Australia TGA Clarifies Digital Scribe Medical Device Boundaries

On 16 October 2026, Australia's Therapeutic Goods Administration (TGA) published its news notice Outcome of digital scribe review and corporate report Digital scribe review outcomes, alongside updated Digital scribes regulatory guidance. While none of the 12 digital scribe suppliers examined in the TGA's focused review identified their software as a medical device, the TGA found that 8 of the 12 products included functions likely to meet the statutory definition of a medical device under section 41BD of the Therapeutic Goods Act 1989, 2 required additional information to determine their regulatory status, and 2 appeared unlikely to be medical devices based on available information.

Targeted Review Scope and Findings

To evaluate how artificial intelligence (AI) ambient listening and clinical documentation tools are being supplied in Australia following its initial 14 August 2025 information notice on digital scribes, the TGA conducted a targeted compliance review:

1. Initial environmental scan: In 2025, the TGA identified approximately 100 suppliers of digital scribes available in Australia, and observed during 2026 that existing products were launching new features while several new products entered the market.
2. Voluntary supplier survey: The TGA surveyed these suppliers—requesting product documentation, labelling, marketing material, and descriptions of product functionality and intended purpose, alongside feedback from clinicians and patients—and received responses from 40 suppliers.
3. Focused review of 12 products: The TGA focused its review on 12 products (including products holding the greatest market share in Australia as well as some smaller suppliers): Heidi Health, Lyrebird Health, Microsoft Dragon Medical One, Abby Health, mAIscribe, AskSam, VoiceBox Scribe, Medilit, VoiceboxMD, ConsultNote AI, Carepatron, and iMedX.

Although none of the 12 suppliers identified their products as medical devices, the TGA assessed that 8 included functions likely to meet the definition of a medical device, 2 required additional information to determine their regulatory status, and 2 appeared unlikely to be medical devices based on available information. The TGA noted that its review did not test any digital scribe products, check safety and performance, assess compliance with detailed medical device regulatory requirements, or assess privacy or data protections, and the published report does not identify which specific named products fell into each category.

Updated Regulatory Boundary for Digital Scribes

Under the updated Digital scribes guidance (last updated 16 October 2026), a digital scribe is not a medical device when its sole purpose is to record, transcribe, and convert a clinical conversation into structured text records (including via customisable formatting templates), without analysing or interpreting clinical information.

To clarify where additional features cross into regulated software as a medical device (SaMD) under section 41BD of the Therapeutic Goods Act 1989, the updated guidance sets out a seven-function comparison table in "Functions to consider when determining regulatory status":

The updated guidance also provides eight worked examples—five illustrating tools that are not medical devices (Examples 1 to 5: verbatim transcription, conversation summaries, formatting into structured notes, matching clinical codes to explicitly mentioned terms, and drafting discharge summaries/letters) and three illustrating regulated medical devices (Examples 6 to 8):

• Optional "insights" feature with a UI disclaimer (Example 6 — Generates insights for diagnosis, follow-up or treatment): A digital scribe that includes an optional, user-requested "insights" feature (discussed in sales and user material) to suggest potential diagnoses, follow-up, or treatment options is a medical device—even if promoted as an administrative tool and accompanied by a disclaimer stating that "the insights feature is not intended to replace diagnosis or treatment decisions by a health professional."
• Therapeutic marketing claims on an administrative tool (Example 7 — Guides diagnosis and treatment planning and improves patient outcomes): A digital scribe whose software functions are purely administrative (identical to Example 2) is nevertheless a regulated medical device if the manufacturer makes marketing claims that the product is intended to support and guide diagnosis and treatment planning and improve patient outcomes.
• Autonomous digital scribe agent (Example 8 — A digital scribe agent that operates without requiring health professional review): A digital scribe agent that finalises and saves transcripts to the electronic patient record without clinician review and analyses the transcript to autonomously determine necessary follow-up tests and place orders without clinician input or confirmation is a regulated medical device.

Compliance Pathways and the 1 November 2026 CDSS Reform

For suppliers whose digital scribes include regulated medical device functionality, the TGA outlines four compliance pathways:

1. Clinical Decision Support System (CDSS) conditional exemption: A regulated digital scribe may qualify as exempt CDSS software if its sole therapeutic purpose is to provide a recommendation to a health professional about prevention, diagnosis, or treatment; it is not intended to replace the clinical judgement of a health professional; it does not analyse or process information from another medical device; it displays details of how the recommendation was generated so the clinician can independently review the basis; it complies with the Essential Principles for safety and performance; and the sponsor notifies the TGA using the CDSS exemption notification form. The TGA's separate Understanding clinical decision support system software regulation page says that the guidance is under review to align with amendments coming into effect on 1 November 2026. That notice does not establish a grace period for supplying non-compliant digital scribes or set out the amended criteria.
2. Product and promotional modification: Modify the product to remove regulated medical device functions and any associated diagnostic or therapeutic claims across marketing, user documentation, and software features.
3. ARTG inclusion: If the software is a medical device and no exemption applies, apply for inclusion in the Australian Register of Therapeutic Goods (ARTG) and obtain that inclusion before supply.
4. Cease supply: Stop supplying the non-compliant product in Australia.

Pure Global analysis: Suppliers should assess each function alongside the claims in their marketing, user documentation and interface. An optional clinical-inference feature or a diagnostic claim can change the regulatory position even when most of the product performs administrative work. Document whether each affected product qualifies for the conditional CDSS exemption and can meet all its conditions; otherwise obtain ARTG inclusion before supply, remove the therapeutic functionality and claims, or cease supply. The announced 1 November amendments are a separate change to check against the final applicable instrument, rather than a reason to defer current obligations. The Australia market guide explains the wider registration framework.