Search Results For Search is empty
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…
Frameworks and principles
Auditing machine learning algorithms
Official policy proposals and consultations
Anonymisation, pseudonymisation and privacy enhancing technologies guidance: draft guidance and consultation
The ICO is calling for views on its updated draft guidance on anonymisation, pseudonymisation and privacy enhancing technologies. This content…
Reports, resolutions, and position papers
G7 digital and technology ministerial declaration (Framework for G7 collaboration on digital technical standards)
This G7 Ministerial Declaration and Annexes set out the G7’s commitment to working together across vital areas: internet safety; data…
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…
Official policy proposals and consultations
White paper on artificial intelligence – a European approach to excellence and trust
Strategies and roadmaps
An EU strategy on standardisation setting global standards in support of a resilient, green and digital EU single market
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…
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…
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…
