BRC expert chairs Independent Commission to accelerate safe AI adoption in healthcare

A clinical academic at the University of Birmingham, supported by the National Institute for Health and Care Research (NIHR) Biomedical Research Centre: Birmigham, has co-chaired a new report setting out how the NHS can adopt AI advances while maintaining public trust and patient safety.

Professor Alastair Denniston has chaired the National Commission into the Regulation of AI in Healthcare which today has published its recommendations on how the UK can strengthen the regulation of AI in healthcare, so it remains safe, keeps pace with innovation, and continues to earn people’s trust.

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 help many more patients benefit safely and quickly, by supporting the UK to become the best place for innovators to build and safely test AI, the best place for healthcare professionals to use it and, most importantly, the best place for patients to engage with it in their care.

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.

Professor Alastair Denniston

Professor Alastair Denniston from the University of Birmingham, lead for the NIHR Biomedical Research Centre: Birmigham’s Data, Diagnostics and Decision Tools research theme, 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. 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.”

Defining what we want our future AI-enabled healthcare system to look like

Among the key recommendations in the report, the Commission proposes a pathway for faster access to 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 is designed to give UK patients world-first access to promising new models, while ensuring risk is carefully controlled at every step.

Other recommendations include:

• Continuous, real-world monitoring throughout a device’s lifecycle. 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;
• Public access to 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, including any adverse incidents; and
• Tougher powers to protect 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 National Commission into the Regulation of AI in Healthcare – Recommendations for a future regulatory framework

Read the report

Professor Henrietta Hughes, NHS General Practitioner, Deputy Chair of the National Commission and Patient Safety Commissioner for England, said: “Patients have told us that to trust AI is safe, they want to know when it’s used, that it supports rather than replaces clinicians, and that there is clear accountability if things go wrong. That’s exactly what our recommendations deliver.

“Putting people before technology to improve care and give clinicians more time to meet patients’ needs. That’s how we can keep people safe and build the health system’s confidence to embrace AI’s full potential.”

Lawrence Tallon, the MHRA’s Chief Executive 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 independent Commission was established by the Medicines and Healthcare products Regulatory Agency (MHRA) in September 2025 and 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. Additional in-depth deliberative research by research partner the Health Foundation with members of the UK public, published today, provided detailed insight into the UK public’s priorities and expectations for the regulation of AI in healthcare.

Taken together, that engagement found broad public support for AI in healthcare, with clear conditions: strong safety standards, meaningful human oversight, and transparency about when and how AI is being used in someone’s care. The Commission’s recommendations respond directly to these views.