Eight of 12 digital scribe products examined by the Therapeutic Goods Administration (TGA) include functions likely to meet the definition of a medical device, despite none of their suppliers identifying their products as such.
The findings follow a review of digital scribes supplied in Australia and have prompted the regulator to strengthen guidance for suppliers and plan targeted compliance activities as AI-enabled clinical documentation tools become more widely used.
The TGA identified approximately 100 digital scribe suppliers operating in Australia and received responses from 40 to a voluntary survey. It focused its review on 12 products, including those with the greatest market share and several smaller suppliers.
Of those products, eight had functions likely to meet the definition of a medical device, two required further information to determine their regulatory status and two appeared unlikely to be medical devices.
The products examined included Heidi Health, Lyrebird Health, Microsoft Dragon Medical One, Abby Health, mAIscribe, AskSam, VoiceBox Scribe, Medilit, VoiceboxMD, ConsultNote AI, Carepatron and iMedX.
The TGA did not identify which products fell into each category.
The review found that many digital scribes had evolved beyond transcription and clinical note-taking to include generative AI features capable of analysing patient information and producing clinical conclusions or recommendations.
These functions may bring products within medical device regulation where they are intended to influence diagnosis, monitoring, prognosis or treatment.
The regulator found varying levels of awareness among suppliers about when their software was subject to medical device requirements. Some products carried disclaimers stating they were not medical devices or were not intended for diagnosis or treatment, but the TGA said these statements were not sufficient to determine regulatory status.
Digital scribes limited to administrative tasks, transcription and documentation are generally unlikely to be medical devices.
However, some products may qualify as clinical decision support system (CDSS) software, including software subject to an existing conditional exemption from inclusion in the Australian Register of Therapeutic Goods (ARTG).
To qualify for that exemption, software must meet specific conditions, including providing information about how clinical recommendations are generated and not replacing a healthcare professional’s clinical judgement. Exempt CDSS products remain regulated medical devices.
The TGA said the rapid development of AI scribe products had made it difficult to establish their capabilities and intended uses, with information often spread across multiple sources and new features being introduced during the review.
It also raised concerns about clinicians’ ability to assess the reliability of AI-generated clinical recommendations where it was unclear how information had been selected, prioritised or generated.
The review did not involve testing the products, assessing their safety or performance, or examining their privacy and data protection arrangements.
The TGA said it would take a proportionate, risk-based approach to compliance, balancing patient safety with the need to avoid unnecessary disruption to clinical practice.
It has published further guidance to help manufacturers and suppliers determine whether their products are medical devices and understand their regulatory obligations.
The findings will also inform targeted compliance activities where digital scribe functionality meets the definition of a medical device.
The review follows the TGA’s broader examination of medical device software and AI regulation in 2025, which identified concerns about digital scribes generating diagnostic or treatment suggestions beyond their stated documentation purposes.
Add Comment