Members of the public, clinicians, industry and healthcare providers have been asked to share their views on how AI in healthcare should be regulated. 

The Medicines and Healthcare products Regulatory Agency (MHRA) has asked members of the public, clinicians, industry and healthcare providers to share their views on how AI in healthcare should be regulated, as part of a call for evidence. 

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.

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.

“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,” said MHRA chief executive Lawrence Tallon. 

“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,” he added. 

Rethinking safeguards

“We also need 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,” said 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. 

“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,” he added. 

Questions the MHRA is asking include whether the current rules for regulating AI in healthcare are working, or whether they need updating to keep pace with new technology. 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? What should the distribution of responsibilities between regulators, companies, healthcare organisations and individuals involved in the use of technology in healthcare look like?

The commission’s call for evidence runs until 2 February and will help ensure AI technologies are safe, effective, and support innovation that benefits patients and the NHS.

At the end of October last year, the government announced plans to look at how companies and innovators can test new AI products in real-world conditions, with some rules and regulations temporarily relaxed under strict supervision.

But, as Healthcare Today has reported, the journey is not seamless.