MHRA sets out its AI strategy

The Medicines and Healthcare products Regulatory Agency (MHRA) has set out its strategic approach to AI.

Following the Government’s white paper 'A pro-innovation approach to AI regulation' the MHRA have taken steps in the past year to adopt its recommendations 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.

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.”

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 of the government 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

The potential benefits are twofold: 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 they expect these processes and protocols to evolve in line with AI innovation to remain an effective regulator.

Victoria Atkins, Health and Social Care Secretary, 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 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.