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Find out what changes have been made to the AI and Digital Regulations Service.

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2024 list
Article Update description Date User group
Cyber security and resilience for digital healthcare technologies A new content piece has been added to provide developers of digital technologies with guidance on the cyber security and resilience of devices, services and networks. April 18 Developers
Cyber security and resilience for health or care services A new content piece has been added to provide adopters deploying digital technologies with guidance on the cyber security and resilience of devices, services and networks. April 18 Adopters

2023 list
Article Update description Date User group
Data quality considerations for training and testing This page has been updated to include STANDING Together’s Recommendations for diversity, inclusivity, and generalisability in artificial intelligence health technologies and health datasets. November 6 Developers
Is your technology a medical device? New content piece added to support developers in determining if their technology is a medical device. November 6 Developers
Planning for evidence generation This page has been updated to provide information on NICE Advice, which supports health tech companies seeking to enter the NHS market, and on MHRA's AI-Airlock which will be launched in April 2024. November 6 Developers
Understanding routes to NICE health technology assessment This page has been updated to provide information on NICE Advice, which supports health tech companies seeking to enter the NHS market. November 2 Developers
Generating evidence for NICE health technology assessment This page has been updated to provide information on NICE Advice, which supports healthtech companies seeking to enter the NHS market. November 2 Developers
Understanding routes to NICE health technology assessment This page has been updated to provide information on NICE Advice, which supports health tech companies seeking to enter the NHS market. November 2 Developers
Post-market surveillance of medical devices The MHRA has published new guidance on reporting adverse incidents involving Software as a Medical Device under the vigilance system. The content on our website has been updated to reflect the new guidance. July 14 Developers
Thinking about whether a medical device will meet your needs New guidance added on how to assess whether a medical device will meet your needs. June 7 Adopters