TGA concerned AI scribes are doing more than just transcribing
The regulator will not disclose which of the 12 scribes it reviewed include features likely to meet the definition of a medical device.
A TGA review has found that eight AI scribes on the Australian market include functions likely to qualify them as medical devices, which means they would need to be formally registered with proof that they are safe to use.
AI scribes have traditionally been regarded by regulators as doing nothing more than transcribing and providing summaries.
But a long-awaited review, published by the TGA last week, analysed 12 digital scribe products, including those offered by market giants Heidi and Lyrebird Health.
It concluded that eight of the scribes include functions likely to make the products meet the definition of a medical device.
