The Therapeutic Goods Administration (TGA) is preparing to act against suppliers of AI‑powered clinical scribes after a review flagged safety concerns and regulatory non‑compliance.
TGA moves toward enforcement
During the Australian Institute of Digital Health’s HIC2026 conference in Sydney, the regulator announced plans to begin compliance action for organisations that have deployed a scribe operating as a medical device without seeking the required approval. Tracey Duffy, head of the TGA’s product quality division, said the agency is “now moving into compliance for those organisations who have deployed a scribe that’s operated as a medical device and have not sought medical device regulatory approval”.
The broader AI review concluded that Australia’s existing legislative framework is largely adequate, needing only refinements rather than new statutes. Earlier TGA notices have warned about “scope creep,” where an AI scribe that initially falls outside the definition of a medical device gains additional functions that push it into that category.
Clinical and privacy concerns
Doctors are increasingly adopting AI scribes; a recent Digital Rights Watch discussion paper estimates more than 40 percent of Australian clinicians now use such tools. These systems listen to consultations and feed the audio into large language models, similar to ChatGPT, to generate medical notes.
For practitioners, the appeal is clear: the software reduces paperwork and frees time for patient interaction, especially since Medicare reimburses only face‑to‑face encounters, not note‑taking. Yet the benefit to patients is less certain, given limited transparency about data handling and the potential for errors.
AI scribes often do more than transcribe; they summarise and interpret dialogue. Studies show that up to 20 percent of AI‑generated notes contain errors significant enough to affect diagnoses, and earlier research suggested as many as 90 percent required correction. Errors can arise from “hallucinations,” where the system fabricates statements that never occurred, or from biases linked to race, ethnicity, class and gender. For patients with limited English proficiency, misinterpretations can lead to records that diverge sharply from reality.
Clinicians find it difficult to spot these mistakes under time pressure, especially when automation bias encourages acceptance of AI output without thorough review. The result is a trade‑off: either the promised productivity gains disappear, or the health system becomes saturated with unreliable data.
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Privacy is another unresolved issue. The Australian Commission on Safety and Quality in Health Care, Ahpra and the Royal Australian College of General Practitioners have all issued guidance stressing informed consent, but they offer only high‑level information about data use. Vendors typically do not disclose how patient data is stored, who can access it, or which models are employed, leaving clinicians unable to provide concrete answers to patients.
One cautious observation: without clear accountability mechanisms, the risk of systemic data breaches grows, and any loss of patient trust could undermine broader telehealth initiatives that rely on digital record‑keeping.
Calls for stronger regulation
Digital Rights Watch argues that AI scribes should be regulated as medical devices, subject to the same safety testing as other clinical equipment. The TGA currently classifies scribes as medical devices only when they provide diagnostic advice, a narrow definition that lets many vendors avoid scrutiny.
Internationally, countries such as the United Kingdom have issued guidance on ambient voice technology, setting a benchmark that Australia’s current approach does not meet. Experts suggest that the government should require AI service providers to disclose data access details, usage policies and security safeguards, backed by enforceable penalties for violations.
Independent testing is also needed to confirm that AI systems are fair, reliable and truly improve productivity without compromising patient care.
Without such safeguards, Australian patients may lose confidence in the medical system.