Issue 5

This week: the MHRA says a scribe that only transcribes is not a medical device and Healthwatch says patients are the ones catching its errors, a GP builds a telemedicine platform in four evenings, and four new names join the directory.

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Not a device, says the regulator; patients are catching the errors, says the watchdog. Healthwatch England, the statutory patient champion for the NHS, told the Guardian on 31 August that it has heard "multiple stories from patients who have noticed these errors when a health professional hasn't": a scribe summary that turned an MRI result of "null demyelination" into demyelination, a prescribed drug swapped for one with a similar name, a summary letter that dropped a consultant's instruction to get a repeat migraine prescription from the GP. In every case the patient, not the clinician, caught it; 27 different scribes are already in use in English general practice and hospitals. The regulatory line had been drawn five weeks earlier: on 29 July the MHRA, with NHS England, confirmed that ambient voice technology "intended solely for transcription, summarising of clinical conversations, drafting letters, or suggesting clinical codes for a clinician to review" is not regulated as a medical device in Great Britain, while a product that supports diagnosis, treatment or prevention, or takes automated action such as placing orders without clinician review, is. Healthwatch finds that "worrying". The MHRA's own text puts the weight where it always was: clinicians remain responsible for "reviewing and verifying AI generated transcripts, summaries and other outputs before they are used in patient care", a responsibility that "is unchanged by the guidance". If you are building a scribe, or bolting one onto a workflow: transcription-only keeps you out of device regulation, and every uncaught error goes into the record under your name. The moment your tool suggests a diagnosis, a dose or an order, it is a device. The Guardian