The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a ‘call for evidence’, asking for views on how AI in healthcare should be regulated.
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.
Professor Alastair Denniston, head of the UK’s Centre of Excellence in Regulatory Science in AI and Digital Health (CERSI-AI) and the chair of 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.”
The Commission’s call for evidence runs from Thursday 18 December 2025 to Monday 2nd February 2026. Anyone can take part, with submissions invited from members of the public, patients, medical professionals, technology companies as well as from healthcare providers.
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 show that 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.