When a digital scribe becomes a medical device: Where the TGA draws the line

1 September 2025

When a digital scribe becomes a medical device: Where the TGA draws the line

Artificial intelligence is already changing the way healthcare is delivered, but some of the most visible shifts are happening not in diagnosis or treatment, but in documentation. Digital scribes—software tools that listen to patient consultations and generate notes or summaries—are becoming more common in clinics and hospitals. For busy clinicians, they promise to save time, reduce paperwork and improve accuracy. But with these benefits comes a question: when does a digital scribe cross the line from helpful tool to regulated medical device?

The Therapeutic Goods Administration (TGA) has released new guidance to help answer exactly that. Under Australia’s Therapeutic Goods Act, digital scribes are regulated as medical devices if they have a therapeutic purpose—such as diagnosing, monitoring or recommending treatment. That means not every digital scribe is created equal. Software that simply transcribes conversations or produces summaries without analysis does not meet the definition of a medical device. But if the same system goes further—by generating a diagnosis, differential diagnosis or treatment recommendation that wasn’t explicitly stated by the practitioner—it falls squarely into medical device territory.

That distinction matters. Digital scribes deemed medical devices must be approved and listed on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied. They must meet all regulatory requirements around safety, quality and performance. Supplying one without approval is illegal, and the TGA has signalled it will take compliance action against products that overstep their claims.

For developers, this means ongoing vigilance. Software updates can change the intended purpose of a product, shifting it from a simple transcription tool into a regulated device. The TGA expects developers to continually assess whether their products remain compliant, and to pause or adjust distribution if new features move them into medical device classification. For healthcare professionals, it means checking whether the tools they use are appropriately registered, and ensuring they obtain informed consent from patients before using a digital scribe in care.

The regulatory environment doesn’t stop with the TGA. Even when not classified as medical devices, digital scribes in healthcare must comply with a web of other frameworks, including the Privacy Act, the Cyber Security Act, Australian Consumer Law, and professional codes under Ahpra. Clinicians are ultimately responsible for verifying the accuracy of any notes generated, while patients have the right to know when a scribe is being used, how their data is handled, and whether the tool influences clinical decisions.

The rise of digital scribes reflects the rapid integration of AI into clinical workflows. For regulators, the challenge is striking the balance between enabling innovation and safeguarding patient safety. The TGA’s guidance makes clear that the line is drawn at interpretation: transcription alone is not regulated, but analysis that informs diagnosis or treatment is. As healthcare becomes increasingly data-driven, clarity on that distinction will be critical for both industry and clinicians navigating this evolving frontier.