Issued by: Medicines and Healthcare products Regulatory Agency

New National Commission unites clinical leaders, patient advocates and leading tech firms to make the NHS the most AI-enabled healthcare system in world

• New National Commission will help accelerate safe access to AI in healthcare and across the NHS by advising on new regulatory rulebook – set to be published next year

• With expertise from global AI leaders, clinicians and regulators, the Commission will immediately review tech that’s being held back by regulatory uncertainty, like AI assistants for doctors

• It follows new tech being trialled to speed up discharges and let GPs focus on patients instead of taking notes, as tech plays central part in transforming the NHS under the Plan for Change

The NHS should get quicker access to the latest AI tools, thanks to a new National Commission that has been tasked with advising the Medicines and Healthcare products Regulatory Agency (MHRA) on how to re-write the regulatory rulebook on AI in healthcare, which will be published next year.

The UK National Commission on the Regulation of AI in Healthcare will bring in experts from big tech companies – like Google and Microsoft – as well as leading clinicians, researchers and patient advocates, to advise regulators on how to speed up access to the latest tech in a safe way, so British patients can safely benefit from it first.

In the meantime, the Commission will also look at accelerating access to AI assistants for doctors that help by taking notes, with regulatory uncertainty currently holding the tech back. Early tests of ‘Ambient Voice Technology’ shows that it has reduced admin to mean that more people could be seen in A&E and clinicians could spend more time focusing on patients.

The Commission will also help by providing regulatory clarity on various AI tools such as those for radiology and pathology, and remote monitoring systems to support virtual care of patients from their own homes – alerting staff to early signs of deterioration while helping people live independently.

As well as helping British patients feel the benefit of new technology first, by providing regulatory clarity for new AI tools this approach will attract technology companies to invest in developing and using their latest innovations in the UK, driving forward the government’s plan to build an NHS fit for the future as part of the Plan for Change.

Science and Technology Secretary Liz Kendall said:

“AI has incredible potential to help doctors spot and treat diseases earlier. But we need experts to come together so patients can benefit from these opportunities quickly and safely.

“This Commission will ensure the UK leads the way in making these game-changing technologies available in the safest possible way, helping more of us to lead healthy, longer lives and supporting our NHS.”

Health Innovation Minister, Zubir Ahmed, said:

“AI has the potential to transform healthcare, but only if we get the regulation right. This Commission will ensure we harness the power of artificial intelligence to save lives and improve care, whilst maintaining the highest safety standards our patients deserve.

“By bringing together the brightest minds in healthcare, technology and patient safety, our Plan for Change is positioning the UK as the global leader in AI-enabled healthcare. This isn’t just about innovation for innovation’s sake – it’s about building an NHS that works better for patients, catches diseases earlier, and gives our incredible NHS staff the tools they need to provide world-class care.”

The Commission, which will be chaired by Professor Alastair Denniston, practising NHS clinician and head of the UK’s Centre of Excellence in Regulatory Science in AI & Digital Health (CERSI-AI), and deputy chaired by the Patient Safety Commissioner Professor Henrietta Hughes, will guide the MHRA on how cutting-edge AI technologies can be safely and effectively integrated into everyday healthcare.

Lawrence Tallon, Chief Executive of the MHRA, said:

“We want regulation of AI in healthcare to move at the pace of innovation. AI has enormous potential to transform patient outcomes, improving quality, access and equity of care while driving efficiency.

“It is crucial that AI regulation maintains patient safety and public confidence. By bringing together leading voices in healthcare, technology, and patient safety, this Commission will help establish the UK as a global leader in responsible AI healthcare regulation.

“The MHRA will act on the recommendations of the Commission to support the NHS’s digital transformation and advance the UK’s ambition to become a global hub for health tech investment”.

Professor Alastair Denniston, Commission Chair, said:

“I’m honoured to be appointed Chair of the UK National Commission on the Regulation of AI in Healthcare. The safe and effective use of AI in healthcare is one of the defining challenges – and opportunities – of our time.

“This Commission marks a vital step in ensuring the UK leads the way in responsible innovation, and in accelerating the availability of AI technologies that can support better health for everyone. By bringing together diverse expertise we can build a regulatory framework for AI that is trusted by the public and health professionals, and delivers real benefits for patients.”

Professor Henrietta Hughes, Patient Safety Commissioner and Commission Deputy Chair, said:

“It’s a great honour to be appointed as Commission Deputy Chair. AI in healthcare has the potential to bring huge benefits for patients, but it must be carefully regulated. In developing the use of AI in healthcare we must listen to patients’ views to ensure that its use is safe and equitable.”

Dame Jennifer Dixon, CEO of the Health Foundation, said:

“The Health Foundation is delighted to be collaborating on the new Commission for the Regulation of AI in Healthcare. AI is advancing rapidly in healthcare, with growing evidence of its potential to enhance care delivery, improve outcomes and productivity, and enrich patient experience.

“While the NHS 10-Year Plan set a bold vision for AI, regulation must keep pace with innovation and facilitate effective use and spread. A robust and ethical framework is essential to maintain momentum, build trust in the technology among staff and patients and ensure the UK remains a leader in responsible AI in healthcare.”

AI has the potential to revolutionise health and social care, but it presents new challenges for regulators. Unlike pills and hardware devices, more factors can affect the performance of an AI system over time and in different patient groups. A review of existing and creation of a new framework is therefore needed to make sure revolutionary AI technology can be introduced to the NHS rapidly, in a safe, effective and reliable way.

Supported by the Health Foundation as a research partner, the Commission will help shape this new rulebook, which will be published next year. This will help enable key commitments in the government’s 10-Year Health Plan for England and Life Sciences Sector Plan to transform the NHS for the benefit of patients, and drive economic growth in the UK’s life sciences sector.

AI is already being used to analyse and interpret acute stroke brain scans to support doctors when diagnosing and making treatment decisions in 100% of stroke units in England. Thanks to the AI Diagnostic Fund, 50% of hospital trusts are now deploying AI to help diagnose conditions like lung cancer. Separate research has indicated that hospitals using AI-supported diagnostics have seen a 42% reduction in diagnostic errors.

The National Commission’s work will directly support the NHS’s digital transformation for the benefit of patients, and the UK’s ambition to become a global hub for health tech investment

Representatives, including other regulatory bodies, from across the healthcare ecosystem in the UK and internationally, will have voices in the AI National Commission, ensuring advice balances innovation with patient safety.

To ensure the National Commission’s work reflects the full breadth of perspectives, a formal call for evidence will be launched following the initial announcement. This will invite contributions from across the UK and internationally, helping to shape the Commission’s recommendations and address the most pressing challenges in AI regulation. Further details will be shared in the coming weeks.

Notes to editors

• The MHRA enhances and improves the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

• The National Commission on the Regulation of AI in Healthcare is an expert, non-statutory advisory body established by the MHRA to review current regulations and provide recommendations for a new regulatory framework for AI in healthcare. The membership of the Commission is:

Professor Alastair Denniston, Professor of Regulatory Science and Innovation at the University of Birmingham, Honorary Consultant Ophthalmologist at University Hospitals Birmingham NHS Foundation Trust and Executive Director of the UK’s Centre of Excellence for Regulatory Science in AI & Digital HealthTech (CERSI-AI)

Professor Henrietta Hughes, Patient Safety Commissioner

Dame Jennifer Dixon, Chief Executive of the Health Foundation

Dr Ricardo Baptista Leite, CEO, HealthAI - The Global Agency for Responsible AI in Health

Dr Brian Anderson, CEO of Coalition for Health AI (CHAI)

Richard Stubbs, Chief Executive of Health Innovation Yorkshire & Humber

Professor Neil Lawrence, DeepMind Professor of Machine Learning at the University of Cambridge and Chief Scientist at Trent AI

Professor Cathie Sudlow, Head of School of Population Health Sciences, Director of Usher Institute, University of Edinburgh, Director, UKRI Adolescent Health Study, Director of Generation Scotland

Dr Vish Ratnasuriya MBE, practising GP, Chair of Our Health Partnership, co-founder of Primary Care Accelerator and Hon Assoc Professor University of Birmingham

Dr Gabriella Spinelli, Director of RADIANT-CERSI Centre for Regulatory Science & Innovation in Digital Health & Healthcare AI, Brunel University of London

Richard Susskind CBE KC, President of the Society for Computers and Law

Dr Barry Stein, Chief Clinical Innovation Officer, Chief Medical Informatics Officer, Founder of the Center for AI Innovation in Healthcare, Attending Vascular and Interventional Radiologist, Hartford HealthCare

• Any further members will be added to the list on our website in due course

• The Commission will be supported by specialist working groups with deep domain expertise and will receive secretarial and logistical support from the MHRA To will shape a new regulatory rulebook for AI in healthcare, to be published in 2026.

• The 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 judgements to ensure that the benefits justify any risks.

• The MHRA is an executive agency of the Department of Health and Social Care.

• For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.

Quotes from core Commission members can be seen here: (https://shorturl.at/J89AL)

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