The National Commission into the Regulation of AI in Healthcare has published its recommendations on how the UK can strengthen the regulation of AI in healthcare, so it remains safe, keeps pace with innovation, and continues to earn people’s trust.
The report Recommendations for a future regulatory framework, contains new recommendations based on extensive public engagement set out how the NHS could give patients faster access to AI advances with proportionate safeguards to protect patient safety and maintain high levels of trust.
The Commission was established by the MHRA in September 2025 as an independent, non-statutory advisory body to support the safe, fast and trusted regulation, development and use of AI in healthcare, in line with commitments in the 10-Year Health Plan for England and the Life Sciences Sector Plan.
Lawrence Tallon, the MHRA’s Chief Executive said: “I welcome this authoritative and independent report which sets out in more detail than ever before how we should best regulate AI in healthcare. We have heard clearly about the opportunities of AI to speed up and improve care, and to release more of clinicians’ time for the essentially human aspects of their work with patients. We will only realise those opportunities if we have a modern, dynamic regulatory framework that accelerates safe adoption, protects patients and commands public and professional confidence. I am so grateful to the many people who contributed to this expert Commission to set out the roadmap ahead.”
The Commission gathered evidence from more than 12,000 people over the course of a year, including patients, the public, clinicians, healthcare leaders, industry and technology developers, making it the largest engagement of its kind ever undertaken in the UK on the regulation of healthcare technology. Additional in-depth deliberative research by research partner the Health Foundation with members of the UK public, published today, provided detailed insight into the UK public’s priorities and expectations for the regulation of AI in healthcare.
Taken together, that engagement found broad public support for AI in healthcare, with clear conditions: strong safety standards, meaningful human oversight, and transparency about when and how AI is being used in someone’s care. The Commission’s recommendations respond directly to these views.
Recommendations include:
- Faster access to safe and effective AI
- Continuous, real-world monitoring throughout a device’s lifecycle
- Public access to safety information
- Tougher powers to protect patients.
The government and the MHRA will now carefully consider the Commission’s recommendations, with a formal response to follow in due course.
Professor Alastair Denniston, NHS consultant and Chair of the National Commission into the Regulation of AI in Healthcare, said: “We innovate because we believe tomorrow’s healthcare can be better than today’s. But any new innovation – including AI – needs to earn its place and earn our trust. These technologies need to show that they are safe, effective and bring benefits to patients, staff and the wider NHS, without leaving people behind. Over the past year we have heard from more than 12,000 people, including patients, carers, clinicians and the technologists building AI tools. One message came through clearly: people are open to AI improving their care, but only if it is safe, overseen by humans, and if they know when it is being used. These recommendations are designed to make that trust possible, so that the UK can lead the world not just in developing AI for healthcare, but in showing how it can be regulated and used responsibly.”