Drawing a firm line under unregulated deployment, NHS England’s National Chief Clinical Information Officer Alec Price-Forbes wrote to NHS organisations earlier this month to warn them to stop using unregistered AI scribing tools.
AI scribes can be used to automate parts of the clinical documentation process for a medical practitioner, converting a conversation with a patient into a clinical note, summary, or letter that can be incorporated into the patient's health record. These tools often use ambient voice technology - combining speech recognition and AI - to record and transcribe conversations, automate note-taking, and other documentation tasks. The aim is to reduce the administrative burden on clinicians by automating note-taking and other documentation tasks, allowing them to focus more on patient care. Price-Forbes’ letter said that some ambient voice technology [AVT] suppliers have been approaching NHS organisations without having complied with basic NHS governance standards, and that all AVT solutions that generate summarisation require at least Class I - the lowest risk level and self-certifying - medical device status. NHS organisations are required to follow a series of the frameworks, rules, and best practice guidelines to ensure the safe, ethical, and lawful delivery of healthcare services, especially when technologies like AI are involved.
Citing data protection, clinical safety and governance risks, Price-Forbes said: “We are now aware of a number of AVT solutions which, despite being non-compliant... are still being widely used in clinical practice as free trials or through direct commissioning, both by individuals and organisations.”
As commentators have pointed out, the clamp down potentially strikes a blow to innovation. While there’s broad agreement that patient safety demands medical-device oversight, many in the tech sector worry that treating ambient-scribing software like traditional hardware devices will slow adoption. On LinkedIn, Rik Renard, Product Lead at Sword Health called the move “a cold shower for all the ChatGPT wrappers that rushed into the NHS thinking they could move fast in European healthcare”. He commented: “A lot of people hate the burden medical device regulation creates on healthcare innovation (me incl). But I don't see an alternative here. When you have scribes getting deeper into clinical workflows, you can't accept a cowboy wild west where half-baked tools deeply influence patient care.”
The BMA (British Medical Association) has also published advice on the use of ambient scribes in general practice. It asks GPs to consider whether they’ve carried out a clinical safety assessment and data protection impact assessment, if the product has been registered as a Class 1 medical device, and if the product advertises that it is compliant with NHS standards. The BMA warns that the adoption of passive scribes in general practice has gathered significant pace and says that while they “hold enormous potential to improve the efficiency and quality of consultations..”, they also “hold a substantial degree of risk – both in terms of information governance and patient safety”.
In the US, the FDA (Food and Drug Administration) treats AI scribes as medical device software, and this year extended its existing device‐software guidance to cover them.
The market for medical AI scribes has expanded rapidly in the last couple of years. The Financial Times says that funding for AI-driven medical note-taking apps doubled in 2024, reaching $800 million, with companies like Nabla, Corti, and Heidi emerging as leading players. And the Wall Street Journal this week reported that US startup Abridge has raised $300 million in a funding round led by venture-capital firm Andreessen Horowitz, valuing it at $5.3 billion.
