Australia’s Therapeutic Goods Administration has concluded that eight of the 12 digital scribe products it examined carry functions likely to meet the legal definition of a medical device. In the review published on October 16, not one supplier had registered its software as a device.
The 12 covered some of the country’s most widely used tools, among them Heidi Health, Lyrebird Health and Microsoft Dragon Medical One. None appeared on the Australian Register of Therapeutic Goods. The TGA has not said which eight crossed the line, or what the other four did differently.
Clinicians cannot see the verdict on their own tools
The regulator will keep product-level conclusions confidential while it works through individual features with each supplier. A spokesperson told The Medical Republic the TGA does not intend to publish findings on specific products.
That silence frustrated the clinicians expected to act on the report. Newcastle general practitioner Dr Max Mollenkopf asked publicly where the finding leaves a buyer, noting small practices have no chief technology officer to audit a vendor’s claims.
Lyrebird’s regulatory chief, Dr Hassan Ahmad, said the company had not been told of any findings on its product. Heidi Health said it shares the regulator’s safety goals and will keep working with it.
Why the scribe boundary matters beyond Australia
Scribes began as passive transcription. Many now draft notes, propose billing codes and suggest diagnoses, which pulls them toward device rules. Australia is among the first regulators to test that boundary product by product, and its verdicts will be read closely by agencies weighing the same question.
For health systems, the gap is procurement. A buyer of an unregistered device takes on liability questions a registration number normally settles. Until the TGA names names, that due diligence lands on the clinic.
