Regulation and official guidance
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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…
Reports, resolutions, and position papers
AI for healthcare: creating an international approach together
The use of artificial intelligence (AI) in health systems has accelerated globally with different applications being tested and put into…
Strategies and roadmaps
Artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan
The U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action…
Strategies and roadmaps
Software and AI as a medical device change programme
The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical…
Official policy proposals and consultations
Consultation on the future regulation of medical devices in the United Kingdom
Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory…
Regulation and official guidance
Explaining decisions made with AI: a workbook (use case 1: AI-assisted recruitement tool)
Over the last two years, The Alan Turing Institute and the Information Commissioner’s Office (ICO) have been working together to…
Regulation and official guidance
Explaining decisions made with AI: a workbook (use case 2: machine learning for children’s social care)
Over the last two years, The Alan Turing Institute and the Information Commissioner’s Office (ICO) have been working together to…
Regulation and official guidance
Code of practice: automated vehicle trialling
This Code is primarily intended to be used by organisations or individuals planning to trial or pilot automated vehicle technologies…
Regulation and official guidance
A buyer’s guide to AI in health and care
The exciting promise of artificial intelligence (AI) to transform areas of health and care is becoming a reality. Prospective vendors…
Frameworks and principles
