Australia’s Therapeutic Goods Administration (TGA) has published the findings of its review of digital scribes. The central issue is the distinction between software that documents a clinical consultation and functions that analyse information to generate clinical conclusions or recommendations.
At a glance
- The publication: the review outcomes were published on 16 October 2026.
- The context: digital scribes support the documentation of clinical consultations.
- The finding: eight of the 12 products reviewed included functions likely to meet the definition of a medical device.
- The distinction: intended purpose and functionality contribute to determining regulatory status.
- The limitation: the review did not include product testing or an assessment of safety, performance or compliance with detailed regulatory requirements.
What are digital scribes?
Digital scribes are software tools used to capture and organise information during clinical consultations. They can generate clinical notes, summaries, letters or other outputs that may be added to patient records.
These tools may use different technologies, including generative artificial intelligence.
Some perform only transcription and documentation tasks. Others analyse the information collected and generate additional clinical content.
This distinction explains why the term digital scribe does not, by itself, determine whether a product is a medical device.
What did the review find?
TGA identified approximately 100 suppliers of digital scribes available in Australia through a scan of publicly available information.
The authority subsequently conducted a voluntary survey, receiving responses from 40 suppliers. The review focused on 12 products, including products with the greatest market share in Australia and products from smaller suppliers.
None of the suppliers of the 12 products reviewed had identified them as medical devices.
The TGA’s assessment nevertheless found:
| Review outcome | Products |
|---|---|
| Functions likely to meet the definition of a medical device | 8 |
| Additional information needed to determine regulatory status | 2 |
| Products that appeared unlikely to be medical devices, based on the available information | 2 |
These findings concern the products reviewed and do not constitute a statistical estimate of the entire digital scribe market.
From documentation to clinical functionality
The TGA’s guidance distinguishes administrative and documentation activities from functions with a therapeutic purpose, as understood under Australian legislation.
Recording or transcribing a consultation without adding clinical content or suggestions not explicitly stated by the healthcare professional differs from generating diagnostic conclusions or treatment recommendations.
This distinction must be considered alongside the intended purpose and how the product is described and presented. The TGA explains that even software that only summarises consultations may be regulated as a medical device if the manufacturer claims that it is intended to support diagnosis, prognosis or treatment.
Statements that a product is not a medical device or is not intended for diagnostic or therapeutic purposes are therefore insufficient, on their own, to determine its status.
Both functionality and the intended purpose conveyed through product documentation and presentation matter.
What the findings do not establish
The TGA review did not include product testing or assessments of safety, performance, compliance with detailed medical device regulatory requirements, privacy or data protection.
A finding that a function is likely to meet the medical device definition does not, by itself, establish non-compliance by the products reviewed.
Equally, the review does not demonstrate the products’ safety or performance.
It addresses a different question: understanding whether digital scribe functions may meet the medical device definition and how those functions are represented in product information.
Where clinical decision support fits
Some digital scribes may function as clinical decision support system software (CDSS).
The TGA’s guidance distinguishes several regulatory situations.
Software that does not meet the definition of a medical device is not regulated as one. Some software may also be excluded from the scope of TGA regulation when it meets the applicable exclusion criteria.
A different situation applies to CDSS that constitutes a medical device but qualifies for a specific exemption from inclusion in the Australian Register of Therapeutic Goods (ARTG).
The exemption depends on meeting the criteria established under Australian legislation. Describing a product as clinical decision support is not sufficient.
CDSS exempt from ARTG inclusion remains a regulated medical device.
Obligations continue to apply, including compliance with the Essential Principles for safety and performance, notification to the TGA, adverse event reporting and advertising requirements.
Software that is not a medical device, excluded software and CDSS exempt from ARTG inclusion therefore represent different regulatory situations.
At the time the review outcomes were published, the TGA indicated that its CDSS guidance was under review to align with amendments taking effect on 1 November 2026.
Why this development matters
The review shows how an apparently uniform product category can encompass functions with very different regulatory implications.
A tool introduced to reduce documentation work may also include functions that analyse and interpret clinical information. This distinction becomes particularly important when the resulting outputs are integrated into the consultation record.
The significance of the review lies in making this boundary more visible and highlighting the role of intended purpose and functionality in determining whether software qualifies as a medical device.
The findings contribute to the regulatory discussion on digital scribes while keeping questions about medical device qualification separate from those concerning the safety, performance and compliance of individual systems.
This is an Australian regulatory development. Its conclusions do not automatically determine the status of the same products in other jurisdictions.
Official sources
- TGA — Digital scribe review outcomes
- TGA — Digital scribes
- TGA — Understanding clinical decision support system software regulation
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Informational note
This article is for informational purposes only and does not constitute regulatory, legal, technical or professional advice. For applicable requirements and procedures, please refer to the official texts and current documentation issued by the competent authorities.