An independent commission led by NHS doctors has published its formal recommendations on how the United Kingdom can strengthen the regulation of artificial intelligence 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, arrived at its recommendations following an extensive evidence-gathering process involving more than 12,000 stakeholders — including clinicians, healthcare leaders, industry representatives, and technology developers.
Broad Public Support, With Clear Conditions
The commission’s findings revealed broad public support for AI in healthcare, though that support comes with clear conditions. Stakeholders consistently called for strong safety standards, meaningful human oversight, and greater transparency about when and how AI is being used in patient care. These three pillars form the backbone of the commission’s regulatory thinking.
Professor Alastair Denniston, NHS consultant and Chair of the National Commission into the Regulation of AI in Healthcare, stated: “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.”
He added: “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.”
Staged Authorisations: The ‘L-Plates’ Approach
On the matter of faster access to safe and effective AI, the commission recommends that the MHRA introduce staged authorisations for new AI models — a process it likens to ‘L-plates’ for learner drivers. Under this approach, new AI models would be deployed under close supervision with tight guardrails, allowing them to demonstrate real-world safety and performance before being granted fuller authorisation.
The commission stated that 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 of the process.
Continuous Real-World Monitoring Throughout the Device Lifecycle
The commission also recommends that AI-enabled medical devices be subject to continuous, real-world monitoring throughout their lifecycle, rather than evaluation at a single point in time. This recommendation reflects the evolving nature of AI technologies 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 retain the visibility to act quickly if problems emerge. AI-enabled medical devices present a unique regulatory challenge precisely because their behaviour can change post-deployment — making ongoing oversight a critical component of responsible AI deployment.
Public Access to Device Safety Information
Another key element of the commission’s recommendations is a provision for members of the public to easily search for information about the safety of specific AI-enabled medical devices, including any adverse incidents. The intent is to give the public “clear, accessible information” they can trust — making safety data on AI-enabled medical devices more transparent and readily available.
Strengthened Enforcement Powers for the MHRA
The commission also recommends granting the MHRA stronger enforcement powers, enabling the agency to “act decisively” in cases where AI systems “fall short of the standards patients expect.” These enhanced powers are intended to ensure that AI healthcare regulation carries meaningful authority — and that patients are protected when systems underperform or fail to meet required standards.
MHRA Chief Executive Officer Lawrence Tallon responded to the recommendations: “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.”
With the commission’s work now complete, the UK government and the MHRA will carefully consider its recommendations, with a formal response to follow in due course.
Context: Prior Policy Consultation and Current Regulatory Framework
The commission’s recommendations on safe AI rollout follow an earlier ‘policy-shaping’ consultation on AI healthcare regulation, published in June 2026. In the United Kingdom, 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).
The consultation revealed that 50% of respondents believed the existing regulatory framework needed substantial revision, while 21% called for a complete overhaul. Key areas of concern included safety, performance standards, data governance, and privacy.
International Regulatory Developments
The MHRA is not the only regulatory body seeking industry input on AI. The United States Food and Drug Administration (FDA) also issued a call for stakeholder feedback on the use of generative AI in medical devices in August. That same month, the FDA and the MHRA announced plans for a more collaborative approach to shaping the future of healthcare regulation, with AI a key focus of that partnership — signalling growing international alignment around responsible AI deployment in clinical settings.
