Regulators poised to strip back AI rules
Regulators are about to significantly strip back regulation of ambient voice technology (AVT) – one of the fastest-growing healthcare AI tools – HSJ has learned.
The Medicines and Healthcare products Regulatory Agency will make clear that some AVTs, also known as AI scribes, will no longer be classed as a medical device, according to several well-placed sources.
This would remove a key oversight mechanism for a rapidly developing area and a provider market that NHS leaders have likened to the Wild West.
National leaders are seeking to accelerate roll-out of the tech, which will potentially release huge amounts of medics’ time by automating entry into medical records and other admin.
Under guidance that HSJ understands is due to be published shortly by the MHRA, most suppliers would no longer need to seek medical device classification for their ambient scribes.
The regulator will stress that this is only required for AVTs with a “medical intended purpose” – effectively only advanced products which also profess to make medical diagnoses or have a therapeutic function.
The move would mark a major departure from NHS England policy over the past year.
NHSE’s national AVT registry, launched just five months ago to tackle what a national official called a “Wild West” market, requires suppliers to hold at least self-certified Class I accreditation (the lowest risk category of medical device registration).
And a year ago, NHSE warned trusts against adopting “non-compliant” AI technology, stating that tools must have at least Class I accreditation and Class IIa for enhanced “capabilities” such as “generative diagnoses, management plans or other medical referrals and calculations”.
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Source: HSJ, 29 June 2026