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.
AI is already being used in the NHS to spot skin cancers and free up clinicians through voice-enabled technologies.
The recommendations from the Commission aim to help more patients benefit safely and quickly, by supporting the UK to become the best place for innovators to build and safely test AI.
The Independent Commission was established by the Medicines and Healthcare products Regulatory Agency (MHRA) in September 2025. It 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. It is the largest engagement of its kind ever undertaken in the UK on the regulation of healthcare technology.
The Commission recommends that AI-enabled medical devices should be subject to continuous, real-world monitoring throughout their working life, rather than a single point-in-time approval.
The Commission recommends stronger powers for the MHRA, including enhanced enforcement powers, to ensure that where AI systems fall short of the standards patients expect, the regulator can act.
The Commission also recommends that members of the public should be able to easily search for information about the safety of specific AI-enabled medical devices.
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.”
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.”
