Members of the public, clinicians, industry and healthcare providers are invited to share their views on how AI in healthcare should be regulated, as part of a “Call for testimonies” launched by the Medicines and Healthcare products Regulatory Agency (MHRA) today (18 December 2025).
This will support the work of the new group National Commission for the Regulation of AI in Health Care which brings together global AI leaders, clinicians, regulators and patient advocates and advises the MHRA on the future of AI regulation in health.
This is a vital opportunity for all voices, including patients, healthcare professionals, innovators and the public, to influence the development of a new set of standards and safeguards for how AI is used in healthcare.
This contribution 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 aims to hear from everyone, whether they are familiar with how AI is used in healthcare or simply have a thought about the rules that should be in place to ensure it is regulated in a proportionate way.
Key themes include:
· Modernizing the rules of AI in healthcare: Are current rules for regulating AI in healthcare working or do they need to be updated to keep pace with new technologies?
· Ensuring patient safety as AI evolves: As AI systems become more advanced and are used in new ways, how can we quickly detect and resolve any issues, especially with new types of AI that can learn and evolve over time?
· Clarify responsibility: What should the distribution of responsibilities look like between regulators, businesses, healthcare organizations and individuals involved in the use of technology in healthcare?
MHRA Chief Executive Lawrence Tallon, who took over this role earlier this year and who led the formation of the Commission, said:
AI is already revolutionizing our lives, its possibilities and capabilities are constantly expanding, and as we move forward in this new world, we must ensure that its use in healthcare is safe, proportionate to risk and engenders public trust.
The National Commission brings together a multitude of experts, including patient 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 world’s safest and most advanced AI healthcare system at this truly crucial time.
Professor Alastair Denniston, Director of the UK Center of Excellence in Regulatory Science in AI and Digital Health (CERSI-AI) and Chair of the Commission, said: “We are beginning to see how AI-based health technologies could benefit patients, the NHS as a whole and the country as a whole.
But we also need to rethink our safeguards. It’s not just about the technology “in the box”, it’s also about how the technology works in the real world..
It is about how AI is used by healthcare 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 very important.
This is an opportunity for everyone to help shape what a future AI-powered healthcare service will look like and how security will be ensured across the system.
Professor Henrietta Hughes, Patient Safety Commissioner for England and Vice-Chair of the Commission, said:
Patients are directly impacted by AI-related healthcare decisions, from diagnostic accuracy to privacy and access to treatment.
The lived experience and perspectives of patients and the public are essential to identify potential risks and opportunities that technologists and clinicians may miss.
Your opinions matter and each of us has the opportunity to shape the role AI will play in our lifetimes and for generations to come. So please let us know through this call for evidence.
We will listen and integrate the findings to design safe, fast, and reliable systems that truly serve patients and the public.
The Commission’s call for evidence, which runs from Thursday 18 December 2025 to Monday 2 February 2026, will help ensure that AI technologies are safe, effective and support innovation that benefits patients and the NHS.
Anyone can participate, with contributions invited from members of the public, patients, healthcare professionals, technology companies as well as healthcare providers.
The information collected will help to inform the work of the Commission and inform its recommendations to the MHRA in 2026.
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Notes to editors
- More information can be found on our website. You can submit evidence directly here.
- A survey of the public and NHS staff carried out 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 supported the use of AI for patient care, and an even larger proportion said they supported the use of AI for administrative purposes (61% of the public and 81% of NHS staff surveyed).
- Data from the Nuffield Trust shows that 28% of GPs currently use AI tools in their clinical practice. GPs highlight the lack of regulatory oversight of AI as a major concern, as well as misleading or incorrect results.
- THE UK AI market expected to reach £1 trillion by 2035with health care and social services expected to see the largest net employment gains.
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK, ensuring that they work and are sufficiently safe. All of our work relies on sound, fact-based judgments to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media inquiries, please contact newscentre@mhra.gov.ukor call 020 3080 7651.