Any ISO standards around Artificial Intelligence and Machine Learning?
- Thread starter SGquality
- Start date
@Sidney Vianna answered your question but just so you're aware and if you plan on marketing in the US, FDA has published an "action plan" on the subject that may give a little insight into regulatory thinking on the matter.
primavesvera
Involved In Discussions
This might be interesting to you: Hancock: UK will work with G7 and others to look at AI standards
The MHRA in the UK published a guide called "A guide to good practice for digital and data-driven health technologies" and as yodon mentioned, the FDA is planning to have something similar to Good Machine Learning Practices (GMLP).
There are some enthusiast working on this: johner-institut/ai-guideline
So, nothing really internationally at this moment.
If anybody has different information, please do share.
The MHRA in the UK published a guide called "A guide to good practice for digital and data-driven health technologies" and as yodon mentioned, the FDA is planning to have something similar to Good Machine Learning Practices (GMLP).
There are some enthusiast working on this: johner-institut/ai-guideline
So, nothing really internationally at this moment.
If anybody has different information, please do share.
mihzago
Trusted Information Resource
as others have already mentioned, there are several standards under development, while a handful of guidance documents were issued by various countries. UK is the most recent one I think.
There's are two from China, but they're in Chinese and I don't have a translated copy.
NMPA, “Technical Guideline on AI-Aided Software” (June 2019)
NMPA, “Introduction to review points for decision-making medical device software using deep learning technology” (September 2019).
In the US, in addition to the FDA's AI/ML action plan, there are two other relevant guidance documents from a few years ago. While their main focus are radiology devices, they are widely applied by the FDA reviewers to other device areas that use diagnostic software containing ML:
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in - Premarket Notification (510(k)) Submissions
There's are two from China, but they're in Chinese and I don't have a translated copy.
NMPA, “Technical Guideline on AI-Aided Software” (June 2019)
NMPA, “Introduction to review points for decision-making medical device software using deep learning technology” (September 2019).
In the US, in addition to the FDA's AI/ML action plan, there are two other relevant guidance documents from a few years ago. While their main focus are radiology devices, they are widely applied by the FDA reviewers to other device areas that use diagnostic software containing ML:
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in - Premarket Notification (510(k)) Submissions
MaHoDie
Starting to get Involved
Maybe a bit late, but might be useful:
(Attention I have not checked the quality of each ISO/ IEC documents)
ISO/IEC 23894:2023
Information technology — Artificial intelligence — Guidance on risk management
AAMI CR34971:2022
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
ISO/IEC TR 24028:2020
Information technology — Artificial intelligence — Overview of trustworthiness in artificial intelligence
ISO/ IEC TR 24027:2021
Information technology — Artificial intelligence (AI) — Bias in AI systems and AI aided decision making
ISO/IEC 38507:2022
Information technology — Governance of IT — Governance implications of the use of artificial intelligence by organizations
ISO/IEC TR 29119-11:2020
Software and systems engineering — Software testing — Part 11: Guidelines on the testing of AI-based systems
ISO/IEC 22989:2022
Information technology — Artificial intelligence — Artificial intelligence concepts and terminology
DIN SPEC 92001-1:2019
Artificial Intelligence - Life Cycle Processes and Quality Requirements - Part 1: Quality Meta Model;
DIN SPEC 92001-2:2020
Artificial Intelligence – Life Cycle Processes and Quality Requirements – Part 2: Robustness
ISO/IEC 23053:2022
Framework for Artificial Intelligence (AI) Systems Using Machine Learning (ML)
ISO/TR 24291:2021
Health informatics — Applications of machine learning technologies in imaging and other medical applications
ISO/IEC TR 24372:2021
Information technology - Artificial intelligence (AI) - Overview of computational approaches for AI systems
ISO/IEC TR 24030:2021
Information technology — Artificial intelligence (AI) — Use cases
DRAFT BS 30440
Validation framework for the use of AI within healthcare - Specification
ISO/IEC 2382-28:1995
Information technology Vocabulary Part 28: Artificial intelligence Basic concepts and expert systems
(Attention I have not checked the quality of each ISO/ IEC documents)
ISO/IEC 23894:2023
Information technology — Artificial intelligence — Guidance on risk management
AAMI CR34971:2022
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
ISO/IEC TR 24028:2020
Information technology — Artificial intelligence — Overview of trustworthiness in artificial intelligence
ISO/ IEC TR 24027:2021
Information technology — Artificial intelligence (AI) — Bias in AI systems and AI aided decision making
ISO/IEC 38507:2022
Information technology — Governance of IT — Governance implications of the use of artificial intelligence by organizations
ISO/IEC TR 29119-11:2020
Software and systems engineering — Software testing — Part 11: Guidelines on the testing of AI-based systems
ISO/IEC 22989:2022
Information technology — Artificial intelligence — Artificial intelligence concepts and terminology
DIN SPEC 92001-1:2019
Artificial Intelligence - Life Cycle Processes and Quality Requirements - Part 1: Quality Meta Model;
DIN SPEC 92001-2:2020
Artificial Intelligence – Life Cycle Processes and Quality Requirements – Part 2: Robustness
ISO/IEC 23053:2022
Framework for Artificial Intelligence (AI) Systems Using Machine Learning (ML)
ISO/TR 24291:2021
Health informatics — Applications of machine learning technologies in imaging and other medical applications
ISO/IEC TR 24372:2021
Information technology - Artificial intelligence (AI) - Overview of computational approaches for AI systems
ISO/IEC TR 24030:2021
Information technology — Artificial intelligence (AI) — Use cases
DRAFT BS 30440
Validation framework for the use of AI within healthcare - Specification
ISO/IEC 2382-28:1995
Information technology Vocabulary Part 28: Artificial intelligence Basic concepts and expert systems