The Medicines and Healthcare products Regulatory Agency (MHRA) is updating regulations applying to software and artificial intelligence (AI) as a medical device.
These measures are described by the Government as a demonstration of "the UK’s commitment, following our exit from the European Union, to drive innovation in healthcare and improve patient outcomes."
The fast-developing field of software and artificial intelligence (AI) as a medical device has an increasingly prominent role within health systems with applications of AI ranging from screening, to diagnosis, to treatment, and to management of chronic conditions.
Regulatory measures will now be updated to take account of these technological advances, and the MHRA has developed anextensive work programmeto inform regulatory changes including key reforms across the software as a medical device lifecycle, from qualification to classification, to requirements that apply pre and post-market.
"This announcement of an exciting step change in the regulatory approach in this fast moving area underpins the MHRA’s commitment to support responsible innovation that champions patient safety," said Graeme Tunbridge, Director of Devices at MHRA. "We will continue to evolve our regulations and guidance to respond to this fast-paced field and carry out further research into how best to manage the challenges posed by artificial intelligence as a medical device.
MHRA will consider challenges and opportunities posed by AI as a medical device, ensuring these devices are appropriately evidenced and address issues of human interpretability (lack of transparency of AI) and adaptivity (retraining of AI models).
In a separate announcement, BEIS is granting MHRA £194,000 from the Regulatory Pioneers Fund to support further research into how adaptive AI algorithms in medical devices ‘change’ and how to regulate their decisions.
James is the Editor of GovX Digital, and has been covering digital government and public sector reform for 20 years. He also oversees the development of the agenda for the UK's biggest public sector transformation conference.