Doctors need better guidance on AI scribes

The review by the Therapeutic Goods Administration, which focused on 12 specific products, found many now include generative AI-enabled features, some of which may require regulation as medical devices.

While two thirds of the products looked at included functions likely to meet the definition of a medical device, the TGA has not named those products.

When asked for clarification on which products this included, the medicines regulator said the review “was not an assessment of the safety or performance of individual products”.

This is despite the TGA in July telling Medical Forum the review had been looking at public information and materials provided by developers to confirm if individual digital scribe products were medical devices.

An expert in AI has warned the TGA not to put the onus on doctors to identify whether a digital scribe might cross over into being a medical device.

Transcription or more than that?

In Australia, if an AI scribe is used for transcribing and summarising a conversation, it is treated as a regular administrative tool and not regulated by the TGA.

However, where an AI tool is used beyond that for analysing or interpretation, such as providing diagnoses or prognoses, it may be considered a medical device and would have to comply with regulatory frameworks, including being listed on the Australian Register of Therapeutic Goods (ARTG).

The review found digital scribe developers and deployers were determining their products were administrative tools and not medical devices, and as a result did not include their product in the ARTG.

The TGA told Medical Forum the review was “undertaken to better understand digital scribe products available in Australia, assess whether particular functions may meet the definition of a medical device, and improve awareness of regulatory obligations”.

It looked at product documentation, labelling, marketing material and descriptions of product functionality and intended purpose.

“The review was not an assessment of the safety or performance of individual products, nor did it assess detailed compliance with medical device regulatory requirements,” the spokesperson said.

“The TGA has not disclosed which specific digital scribes included functions likely to meet the definition of a medical device, as further follow up with suppliers of these devices is ongoing.”

Some of the digital scribe products looked at hold the greatest market share in Australia. The TGA confirmed it is working with the suppliers to determine the regulatory status of particular features, and what options were available.

“The TGA does not intend to publish product-specific findings in relation to the digital scribe review at this time but will continue to manage compliance matters in accordance with our regulatory compliance framework.” 

As part of the review, the TGA updated its digital scribe guidance for manufacturers, suppliers, developers, clinicians and patients to outline when digital scribes may be regulated as medical devices and the obligations that may apply.

The guidance suggests health professionals should regularly assess whether any AI software is appropriate and compliant by considering whether its "intended purpose meets the definition of a medical device" and if so, whether it is included in the ARTG or exempt.

A November 2025 survey carried out by the RACGP found 40% of GP respondents were using AI scribes and that number is likely to have increased in the past year.  

A 'seismic shift'

Alex Jenkins, director of the WA Data Science Innovation Hub at Curtin University, said he was not surprised such technology had become commonplace for doctors, given the potential to save administrative work.

“These services are now evolving, such that they are essentially providing interpretation of medical facts, and I suppose that is an inevitable progression of the tool,” he said.

He said what might look like a minor functionality increase could now be playing an active role in medical treatment, adding that there was potential for issues to arise if doctors used digital scribes that went beyond transcription.

"That is a seismic shift from a regulatory perspective," Mr Jenkins said.

“All AI services that use large language models are subject to the chance of hallucination.”

AI hallucination is a response generated that contains false, misleading, or completely fabricated information, yet is presented as a confident and factual statement.

“I'm not familiar with the particular products and how they manage the risk of hallucination, but this is a shift away from a medical scribe being an aide to a doctor's administrative workflow to now becoming a function that's participating in the in the provision of healthcare," he said.

Mr Jenkins called on the TGA to clearly lay out how these services would be tested in the future and for doctors to be given greater guidance around which AI scribe products may be considered medical devices, so they could make informed decisions about the technology they use.

“It should not be up to the doctor to make that distinction," he said.

“If the TGA are not going to come out and say which scribes are considered to be acting as medical devices, that that makes it very difficult for doctors.

“My call would be for the TGA to very clearly lay this out and not leave it up to a legal precedent, because if we're talking about technology that is potentially identifying, recommending, or suggesting a diagnosis or putting forward a treatment, that is a significant shift in the use of AI for healthcare consumers.

“I think that the TGA must be proactive with that kind of advice, and it's not a good idea to leave it up to a legal precedent, because it is an enormous grey area otherwise."