TGA review raises concerns over regulation of AI medical scribes
19 Oct 2026
The findings come from the TGA’s Digital scribe review outcomes report, which examined how these tools work and whether their functions fall under existing medical device rules.
The review included products used in Australian general practice, such as Heidi Health, Lyrebird Health and Microsoft Dragon Medical One. Other products assessed included Abby Health, mAIscribe, AskSam, VoiceBox Scribe, Medilit, VoiceboxMD, ConsultNote AI, Carepatron and iMedX.
The TGA said it needed more information about two products. The remaining two appeared unlikely to be medical devices based on the information available. The regulator did not identify which products fell into each category.
AI tools are moving beyond note-taking
The TGA found that suppliers generally viewed their products as administrative tools rather than medical devices. As a result, they had not listed them on the Australian Register of Therapeutic Goods (ARTG).
The regulator said this made it harder to understand how the software worked and whether some of its functions required medical device regulation.
AI medical scribes were first used mainly to transcribe consultations and summarise clinical notes. However, some now use generative AI to identify relevant clinical information and produce conclusions or recommendations.
Under existing rules, software that generates clinical recommendations or conclusions to support medical decisions may be classified as a medical device.
The TGA said suitable safeguards, clear information and regulatory oversight are important when these tools perform functions that could affect diagnosis, monitoring or treatment.
Doctors must remain involved
Dr Steven Kaye, Deputy Chair of the RACGP Expert Committee – Practice Technology and Management, described the review as timely.
He told newsGP that regulating AI in clinical care could benefit doctors, healthcare staff and patients.
AI scribes have become increasingly common in Australian general practice. A newsGP poll published in November found that 40% of surveyed GPs were using the technology, with adoption likely to have increased since then.
The TGA said healthcare professionals currently need to understand how these tools work, including their reliability and limitations. When an AI scribe produces clinical recommendations, users may not know how it selected or prioritised information or reached its conclusions.
Dr Kaye stressed the importance of identifying the information sources used by AI systems. He also said clinicians must review and edit AI-generated notes to identify errors or fabricated information before it enters a patient's clinical record.
He expects AI scribes to become more advanced, with a growing role in clinical interpretation and decision support. He said clinicians must remain directly involved in authorising clinical decisions.
A spokesperson for Heidi Health said the company would continue working with the TGA to address the report's findings. The company also highlighted its commitment to clinical evaluation, data protection and independent assurance.
Lyrebird Health was also approached for comment.
The TGA clarified that the review did not involve product testing or assessments of safety, performance or compliance with detailed medical device requirements. Privacy and data protection were also outside the scope of the review.
TGA review raises concerns over regulation of AI medical scribes
Source: Therapeutic Goods Administration (TGA), Digital scribe review outcomes, as reported by RACGP newsGP.