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Topics
Clinical decision support software: Guidance for industry and Food and Drug Administration staff
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Official policy proposals and consultations
Reforming the framework for better regulation: A consultation
Our exit from the EU provides us with the opportunity to think boldly about how we regulate and for the…
Reports, resolutions, and position papers
Pro-innovation regulation of technologies review: Digital technologies
This report was presented by Sir Patrick Vallance, the Government Chief Scientific Adviser, to the Chancellor of the Exchequer and…
Reports, resolutions, and position papers
HM Government response to Sir Patrick Vallance’s pro-innovation regulation of technologies review: Digital technologies
This content is available under the Open Government Licence v3.0
Regulation and official guidance
Software and artificial intelligence (AI) as a medical device
Software (including AI) plays an essential part in health and social care. In the UK, many of these products are…
Reports, resolutions, and position papers
CDEI portfolio of AI assurance techniques
The portfolio of AI assurance techniques has been developed by the Centre for Data Ethics and Innovation (CDEI), initially in…
Policy item
Catalogue of tools & metrics for trustworthy AI
Frameworks and principles
Predetermined change control plans for machine learning-enabled medical devices: Guiding principles
In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles…
