Regulation and official guidance
UK
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…
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Anonymisation, pseudonymisation and privacy enhancing technologies guidance: draft guidance and consultation
The ICO is calling for views on its updated draft guidance on anonymisation, pseudonymisation and privacy enhancing technologies.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…
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
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…
Official policy proposals and consultations
Data: a new direction
This consultation presents proposals that build on the key elements of the current UK General Data Protection Regulation (UK GDPR),…
Legislation
Data protection and digital information bill
The Data Protection and Digital Information Bill was introduced to Parliament on 18 July 2022 following publication of the government’s…
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
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…
