Regulation and official guidance
Generative AI framework for HMG
The Generative AI Framework for HMG is guidance on using generative AI safely and securely for civil servants and people…
Regulation and official guidance
Regulation and official guidance
Implementing the UK’s AI regulatory principles: Initial guidance for regulators
“This guidance sets out the considerations that regulators may wish to have when developing tools and guidance to implement the…
Regulation and official guidance
Introduction to AI assurance
“The Introduction to AI assurance provides a grounding in AI assurance for readers who are unfamiliar with the subject area.…
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…
Regulation and official guidance
Clinical decision support software: Guidance for industry and Food and Drug Administration staff
Regulation and official guidance
How to use AI and personal data appropriately and lawfully
Increasingly, we are seeing an uptake in applications of artificial intelligence (AI). The use of AI has the potential to…
Regulation and official guidance
Guidance on GxP data integrity
The guidance is intended to be a useful resource on the core elements of a compliant data governance system across…
Regulation and official guidance
Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system
Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must…
Regulation and official guidance
Artificial intelligence in public services
Regulation and official guidance
Guidance: medical device stand-alone software including apps
Information on when software applications are considered to be a medical device and how they are regulated. This content is…
Regulation and official guidance
Digital technology assessment criteria (DTAC)
The Digital Technology Assessment Criteria for health and social care (DTAC) gives staff, patients and citizens confidence that the digital…
Regulation and official guidance
Data ethics framework
Guidance for public sector organisations on how to use data appropriately and responsibly when planning, implementing, and evaluating a new…
