TGA Regulation and AI Scribes
TGA Regulation and AI Scribes
The Therapeutic Goods Administration published guidance on digital scribes in August 2025, consolidating a regulatory position that had been developing across 2024 and 2025. The TGA's digital scribes guidance page addresses when a digital scribe is regulated as a medical device under the Therapeutic Goods Act 1989, what responsibilities apply when it is, and what practices and clinicians should understand about the products they are using.
This article summarises the TGA position, identifies the practical implications for Australian practices, and covers the questions worth asking any vendor before contracting.
The TGA Position in Summary
The core distinction in the guidance is between scribes that transcribe and scribes that interpret. A digital scribe intended only to transcribe or translate clinical conversations into written records, without performing analysis or interpretation, is not considered a medical device. These products do not have a therapeutic use under the Therapeutic Goods Act 1989.
A digital scribe that analyses or interprets the conversation and generates a diagnosis, differential diagnosis, or treatment recommendation not explicitly stated by the healthcare practitioner is considered a medical device. Such products must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.
The TGA has also flagged that digital scribes that meet the medical device definition but are not ARTG-listed are being supplied illegally, and has indicated enforcement action against non-compliant suppliers. This is a meaningful shift in posture. The regulatory environment is no longer advisory. Suppliers who develop features that cross the threshold from transcription into interpretation without updating their regulatory status carry material compliance risk, which ultimately flows through to the practices using their products.
Alongside the core classification, the TGA guidance identifies specific responsibilities for safe and appropriate use.
Informed consent. Healthcare professionals must tell patients when they plan to use a digital scribe and provide sufficient information for informed consent.
Consumer rights in relation to personal information. Patients have a right to know what the scribe does and how it affects their privacy.
Review of software updates. Developers must regularly assess whether changes to their product affect its intended purpose. If updates introduce functionality with a therapeutic use, the product becomes a medical device and must either cease supply until ARTG-listed or remove the functionality.
Reporting of safety concerns. The TGA encourages reporting of any concerns about non-compliance or questionable practices using its dedicated form.
How the Framework Interacts With Other Regulation
The TGA's digital scribes guidance does not operate in isolation. The TGA page explicitly references that digital scribes in Australian healthcare may also need to comply with other frameworks.
The Privacy Act 1988 and Australian Privacy Principles, administered by the OAIC. APP 8 covers cross-border disclosure, which applies when data is processed offshore.
OAIC guidance on privacy and the use of commercially available AI products, which applies to AI scribe deployment.
The AHPRA shared Code of conduct and AHPRA AI in healthcare guidance, which set professional expectations for practitioners using AI tools.
The Medical Board of Australia's Good medical practice code of conduct, which covers informed consent and record-keeping generally.
The Australian Commission on Safety and Quality in Health Care's Pragmatic AI guidance for clinicians, referenced directly by the TGA.
Together, these form the regulatory perimeter inside which AI scribes operate in Australia.
Practical Implications for Australian Practices
Three implications follow from the TGA position and apply regardless of which scribe the practice uses.
Documentation scribes and clinical decision support tools are now distinct regulatory categories. A vendor offering a single product that performs both functions needs to be clear about which side of the line the product sits on, and whether it is ARTG-listed if applicable. Products with marketing or feature material that blurs the distinction warrant additional due diligence before contracting.
Vendor due diligence questions have expanded. Asking a vendor explicitly whether the product generates diagnostic or treatment recommendations not stated by the clinician, and whether the product is listed on the ARTG if so, is now a reasonable and advisable step in procurement. Avant's guidance on AI for medical documentation reinforces this, identifying regulatory oversight as one of the material risks clinicians should evaluate.
The clinician's role as the source of clinical judgment is made explicit in the regulatory position. The clinician remains responsible for diagnosis and clinical decisions. The scribe produces documentation. This was already the case under general professional standards, and the TGA position now provides a formal basis for it.
Where Lyrebird Sits Under the Framework
Lyrebird is a documentation tool. It transcribes the consult, drafts a clinical note in the format the clinician uses, and writes that note back to the EMR through integrations such as the Best Practice integration. It does not generate diagnostic or treatment suggestions that were not stated in the consult. The clinician remains the source of clinical reasoning.
This positioning is deliberate, and reflects the product design rather than being a concession to the August 2025 guidance. A documentation tool that does not extend into clinical reasoning is simpler to deploy, simpler to audit, more straightforward to explain in a patient consent conversation, and sits clearly outside the medical device definition under the Therapeutic Goods Act 1989. The Lyrebird compliance page tracks the current Australian regulatory position.
Questions Worth Asking a Vendor
Six questions cover the material points under the TGA framework.
- Does the product generate diagnostic or treatment recommendations that the clinician did not state in the consult, and if so, is the product listed on the ARTG? A product that makes unstated clinical suggestions and is not ARTG-listed is a regulatory risk for the vendor and for the practice that uses it.
- Where is patient data processed and stored? Australian processing and storage removes the APP 8 offshore-transfer disclosure requirement from each consent conversation.
- Is the product's training data derived from customer patient conversations? Most paid products do not train on customer data, but written confirmation is reasonable to request.
- What is the software update policy, and how are practices notified of changes that could affect clinical behaviour? The TGA specifically identifies update review as a responsibility under its guidance. If a scribe adds features that cross the threshold into therapeutic use, the practice needs to know.
- How is consent recorded, and what audit trail is produced? Per-consult, timestamped, exportable consent logging is the standard to look for. See the patient consent guide for the full framework.
- What is the process for reporting a safety concern, and what response time applies? The TGA guidance identifies safety reporting as a practitioner responsibility. A vendor with a clear channel and stated response time is easier to work with if an issue arises.
For a related practical checklist, see Evaluating Ambient Documentation Vendors and The 2026 Clinician's Checklist for Safe AI Use.
Questions Worth Asking Within the Practice
Three internal questions reflect the TGA's framing of practice-level responsibility.
- Is there a documented practice position on AI scribe use, covering which scribe is used, what consent is obtained, and how notes are reviewed? This is useful for consistency across clinicians and for responding to MDO or auditor queries. It also aligns with the NSQHS Clinical Governance Standard's expectation of documented clinical governance around new technologies.
- Would the practice be able to produce evidence of patient consent on a per-consult basis, not just in aggregate? This is the standard that MDO queries and audits increasingly expect.
- Is there a mechanism for identifying scribe-related errors? A light quality assurance loop, identified in the GCHHS evaluation as one of the factors separating successful deployments, makes issues visible early.
What Is Likely To Develop Next
The TGA has indicated that the regulation of software-based medical devices, including digital scribes, will continue to evolve. Reforms implemented from 25 February 2021 onwards reshaped software as a medical device (SaMD) regulation significantly, and further guidance iterations are likely over 2026 and 2027. The TGA's broader guidance on software-based medical devices is the authoritative ongoing reference.
Practices are not expected to monitor this closely. Vendors are. A vendor engaging proactively with the TGA is a materially safer long-term partner than one that is not. The Lyrebird compliance page tracks the current Australian regulatory position specifically for Lyrebird customers.
Next Steps
To trial Lyrebird directly, book a demo. Lyrebird Free is available for free to Best Practice clinics.
