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.
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 keep pace with innovations in AI, while continuing to earn people’s trust.
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.”
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 will provide patients world-first access to promising new models, while ensuring risk is carefully controlled at every step.
Continuous monitoring
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.
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.
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.
Protecting patients 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 decisively.
The government and the MHRA will now carefully consider the Commission’s recommendations, with a formal response to follow in due course.
'AI should support pharmacies'
The Royal College of Pharmacy president, Tase Oputu, said: “We welcome the National Commission’s recommendations and its vision of a Safe, Fast and Trusted approach to AI in healthcare.
"They align closely with principles we highlighted in our contribution to the Commission’s work, including proportionate, risk-based regulation, transparency, clear accountability, meaningful human oversight and ongoing monitoring.
“For pharmacy and medicines, it is essential that AI supports, rather than replaces, professional judgement, with patients at the centre of how it is used. We look forward to working with our members and partners to ensure AI is adopted safely, effectively and responsibly across pharmacy and healthcare.”
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.
The Commission 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.
