Understanding regulations of AI and digital technology in health and social care
Learn what regulations to follow and how to evaluate effectiveness, whether you're a 'developer' of AI and digital technology or an 'adopter' who will buy or use them in health and social care.
This website has been meticulously curated by 4 key regulatory and evaluation authorities for health and social care: NICE, MHRA, CQC and HRA
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Regulations for developers
Developers, also known as manufacturers, take AI or digital technologies from an idea into a market-ready product.
Developers' guidance -
Regulations for adopters
Adopters can buy, deploy or use the technology in a health or social care setting.
Adopters' guidance
Latest from our blog
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Exploring the future of Medical Device regulation with the MHRA’s AI Airlock
NHS England’s Federated Data Platform (FDP) team are engaging with the MHRA AI Airlock programme to test PCCPs in a sandbox environment, addressing challenges of regulating AI medical devices.
Published at July 13, 2026 by Charlie Templeman-Coleman, Delivery Manager | Federated Data Platform (FDP), NHS England
- Adopters
- Machine learning
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DCB Standards vs ISO 14971: What Healthcare IT Deployers in England Need to Know
Understanding Your Rights and Responsibilities in Safe Health IT Deployment
Published at April 7, 2026 by Hadi Shahidipour – Clinical Lead & Senior Regulatory Specialist at NHS England
- Adopters
- Developers
- Implementation
- Procedures
- Integration
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Finding clarity in AI Regulation: A clinicians first look at the AI and Digital Regulations Service
AIDRS collaborated with CERSI‑AI’s Clinical AI Fellow for a clinician‑focused review of the guidance. This blog shares insights on understanding regulation and supporting responsible AI adoption in health care.
Published at January 27, 2026 by Mariha Ashraf, Clinical Research Fellow, CERSI-AI
- Adopters