This page lists the regulations and standards pertaining to healthcare AI, at an international and EU level, as well as nationally in the UK and US.
The below does not comprise an exhaustive list but all links and descriptions were accurate when the page was last updated.
- Software as a Medical Device (SaMD): Clinical Evaluation: International Medical Device Regulators Forum [2017-09-21]
- Software as a Medical Device (SaMD): Application of Quality Management System: International Medical Device Regulators Forum [2015-10-02]
The above IMDRF documents are valid to AI even though they do not expressly reference AI.
The IMDRF also operates a Artificial Intelligence Medical Devices working group. In May 2022, the group published:
All ISO standards which are relevant to AI:
Artificial intelligence Working Group:
The working group focuses on the entire AI eco-system and was launched in 2018. The remit included a transfer of older standards related to big data. Alongside the additional Artificial Intelligence standards, these are being released as they become ready and agreed.
Quality Frameworks for developing medical device software:
European Commission:
- Proposal for a Regulation laying down harmonised rules on artificial intelligence [2021-04-21]
- Press Release: “Europe fit for the Digital Age: Commission proposes new rules and actions for excellence and trust in Artificial Intelligence” [2021-04-21]
European Medicines Agency (EMA):
- MDR: Medical Device Regulation [Came into effect fully on 2021-05-26]
- The original regulation was published in 2017 and updated in 2020.
In addition to the above regulation, the EMA has published the following:
- Report: HMA-EMA Joint Big Data Taskforce Phase II report: Evolving Data-Driven Regulation [2019]
- News: Artificial intelligence in medicine regulation [2021-08-16]
- News: A vision for use of real-world evidence in EU medicines regulation European Medicines Agency (EMA) [2021-11-24]
- Report: Horizon Scanning Assessment Report – Artificial Intelligence [2021-08-06]
Medicines and Healthcare products Regulatory Agency (MHRA):
The MHRA announced the Software and AI as a Medical Device Change Programme which launched a consultation to lead to a defined work program by the end of 2021.
In addition, the following guidance was jointly published the by UK Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA), and Canada Health:
Ada Lovelace Institute:
- Algorithmic Impact Assessment (AIA) [2022-02]
In 2022, the UK Government announced the pilot of an impact assessment tool to support the ethical development and adoption of artificial intelligence (AI) within healthcare. Within the pilot scheme, teams who wish to access the high quality NHS imaging data from both the National Covid-19 Chest Imaging Database (NCCID) and the National Medical Imaging Platform (NMIP) will need to conduct an AIA. Read gliff.ai’s press release here for more details.
British Standards Institution (BSI):
- White Paper on Artificial Intelligence [Overview of standardization landscape in artificial intelligence]
Food & Drug Administration (FDA):
- Software as a Medical Device (SAMD): Clinical Evaluation [2017-12-08]
- Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) [2019]
- Artificial Intelligence/Machine Learning (AI/ML)-Based.: Software as a Medical Device (SaMD) Action Plan [2021-01]
In addition, the FDA has published the following reports:
- Developing a Software Precertification Program: A Working Model (Version 1.0)
- Framework for FDA’s Real-World Evidence Program
- Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions
The following guidance was jointly published the by UK Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA), and Canada Health:
Consumer Technology Association (CTA):
