If you are involved in healthcare innovation, there is undoubtedly one recurring buzzword - artificial intelligence (AI) - with no signs of interest in the topic slowing.

At the same time, the competing narrative is ensuring safety, efficacy, and value instead of accelerating integration and investment too quickly.

Innovation Minister Richard Lochhead recently told the Scottish Parliament that AI was “already having a profound impact on our lives” but also reflected on the potential benefits “for productivity, healthcare, and general quality of life” with AI already being piloted across NHS.

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 are running a project to use AI to detect skin cancer in the primary care environment.

These are promising developments and bring to life Scotland’s vision to become a leader in the development and use of AI. 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 AI to ensure legislation meets Scotland’s needs, in addition to an independent review 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 benefits of AI but also recognise its ever-changing nature - and the reality that if AI does not stand still, neither can regulation.

The challenges that AI as a medical device (AIaMD) can pose over and above classically-programmed software is part of a change programme, announced in June by The Medicines and Healthcare products Regulatory Agency (MHRA). 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 also requires the way these devices are regulated to be carefully considered and adapted to take account of new technology.

Against this backdrop, it is inevitable this will continue to be a period of transformation, making the regulatory landscape overwhelming for both innovators and adopters of AI.

At InnoScot Health we remain absolute in ensuring regulatory procedures are correctly followed from the outset of any healthcare project, AI or otherwise. It ensures clarity in the path to market, prevents important steps being missed; and importantly maintains standards, trust and a level playing field by all those involved.

We will continue to offer our expertise, welcome the potential of AI and proactively be part of the discussions. Guidance, support, and online consultation booking are available via our website www.innoscotcom alongside a recent webinar on AI as a medical device.

We are committed to supporting NHS innovators navigate this period of transformation and ensure innovative AI-related technologies can be safely and successfully adopted into healthcare.

Elaine Gemmell is Head of Regulatory Affairs at InnoScot Health