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.

Quick links

Sustainable Development Goals

This committee contributes with 267 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
246

Published ISO standards *

of which 234 under the direct responsibility of ISO/TC 215

62

ISO standards under development *

of which 57 under the direct responsibility of ISO/TC 215

35
Participating members
34
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/MA 1   ISO 27269 Maintenance Agency 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 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 268 Sustainable cities and communities 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
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
27-30 May 2025 London (United Kingdom) 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. Store
  3. Standards catalogue
  4. TC
  5. ISO/TC 215