This presentation makes the case for urgent regulatory reform in response to the growing use of artificial intelligence (AI) medical scribes in Australian clinics. AI scribes—also known as ambient voice or virtual scribes—now routinely “listen in” on clinical consultations to generate records such as progress notes, discharge summaries, and referral letters. Despite their widespread adoption, surveillance capability and complex data-handling functions, these products remain effectively unregulated in Australia, excluded from oversight by the Therapeutic Goods Administration (TGA).
I argue that this regulatory gap exposes clinicians to significant legal risk and leaves patients without adequate protections. I will highlight how AI scribes raise issues under privacy, health records, and surveillance devices laws, with little formal guidance or governance. While professional bodies and indemnity insurers have attempted to fill the void, their efforts underscore, rather than resolve, the absence of enforceable standards.
In contrast, the UK has recently moved to regulate AI scribes under medical device law, with NHS England mandating compliance with formal standards and registration with the Medicines and Healthcare products Regulatory Agency. This shift suggests a regulatory pathway that Australia could follow.
I will conclude that the current reliance on self-regulation and professional discretion is no longer tenable. As AI scribes become embedded in clinical workflows, Australia must introduce clear, enforceable regulatory standards to ensure safety, accountability, and public trust in digital healthcare.