Health Technologies

MHRA seeks input on AI regulation at ‘pivotal moment’ for healthcare

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 an 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.

Chief executive of the MHRA Lawrence Tallon took over the role earlier this year and has spearheaded the formation of the Commission.

Tallon 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.”

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.

Professor Henrietta Hughes is patient safety commissioner for England and deputy chair of the Commission.

Hughes 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.”

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