In consulting rooms across Australia, millions of patients this year have been asked whether they mind artificial intelligence transcribing the 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. The biggest of them is Heidi, built in Melbourne by a former vascular surgery resident, and it runs in about 2.8 million patient visits a week worldwide. It is exempt for a single reason: as it works today, it only writes things down.
That’s about to change. On Tuesday night the company announced it had raised $US340 million ($476 million) to roll out AI agents that will help tackle a global healthcare worker shortage.
The capital raise, led by Australian venture capital firm Blackbird, values the company at $1.26 billion, making it Australia’s latest “unicorn”, or billion-dollar tech start-up. American venture capital firm General Catalyst has separately provided a $US240 million loan to be repaid from revenue Heidi makes from investing that money into its business. Blackbird, its first backer, has repeatedly called Heidi the fastest-growing company in its portfolio, ahead of Canva.
In Australia, Heidi says its software has been rolled out at the Royal Children’s Hospital Melbourne, Children’s Health Queensland and Metro South Health in Brisbane, and that its annual recurring revenue grew from $US1 million to $US50 million in the two years to April.
“From the day I started Heidi, the ambition was always bigger than writing doctors’ notes,” chief executive Thomas Kelly said in announcing the raise. “I imagined that AI would sit alongside clinicians and complete real work under their supervision.”
In the near term, Kelly told this masthead, Heidi’s agents will take on work such as clinical coding, follow-up and checking on patients over time, with the doctor approving each task. The company will provide more detail on how this would work in practice in a larger product release within a month.
Tatiana Lowe, an emergency physician and medical director of telehealth service My Emergency Doctor, which uses Heidi, said she would hand off workers’ compensation certificates, the wording of death certificates and writing up medication charts to the app, though she would still sign the documents.
Lowe, whom Heidi made available for interview, would not hand over complex diagnostic decisions, or a conversation with a family at the end of a patient’s life. “It’s something that I might do twice a day, but this is the only time they’re ever going to hear it,” she said. “They will reference their life by that discussion.”
Further out, Kelly has described Heidi handling clinical tasks such as repeat prescriptions and drug-dose calculations, which he acknowledged may mean his software becomes a regulated medical device.
Heidi’s coming capabilities will not be released in Britain or the European Union, a decision that Kelly attributed to differing regulatory regimes.
Sean Stevens, who chairs the RACGP’s digital health and innovation specific interest group and is a clinical adviser to rival scribe company Lyrebird Health, said that the new functionality would probably require TGA oversight.
“When it steps into that territory, then I think it becomes software as a medical device and needs regulation,” Stevens said.
A Therapeutic Goods Administration spokesman said the regulator did not have a view on vendors’ commercial decisions, such as when products are released in other markets. But clinical AI features that meet the definition of a medical device must comply with its requirements before they are supplied in Australia, the spokesman said, with devices regulated according to their intended purpose and risk.
“The TGA’s 2024 AI review found the existing regulatory framework remains fit for purpose and sufficiently flexible to accommodate emerging technologies,” the spokesman said.
Tom Sulston, head of policy at Digital Rights Watch, said Australians should be concerned that they have fewer protections than patients in Britain or Europe. “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,” he said.
Australia’s health regulator has spent the past year conducting a review of AI scribes that is now complete.
In Sydney on August 3, the regulator’s product quality division head, Tracey Duffy, told a conference that the review had found scope creep, “inclusion of AI that’s influencing decisions of clinicians”, and a lack of transparency about how vendors manage their systems. She said that action could follow over the next 12 months.
The TGA told this masthead that it would publish the review’s outcomes and updated guidance shortly, and that any compliance matters would be handled under its compliance framework. It did not say whether any action involved Heidi.
The Australian Health Practitioner Regulation Agency, which regulates doctors, said questions about the line between administrative tools and those that influence clinical decisions “are receiving significant attention across the regulatory system”, and it would update its guidance as needed.
Up to June 30, the practitioner regulation agency had received 19 notifications about practitioners using AI scribes. Most concerned privacy breaches, patients who had not consented to the consultation being scribed, and practitioners refusing to release scribed notes.
Heidi co-founder Waleed Mussa said that the company had a good relationship with regulators, wanted pragmatic regulation and told authorities in advance what it planned to build.
Clinical errors across the sector remain a risk. Lowe said she proofreads every consult and the errors are now rare, but she still finds them. Her favourite: a patient allergic to the antibiotic Keflex, recorded by Heidi as allergic to “Catholics”. The ABC earlier this year reported a case in which a scribe wrongly recorded that a patient used illicit drugs.
Elizabeth Deveny, chief executive of the Consumers Health Forum of Australia, said research shows that people check automated work less as they get used to it. With a scribe, an unchecked error may enter a record; with an agent, it may result in something happening. Research by the forum last year found only about half of people surveyed thought AI scribes acceptable, and fewer than one in 10 were comfortable with AI deciding treatment options.
She said productivity alone should not be the test. “Some friction is waste,” Deveny said. “But some friction is the point where someone notices something is wrong.”
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David Swan is the technology editor for The Age and The Sydney Morning Herald. He was previously technology editor for The Australian newspaper.Connect via X or email.From our partners
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