MHRA seeks views on healthcare AI regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a call for evidence on artificial intelligence (AI) regulation in the NHS. The input will inform the work of the recently created National Commission into the Regulation of AI in Healthcare, which advises the MHRA on the future of health AI regulation.

The commission brings together experts from the technology industry, the NHS, law, patient groups, the government and the public, with the aim to tackle the most important issues around AI regulation in healthcare. The MHRA is looking for views from a wide spectrum of people, including patients, NHS staff, innovators and the general public as it looks to create a new set of standards and safeguards around AI in healthcare.

MHRA chief executive Lawrence Tallon said AI is already “revolutionising our lives”, adding: “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 MHRA wants to hear from anyone who have thoughts about what rules should be in place, whether or not they’re familiar with how AI is being used in healthcare.

It is particularly interested in views on whether the current rules for regulating AI in healthcare are working or if they need updated to keep up with the innovation landscape, who should be responsible for the use of AI in healthcare, and how to address problems quickly when new types of AI can learn and change over time.

Henrietta Hughes, patient safety commissioner for England and deputy chair of the newly formed commission, said that patients have to deal with the “direct consequences of AI healthcare decisions”, adding: “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.”

In May 2024, the MHRA launched an AI sandbox to test regulatory issues for standalone AI medical devices with the aim of balancing appropriate oversight to protect patient safety with the agility needed to respond to the challenges these products bring, ensuring regulation does not act as a barrier to innovation.

In April 2024, the MHRA set out its AI regulatory strategy, outlining its approach to ensure patient safety and industry innovation. The agency also launched a roadmap for regulations on medical technologies in January 2024, explaining plans for a new framework.

The framework will cover both existing technologies, as well as future ones, including new implantable devices, the use of artificial intelligence (AI), software and any diagnostic technologies used for early detection and prevention of disease.

The call for evidence is open until 2 February 2026 and will inform the commission’s recommendations on regulation to the MHRA.