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In February 2024 the Secretary of State for DSIT (the Department for Science, Innovation and Technology) wrote to several regulators, including the MHRA (Medicines and Healthcare Products Regulatory Agency), requesting the publication of their respective strategic approaches to artificial intelligence by 30 April 2024.
The approach set out by MHRA on 30 April is aligned to the government’s AI White Paper’s five principles; safety, security and robustness; appropriate transparency and explainability; fairness; accountability and governance; and contestability and redress.
The MHRA has reaffirmed that the current Medical Devices Regulations from 2002 still stand, and that where artificial intelligence is adopted for use as a medical device it must conform to these requirements across a product’s whole lifecycle. The organisation also highlights the legal obligations for manufacturers in terms of their responsibility and accountability to mitigate risks and address product safety and performance.
The MHRA’s strategic approach to AI includes a variety of new updates, including:
The strategic approach to AI publication also states there are currently “approximately three full-time equivalent employees” working on workstreams in relation to the use of AI as a medical device, and that this is expected to rise over the next 12 months to approximately 7.5 full-time employees through the £10 million governmental funding provided to MHRA as part of the government’s response to AI regulation.
Looking inward to the MHRA’s own operations as an organisation, the MHRA’s strategic approach to AI notes there are approximately 15 full-time staff working on the organisation’s approach to expanding and optimising AI in the delivery of regulatory services. The publication also several further organisational updates, including:
Clara joined techUK in October 2023. She brings experience across a range of domestic and global health issues, with particular focus on digital health, HIV/AIDS and climate change and health.
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