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

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.