Eight of 12 digital scribe products examined by the Therapeutic Goods Administration have functions likely to meet the legal definition of a medical device, raising questions about regulatory compliance in Australia’s rapidly expanding AI healthcare market.
In a report published today, the regulator revealed that none of the suppliers of the 12 products it reviewed had identified their software as a medical device.
The review included some of Australia’s best-known digital scribe products, including Heidi Health, Lyrebird Health, and Microsoft Dragon Medical One, alongside nine other products.
However, the TGA has not publicly identified which eight products it considers likely to meet the medical device definition.
A spokesperson for Heidi Health responded with the following statement:
“Heidi shares the TGA’s commitment to patient safety. We engage regularly with the regulator and will continue working collaboratively to address the report’s findings.
“As an Australian-founded healthcare technology company built by clinicians, we recognise that trust must be earned through rigorous clinical evaluation, strong data protection and independent assurance. These are essential foundations for AI in healthcare.
“Australia’s healthcare workforce is under sustained pressure as demand for care grows.
“Safe AI designed specifically for healthcare can help reduce administration and give clinicians more time with patients.
“We are committed to working with the TGA and government to ensure Australians benefit from this technology safely and responsibly.
A follow-up question asking if Heidi was one of the eight products identified as possibly being a medical device has so far gone unanswered.
TMR has asked the TGA why it has not identified the eight and whether it will in the future, but had not received a response by deadline.
Of the remaining four products, two required further information to determine their regulatory status, while two appeared unlikely to qualify as medical devices based on the information available.
The 12 products examined were:
- Heidi Health;
- Lyrebird Health;
- Microsoft Dragon Medical One;
- Abby Health;
- mAIscribe;
- AskSam;
- VoiceBox Scribe;
- Medilit;
- VoiceboxMD;
- ConsultNote AI;
- Carepatron; and,
- iMedX.
The TGA said it had identified approximately 100 digital scribe suppliers operating in Australia through an environmental scan, with 40 suppliers responding to a voluntary survey.
It selected 12 products for closer examination, including those with the greatest Australian market share and some smaller suppliers.
“Of the 12 scribes we reviewed, none of the suppliers identified their products as medical devices,” the regulator said.
Alex Zacher, managing director of iMedX, confirmed that iMedX had not been advised by the TGA that any “current function of InstaNote was likely to meet the definition of a medical device, and it did not request any changes”.
“We are pleased about this,” said Mr Zacher.
“InstaNote is not currently included in the Australian Register of Therapeutic Goods as a medical device and is not relying on an exemption.
“Based on its current functionality and intended purpose, iMedX does not consider InstaNote to require inclusion in the ARTG as a medical device.”
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Beyond transcription
The TGA said many digital scribes were originally developed for administrative tasks, including transcription, documentation, and summarising clinical consultations.
However, newer generative AI features increasingly allow products to analyse clinical information, identify relevant findings, and produce outputs that could influence diagnosis or treatment.
The regulator found that some products generated clinical conclusions, recommendations or other outputs potentially affecting patient care.
Software performing those functions may be regulated as a medical device under the Therapeutic Goods Act 1989.
By contrast, software limited to transcription or administrative documentation is generally unlikely to meet the definition.
The TGA said some suppliers appeared not to have considered whether medical device regulatory requirements applied to their products.
It also found that suppliers sometimes relied on disclaimers stating that their products were not medical devices or were not intended for diagnosis or treatment.
“Statements or disclaimers are not sufficient in determining if a product is, or is not, a medical device,” the report said.
The regulator warned that AI-generated recommendations could create additional challenges for clinicians trying to establish how information had been selected, prioritised, or generated.
No safety testing undertaken
The TGA emphasised that its review was not an assessment of the clinical safety or performance of the 12 products.
“We did not test any digital scribe products, check the safety and performance, or assess compliance with detailed medical device regulatory requirements as part of this review,” it said.
It also did not assess the products’ privacy or data protection arrangements.
The finding that eight products were likely to have medical device functions therefore does not establish that those products are unsafe or that individual suppliers have breached the law.
The review instead examined product functionality, intended purpose, documentation and marketing information to identify where medical device requirements might apply.
Compliance action to follow
Under Australian law, software meeting the definition of a medical device generally requires inclusion in the Australian Register of Therapeutic Goods before it can be supplied, although certain clinical decision support systems may qualify for a conditional exemption.
The TGA noted that exempt clinical decision support software remains subject to medical device regulation, even where inclusion in the register is not required.
The regulator said it would use the review findings to guide further compliance work, education, and clarification of regulatory obligations.
“With the scale of adoption and the speed at which new products enter the market, addressing compliance requires a proportionate and risk-based approach,” it said.
That approach would seek to protect patients while avoiding unnecessary disruption to clinical practice and access to useful technologies.
The TGA said it would undertake targeted compliance activities where digital scribe functions met the medical device definition.
It also intends to provide further guidance to manufacturers, developers, suppliers, clinicians, and patients about the regulatory boundaries applying to digital scribes.
The findings come as AI scribes become increasingly embedded in Australian healthcare, with software developers regularly adding features that can change a product’s regulatory status.
The TGA’s review found that existing products were launching new functions and additional suppliers had entered the Australian market during 2026.
The report leaves a significant question unanswered for clinicians and health services using the 12 products: which eight have functions the regulator believes are likely to require medical device regulation?
TMR has reached out to the 12 tested product developers for comment but has had no response by deadline.
The post Eight of 12 AI scribes may be medical devices, TGA finds appeared first on Medical Republic.
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