The Medicines and Healthcare products Regulatory Agency (MHRA) announcement of its new artificial intelligence (AI) strategy represents “a milestone in safely and successfully integrating AI into our more progressive healthcare future,” an expert believes

Head of Regulatory Affairs at formal NHS Scotland partner InnoScot Health, Elaine Gemmell has welcomed the MHRA setting out its strategic approach to AI, calling the framework “a significant step towards placing increased focus on truly innovation-led patient care”.

Elaine – named an Honorary Professor in the School of Engineering and Physical Sciences at Heriot-Watt University last year – believes the MHRA is making effective progress in that direction by publishing its response to the UK Government’s 2023 white paper entitled ‘A pro-innovation approach to AI regulation’.

She stated: “AI is an exciting, burgeoning, ever-advancing area, but one which also requires a strong, risk-proportionate regulatory framework.

“If we can get the balance right between evidence-based regulatory decision-making and fully harnessing AI’s vast potential for more targeted, efficient approaches to healthcare then it could be nothing less than transformational.”

The MHRA says that incorporating AI into its regulatory processes will help the agency home in on key priorities such as innovation and patient engagement.

It believes that AI offers “greater scope” to focus specialist expertise in these areas, in tandem with “the opportunity to improve the efficiency of the services we provide,” allowing patients to safely access medical products sooner.

Dr Laura Squire, Chief Quality and Access Officer at the MHRA, said that the agency increasingly expects AI to command more of its attention and it must therefore ensure it understands “the impact of that in order to continue to regulate effectively”.

Elaine continued: “It is pleasing to see the MHRA taking a lead on adopting the forward-thinking regulatory outlook we require, ensuring that aims to realise accelerated integration of AI into healthcare are done so both safely and securely, while allowing it to place a stronger focus on innovation.

“The MHRA pledging that its regulatory processes and protocols will evolve in line with AI marks a further approach that is to be applauded.”

The agency is currently implementing a regulatory reform programme for AI-led medical devices which “considers the risks of these products while permitting scope for further development of transformative healthcare”.

The InnoScot Health team offers skilled regulatory experts, dispensing advice and support to healthcare innovators across Scotland, while facilitating and underlining the country’s reputation as a centre of excellence for medical device innovation. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive and Medical Device Regulation.