MHRA sets out strategic approach to AI

The Medicines and Healthcare products Regulatory Agency (MHRA) set out its strategic approach to artificial intelligence (AI) on 30 April.

(c) Igor Omilaev/Unsplash

(c) Igor Omilaev/Unsplash

The move followed publication of its the government's white paper ‘A pro-innovation approach to AI regulation' in 2023.

As part of its role in enabling the UK to be a science and technology superpower by 2030, the MHRA was asked to provide a strategic, independent view of its approach to AI in the field of medicine and science and the steps the organisation is taking in line with the expectations set out in the white paper.

The MHRA considered the opportunities and risks of AI from three perspectives: as a regulator of AI products; as a public service organisation delivering time-critical decisions; and as an organisation that makes evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties.

The agency's strategy recommendation are based on five key strategic principles encompassing: safety, security and robustness; appropriate transparency and explainability; fairness, accountability and governance; and contestability and redress.

Dr Laura Squire, chief quality and access officer at the MHRA, said: 'AI offers us the opportunity to improve the efficiency of the services we provide across all our regulatory functions from regulatory science, through enabling safe access for medicines and medical devices, to post market surveillance and enforcement.'

The MHRA is currently in the process of implementing its own regulatory reform programme related to AI-driven medical devices to include risk proportionate regulation of AI as a medical device (AIaMD). This considers the risks of these products while permitting scope for further development of transformative healthcare.

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 its Spring Budget, the government announced a £3.4bn investment in its budget for the latest technology for the NHS, to help doctors and nurses focus on patients rather than admin.

 

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