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List of Regulations and Standards for Healthcare AI

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.

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:

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:

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’s press release here for more details.

British Standards Institution (BSI):