Eight of the 12 AI scribes examined by Australia’s medicines and medical devices regulator may qualify as medical devices, despite none of their suppliers classifying them that way. The finding comes from the Therapeutic Goods Administration’s (TGA) Digital scribe review outcomes, published on 16 October 2026.
The findings come as AI scribes become increasingly embedded in Australian healthcare, including two-way integration with leading practice management systems.
In separate online polls conducted by the Royal Australian College of General Practitioners (RACGP), the proportion of GP respondents using AI scribes climbed from 22% in August 2024 to 40% in November 2025. Australian-founded Heidi Health reports supporting approximately 2.8 million patient interactions a week across 190 countries. Lyrebird Health, another Australian developer, has expanded beyond local general practices and specialist clinics into the UK’s NHS.
Originally designed to reduce time spent on clinical documentation, AI scribes are evolving beyond basic note-taking. Some now generate clinical recommendations, bringing them within the scope of medical device regulation.
What did the TGA review find?
The TGA identified around 100 digital scribe suppliers in Australia, received 40 responses to its voluntary survey and examined 12 products in more detail. These included Heidi Health, Lyrebird Health and Microsoft Dragon Medical One. As noted, the TGA considered that 8/12 could qualify as medical devices. Some products carried disclaimers stating they were not medical devices, despite offering functions that could influence clinical decisions.
Of the remaining 4 products, 2 required further information to determine their regulatory status, while the other 2 appeared unlikely to qualify as medical devices.
The review did not test product safety or performance, or assess regulatory compliance. Nor did the TGA identify which products fell into each category or establish that any supplier had breached its obligations.
When does an AI scribe become a medical device?
The term ‘medical device’ might bring to mind pacemakers or surgical implants. But everyday products such as compression stockings, adhesive bandages and corrective glasses can also fall under TGA regulation. What matters is their intended medical purpose, not how sophisticated they are.
For AI scribes, the regulatory dividing line is whether the software simply records clinical information or starts interpreting it.
AI scribes that transcribe consultations or summarise information supplied by clinicians generally perform administrative functions and are unlikely to be regulated as medical devices. That changes when software generates its own clinical conclusions, suggests diagnoses or recommends treatments. These functions may bring it within the TGA’s medical device framework.
Consider a scribe preparing a referral letter. Summarising the outcomes of the consultation is one thing. Adding its own suggested diagnosis or recommending further investigations is another – and could change how the software is regulated.
Some clinical decision support system (CDSS) software may be exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG). However, exempt software must still meet applicable medical device requirements.
Rapid adoption raises new questions for healthcare practices
As AI scribes often connect directly with practice management systems, their outputs can move into patient records without manual intervention. That saves time, but errors may also be carried into clinical documentation if clinicians don’t check the results.
Dr Rob Hosking, Chair of the RACGP Expert Committee – Practice and Technology Management, has warned against relying on AI-generated notes without reviewing them, telling NewsGP that,
“When we’re in a hurry, the temptation is to just hit import or copy and paste into your notes …but they certainly do make mistakes, and you have to check.”
For healthcare practices, this reinforces the need to assess both the software’s capabilities and the safeguards around its use.
Practices evaluating an AI scribe should ask:
- Does the software generate diagnoses or treatment recommendations, or only document them?
- Has the supplier assessed whether any functions are regulated as medical devices?
- Who checks AI-generated notes before they enter the patient record?
- What happens when a software update introduces new clinical functions?
What the findings mean for AI developers
Healthtech developers should be aware that adding new features could mean taking on new regulatory obligations. An update that introduces diagnostic suggestions or treatment recommendations may change a product’s classification, even if it started life as an administrative tool.
Marketing claims matter too. Promoting software as an aid to diagnosis or treatment could bring it within medical device regulation. A disclaimer describing the product as an administrative assistant won’t necessarily override those claims or its actual functionality.
Regulatory status could also become a point of difference in a crowded AI scribe market. Hospitals and healthcare practices may increasingly expect suppliers to demonstrate appropriate safeguards and explain how their products meet applicable requirements.
What happens next?
The TGA plans further guidance on digital scribe regulation, clarification of CDSS exemptions and targeted compliance activities. It says its approach will account for the rapid adoption of the technology while minimising unnecessary disruption to clinical practice.
The review does not amount to a recommendation to stop using AI scribes. But it does give healthcare organisations reason to look more closely at the software they already use – particularly whether its capabilities have changed since it was first purchased.
Suppliers can refer to the TGA’s digital scribe guidance to assess their regulatory obligations.
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