Safe AI in General Practice: What the TGA's Scribe Review Found — and What It Means for Your Clinic

Australia's Therapeutic Goods Administration (TGA) spent twelve months engaging with AI scribe vendors, then moved to compliance action in August. On 16 October 2026 it published what that review found — and the findings land closer to your consulting rooms than you might expect. Of the twelve scribe products the TGA examined in depth, eight included functions the regulator considers likely to make them medical devices — yet not one supplier had identified its own product that way. Under the TGA's published guidance, a digital scribe that only records and transcribes a consultation is not a medical device; one that analyses or interprets — for example by generating a diagnosis or treatment recommendation the practitioner never stated — is a medical device, and must be listed on the Australian Register of Therapeutic Goods (ARTG) before it can be supplied. None of that moves responsibility away from your clinic: the regulators are blunt that the practitioner who signs the record owns its accuracy. Here is what the review found, and the six questions worth asking before any AI tool enters your practice.

When is an AI scribe a medical device in Australia?

The TGA's position is on its digital scribes page (tga.gov.au, last updated 16/10/2026). A scribe intended only to record, transcribe and translate clinical conversations into written records — without adding clinical content or suggestions the health professional never stated — is not considered a medical device. But a scribe is likely to be a medical device if it identifies, recommends or suggests diagnoses; identifies or suggests treatments or investigations; prioritises, triages or monitors patients; or generates clinical conclusions or assessments. A device in that sense must meet all relevant regulatory requirements and be included in the ARTG before it is supplied in Australia.

The TGA also warns developers about scope creep: if a software update introduces functionality with a therapeutic use, the product becomes a medical device, and the developer must either stop supplying it until it is approved and included in the ARTG, or remove the functionality that gives it a therapeutic use. That matters to practices as much as vendors: the tool you approved twelve months ago may not be the tool running in your consulting rooms today.

What the TGA's review found (published 16 October 2026)

The TGA's environmental scan identified around 100 digital scribe products potentially supplied in Australia. Forty suppliers responded to a voluntary survey, and the TGA focused its review on twelve products, weighted toward those holding the greatest market share (TGA, "Digital scribe review outcomes", 16/10/2026). Of those twelve:

• Eight included functions likely to meet the definition of a medical device — typically generative-AI features that analyse information, determine what is clinically relevant, or generate clinical conclusions or recommendations that may influence diagnosis or treatment.
• Two required additional information to determine their regulatory status.
• Two appeared unlikely to be medical devices on the available information.

Not one of the twelve suppliers had identified its own product as a medical device. And a finding the TGA stated plainly deserves quoting: some products carried statements that they were not a medical device or not intended for diagnosis or treatment, but "statements or disclaimers are not sufficient in determining if a product is, or is not, a medical device" (TGA, 16/10/2026).

Two limits on the review are worth knowing before it changes how you talk to vendors. The TGA did not test any product — it reviewed documentation, labelling, marketing material and supplied information, not safety or performance data. And it did not assess privacy or data protections; that question sits under the Privacy Act, not the Therapeutic Goods Act. What the TGA will do with the findings is set out in the same publication: updated guidance for manufacturers, continued education, and "targeted compliance activities" where scribe functionality meets the device definition (TGA, 16/10/2026) — a proportionate, risk-based program, with the TGA's product quality division head having indicated in August that compliance action could run over the following twelve months (The Medical Republic, 3–4/08/2026).

For practices, the enforcement target is the supplier, not the clinic — but the practical question lands on your desk: if a tool your practitioners use has drifted into device territory without ARTG listing, it is being supplied unlawfully, and it is your patients' consultations inside it. The review's sharpest lesson is that a vendor's own label ("administrative tool, not a medical device") is not the answer. The TGA has just demonstrated that function, not marketing language, is what counts.

The CDSS exemption changes on 1 November — what it is, factually

One piece of legislation sits underneath the scribe debate. From 1 November 2026, the exemption that lets some clinical decision support system (CDSS) software stay off the ARTG has five limbs, under the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026 (F2026L01167, registered 7/09/2026). In summary, exempt CDSS software must be a medical device that:

1. is intended by its manufacturer to make a recommendation to a health professional for the sole purpose of assisting the health professional in making a decision about preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury;
2. does not process, analyse, compress or decompress a medical image or signal from another medical device;
3. does not replace the clinical judgement of a health professional in making a diagnosis or treatment decision;
4. is not intended to make a clinical diagnosis or treatment decision itself (including in vitro diagnostic software); and
5. displays the clinical practice guidelines, calculations or logic it used, in a way that lets a health professional readily interpret and verify any recommendations while using the software.

Software must meet all five limbs to qualify. The TGA frames the amendments as clarification, not expansion: they "do not change the scope of the CDSS exemption or introduce new regulatory requirements" (TGA news, 8/09/2026). This article is a factual summary, not legal advice — whether any specific product qualifies is a question for the vendor, and for your medical defence organisation if the answer is unclear.

When output goes unchecked, the review step is what fails

The ABC reported on 14 August 2026 that a patient discovered her specialist's post-operative letter to her GP contained a fabricated claim — that she used illegal drugs, something she had never disclosed or done. The letter had been generated with an AI scribe and sent on without anyone checking it. The same reporting cited other documented errors, including a scribe recording the wrong breast in a breast cancer diagnosis, and epilepsy recorded for a patient who did not have it (ABC, 14/08/2026, citing a Digital Rights Watch report).

The clinical lesson is not that transcription technology is hopeless: in every one of these cases the safeguard was the same — a human reading the output before it was relied on. In the reported case, that step was skipped. The TGA's review makes the category clearer but also larger than "a dozen products": around 100 scribes are potentially supplied in Australia (TGA, 16/10/2026). Regulation of the category is still settling. The review step is what stands between a rough draft and a patient's permanent record.

Your professional obligations haven't changed

Three regulators have now said versions of the same thing.

Ahpra's guidance for practitioners using AI in healthcare (ahpra.gov.au, page reviewed 22/08/2024) holds that the practitioner remains responsible for safe, quality care regardless of the tool: apply human judgment to AI output, obtain informed consent and note the patient's response, check the accuracy of AI-scribed records, and understand where the data goes — including whether it is used to train models. The guidance is updated regularly, so re-read it before finalising a practice policy.

The RACGP's AI scribes fact sheet (page last updated 29/06/2026) is the practice-side checklist: obtain patient consent before use, know where data is stored, review vendor terms and conditions for secondary use of patient information, and — its clearest line — the output of an AI scribe must be carefully checked by the GP using it, who remains responsible for the accuracy of the health record. The RACGP also recommends independent legal advice or a conversation with your medical defence organisation before signing anything.

The Department of Health, Disability and Ageing has weighed in too, warning in a freedom-of-information release reported by Guardian Australia (05/07/2026) that AI scribes have "little oversight", that data may be stored offshore with limited transparency, and that consent practices vary widely. The department was pointed about marketing, noting vendors advertising "30% revenue increase" claims to health professionals. Its position on consent is the useful one: informed consent means patients understand both the benefits and the limitations of the tool.

Six questions to ask before an AI tool enters your clinic

These condense the guidance above into a checklist a practice manager can run this week:

1. What does the tool actually do — transcribe, or interpret? The TGA's review found eight of twelve scribes performing functions that likely make them medical devices, despite vendors' own labels (TGA, 16/10/2026). Don't ask whether the vendor calls it a medical device; ask which of the TGA's device functions — suggesting diagnoses, triaging, generating clinical conclusions — their product performs, and how they know.
2. How is patient consent obtained and recorded? Not a poster in the waiting room — a documented response per patient, noted in the record (Ahpra, reviewed 22/08/2024).
3. Where is the data stored, and is it used to train models? Including whether anything leaves Australia (DoHDA via Guardian, 05/07/2026; Ahpra). Note the TGA's review did not assess privacy at all — this one is on you.
4. What do the vendor's terms say about secondary use? Read them before signing, not after (RACGP fact sheet, updated June 2026).
5. Who reviews the output, every time — and how is that enforced? The ABC's reported case was a review step that quietly disappeared. Decide who signs off, and make it visible in the workflow.
6. What AI tools is the practice actually running? Keep a simple inventory: tool, vendor, what it does, where data goes, date last checked. When an update ships — the exact mechanism the TGA warns about — the inventory tells you what to re-ask.

Where accreditation is heading

The RACGP Standards for general practices 6th edition were released in 2026 with greater emphasis on clinical governance and digital health technologies, including AI (AGPAL, 26/08/2026). Practices are not assessed against it yet: accreditation under the National General Practice Accreditation Scheme continues against the 5th edition, and transition arrangements — including timing — have not been published, so treat any claimed transition date with caution and check the current position before acting on it.

The AI-tool inventory is the piece a practice can usefully do now. It answers today's questions and it is exactly the evidence a governance-focused edition of the Standards will want to see. Building it early turns a future compliance exercise into a habit.

How ClinicIQ draws the line

The TGA's findings are the case for how we build. Docsert AI structures documents from data the clinician supplies — templates plus the clinician's own content. It does not generate clinical content, and it does not diagnose, interpret or recommend; the clinician reviews, edits and approves every output before it goes anywhere. We describe the design plainly and let you judge it against the TGA's published line, because the review showed that a vendor's label of its own product is worth little — function is what counts, and the functions to inspect are the ones the TGA lists.

Our wider position is the one the regulators describe. ClinicIQ's tools are built by a registered nurse to fit the systems Australian practices already run on, and where a tool could change clinical workflow, we would rather it was piloted than imposed — talk to us about testing it in a live clinic before committing practice-wide.

Get the inventory done while the compliance program warms up

The TGA's review moved into compliance action in August, and its published outcomes commit to targeted compliance activities where scribe functionality meets the device definition (TGA, 16/10/2026) — which makes this a reasonable week to document what is running in your practice. Our free Accreditation Readiness Checklist includes the governance domains where an AI-tool inventory earns its keep, and we include a review of that inventory — against the six questions above — in our fixed-price accreditation-readiness assessment. Book a readiness assessment to get a date in the calendar — and if you are at GP26 in Adelaide (20–22 November), it is the same conversation in person.

This article is general information for Australian GP practices, not legal or regulatory advice. Regulator pages and legislation change — confirm against the current TGA guidance, the therapeutic goods legislation and your medical defence organisation's advice before acting. Patient care decisions remain the responsibility of the treating practitioner.