Commission calls for ‘L-plate’ system to ensure NHS AI safety

AI could be introduced into the NHS under staged ‘L-plate’ authorisations as part of recommendations designed to balance faster adoption with patient safety.

The proposed system would allow new AI models to operate under close supervision and tight safeguards while demonstrating their safety and performance in real-world healthcare settings.

Other recommendations include continuous monitoring of AI-enabled medical devices, public access to safety information and stronger regulatory enforcement powers.

Professor Alastair Denniston, NHS consultant and chair of the National Commission into the Regulation of AI in Healthcare , said: “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.

“These recommendations are designed to make that trust possible, so that the UK can lead the world not just in developing AI for healthcare, but in showing how it can be regulated and used responsibly.”

The independent commission was established by the Medicines and Healthcare products Regulatory Agency (MHRA) in September 2025 and includes expertise across healthcare, regulation and artificial intelligence.

It gathered evidence from more than 12,000 people, including patients, members of the public, clinicians, healthcare leaders, technology developers and industry representatives.

The engagement found broad public support for healthcare AI, but with conditions including strong safety standards, human oversight and transparency about when and how AI is used in care.

Under the proposed staged authorisation model, new AI models could initially be deployed with tighter safeguards, similar to ‘L-plates’ for learner drivers, before receiving fuller authorisation based on their real-world safety and performance.

The commission also recommends continuous monitoring throughout the working life of AI-enabled medical devices rather than relying solely on approval at a single point in time.

This is intended to reflect how AI technologies can evolve after deployment and allow regulators to respond if problems emerge.

The recommendations also say members of the public should be able to search for safety information about specific AI-enabled medical devices, including adverse incidents.

Patients should be informed when AI is being used in their care through what the commission describes as a proportionate approach as the technology becomes more widely used in NHS services.

The commission has also called for stronger enforcement powers for the MHRA to act when AI systems fall short of required standards.

Lawrence Tallon, chief executive of the MHRA, 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 government and the MHRA will now carefully consider the commission’s recommendations, with a formal response expected in due course.