Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell, considers the current landscape

If you are involved in healthcare innovation, then there is undoubtedly one recurring buzzword of the moment – artificial intelligence (AI) – and there are no signs of that ongoing interest slowing.

At the same time, there is a competing narrative of ensuring safety, efficacy, and value instead of accelerating integration and investment too quickly when patient benefits can sometimes remain unclear.

Innovation Minister Richard Lochhead recently told the Scottish Parliament that AI was “already having a profound impact on our all our lives, our society and economy” and noted that international authorities were now discussing “what level of regulation may be required to address the risks.”

Nevertheless, he also touched on the potential benefits “for the world, for our economies, productivity, healthcare, education and general quality of life” with AI already being successfully piloted in the healthcare setting by NHS health boards across Scotland.

NHS Greater Glasgow and Clyde and NHS Grampian are currently considering the use of AI to help identify signs of lung cancer on patient X-rays, and breast cancer cases from mammogram scans.

NHS Forth Valley – in collaboration with the Scottish Health and Industry Partnership (SHIP) and the West of Scotland Innovation Hub – are running a project to use AI to detect skin cancer in the primary care environment – with the aim of initial diagnosis in under 25 minutes by 2025.

These are undoubtedly promising developments, and bring to life Scotland’s vision to become a leader in the development and use of AI in a way which is trustworthy, ethical, and inclusive. But achieving this vision also requires government leadership and regulatory action.

While medical device regulation is a reserved matter for the UK Government, the Innovation Minister is proposing a Four Nations Summit on the implications of AI to ensure legislation meets Scotland’s needs and the right supportive environment is created for businesses to thrive and people to be protected. This is in addition to an independent review to be conducted by the Scottish AI Alliance, a partnership between The Data Lab and the Scottish Government, setting out what Scotland needs to do to maximise the benefits of the technology while controlling the risks.

Like many others, we at InnoScot Health recognise the significant potential benefits of AI but also recognise challenges over its ever-changing nature, particularly when it comes to medical devices – and the reality is that if AI does not stand still, then neither can regulation.

But navigating the regulatory landscape for AI technology can be overwhelming for both innovators and adopters of AI.

The supply of safe, effective, and innovative medical products is already underpinned by a robust regulatory framework via The Medicines and Healthcare products Regulatory Agency (MHRA); however, the challenges that AI as a medical device (AIaMD) can pose over and above classically programmed software is part of an ongoing change programme (Software and AI as a Medical Device Change Programme – Roadmap).

Whilst this is important to ensure regulatory requirements for software and AI are clear and patients are protected, the continual evolution of AI through machine learning requires the manner in which these devices are regulated to be carefully considered and adapted to take account of new technology.

So it is inevitable this will continue to be a period of change, and evolution. What we can, and must do, is embrace this, proactively be part of the discussions, welcome the potential of AI, and continue to provide the latest guidance and support to NHS innovators as we navigate this period of transformation in healthcare technology.

At InnoScot Health we are keeping up to date with the latest developments, welcoming experts to deliver presentations at our popular online webinar series – we recently had MHRA speak about Artificial Intelligence as a Medical Device – and anyone can watch that via our YouTube channel; and continuing to provide NHS innovators with advice and guidance through our regular online consultations.

Regardless of the type of project, AI or otherwise, we remain absolute in ensuring regulatory procedures are correctly followed from the outset of any healthcare project and are committed to guiding innovators through this process. It ensures clarity in the path to market and prevents important steps being missed or resource being focused in the wrong area. Of course, it also maintains standards, trust between tech developers and the health and social care professionals using these technologies, and creates a level playing field so that all those involved in developing health technology meet all the relevant standards on safety, effectiveness, and fairness.

Fundamentally, regulation is key to the successful adoption of any technologies amongst healthcare professionals, engendering the correct development pathway as well as ensuring staff and patient confidence.

We at InnoScot Health will continue to closely monitor developments in this area, offer our expertise to the discussions and work to offer the best advice and support to innovators across NHS Scotland, to ensure innovative AI-related technologies can be safely and successfully adopted into healthcare.