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, , 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.
Notes to editors
