CANBERRA,
OCTOBER 16
INDIAN ABROAD NEWSDESK
Australia’s medical regulator has raised concerns about artificial intelligence software used to prepare clinical notes, saying several tools include functions that may require regulation as medical devices.
In its report, Digital scribe review outcomes, published on October 16, the Therapeutic Goods Administration (TGA) said it had reviewed 12 products. Eight included functions likely to meet the definition of a medical device, two required further information to determine their status, and two appeared unlikely to qualify based on the information available.
Digital scribes use technology to assist doctors with consultation records, summaries and other documentation. These tools can reduce paperwork, but more advanced systems may analyse clinical information or generate recommendations that influence medical decisions.
The TGA said not every digital scribe is a medical device. The regulatory question depends on what the software is designed to do and whether its functions fall within the relevant legal definition.
The review did not test the safety or performance of the products, nor did it assess their privacy and data-protection arrangements. The regulator said it would provide further guidance and undertake compliance activity proportionate to the circumstances.
For patients, the findings underline the importance of asking how their medical information is recorded, stored and used when AI tools are involved in consultations.
The review is part of Australia’s broader effort to support useful healthcare innovation while maintaining appropriate safeguards for patients.
