Clarity for Healthcare Organisations

The Therapeutic Goods Administration has published the outcomes of its review into digital scribes supplied in Australia, providing important clarification for healthcare organisations and technology providers as clinical documentation technology continues to evolve.

Digital scribes are becoming an increasingly visible part of the Australian healthcare landscape. As these technologies evolve beyond traditional transcription and documentation, understanding where administrative support ends and regulated clinical functionality begins is increasingly important.

On 16 October 2026, the Therapeutic Goods Administration published the outcomes of its review of digital scribes supplied in Australia.

The TGA highlighted an important distinction: not all digital scribes are medical devices. However, some emerging functions, particularly those that analyse information and generate outputs that may influence clinical decision-making, may fall within Australia’s medical-device regulatory framework. [tga.gov.au]

What the TGA digital scribe review means for InstaNote?

As part of the TGA’s review, InstaNote was one of the digital scribe products reviewed in greater detail.

Following the information provided to support that review, iMedX was advised directly by the TGA that its review of InstaNote did not identify concerns suggesting that InstaNote may be a medical device and that the TGA did not require further action at that time.

For our customers, that gives useful regulatory clarity regarding InstaNote’s current functionality.

Importantly, the TGA’s published report does not disclose the regulatory outcome for individual products reviewed.

Our statement about InstaNote is therefore based on the product-specific outcome communicated directly to iMedX following the review.

The distinction is in what the technology does

The TGA’s guidance states that digital scribes intended only to transcribe and translate clinical conversations into written records, without performing analysis or interpretation, are not considered medical devices. Conversely, functionality that analyses or interprets clinical conversations, such as generating a diagnosis, differential diagnosis or treatment recommendation that was not explicitly stated by the healthcare practitioner, is considered medical-device functionality. [tga.gov.au]

That distinction reinforces an important principle for the responsible development of clinical AI: functionality, intended purpose and the way technology supports the clinician matter.

As AI capabilities advance, suppliers must continue assessing changes to their products. The TGA specifically notes that developers and suppliers need to consider whether changes in digital-scribe functionality alter the product’s regulatory position. [tga.gov.au]

Responsible innovation

At iMedX, we believe innovation in healthcare AI needs to be accompanied by appropriate governance, transparency and regulatory awareness.

The outcome of the TGA review provides additional clarity around InstaNote’s current functionality, while also reinforcing our responsibility to continue assessing the regulatory implications of future functionality as the platform evolves.

For health services evaluating digital scribe technology, this is an increasingly important part of due diligence. The question is not simply whether a solution uses AI. Organisations need to understand what the technology does, what outputs it creates and whether those outputs move from documentation support into clinical decision-making.

We welcome the TGA’s increased clarity in this area and its continued guidance for the Australian healthcare sector.

Read the TGA’s Digital Scribe Review Outcomes:
Digital scribe review outcomes | Therapeutic Goods Administration