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MHRA outlines strategic approach to AI regulation in healthcare for patient safety


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MHRA’s strategic principles aim to foster innovation while upholding rigorous standards of patient safety and regulatory integrity

In a recent announcement the Medicines and Healthcare products Regulatory Agency (MHRA) unveiled its strategic approach to artificial intelligence (AI), as it sets out to embrace the transformative potential of AI in healthcare regulation.

Building upon the Government’s white paper ‘A pro-innovation approach to AI regulation’, released in 2023, the MHRA outlined five key strategic principles guiding its adoption of AI.

These principles encompass safety, security, and robustness; appropriate transparency and explainability; fairness, accountability, and governance; and contestability and redress.

A science-led organization, the MHRA was tasked with providing an independent view of its approach to AI in medicine and science, aligning with a government white paper.

Recognising its role in UK’s goal to be a science and tech leader by 2030, MHRA is tasked to evaluate AI’s opportunities and risks across regulatory, public service, and evidence-based decision-making area.

Dr. Laura Squire, Chief Quality and Access Officer at the MHRA, emphasised the agency’s commitment to leveraging AI to enhance regulatory efficiency while ensuring proportional risk management.

Squire said, “AI offers us the opportunity to improve the efficiency of the services we provide across all our regulatory functions, through enabling safe access for medicines and medical devices, to post market surveillance and enforcement.”

“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.”

Health and Social Care Secretary, Victoria Atkins, echoed Dr. Squire’s sentiments, highlighting the potential of AI to revolutionise healthcare delivery as AI “is already transforming the way we deliver healthcare, cutting waiting lists for patients and freeing up time for NHS staff.”

Atkins emphasised the importance of harnessing technology to create a faster, simpler, and fairer healthcare system as  in recent announcement the government has allocated “a £3.4 billion investment in the latest technology for the NHS, to help doctors and nurses focus on patients rather than admin.”

She praised the MHRA’s principles as essential in ensuring the safe and transparent integration of AI across the health service.

The MHRA’s approach reflects a dual focus on innovation and patient safety, aiming to fast-track access to medical products while maintaining rigorous regulatory standards.

The agency’s ongoing regulatory reform program includes risk proportionate regulation of AI as a medical device (AIaMD), recognising the need for flexible regulation to accommodate evolving technology “as in the coming years AI is likely to be integral to ensuring effective product regulation and patient safety.”


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