TGA Reviews 12 Digital Scribe Products in October 2026: Eight Feature Sets Likely Constitute Medical Devices

15 October 2026. The Australian Therapeutic Goods Administration (TGA) has published the outcome of its review of digital scribes. These products are being adopted rapidly in Australian clinics, and their functionality has expanded from simple audio transcription to generating clinical summaries, extracting key points and producing clinical recommendations. The question the TGA set out to answer was narrow: which of these functions already constitute a medical device.

How the review was conducted

The TGA first carried out an environmental scan of publicly available information and identified approximately 100 suppliers. It then issued a voluntary questionnaire and received responses from 40 suppliers. Twelve products were taken into substantive review. Selection was based on products with a relatively high share of the Australian market, together with a small number of smaller suppliers. The 12 products include Heidi Health, Lyrebird Health and Microsoft Dragon Medical One.

The review was based on product documentation, labelling, marketing materials and functional descriptions submitted by suppliers. The TGA also took into account information voluntarily provided by clinicians and patients. No product testing was carried out during the review.

Twelve products, and none declared as a medical device

The results were not lenient. Of the 12 products, no supplier had declared its product to be a medical device. In the TGA's assessment:

• 8 products contain functions that are likely to meet the definition of a medical device;
• 2 products require further information before their regulatory status can be determined;
• 2 products are unlikely, on the information currently available, to be medical devices.

The TGA attributed this outcome to the way functionality has evolved. Many products began as transcription and documentation tools, and subsequently added generative functions that analyse information, determine which content is clinically relevant, and even generate clinical conclusions or recommendations. Once those outputs may influence diagnosis, monitoring, prognosis or treatment, the product is likely to fall within the definition of a medical device. Some digital scribes are therefore, in substance, performing the role of clinical decision support software (CDSS).

Exemption is not the absence of regulation

Some suppliers argued that their products are exempt CDSS. The TGA set out the conditions in specific terms. All four of the following must be satisfied:

• the sole purpose of the product is to provide healthcare professionals with advice on the prevention, diagnosis or treatment of disease;
• the product does not replace clinical judgement;
• the product does not analyse information derived from other medical devices; and
• the product demonstrates how the advice is generated.

Only where all four conditions are met may the product be excluded from inclusion in the Australian Register of Therapeutic Goods (ARTG). The second half of that statement matters: an exempt CDSS is still a regulated medical device and must still meet applicable regulatory requirements.

Disclaimers do not determine regulatory status

Another practice singled out in the review is the use of disclaimers. Some products carry statements such as “this product is not a medical device” or “not intended for diagnosis or treatment”. The TGA's position is clear: such statements do not determine whether a product is a medical device. The determination rests on the intended purpose and the actual functionality of the product.

What the TGA did not do

The review report devotes a dedicated section to this point. The TGA did not test any product, did not verify safety and performance, did not assess whether products comply with the detailed regulatory requirements for medical devices, and did not assess privacy and data protection arrangements. This boundary is important: the conclusion for the eight products is that their functions are likely to constitute a medical device, not that the products are non-compliant.

Next steps

Follow-up action will be proportionate to risk. The TGA stated that it will use the results of this review to refine its regulatory approach to digital scribes, continue to issue guidance and conduct education, and carry out targeted compliance checks on functions that constitute medical devices.

Sources and scope of verification

Sources:

• Therapeutic Goods Administration (TGA) — Outcome of digital scribe review, published 15 October 2026: https://www.tga.gov.au/news/news-articles/outcome-digital-scribe-review
• Therapeutic Goods Administration (TGA) — Digital scribe review outcomes, published 15 October 2026: https://www.tga.gov.au/resources/publication/corporate-reports/digital-scribe-review-outcomes
• Therapeutic Goods Administration (TGA) — Digital scribes (regulatory guidance)

Verification scope and access date: this article is based solely on the publicly available content of the above official tga.gov.au pages as accessed on 21 October 2026. No secondary media reports were relied upon. The official pages do not publish a remediation deadline, and no timeline commitment is made in this article.

Applicability statement: this article addresses the Australian regulatory framework only and does not cover the classification rules of any other country or region. The TGA has expressly stated that this review did not involve product testing and did not assess privacy and data protection. Accordingly, the conclusions described here do not constitute a determination that any specific product is or is not compliant, and do not constitute legal advice. Each product must be assessed individually against its intended purpose and functional scope.

AIMEILI Regulatory Interpretation

The central lesson of this review is that regulatory status for digital scribes is now decided at the level of individual functions rather than at the level of the product category. The TGA did not treat “digital scribe” as a self-contained classification question; it examined what each product actually does with the information it captures. For sponsors and regulatory affairs teams, this means that a single platform may simultaneously contain non-device documentation functions and device functions, and the boundary can shift with every feature release.

Three points deserve particular attention. First, the CDSS exemption is narrow and cumulative. The requirement that the product not analyse information derived from other medical devices, and the requirement to demonstrate how advice is generated, are frequently the decisive conditions. A product that ingests data from monitoring equipment or that outputs a recommendation without a traceable basis is unlikely to satisfy them. Second, the TGA has expressly rejected the use of disclaimers as a classification tool. Statements in labelling, instructions for use, websites and sales materials will be read alongside the product's actual behaviour, and inconsistencies between the two create enforcement exposure. Third, exempt CDSS remains a regulated medical device: the exemption concerns ARTG inclusion, not the obligation to meet applicable regulatory requirements.

It is equally important to read the review for what it does not say. The TGA did not test products, did not verify safety and performance and did not assess privacy or data protection. The finding is a classification signal, not a conformity finding. Sponsors should therefore avoid treating the publication as either a clearance or a deficiency notice for any named product.

Business Impact

The practical consequences fall into four areas.

• Portfolio and feature-level gap assessment. Manufacturers and distributors should map every feature against the TGA's functional criteria, document which outputs may influence diagnosis, monitoring, prognosis or treatment, and record the rationale for functions assessed as non-device.
• Intended purpose and claims review. Indications for use, labelling, instructions for use, marketing content and sales enablement materials must be aligned with the intended purpose and with actual product behaviour. Disclaimer language should be removed or revised where it conflicts with functionality.
• Regulatory pathway and evidence. Where functions constitute a medical device, sponsors should confirm the applicable classification, conformity assessment route and ARTG inclusion strategy, and ensure the technical documentation, risk management file, clinical evaluation and software lifecycle records support the intended purpose, including evidence of how recommendations are generated.
• Governance and market access planning. Distributors and CROs supporting Australian market entry should build classification review into release governance, since new generative features can change regulatory status between versions. Procurement and hospital customers are also likely to ask suppliers to evidence their regulatory position following publication of this review.

The TGA has not published a remediation deadline, but it has stated that targeted compliance checks on device functions will follow. Suppliers operating in Australia should treat the review as an advance signal of enforcement priorities rather than as a future obligation.