Sep 21, 2026 · 37 min · 12 segments
The National Commission into the Regulation of AI in Healthcare has just published its blueprint for regulating AI in the health service. To pick out what this latest document matters for lawyers…
Marcus Coates WalkerGuest
Robert KellarGuest
Rosalind EnglishHost
Well, it was set up by the MHRA, which is the Medical and Healthcare Products Regulatory Agency in September 2025.
Chaired by Professor Alistair Denniston, and it brought together a number of leading lights and luminaries from the healthcare world, technology world, and the legal world.
And indeed, its findings were informed by a call for evidence process, which involved, amongst other things, a UK-wide research and engagement programme, engagement with healthcare professionals, industry and patients.
It sounds like it's just about the regulation of medical devices, but in fact, it goes quite a lot broader than that and deals with issues of safety, accountability, governance, transparency, and public confidence.
And in a nutshell, the overall vision of the commission is to support the deployment of AI in the healthcare sector in a way that's safe, fast, and trusted.
or to put it in a slightly longer way to unpack that, to support timely access to the technology, to strengthen patient safety and public confidence, and also to provide greater clarity and predictability for those that manufacture and develop medical AI.
As you pointed out in your introduction, Ros, there are 44 recommendations, and those are split into three groups, if you like.
The second group is about how responsibility for devices should be split or allocated across the healthcare system.
And I think the important thing to emphasise at the outset is that this is a report which really just sets our direction of travel It doesn't contain granular detail.
That's for the government to work out and perhaps legislate about in due course.
And at some point we'll get a formal governmental response, albeit no data I think has been penciled in for that yet.
Well, it was set up by the MHRA, which is the Medical and Healthcare Products Regulatory Agency in September 2025.
Chaired by Professor Alistair Denniston, and it brought together a number of leading lights and luminaries from the healthcare world, technology world, and the legal world.
And indeed, its findings were informed by a call for evidence process, which involved, amongst other things, a UK-wide research and engagement programme, engagement with healthcare professionals, industry and patients.
It sounds like it's just about the regulation of medical devices, but in fact, it goes quite a lot broader than that and deals with issues of safety, accountability, governance, transparency, and public confidence.
And in a nutshell, the overall vision of the commission is to support the deployment of AI in the healthcare sector in a way that's safe, fast, and trusted.
or to put it in a slightly longer way to unpack that, to support timely access to the technology, to strengthen patient safety and public confidence, and also to provide greater clarity and predictability for those that manufacture and develop medical AI.
As you pointed out in your introduction, Ros, there are 44 recommendations, and those are split into three groups, if you like.
The second group is about how responsibility for devices should be split or allocated across the healthcare system.
And I think the important thing to emphasise at the outset is that this is a report which really just sets our direction of travel It doesn't contain granular detail.
That's for the government to work out and perhaps legislate about in due course.
And at some point we'll get a formal governmental response, albeit no data I think has been penciled in for that yet.
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