MHRA’s AI regulatory strategy ensures patient safety and industry innovation into 2030

The MHRA has today set out its strategic approach to artificial intelligence (AI)

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (30 April 2024) set out its strategic approach to artificial intelligence (AI).

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.

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.

"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."

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

"I am pleased that MHRA has set out these principles, which will help ensure that AI continues to be used in a safe, secure, and transparent way across the health service."

The potential benefits are two-fold: improved efficiencies will result in UK patients benefiting from enabling safe access to medical products earlier than may have been possible previously, while the MHRA will have greater scope to focus specialist expertise on priorities such as innovation and patient engagement.

At the same time, there is a fundamental requirement for all regulatory decisions to be based on robust evidence. The MHRA process of considering submissions, premises inspections and data examination is reliant on this evidence and as a regulator we expect these processes and protocols to evolve in line with innovative AI.

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.

From: Medicines and Healthcare products Regulatory Agency