The National Commission into the Regulation of AI in Healthcare has today, 10 September 2026, 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 used in the NHS to spot serious health problems early, for example strokes and skin cancers, and to free up clinicians’ time through voice-enabled technologies. The Commission’s recommendations aim to help many more patients benefit safely and quickly, by supporting the UK to become the best place for innovators to build and safely test AI, the best place for healthcare professionals to use it and, most importantly, the best place for patients to engage with it in their care.
In launching this report, Professors Alastair Denniston and Henrietta Hughes, both practicing NHS doctors, said:
“The National Commission into the Regulation of AI in Healthcare is about defining what we want our future AI-enabled healthcare system to look like, and how we use regulation to shape that future. This is about creating a future healthcare system that is increasingly tech-enabled and always people-centred.”
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 independent Commission was established by the Medicines and Healthcare products Regulatory Agency (MHRA) in September 2025 and includes diverse expertise across health, regulation and AI, including international contributors from around the world including the USA and Singapore.
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.
Faster access to safe and effective AI
The Commission recommends that the MHRA introduce staged authorisations for new AI models, similar to ‘L-plates’ for learner drivers. New models would be deployed under close supervision and tight guardrails, allowing them to demonstrate real-world safety and performance before being granted fuller authorisation. This staged approach is designed to give UK patients world-first access to promising new models, while ensuring risk is carefully controlled at every step.
Continuous, real-world monitoring throughout a device’s lifecycle
Rather than a single, point-in-time approval, the Commission recommends that AI-enabled medical devices should be subject to continuous, real-world monitoring throughout their working life. This reflects how AI technologies evolve after they are deployed, rather than at the point of approval alone. This would help ensure that as AI systems learn and adapt, patients remain protected and regulators have the visibility they need to act quickly if problems emerge.
Public access to safety information
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, including any adverse incidents. This would build on tools such as the MHRA’s interactive Drug Analysis Profiles, giving patients and the public clear, accessible information they can trust. Alongside this, patients have told the Commission that they want to know when AI is being used in their care, and the recommendations set out a proportionate approach to keep patients informed as AI becomes more embedded in NHS services.
Tougher powers to protect patients