MHRA publishes its strategic approach to AI

The Medicines and Healthcare products Regulatory Agency (MHRA) has set out its strategic approach to artificial intelligence (AI) in a new publication, available from here.

Following publication of the UK Government’s white paper ‘A pro-innovation approach to AI regulation’, in 2023, the MHRA reports it has “taken significant steps in the past 12 months to adopt its recommendations in the work we do based on five key strategic principles.”

These principles encompass safety, security and robustness; appropriate transparency and explainability; fairness, accountability and governance; and contestability and redress, according to a press release dated 30 April 2024.

Dr Laura Squire, Chief Quality and Access Officer at the MHRA, said: “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.”