AI scribes may have functions that require medical device regulation, according to an Australian review that found eight of 12 products likely to meet the definition. The Therapeutic Goods Administration (TGA) said none of the suppliers had identified their products as medical devices.
The regulator did not name the eight products. Its review included Heidi Health, Lyrebird Health and Microsoft Dragon Medical One, along with nine other products, but the findings do not identify which systems may have regulated functions.
Why AI scribes may fall under device rules
Digital scribes were initially developed for administrative work such as transcription, documentation and summarising consultations, the TGA said. Newer generative AI features can analyse clinical information, identify findings and produce outputs that could affect diagnosis or treatment.
Software that performs those functions may meet the legal definition of a medical device under the Therapeutic Goods Act 1989. Tools limited to transcription or administrative documentation are generally unlikely to meet that definition, according to the regulator.
The TGA said some suppliers appeared not to have considered whether device rules applied. It also found that some relied on disclaimers saying their products were not devices or were not intended for diagnosis or treatment. The report said those statements alone do not determine a product’s regulatory status.
The regulator identified approximately 100 digital scribe suppliers in Australia through an environmental scan. Forty suppliers responded to a voluntary survey, and the TGA selected 12 products for closer examination, including products with the greatest Australian market share and some smaller suppliers.
What the review did and did not establish
The TGA’s findings concern functions and likely regulatory status, not product safety. The agency said it did not test any of the 12 products, check their safety or performance, or assess compliance with detailed medical device requirements. It also did not assess privacy or data protection arrangements.
That distinction matters: the finding that eight products likely have functions meeting the device definition does not establish that they are unsafe or that their suppliers broke the law. The review examined functionality, intended purpose, documentation and marketing information to identify where requirements might apply.
The source report is available in Health Services Daily’s coverage. Meditech Today has also reported on oversight of AI medical devices in South Korea and AI device authorization patterns. For a wider view of health technology policy, see its report on digital therapeutics in India.
Compliance work and guidance are next
Under Australian law, software that meets the medical device definition generally needs inclusion in the Australian Register of Therapeutic Goods before supply. Some clinical decision support systems may qualify for a conditional exemption, although exempt software remains subject to medical device regulation.
The TGA said it would use the review to guide further compliance work, education and clarification of regulatory obligations. It plans targeted compliance activity where digital scribe functions meet the definition. The regulator said targeted compliance activities would focus on cases where AI scribes may have functions meeting that definition.
The report also notes that product functions are changing as developers add features and new suppliers enter the Australian market. The eight products remain unnamed, leaving users of the reviewed tools without a product-by-product answer about which functions the regulator considers likely to require regulation.
