Health Check | Episode 1 - AI in healthcare and the UK regulatory environment
Hello and welcome to OC Health Check, the podcast that takes the temperature on regulatory developments affecting the life sciences and health care sector in The UK and offers a prescription to these challenges. I am Anna Lundy.
Speaker 2:And I'm Peter Rudd Clark. We're both regulatory lawyers from Osborne Clark. So a quick word on why we're doing this podcast series. It seems to be a really critical time in the life sciences health care sector. There's a huge amount going on.
Speaker 2:So we wanted to bring to people some bite sized briefings on all the change that's happening. This should be pretty useful for anyone, whether you're a manufacturer, an investor, in house lawyer, or just an interested member of the public. In this particular episode, we're looking at AI, and our overseers to why we're looking at this topic and why it matters so much now.
Speaker 1:Well, it was a bit of a bumper year for AI and life sciences in 2024. So first of all, we had the MHRA publishing its AI strategy. And as part of that strategy, it established the AI airlock pilot, which is effectively a regulatory sandbox for AI as a medical device. And that's aimed at understanding and mitigating risks associated with AI as a medical device prior to piercing on the market. The Liberal government towards the end of last year also established the regulatory innovation office or the RIO, which is dealing with digital technology as a priority.
Speaker 1:And we also had Lord Darcy publishing his report on the NHS. He noted that it was in serious trouble and advocated for integrating advanced digital solutions into the health care system, noting that there was great potential for AI to transform patient care from discovery of new treatments to automating routine processes.
Speaker 2:Yeah, so that was all very 2024. What can we look forward to this year, 2025?
Speaker 1:Well, this year we're expecting pretty major changes to how AI is regulated in the medical space. So firstly, very excitingly, are expecting the new medical devices and IVD regulations to be published in The UK, and this will be the first real overhaul of those regimes since 02/2002, so long overdue you might say, and we're all waiting to see whether it will bring us into line with the EU position or whether it will diverge from that drawing on some of the lessons that have already been learned from the MDR and the IVDR in the EU. For example, how will the new UK position deal with transformative technologies such as AI? And next, we'll also see the findings from the AI airlock that I just mentioned. They'll be published, and these will inform future airlock projects and influence AI as medical devices.
Speaker 1:So this is really important one to watch out for. And the MHRA is also set to publish its guidance on cybersecurity and human factors specific to AI as a medical device this spring. So another bumper year to be expected.
Speaker 2:So lots happening on the legal regulatory side, but I know as you mentioned, there's obviously a political side of this as well with the new Labour government.
Speaker 1:Yeah. Absolutely. So following Lord Darcy's report, which was published in November 2024, which was incredibly fast out of the blocks from its commissioning once labor had got into par, we can also expect to see the health secretary Wes Streating's ten year health plan being published published this spring, and this will detail the government's plans on reforming the NHS, and we do expect this to lean heavily on Lord Darcy's findings. But for our listeners, just taking a bit of a step back, how wide is the MHRA's jurisdiction over all of this?
Speaker 2:Yeah. So the MHRA's remit is pretty broad and extensive. So it covers medical devices, pharmaceutical products, borderline products. Those are products which could be classified perhaps under another regulatory system, but they've got a medical element to them. And within all that, the MHRA covers software as a medical device as well.
Speaker 2:And within all that comes artificial intelligence. So, yeah, the MHRA is a very active regulator in this area and they're the ones who will be taking forward The UK's response to what is a an opportunity and a challenge laid down by the advent of AI in health care. So if you look at a few examples, if you look at pharmaceutical products, increasingly, manufacturers are finding that using AI in the drug discovery phase can really speed up getting a product to the market. That sort of technology, that approach is pretty new. And in The UK, it's the MHRA that will have to review how those products have been put through clinical trials, brought to market before they can be approved and given authorization and and put on the market.
Speaker 2:And in the space of medical devices, that CMHRA's remit is as you mentioned, Anna, new medical device regulations are coming down the track. We're expecting to see them at some point this year. The law is, as you've said, Anna, is going to have to catch up with a huge amount of development in this area since the regulations came in in 02/2002, which frankly are based on nineteen nineties European law. So that's the MHRA, very active in this area. It's got plenty on its plate, and it's the one to watch to see what's gonna happen in the future.
Speaker 1:Goodness, you mentioned, you know, huge developments and I talked about some of the big the big things we expect to see this year and and there's a lot for our clients to think about. What are you seeing in practice?
Speaker 2:Well, the primary concern often for a client coming to us with a product that's got AI as part of it or a piece of software is to work out its classification. So is it, technically speaking, a medical device? Does it come within the regulatory system that applies to life sciences products? Or else is it a product or service which falls just outside of that regulatory area? And that's important because if a product is regulated as a medical device, then it's one of the most highly regulated areas on the market.
Speaker 2:Manufacturers have to do a lot more to be compliant with regulations. You'll often see a a product which maybe was developed with consumers in mind, but then it goes into the market. It becomes increasingly involved in health care. And then the next iteration of the product could be more advanced, might have more features on it, and that might bring it into the the medical space. So the classic example is is some sort of wellness product or lifestyle product like a a fitness watch or device that does some sort of tracking and giving the user some feedback.
Speaker 2:But as soon as that product starts to do things like collect health data, give information to a user that could be used to diagnose or monitor conditions, then it triggers healthcare regulations, becomes regulated by the MHRA and comes with much more regulatory burdens than a equivalent device that's just outside of those regulations. So we see that a lot of that. And I think as new regulations come in and as we get new MHRA guidance and as the whole regulatory system responds to the advent of AI, those questions over classification are gonna become more and more important and probably affect more and more manufacturers. Other examples we've seen and I think we'll see more of is investigations. So we may see a manufacturer put a product into the market.
Speaker 2:They've carried out an assessment. They think it's not regulated as a medical device, but you may then get contacted by the MHRA who's looked to your product, and they've asked questions about it. They said, look, you know, you've put it on the market. It seems to be doing these things. It seems to be monitoring health conditions.
Speaker 2:In our view, it's regulated as a medical device. You need to respond to that. And then the manufacturer has a choice. Do you engage with the MHRA and try and argue your case that it's not regulated as a medical device? Or do you have to accept the MHRA's position and then start quickly to get your ducks in a row and get regulated and approved on that basis.
Speaker 2:So products will often come at a a crossroads, you know, how are you regulated?
Speaker 1:Sounds like it's a bit of a critical moment for the MHRA. At the same time, as all these issues are becoming much more critical for society and health care more broadly, what's the EU position on all this? How are they taking forward AI?
Speaker 2:So it's really interesting. This area is has really been affected by by Brexit. So all the laws we've been talking about have got their origins in EU law. But the EU has diverged from The UK model. And the question now for The UK is will it cleave to the EU system or will it do something a bit different?
Speaker 2:So the EU's got its relatively new medical devices regulation 2017. It's also got the new EU AI act as well. So there's a model out there the MHRA could follow, but the signals are that perhaps in the area of AI, the MHRA may do something a bit different. But this is all against the backdrop of certainly in The UK and the government talking about cutting regulation, removing red tape to try and improve growth prospects in The UK. That's been added to the mix in the last couple of months.
Speaker 2:Will it have an impact on how AI is regulated and how life sciences products are regulated in The UK? Quite possibly. If that happens, then I think we might see a bit of a lighter touch regime in The UK compared to the EU, but proof will be in the pudding. We'll have to see what's published.
Speaker 1:Absolutely. And it's going to be definitely one for businesses who are placing these sorts of products on the market in both The UK and The EU.
Speaker 2:But, of course, we must forget in the middle of all this that the EU regime, the c marking system still applies in The UK. We know until 2030. Mhmm. So manufacturers can be compliant with the EU system for their products on The UK market, but we don't know how long that's gonna last for and whether the 2030 date will be extended or whether we finish then. Either way, what is clear is that a new system is going to come in The UK.
Speaker 2:So with with that in mind, OC HealthCheck takes the temperature on development. So let's take the temperature on AI health care in The UK. What do we think about it?
Speaker 1:Well, it is definitely getting pretty hot out there, Pete. This year is gonna be a big year for developments in the AI space. Businesses will need to be keeping a key eye on those throughout the course of 2025. There's definitely gonna be quite a lot to stay on top of during the course of this year.
Speaker 2:Yep. So as you take the service from these developments, stay on top of what's important for your business, don't forget we have a really useful microsite as part of the Osman plot website where we're tracking these developments and we'll keep you all updated.
Speaker 1:Thanks very much. Thanks for listening.