equipment, software, and systems IEC
IEC/SyC AAL Active Assisted Living IEC
IEC/TC 62 Medical equipment, software, and systems IEC
ISO/CASCO Committee on conformity assessment ISO
ISO/IEC JTC 1 Information technology ISO/IEC
ISO/IEC JTC 1/SC 27 Information security, cybersecurity and privacy protection ISO/IEC
ISO/IEC JTC 1/SC 32 Data management and interchange ISO/IEC
ISO/IEC JTC 1/SC 37 Biometrics ISO/IEC
ISO/IEC JTC 1/SC 41 Internet of things and digital twin ISO/IEC
ISO/IEC JTC 1/SC 42 Artificial intelligence ISO/IEC
ISO/TC 12 Quantities and units ISO
ISO/TC 37 Language and terminology ISO
ISO/TC 106 Dentistry ISO
ISO/TC 145 Graphical symbols ISO
ISO/TC 176/SC 2 Quality systems ISO
ISO/TC 176/SC 3 Supporting technologies ISO
ISO/TC 212 Medical laboratories and in vitro diagnostic systems ISO
ISO/TC 249 Traditional Chinese medicine ISO
ISO/TC 262 Risk management ISO
ISO/TC 276 Biotechnology ISO
ISO/TC 304 Healthcare organization management ISO
ISO/TC 307 Blockchain and distributed ledger technologies ISO
ISO/TC 314 Ageing societies ISO

 

Organizations in liaison (Category A and B)
Acronym Title Category
BBMRI-ERIC Biobanking and BioMolecular resources Research Infrastructure A
CDISC Clinical Data Interchange Standards Consortium, Inc. A
COCIR European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry A
DICOM DICOM Standards Committee A
EFPIA European Federation of Pharmaceutical Industries and Associations A
GS1 GS1 A
HL7 Health Level Seven International A
HON Health On the Net Foundation A
ICC - commerce International Chamber of Commerce A
ICN International Council of Nurses A
IEEE Institute of Electrical and Electronics Engineers, Inc A
IFCC International Federation of Clinical Chemistry and Laboratory Medicine A
IHE Integrating the Healthcare Enterprise International A
IHTSDO International Health Terminology Standards Development Organization A
IMIA International Medical Informatics Association A
INLAC Latinoamerican Institute for Quality Assurance A
ISTHealth International Society for Telemedicine & eHealth A
ITU International Telecommunication Union A
OECD Organisation for Economic Co-operation and Development, OECD A
UNECE United Nations Economic Commission for Europe A
WHO World Health Organization A
WONCA World Organization of Family Doctors A

Organizations in liaison (Category C)

C liaisons participate at the level of a Working Group

Acronym Title Category
CDISC Clinical Data Interchange Standards Consortium, Inc. C
Continua Health Alliances Continua Health Alliances C
ICH The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use C
IHE Integrating the Healthcare Enterprise International C
Date Month Location TC/SC Note
24 April 2024 Virtual () ISO/TC 215  
16 May 2024 Barcelona (Spain) ISO/TC 215/SC 1  
4-8 November 2024 Kochi (India) ISO/TC 215 *

* Information definite but meeting not yet formally convened
** Provisional

ISO/TC 215 - Secretariat

ANSI [United States]

American National Standards Institute
1899 L St NW, 11th Floor
Washington 20036 DC
United States

Tel: +1 212 642 49 00 / +1.202.293.8020
Fax: +1 212 398 00 23 / +1.202.293.9287
Web:

  2. Taking part
  3. Who develops standards
  4. Technical Committees
  5. ISO/TC 215