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Regulation of AI scribes in clinical practice

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Lara Shemtob, Azeem Majeed, Thomas Beaney , 2025-06-20 09:36:00

  1. Lara Shemtob, general practitioner1,
  2. Azeem Majeed, professor of primary care and public health1,
  3. Thomas Beaney, clinical researcher2
  1. 1Department of Primary Care and Public Health, Imperial College London, London, UK
  2. 2George Institute for Global Health, Imperial College London, London, UK
  1. Correspondence to: L Shemtob lara.shemtob{at}nhs.net

Defining responsibilities for clinical information

Over 100 AI scribe products are being marketed to healthcare services internationally.1234 Industry predictions speculate that up to 30% of healthcare providers will be using some form of AI scribe technology by the end of 2025.5 AI scribes transcribe clinical consultations in real time, producing condensed notes that can be entered into electronic health records.678 They can improve efficiency by reducing time spent writing notes and freeing up physician time for patient facing care. Although some research suggests that transcription tools may reduce documentation time by only one minute per contact, users benefit from a reduction in perceived workload.9 The developers of one tool report larger time savings of at least 90 minutes a day for general practitioners.10

Some companies are adding AI scribes to their existing toolkits for healthcare, available to hundreds of thousands of users in the NHS alone.11 Given this roll out, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and NHS England have released guidance in 2025.1213

The new regulatory classification of AI scribes as “software as a medical device” puts the status …

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