The Medicines and Healthcare products Regulatory Agency (MHRA) has published its strategic approach to artificial intelligence (AI) which aims to ensure patient safety and industry innovation into 2030.
The MHRA welcomed the publication of the Government’s white paper ‘A pro-innovation approach to AI regulation’, published in 2023, and have 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.
The MHRA was asked to provide a strategic, independent view of the agency’s 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 this white paper. The document, titled: ‘Impact of AI on the regulation of medical products Implementing the AI White Paper principles’, was published on 30 April.
As a science-led organisation, the MHRA has a key role to play in enabling the achievement of the goal for the UK to be a science and technology superpower by 2030, and is considering the opportunities and risks of AI from three perspectives:
- as a regulator of AI products
- as a public service organisation delivering time-critical decisions
- as an organisation that makes evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties.
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. 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.”
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.
In the coming years AI is likely to be integral to ensuring effective product regulation and patient safety, and therefore measuring and understanding its impact is essential for the agency to remain an effective and innovative regulator.
