TGA Finds Eight of Twelve AI Scribes May Be Medical Devices

Australia’s medicines regulator has found that eight of twelve digital AI scribe products it reviewed have functions likely to meet the legal definition of a medical device, even though none of their suppliers had identified the software as one, The Medical Republic reported on October 16.

The Therapeutic Goods Administration examined products with significant Australian market share and some smaller suppliers, naming Heidi Health, Lyrebird Health, Microsoft Dragon Medical One, Abby Health, mAIscribe, AskSam, VoiceBox Scribe, Medilit, VoiceboxMD, ConsultNote AI, Carepatron and iMedX among the twelve. It has not said which eight crossed the line. Two needed more information and two appeared unlikely to qualify on the material available.

The TGA stressed it did not safety-test the products or check privacy arrangements. Many scribes began as transcription tools, but newer generative features can analyse clinical information, flag findings and produce outputs that could influence diagnosis or treatment. Disclaimers saying a product is not a medical device are not enough, the regulator said. Software that meets the definition generally needs to be on the Australian Register of Therapeutic Goods before it is supplied, though some clinical decision-support systems can claim a conditional exemption while still facing device rules.

What it means in practice

Clinics already using these tools now face an awkward gap: they know eight of twelve reviewed products may need device regulation, but not which ones. That uncertainty sits beside earlier health-AI coverage such as hospital networks sharing playbooks for imaging triage and Heidi’s unicorn raise, and it will shape how Andrew Charlton’s systems-regulation plan for frontier labs lands in clinical software.

Heidi said it shares the TGA’s patient-safety focus and will keep working with the regulator. iMedX said it had not been told that InstaNote’s current functions meet the device definition. The TGA plans targeted compliance work, more guidance for suppliers and clinicians, and a proportionate approach that protects patients without yanking useful tools out of clinics overnight.

What to watch: whether the TGA names the eight products, how quickly suppliers seek ARTG inclusion or redesign features, and whether health services pause new scribe rollouts until the status of each tool is clear.