Tougher UK penalties proposed for AI health firms over safety breaches
Artificial Intelligence healthcare firms could face tougher penalties in the UK for falling short of safety rules under calls for greater regulation of the technology.
The measure is among 44 recommendations published by an independent commission established by the Medicines and Healthcare Products Regulatory Agency, MHRA, amid the technology's increasing use.
Under the proposed changes, the MHRA could impose financial penalties on manufacturers that fail to comply with legal requirements and put patients at risk.
It could also see early warnings about potential safety issues with devices shared more quickly among healthcare providers and the general public.
Stronger oversight was also recommended to ensure laws and guidelines keep pace with the evolving technology.
Patients should be informed about the use of AI in their care and given the ability to opt out "where possible or appropriate", the commission said.
Under the proposals, newer AI models could be rolled out under "tight guardrails" through a staged authorisation process likened to L-plates.
Meanwhile, medical devices assisted by the technology would be subject to "continuous" monitoring, rather than checks at regular intervals.
Meanwhile, working group chair and DeepMind Professor of Machine Learning at the University of Cambridge Professor Neil Lawrence said generative AI "is not like other medical technologies we've regulated before".
"It can behave differently in different circumstances, and it can evolve after its initial deployment," he said.
"That means we can't rely on a single point of approval and assume the job is done."
The recommendations were drawn up following feedback from 12,000 people, including patients, healthcare professionals and AI developers.
Deputy chair of the National Commission Deputy chair of the National Commission Professor Henrietta Hughes said patients wanted to know "when it's used, that it supports rather than replaces clinicians".
By Jessica Coates, Press Association
Press Association: News
source: PA
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