Regulation and official guidance
Regulatory body
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…
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Anonymisation, pseudonymisation and privacy enhancing technologies guidance: draft guidance and consultation
The ICO is calling for views on its updated draft guidance on anonymisation, pseudonymisation and privacy enhancing technologies.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…
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…
Official policy proposals and consultations
Guidance on the AI auditing framework: draft guidance and consultation
Applications of artificial intelligence (AI) increasingly permeate many aspects of our lives. We understand the distinct benefits that AI can…
Regulation and official guidance
Explaining decisions made with AI
This co-badged guidance by the ICO and The Alan Turing Institute aims to give organisations practical advice to help explain…
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…
Frameworks and principles
Evidence standards framework (ESF) for digital health technologies
Regulation and official guidance
Guidance on AI and data protection
This guidance covers what we think is best practice for data protection-compliant AI, as well as how we interpret data…
Frameworks and principles
Good machine learning practice for medical device development: guiding principles
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)…
