Regulator ‘missing many AI incidents’

Safety concerns linked to AI voice tech are not being properly reported because many providers are unaware of the regulation system or too busy to use it, experts have told HSJ.

The Medicine and Healthcare products Regulatory Authority is responsible for ensuring ambient voice technology products, in which the NHS is about to invest heavily, are safe.

Data shared with HSJ showed there had only been five reports under the regulator’s “yellow card” system covering the 12 months to the beginning of May.

The regulator said the five reports covered “a range of issues relating to the system capturing incorrect information; file save errors; and concerns relating to patient consent of use of the product”.

However, experts said five reports was fewer than they would have expected, considering AVT systems are already being used widely in primary care, and in secondary care under what providers are describing as pilots.

HSJ checked each of the 23 AVT providers registered with NHSE against the MHRA’s “yellow card” reporting website, and only three were recognised.

An MHRA spokesperson said in this case, complainants could fill out a separate form. However, after being asked by HSJ about the missing 20, the regulator said it had now added all of them.

But Hugh Harvey, founder of healthtech consultancy Hardian Health, told HSJ: “The yellow card system is the recommended way for users to report issues with medical devices, but it is currently underused, partly due to a lack of awareness, and partly due to the friction involved in doing so.”

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Source: HSJ, 26 May 2026