‘We can’t afford to wait years for AI regulation’ says Tallon

Lawrence Tallon, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said that “we cannot afford to wait years” for AI to be regulated at the pace of innovation.

Speaking at the AI in Health Summit at the Royal College of Physicians on 1 October 2025, Tallon said: “If we want to get innovation at scale, we’re going to have to automate and adopt AI at a far greater scale”.

He explained that regulation is “often seen as a barrier but could become an enabler” if it is “responsive to AI but is also responsible”.

Tallon said that regulations on medical devices are not up to date as they were “largely written before the year of AI”, adding that “we need to modernise them for that era”.

He also highlighted that regulation of ambient voice technology used for clinical note taking and transcription is “slightly ambiguous” at the moment.

A national commission was launched in September 2025 to review technology being held back by regulatory uncertainty and advise the MHRA on speeding up access to the latest AI tools.

The UK National Commission on the Regulation of AI in Healthcare will be chaired by Professor Alastair Denniston, head of the UK’s Centre of Excellence in Regulatory Science in AI & Digital Health, who spoke alongside Tallon in the session.

Denniston told attendees: “The exciting thing about the commission is that rather than purely looking at the technology end, it’s looking at the system end.

“If you think about the progress we’ve seen in AI and the proof of concepts, we’ve seen it’s been quite technology driven and a lot of focus and amazing progress has been made in making the technologies ready.

“But I think we as a system need to also get ready and part of that is the regulatory landscape that these innovations drop into.

“Conventionally, we’ve thought of regulation in quite a narrow way, but I think AI technology is, by the nature, they’re kind of complex interventions – they disrupt the whole pathway.

“One of things about the commission is to actually look really holistically and broadly as to what the changes are system-wide that we need to make.”

Denniston confirmed that the scope of the national commission is envisaged to be up to one year.

“The aim is to continue to iterate through the process, to provide outputs, to be very open and transparent about the progress and to seek input from the wider community,” he said.

Tallon said that “we cannot afford to wait years for this, so its not a national commission that’s going to take three years and then come back, this is an applied rapid piece of work that needs to be done properly”.

In response to a question about fears that more regulation could drive innovators to go to Europe or elsewhere, Tallon said: “We don’t need overregulation, but nor do we need deregulation that puts patients at risk.

“The one thing that I guarantee will slow innovation is if we lose patient and public trust and confidence.”