What Happened
In consulting rooms across Australia, millions of patients this year have been asked whether they mind AI transcribing their appointment. About 40 per cent of GPs were using a tool of that kind late last year, according to a Royal Australian College of General Practitioners poll, up from 22 per cent in 2024. None of those products are approved by the Therapeutic Goods Administration.
They don't need to be, for now. The biggest of them is Heidi, built in Melbourne by a former vascular surgery resident. It runs in about 2.8 million patient visits a week worldwide and is currently exempt from TGA oversight for a single reason: as it works today, it only writes things down.
That is about to change. On Tuesday night Heidi announced it had raised $US340 million (A$476 million) to roll out AI agents designed to help tackle a global healthcare worker shortage. The raise was led by Australian venture capital firm Blackbird, which has repeatedly called Heidi the fastest-growing company in its portfolio, ahead of Canva. American firm General Catalyst separately provided a $US240 million loan to be repaid from revenue. The combined funding values the company at A$1.26 billion, making it Australia's latest unicorn.
Chief executive Thomas Kelly said the raise marked a shift in the company's scope. "From the day I started Heidi, the ambition was always bigger than writing doctors' notes," Kelly said. "I imagined that AI would sit alongside clinicians and complete real work under their supervision."
Why It Matters
The move from transcription to active clinical tasks puts Heidi in a different regulatory category. One GP quoted in the Sydney Morning Herald report drew a line at the point where software begins influencing clinical decisions, describing that as the threshold where it "becomes software as a medical device and needs regulation."
Patient advocates have raised concerns about the data involved. "It's not OK for us to be treated like guinea pigs for tech companies to test out their incomplete products, especially when the data being used is our most sensitive and private information," one advocate said, as reported by the Sydney Morning Herald.
The TGA conducted a review of AI in 2024. Its position, as reported by the Sydney Morning Herald, is that "the existing regulatory framework remains fit for purpose and sufficiently flexible to accommodate emerging technologies." Critics argue that position has not kept pace with how quickly these tools are expanding their scope.
Researchers writing in The Conversation have separately flagged questions about what happens to patient data captured by AI scribes, noting the "inclusion of AI that's influencing decisions of clinicians" raises distinct questions from simple transcription.
Key Details
Heidi's annual recurring revenue grew from $US1 million to $US50 million in the two years to April. In Australia, the company says its software has been deployed at the Royal Children's Hospital Melbourne, Children's Health Queensland and Metro South Health in Brisbane.
The new AI agents are intended to handle tasks beyond note-taking, including patient-facing interactions about medicines. Kelly described one scenario involving medication counselling: "It's something that I might do twice a day, but this is the only time they're ever going to hear it. They will reference their life by that discussion."
Background and Context
AI scribes entered Australian GP clinics without a specific regulatory pathway because transcription software, which only records and summarises, sits outside the TGA's definition of a medical device. The RACGP poll showing 40 per cent adoption late last year, up from 22 per cent in 2024, reflects how quickly that baseline spread before any formal framework was in place.
Heidi was founded by a former vascular surgery resident and is headquartered in Melbourne. Blackbird, its first backer, led the latest raise.
What Comes Next
Heidi's expansion into AI agents that interact directly with patients will test whether the TGA's 2024 position, that its framework is flexible enough to handle emerging technologies, holds in practice. The company has not disclosed a timeline for the Australian rollout of the new agent features. Regulatory watchers and patient groups are likely to press for clarity on data handling and device classification as the product moves beyond transcription.