The regulator says it will not identify which eight had functions potentially requiring medical device regulation, leaving GPs questioning how they can make informed purchasing decisions.
The Therapeutic Goods Administration has confirmed it will not publicly identify which eight digital scribe products it found had functions likely to meet the definition of a medical device, despite acknowledging that none of the 12 products examined was included in the Australian Register of Therapeutic Goods at the time of its review.
In a response to Health Services Daily, the regulator said it was continuing to engage with suppliers to determine the regulatory status of particular features but had no plans to release product-specific findings.
“The TGA has not disclosed which specific digital scribes included functions likely to meet the definition of a medical device, as further follow up with suppliers of these devices is ongoing,” a spokesperson told HSD.
“The TGA is currently engaging with these suppliers to determine the regulatory status of particular features, and what options are available.”
The spokesperson confirmed that “the TGA does not intend to publish product-specific findings in relation to the digital scribe review”.
The decision has raised questions about how clinicians and healthcare organisations can assess the regulatory status of products they are already using or considering purchasing.
Newcastle GP Max Mollenkopf questioned the value of publishing findings that identified potential regulatory issues without revealing which products were involved.
“Weird move by the TGA to name 12 of the biggest scribes in the Australian market, discuss that a bunch of them are likely (currently unregistered) medical devices but then fail to say which are and which aren’t,” he wrote on LinkedIn.
“So where does that leave me as an end consumer?”
Dr Mollenkopf said the findings left him confused about how to choose a digital scribe product, particularly given the limited technical resources available to smaller general practices.
“This remains a tough spot for small GP practices. We don’t have a CTO. Our IT team is some dude named bill who updates BP and fixes the printer on a contract basis,” he wrote.
“And we small GP practice owners are expected to examine these products and determine whether they are or aren’t fit for purpose and are or aren’t safe to use … all while the TGA throws doubt on the fire without helping us to determine which is safe.”
Eight of 12 flagged
Dr Hassan Ahmad, Lyrebird’s director of medical and regulatory affairs, told HSD today that the TGA had not advised Lyrebird of any findings.
“The TGA has said it will contact suppliers individually about next steps, and we will work with it on anything it raises,” he said.
“Our scribe is not included in the ARTG, and we have previously engaged directly with the TGA on its regulatory status.
“The TGA’s amendments to the exemption for clinical decision support software take effect on 1 November, and its guidance on that software is currently under review. Any steps we take in relation to the exemption will follow the amended requirements and the TGA’s guidance.”
The TGA’s review, published on Friday, found that eight of 12 digital scribe products examined included functions likely to meet the legal definition of a medical device.
Two products required further information to determine their regulatory status, while two appeared unlikely to qualify as medical devices based on the information available.
None of the 12 suppliers had identified their products as medical devices.
The review included some of Australia’s best-known digital scribes, including Heidi Health, Lyrebird Health and Microsoft Dragon Medical One, alongside Abby Health, mAIscribe, AskSam, VoiceBox Scribe, Medilit, VoiceboxMD, ConsultNote AI, Carepatron and iMedX.
The TGA had identified approximately 100 digital scribe suppliers operating in Australia and received responses from 40 suppliers to a voluntary survey before selecting 12 products for closer examination.
The regulator found that while digital scribes were originally developed for administrative tasks such as transcription and clinical documentation, newer functions could generate clinical conclusions, recommendations or other outputs capable of influencing diagnosis or treatment.
Such functionality may bring software within Australia’s medical device regulatory framework.
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No products on register
In its response to HSD, the TGA confirmed that none of the 12 products was included in the Australian Register of Therapeutic Goods at the time of the review.
However, it stressed that some clinical decision support software may qualify for an exemption from ARTG inclusion.
“Some of the digital scribing tools included clinical decision support features that may be exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG), although exempt clinical decision support software remains a regulated medical device and must comply with applicable regulatory requirements,” the spokesperson said.
“The TGA does not currently publish which clinical decision support systems are exempt.”
The distinction means that a product’s absence from the ARTG does not necessarily establish a breach of medical device regulations.
Equally, the TGA’s findings do not establish that any of the eight products is unsafe or being supplied unlawfully.
The regulator reiterated that its review had not involved testing the products or assessing their clinical safety, performance or detailed regulatory compliance.
“The review was not an assessment of the safety or performance of individual products, nor did it assess detailed compliance with medical device regulatory requirements,” the spokesperson said.
Instead, the exercise was intended to better understand the Australian market, identify functions potentially meeting the medical device definition and improve awareness of regulatory obligations.
Clinicians urged to assess reliability
Despite declining to identify the eight products, the TGA has advised healthcare professionals to understand the capabilities and limitations of the software they use.
“Healthcare professionals should understand the intended use, reliability and limitations of digital scribe software and consider the basis and reliability of outputs where products make diagnostic or treatment recommendations,” the spokesperson said.
The regulator said it had published guidance for clinicians and patients about when digital scribes may be regulated as medical devices and the obligations that may apply.
It also confirmed that it would continue managing compliance matters under its existing regulatory compliance framework.
The TGA’s position leaves clinicians without a public, product-specific account of which digital scribes were flagged in its review, while the regulator continues discussions with suppliers behind closed doors.
HSD has sought further comment from Heidi Health, Lyrebird Health and the Medical Software Industry Association, but none had responded by deadline.