The addition of generative AI features to scribes used during medical consultations has turned them from passive transcription tools into medical devices requiring regulation, the Therapeutic Goods Administration (TGA) has found after a review of 12 popular AI tools.
The TGA, which maintains the Australian Register of Therapeutic Goods (ARTG) that lists all therapeutic products approved for sale in Australia, undertook a review of the tools over concerns that their expanding feature sets were taking some products out of their lanes.
It identified around 100 suppliers of digital scribes in Australia and sent them a voluntary survey that received 40 responses, then focused on the 12 most widely used AI scribes, from companies including Heidi, Lyrebird, Microsoft, Abby Health, VoiceBox, iMedX, and more.
Eight of the 12 products “included functions likely to meet the definition of a medical device,” the TGA concluded, with two others requiring “additional information to determine their regulatory status” and just two considered “unlikely to be medical devices.”
“Many of these products were originally designed and marketed to support transcription, documentation and administrative tasks,” the agency noted in publishing its review, which found many vendors “may not have previously considered” regulatory requirements.
Those requirements will be increasingly prominent as AI scribes expand their reach – with platforms increasingly adding features that record consultations as voice or video and generate clinical notes and recommendations after analysing the information.
Many of the tools the TGA examined “included functions likely to meet the definition of a medical device,” the agency said, adding that some suppliers “may not have previously considered” that they might need to be approved by and registered with authorities.
Tracing the fine line between assistant and advisor
The TGA has also published guidelines to clarify when AI scribes should be considered regulatable medical devices – a standard that is met when scribes “diagnose, monitor, predict, provide a prognosis, treat, alleviate or compensate for a disease, injury or disability.”
An AI scribe is likely to cross the threshold, the guidelines note, if it “identifies, recommends or suggests” diagnoses, treatments or investigations; prioritises, triages or monitors patients; or generates clinical conclusions or assessments.
When genAI processes that information and correlates it against external sources, it found, such products “analyse information and generate outputs that may influence clinical decisions” – making them clinical decision support systems (CDSS) that must be registered.
“Where software generates clinical recommendations, conclusions or other patient-specific outputs that support clinical decision-making, those functions must be designed, validated and supported with appropriate safeguards,” the TGA found.
“When digital scribes make diagnostic or treatment recommendations, it may not always be clear how information has been selected, prioritised or generated,” it said, noting that “this makes it difficult for users to understand the basis of the output and assess its reliability.”
Not all CDSS tools must be registered on the ARTG “but are still regulated medical devices that must comply with regulatory requirements,” the TGA added, noting that “to be exempt, the scribe cannot analyse information that came from another medical device and must display details of how the recommendation was generated.”
Privacy breach or invaluable clinical tool?
The TGA’s review caps off a year of intensifying investigations into the sector, which has seen strong adoption of the tools by time-pressured clinicians despite concerns from some patients that they violate privacy or are being foisted on unsuspecting and unwilling participants.
Makers of AI scribes continue to classify them as administrative tools rather than medical devices – as the TGA guidance bites, experts also advise doctors to more actively consider how they use the tools, reshaping their consultations and dictations accordingly.
One review, for example, found AI scribes actually perform three different functions and warned that “the field should stop accepting AI documentation as one undifferentiated category.”
Moving forward, the TGA will use its findings to shape its formal regulatory approach – including clarifying when the scribes can claim a conditional exemption as CDSS software, clarifying education and guidance, and running “targeted compliance activities” for the sector.
That sector continues to explode as scribes – whose adoption by GPs grew from 22 per cent in a 2024 survey to 40 per cent by the end of 2025 – become further normalised in clinical settings, with vendors planning to further expand their capabilities as AI improves.
Australia-based segment leader Heidi, for one, recently raised $480 million (US$340 million) in funding to expand its widely used transcription tool into an agentic “care partner.”
The firm is transitioning “from documenting care to helping clinicians act on it,” co-founder and CEO Dr Thomas Kelly noted, adding that “the ambition was always bigger than writing doctor’s notes.”
“I imagined that AI would sit alongside clinicians and complete real work under their supervision.”
