The National Commission into the Regulation of AI in Healthcare has today, 10 September 2026, 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.
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.”
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.
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.
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. 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.
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. 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.
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 government and the MHRA will now carefully consider the Commission’s recommendations, with a formal response to follow in due course.
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. 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 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.”
Professor Neil Lawrence, Chair of the Technology Working Group and DeepMind Professor of Machine Learning, University of Cambridge, said:
“Generative AI is not like other medical technologies we’ve regulated before. It can behave differently in different circumstances, and it can evolve after its initial deployment. That means we can’t rely on a single point of approval and assume the job is done. These recommendations recognise that reality, and set out a practical, proportionate way to monitor AI technologies through their working life. This means being honest about the uncertainties in these systems, so that patients and clinicians can judge when their outputs are applicable, and when those outputs should be questioned.”
Jennifer Dixon, Chief Executive of the Health Foundation, said:
“The Health Foundation is proud to have supported the Commission’s evidence base for this report. What is striking is how consistent the public’s message has been throughout: people are open to AI playing a bigger role in their care, but that openness depends entirely on trust. A key part of the story is the role of the MHRA as regulator, but the real test will be whether the NHS has the capacity, skills and systems in place to implement and monitor AI applications safely and effectively at the scale now needed.”
Additional supportive quotes:
Matt Westmore, CEO of Health Research Authority said:
“AI has enormous potential to improve health and care, but its success will depend on public trust. The Health Research Authority is committed to making it easier to do health and social care research that people can trust. We know that innovation can only succeed when it is developed and used safely, responsibly and with public trust.
“We welcome the Commission’s focus on transparency, accountability and meaningful public involvement. The recommendations provide an important foundation for supporting safe innovation while maintaining public confidence.”
Caroline Corby, Chair of the Professional Standards Authority for Health and Social Care, said:
“The PSA welcomes the Commission’s report, which marks an important step forward in shaping the regulation of AI in health and care. To realise the benefits of AI while maintaining professional standards, patients and the public need greater understanding of how AI is being used, and professionals need clarity about what is expected of them.
“The Commission’s recommendations rightly recognise that achieving this requires a coordinated, system-wide approach. We will now consider how best to build on our coordination to date across the professional regulators and Accredited Registers we oversee, to support and help drive implementation of those recommendations.”
Dr Stephen Harden, President of the Royal College of Radiologists, said:
“Radiologists and clinical oncologists are at the forefront of healthcare AI, but gaps in the regulatory framework have meant we have not yet seen it fulfil its significant potential. This Commission has come at exactly the right moment. The AI landscape is only getting more complex, and so we are proud to have contributed to this important work. We are particularly pleased to see specific support for monitoring of AI-enabled medical devices once they are in use; getting this right will give doctors confidence to use AI tools, while protecting patient safety. We urge the Government and the MHRA to put these important recommendations into practice without delay. At the Royal College of Radiologists, we will also play our part, including by supporting education and training in AI for all doctors through a national lecture series.”
Tase Oputu, President of the Royal College of Pharmacy, 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.”
Steve Lee, Executive Director, Regulation, ABHI said:
“AI has enormous potential to improve patient outcomes and support a more productive and sustainable NHS, but realising that opportunity depends on getting the regulatory environment right. We welcome the Commission’s focus on a proportionate, predictable and lifecycle-based approach, alongside clearer pathways from regulation through to adoption. Getting this balance right will be critical to maintaining patient trust and safety, while giving innovators the confidence to develop, invest and bring beneficial technologies to patients and helping ensure the UK remains an attractive place from which to develop and deploy AI-enabled healthcare technologies. ABHI was pleased to contribute to the Technology Working Group that informed these recommendations, and we look forward to supporting their continued development and implementation.”
Dr Haris Shuaib, CEO, Newton’s Tree said:
“What stands out from the MHRA’s expert commission’s work is how conditional public support for AI actually is. Newton’s Tree monitors AI in live NHS deployments every day, and our experience is that performance can change once systems are in routine use. The Commission’s emphasis on continuous, real-world monitoring throughout a device’s lifecycle is therefore exactly right, and it positions the UK to lead the world in the safe adoption of AI in healthcare.”
Clare Fripp, Patient Safety and Quality Lead for the UK and Ireland, Philips said:
“Real-world evidence should be part of the regulatory and innovation engine. It can help detect risk after deployment, improve products, demonstrate value and build confidence in broader adoption.”
Dr Emma Lawrence, Head of data tech policy and public affairs, BioIndustry Association (BIA), said:
“Innovators in the UK’s world-leading life sciences sector need clear, safe and predictable routes to market, from regulation through to adoption. AI has the potential to transform how new technologies reach patients and healthcare systems, but only if regulatory frameworks evolve at the pace of innovation. A proportionate, risk-based approach, with the right safeguards introduced at the right time, will be essential to building trust and supporting the widespread adoption of AI.”
Tim Mitchell, Chair of the Academy of Medical Royal Colleges said:
“There can be no doubt that AI is going to have a massive impact on almost every aspect of healthcare. To ensure it is beneficial for patients and all healthcare professionals it is essential that any regulatory environment is both proportionate and appropriate. The National Commission into the Regulation of AI is to be congratulated on striking a good balance between those two – ensuring we can harness the undoubted benefits that seem just around the corner, but at the same time, making sure we limit the risks that inevitably accompany such a fast-developing technology.”
Notes to Editors
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The full report, easy read version and Welsh language version are available on 10 September 2026 at: The National Commission into the Regulation of AI in Healthcare – Recommendations for a future regulatory framework
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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.
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The Commission’s recommendations are informed by a wide range of research and engagement activity, including a call for evidence, sector roundtables with organisations including techUK and the Ada Lovelace Institute, nationally representative polling conducted with Ipsos, and evidence reviews delivered by the Health Foundation as the Commission’s research partner.
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The Health Foundation’s deliberative research, conducted in partnership with Ipsos over a series of workshops between March and April 2026 with 78 members of the public in Cardiff, Milton Keynes and York, explored their priorities for the regulation of AI in healthcare in depth. The Health Foundation’s report, “The public’s views on the regulation of AI in health care”, published today Thursday 10 September 2026, is available here. It sets out five principles for regulating AI in health care developed through this research, including that accuracy is the public’s top priority, human oversight is a critical condition for the use of AI, regulation should be proportionate to the risks involved, and AI should not result in worse care for any group. The Commission’s recommendations, including the new expectation to be informed and continuous lifecycle monitoring, respond directly to this evidence.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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