19.5.2023 JTC1/SC42 Artificial Intelligence held its plenary and working group meetings in Berlin, Germany in April 2023. The DIN meeting centre was a very good facility to hold meetings, both face-to-face and hybrid ones. Here are the most important resolutions.
New standardisation projects
- Technical Report: Information technology – Artificial intelligence – Overview of synthetic data in the context of AI systems
- ISO/IEC 22989 Information technology – Artificial intelligence – Artificial intelligence concepts and terminology, will be made freely available to increase its use in other standardisation committees.
- Ballot to launch a new project for an international standard “Artificial intelligence – Guidance for human oversight of AI systems”
- Ballot to launch a new project for an international standard “Artificial intelligence – Assessment of the robustness of neural networks – Part 3: Methodology for the use of statistical methods”
- Ballot to launch a new project for an international standard “Information technology – Artificial intelligence – Taxonomy of AI system methods and capabilities”
- Ballot to launch a new project for a technical specification “Information technology — Artificial intelligence – Guidance on addressing societal concerns and ethical considerations”
- Ballot to launch a new project for a technical specification “Artificial intelligence – Functional safety and AI systems – Requirements”
- Establishment of target dates for ISO/IEC TR 18988 -Artificial intelligence – Application of AI technologies in health informatics: 2024-12-13. This document is to be developed together with ISO/TC215.
- Scope change for ISO/IEC 42006 “Information technology – Artificial intelligence – Requirements for bodies providing audit and certification of artificial intelligence management systems”
30.3.2023 ISO/TC215 Health Informatics held its plenary and working group meetings in Sapporo, Japan in January 2023. This face-to-face meeting gave an opportunity to quickly negotiate issues informally and build trust among the TC members. The most important decisions are summarized below.
Standard documents approved for publication
- ISO/DIS 11239 Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
- ISO/DTS 20440 Health informatics – Identification of medicinal products – Implementation guidelines for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
- ISO/DIS 29585 Health informatics – Framework for healthcare and related data reporting
Standard documents to be revised
- ISO 17523 Health informatics – Requirements for electronic prescriptions
- ISO/TS 20443:2017 Health informatics – Identification of medicinal products – Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information
- ISO/TS 20451:2017 Health informatics – Identification of medicinal products – Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
- ISO 21549-7:2016 Health informatics – Patient healthcard data – Part 7: Medication data
- ISO 25237:2017 Health informatics – Pseudonymization in N3475, ISO/TC 215 agrees to confirm the document for now and add a preliminary work item for the revision of the document.
- ISO 17090-4:2020 Health informatics – Public key infrastructure – Part 4: Digital signatures for healthcare documents
- ISO/TS 27790:2009 Health informatics – Document registry framework
- ISO 12052:2017 Health informatics – Digital imaging and communication in medicine (DICOM) including workflow and data management
- ISO/TS 22287:2019 Health informatics – Workforce roles and capabilities for terminology and terminology services in healthcare (term workforce)
- ISO/TS 21564:2019 Health Informatics – Terminology resource map quality measures (MapQual)
New standardisation projects
- Health informatics – Identification of Medicinal Products – Methodology and Framework for the Development and Representation of IDMP Ontology for New Project ballot.
- ISO/PWI 22220 Health informatics – identification of persons and organizations.
- Resolution 2023-52: Regarding ISO/DIS 41064: ISO/TC 215 agrees to submit ISO/DIS 41064 Health informatics – Standard communication protocol – Computer-assisted electrocardiography for FDIS ballot which closes on 2023-05-25.
The revision of the IEC 62304 Medical Devices – Software life cycle processes has not been restarted yet although such a standard would be needed to support the European Medical Device Regulation.
1.11.2022 X-eHealth project near completion
The X-eHealth project, funded by the European Commission is coming to an end. One of its objectives was to contribute to standardization and harmonization of eHealth services in the EU by setting European agreements on diverse levels of interoperability. The project web site gives more information.
27.10.2022 Digital therapeutics report to DTR ballot
ISO/TC215 started the draft technical report (DTR) ballot on ISO/DTR 11147 Health informatics – Personalized digital health – Digital therapeutics health software systems on 26.10.2022. Comments are accepted by 21.12.2022.
12.10.2022 AI life cycle standard to DIS ballot
SC42 started the DIS ballot to the document ISO/IEC DIS 5338 Information technology – Artificial intelligence – AI system life cycle processes. The document gives guidance to manufacturers and users what to take into consideration in all stanges of a AI system’s life cycle. The DIS ballot is the last chance to influence the contents of the standard, via national standardization bodies.
4.10.2022 SCP-ECG makes progress
ISO/TC215 approved the DIS 41064 Standard Communications Protocol – Computer-assisted Electrocardiography (SCP-ECG) in a ballot in September 2022. The document needs to be polished to publication by January 2023. The standard has been previously approved as a European standard EN 1064 in 2020 after a long revision period.
19.8.2022 Artificial intelligence terminology standardized
JTC1/SC42 has published the long-awaited AI terminology standard ISO/IEC 22989:2022 Information technology – Artificial intelligence – Artificial intelligence concepts and terminology in July 2022. The European AI standardization committee CEN&CENELEC/JTC21 has suggested its approval also as the European standard of AI terminology.
5.8.2022 JTC 21 responded to the AI standardization request
CEN&CENELEC/JTC 21 responded to the EU Commission’s standardization request about AI standards in the end of June 2022. The Commission would like to see European AI standards completed by the end of October 2024.
2.7.2022 AI Machine Learning framework published
JTC1 published the ISO/IEC 23053:2022 Framework for Artificial Intelligence (AI) Systems Using Machine Learning (ML) in June 2022. The framework describes the system components and their functions in the AI ecosystem.
2.6.2022 Label 2 Enable promotes ISO TS 82304-2 Health apps quality doc
The EU funded Label 2 Enable project started in June to promote the application of ISO/TS 82304-2:2021 document in the evaluation of mobile health apps in Europe. The use of this document in all countries would speed up the approval of health apps into use and reduce costs to health app producers.
2.4.2022 AI Use Cases revisited
JTC1/SC42/WG4 is revising the technical report ISO/IEC TR 24030:2021 Information technology – Artificial intelligence (AI) – Use cases in 2022 although the first version was published as recently as 2021. The new version contains only examples of AI systems which are actually in use.
3.1.2022 Security standard for medical device software
IEC/SC62 and ISO/TC215 have published the standard IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle for medical device software producers. Applying this standard would make the devices more secure to their users in health care.
4.11.2021 Feedback of IEC 62304 future received by ISO/TC215
The new version of ISO/IEC 62304:2006 Medical device software – software life cycle processes failed the ballot in spring 2021. Countries provided feedback how to carry on the revision but new work is not starting soon.
15.9.2021 Mobile health apps quality technical specification published
The technical specification ISO/TS 82304-2:2021 Health software – Part 2: Health and wellness apps – Quality and reliability was published in August 2021. The document gives guidance to mobile health app producers and gives tools to evaluate the quality of these apps.