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
Supported by
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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 case studies
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Navigating the complex world of regulation: AI innovators need a starting point
This case study explores workshops with AI developers and NHS adopters, uncovering barriers in navigating regulation and shaping AIDRS to provide clearer, practical pathways to support innovation.
Published at September 23, 2025 by Alice Eastwood, BJSS
- Developers
- Adopters
- Implementation
- Procedures
- Training
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Governance considerations for the use of synthetic data in health and care research
This case study explores governance considerations for using synthetic data in health and care research, showcasing its application in clinically valid lung cancer risk prediction.
Published at November 25, 2024 by Gemma Warren
- Developers
- Adopters
- Patient data
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Setting up an ‘implementation and governance framework’ for Artificial Intelligence (AI) pilot studies taking place in an NHS Trust
A case study exploring the implementation and governance process created by a Consultant Radiologist working in an NHS Trust.
Published at October 21, 2024 by Rebecca Evans
- Adopters
- Implementation
Latest from our blog
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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
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Building on the Spirit of Exploration – Phase 2 of the MHRA’s AI Airlock
This blog from the MHRA’s AI Airlock team reflects on discoveries from their pilot phase and shares early insights as they move into Phase 2.
Published at December 11, 2025 by Jincy Robin, AI Airlock Project Support Officer, MHRA
- Developers
- Adopters
- Implementation
- Machine learning
- Pilot
- Procedures
- Research
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Regulatory clarity is key to unlocking AI
This blog looks at common questions that arise during the AI deployment lifecycle and how accessible answers are paramount if AI is to scale.
Published at September 22, 2025 by Robin Carpenter - Head of AI Governance & Policy at Newton's Tree