An independent commission led by NHS doctors has published its recommendations on how the UK can strengthen the regulation of artificial intelligence (AI) in healthcare, ensuring it remains safe, keeps pace with innovation, and continues to earn the public’s trust.
The National Commission into the Regulation of AI in Healthcare, established by the Medicines and Healthcare products Regulatory Agency (MHRA) in September 2025, put together its recommendations after gathering evidence from more than 12,000 stakeholders including clinicians, healthcare leaders, and industry and technology developers.
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The commission’s ensuing recommendations come in response to findings from its engagement with stakeholders, wherein it was found that there is broad public support for AI in healthcare, but with clear conditions regarding strong safety standards, meaningful human oversight, and transparency about when and how AI is being used in someone’s care.
Regarding faster access to safe and effective AI, the commission recommends that the MHRA introduce staged authorisations for new AI models, which it likens to ‘L-plates’ for learner drivers.
The approach would mean that new models would be deployed under close supervision with 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, the commission stated.
Also with safety in mind, the commission recommends that AI-enabled medical devices be subject to continuous, real-world monitoring throughout their lifecycle rather than at a single point in time – an approach intended to reflect how AI technologies evolve after they are deployed.
According to the commission, this approach would help ensure that as AI systems learn and adapt, patients remain protected and regulators have the visibility to act quickly if problems emerge.
Other key constituents of the commission’s recommendations include a provision for members of the public to be able to easily search for information about the safety of specific AI-enabled medical devices, including any adverse incidents, with a view to giving the public “clear, accessible information” they can trust.
Meanwhile, stronger powers for the MHRA could be in order, including enhanced enforcement powers that would ensure that the agency can “act decisively” in cases where AI systems “fall short of the standards patients expect”.
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.”
With work by the commission complete, the UK government and the MHRA will now carefully consider the its recommendations, with a formal response to follow in due course.
Commenting on the commission’s regulations, MHRA CEO Lawrence Tallon said: “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.”
Safe AI rollout recommendations follow commission’s AI policy advisements
The commission’s recommendations regarding AI’s safe roll-out in healthcare follow the publication of its ‘policy-shaping’ consultation surrounding the technology’s regulation in healthcare in June 2026.
In the UK, AI in healthcare is currently regulated under the nation’s medical device regulation (MDR), with the technology classified under the designations of software-as-a-medical-device (SaMD) or AI-as-a-medical-device (AIaMD).
Regarding the current regulatory approach, 50% of respondents said the existing framework needed substantial revision, while 21% called for a complete overhaul. Areas of concern highlighted in the survey included safety, performance standards, data governance, and privacy.
The MHRA is not the only regulatory body seeking industry feedback regarding AI. The US Food and Drug Administration (FDA) also issued a call for stakeholder feedback regarding the use of generative AI in medical devices in August. That same month, the FDA and MHRA announced plans for a more collaborative approach to help shape the future of healthcare regulation, with AI a key focus of the partnership.
