The MHRA says that when it comes to use the use of AI as a medical device, it emphisises that there needs to be a strong focus on the use of cybersecurity features. Credit: Shutterstock / S.Borisov

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has set out what it calls, a strategic approach, artificial intelligence (AI) in healthcare as the UK government considers plan to legislate and regulate the technology.

The MHRA report, presented to the UK government, sets out the call for regulation in the AI heathtech space as well as calling on the UK government to find international alignment when it comes to constraining the tech or else risk losing out. At the same time the paper suggests that many Class I devices using AI, able to be on the market without authorisation, could be bumped up to Class II.

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The MHRA says that when it comes to use the use of AI as a medical devices there needs to be a strong focus on the use of cybersecurity features with plans to publish another advisory paper on the subject in 2025.

Laura Squire, chief quality, and access officer at the MHRA, said: “While taking this opportunity we must ensure there is risk proportionate regulation of AI as a Medical Device (AIaMD) which takes into account the risks of these products without stifling the potential they have to transform healthcare.

“Increasingly, we expect AI to feature in how those we regulate undertake their activities and generate evidence and we therefore need to ensure we understand the impact of that in order to continue to regulate effectively.”

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Elsewhere in the MHRA report, the body calls for the transparency and explainability of AI and AI regulations, urging that companies must provide a clear statement of the purpose of the device and keep their device constrained within that remit. Another principle in the paper calls for  fairness in encouraging both the government and medical device manufacturers to ensure that AI-assisted technologies that could be used in vital life-saving surgeries are not purely reserved for the highest status or highest paying users.

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Health and Social Care Secretary, Victoria Atkins, said: “Artificial intelligence is already transforming the way we deliver healthcare, cutting waiting lists for patients and freeing up time for NHS staff.

“I want to see AI and technology harnessed as part of our plan for a faster, simpler, and fairer healthcare system. In the budget the government announced a £3.4 billion investment in the latest technology for the NHS, to help doctors and nurses focus on patients rather than admin.”

Understanding the appropriate classification for AI enabled heathcare devices has for some time been a point of concern for medical device manufacturers in the UK. In April of this year the subject took center stage among a panel small medtech firms at BioTrinity 2024.