MHRA seeks input on AI regulation at ‘pivotal moment’ for healthcare
National Commission is seeking evidence to shape regulation of AI in healthcare and support the UK’s ambition for a world-leading, AI-enabled NHS
Members of the public, clinicians, industry and healthcare providers are being asked to share their views on how AI in healthcare should be regulated, as part of a “Call for Evidence” launched by the Medicines and Healthcare products Regulatory Agency (MHRA) today (18 December 2025).
This will support the work of the newly formed National Commission into the Regulation of AI in Healthcare which brings together global AI leaders, clinicians, regulators and patient advocates and advises the MHRA on the future of health AI regulation.
It is a vital opportunity for all voices, including patients, health professionals, innovators, and the public, to influence the development of a new set of standards and safeguards for how AI is used in healthcare.
The input will help the MHRA to effectively regulate new AI technologies in the NHS and wider healthcare and ensure they support innovation and meet the needs of patients and families.
The call for evidence seeks to hear from everyone, whether they are familiar with how AI is being used in healthcare or simply have thoughts about what rules should be in place to ensure it is proportionately regulated.
Key themes include:
· Modernising the rules for AI in healthcare: Are the current rules for regulating AI in healthcare working, or do they need updating to keep pace with new technology?
· Keeping patients safe as AI evolves: As AI systems become more advanced and are used in new ways, how can we spot and address any problems quickly, especially with new types of AI that can learn and change over time?
· Clarifying responsibility: What should the distribution of responsibilities between regulators, companies, healthcare organisations and individuals involved in the use of technology in healthcare look like?
Chief Executive of the MHRA Lawrence Tallon, who took over the role earlier this year and who has spearheaded the formation of the Commission, said:
AI is already revolutionising our lives, both its possibilities and its capabilities are ever-expanding, and as we continue into this new world, we must ensure that its use in healthcare is safe, risk-proportionate and engenders public trust and confidence.
The National Commission brings together a host of experts including patients’ groups, clinicians, industry, academics and members from across government. Today we are asking the public to contribute by sharing their thoughts, experiences and opinions.
We want everyone to have the chance to help shape the safest and most advanced AI-enabled healthcare system in the world at this truly pivotal moment.
Professor Alastair Denniston, head of the UK’s Centre of Excellence in Regulatory Science in AI and Digital Health (CERSI-AI) and who chairs the Commission, said: “We are starting to see how AI health technologies could benefit patients, the wider NHS and the country as a whole.
But we are also needing to rethink our safeguards. This is not just about the technology ‘in the box’, it is about how the technology works in the real world.
It is about how AI is used by health professionals or directly by patients, and how it is regulated and used safely by a complex healthcare system such as the NHS.
This call for evidence, and the information it will provide, is so important.
This is everyone’s opportunity to help shape what a future AI-supported healthcare service will look like, and how safety is ensured across the system.
Professor Henrietta Hughes, Patient Safety Commissioner for England and deputy chair of the Commission, said:
Patients bear the direct consequences of AI healthcare decisions, from diagnostic accuracy to privacy and treatment access.
The lived experience and views of patients and the public are vital in identifying potential risks and opportunities that technologists and clinicians may miss.
Your views matter and each of us has the opportunity to shape the role AI will play in our lifetime, and for the generations to come. So please let us know through this call for evidence.
We will listen and incorporate the findings to design safe, fast and trusted systems that truly serve patients and the public.
The Commission’s call for evidence, which runs from Thursday 18 December 2025 to Monday 2nd February 2026, will help ensure AI technologies are safe, effective, and support innovation that benefits patients and the NHS.
Anyone can take part, with submissions invited from members of the public, patients, medical professionals, technology companies as well as from healthcare providers.
The information gathered will help inform the Commission’s work and help inform its recommendations to the MHRA in 2026.
ENDS
Notes to editors
- The link for submission will be live from 9.30am on Thursday 18 ecember 2025 - https://www.gov.uk/government/calls-for-evidence/regulation-of-ai-in-healthcare
- A survey of the public and NHS staff conducted by the Health Foundation in 2024 found that more than half of the UK public surveyed (54%) and three-quarters of NHS staff surveyed (76%) said they support the use of AI for patient care, and an even greater proportion said they support the use of AI for administrative purposes (61% of the public and 81% of NHS staff surveyed)
- [Data from the Nuffield Trust shows that](https://www.nuffieldtrust.org.uk/research/how-are-gps-using-ai-insights-from-the-front-line 28% of GPs currently use AI tools in their clinical practice. With GPs emphasising a lack of regulatory oversight of AI as a major concern, as well as misleading or incorrect outputs.
- The UK AI market is projected to reach £1 trillion by 2035, with health and social care expected to see the largest net job gains.
- 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 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.