The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a Call for Evidence, asking for members of the public, clinicians, industry and healthcare providers for their views on how AI in healthcare should be regulated.

The responses will support the work of the newly formed National Commission into the Regulation of AI in Healthcare.

The Commission will bring together global AI leaders, clinicians, regulators and patient advocates and advise the MHRA on the future of health AI regulation.

The response 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 themes include modernising the rules for AI in healthcare; keeping patients safe as AI evolves and clarifying responsibility between regulators, companies, healthcare organisations and individuals.

Chief Executive of the MHRA Lawrence 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."

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."