Independent commission sets out blueprint for safer AI adoption in healthcare
An MHRA-established commission has recommended staged authorisations, continuous monitoring and stronger enforcement powers for AI in healthcare.
Commission publishes recommendations
The National Commission into the Regulation of AI in Healthcare has published recommendations on how the UK can strengthen regulation of artificial intelligence in healthcare, according to the Medicines and Healthcare products Regulatory Agency (MHRA).
The commission says its proposals are intended to keep healthcare AI safe, keep regulation aligned with innovation and maintain public trust. AI is already used in the NHS to help identify serious health problems, including strokes and skin cancers, and to support clinicians through voice-enabled technologies, the MHRA says.
The commission was established by the MHRA in September 2025. It includes expertise across health, regulation and AI, with international contributors including from the United States and Singapore.
Main recommendations
The commission recommends staged authorisations for new AI models. Under the proposal, models would be deployed with close supervision and tight safeguards so they can demonstrate safety and performance in real-world use before receiving fuller authorisation.
It also recommends continuous, real-world monitoring of AI-enabled medical devices throughout their working life. The commission says this reflects the way AI systems can evolve after deployment and would help regulators identify problems quickly.
Another recommendation is to give the public easy access to safety information about specific AI-enabled medical devices, including adverse incidents. The commission says patients should also be informed when AI is being used in their care.
The commission further recommends stronger powers for the MHRA, including enhanced enforcement powers, so the regulator can act when AI systems do not meet expected standards.
Public engagement
The commission gathered evidence from more than 12,000 people over a year, including patients, members of the public, clinicians, healthcare leaders, industry representatives and technology developers. The MHRA says this was the largest UK engagement exercise of its kind on healthcare technology regulation.
The engagement found broad public support for healthcare AI, subject to strong safety standards, meaningful human oversight and transparency about how AI is used in care.
The government and the MHRA will now consider the recommendations, with a formal response to follow in due course.
Announcing body: Medicines and Healthcare products Regulatory Agency, 10 September 2026.
Key takeaways
- The commission recommends staged authorisations for new AI models, with close supervision and safeguards before fuller approval.
- It proposes continuous monitoring of AI-enabled medical devices throughout their working life, rather than approval at a single point.
- The recommendations include searchable public information on device safety and adverse incidents, plus stronger enforcement powers for the MHRA.
- The government and the MHRA will consider the recommendations and issue a formal response in due course.
FAQ
Who made the recommendations?
The recommendations were made by the National Commission into the Regulation of AI in Healthcare. The commission was established by the Medicines and Healthcare products Regulatory Agency in September 2025 and includes expertise in health, regulation and AI.
What is staged authorisation?
The commission recommends that new AI models be introduced under close supervision and tight safeguards. They would need to demonstrate real-world safety and performance before receiving fuller authorisation.
What information should the public receive?
The commission recommends that people should be able to search for safety information about specific AI-enabled medical devices, including adverse incidents. It also says patients should be told when AI is used in their care.
What happens next?
The government and the MHRA will carefully consider the commission’s recommendations. A formal response will follow in due course.