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.
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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 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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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
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Reflections on building the AI and Digital Regulations Service
The role of collaboration in regulating AI assisted care.
Published at September 10, 2024 by Moritz Flockenhaus
- Developers
- Adopters
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Research transparency: using plain language to explain research
The HRA perspective on Research Transparency involving AI in healthcare and the importance of using plain language to promote trust and understanding.
Published at May 17, 2024 by Rebecca Evans
- Developers
- Adopters
- Research