Clinical AI governance under TGA, AHPRA, OAIC, and ACSQHC.

The TGA's Software as a Medical Device (SaMD) grace period ended November 2024. Clinical decision support systems, AI scribes with diagnostic features, and predictive triage algorithms may require ARTG registration. The Therapeutic Goods Administration classifies AI software using IMDRF risk factors. Adaptive AI and LLMs create new classification questions, and post-market surveillance for AI that evolves after deployment is now expected.

AHPRA's August 2024 guidance is clear: practitioners are "ultimately responsible" for AI used in their practice. That covers checking AI scribe accuracy, understanding bias risks for Aboriginal and Torres Strait Islander communities, holding professional indemnity insurance that covers AI use, and verifying AI-generated clinical documentation. Nearly 1 in 4 GPs are already using AI scribes, and many organisations lack policies that consistently translate AHPRA obligations into practice.

Health information is classified as "sensitive information" under the Privacy Act and the Australian Privacy Principles. AI scribes process consultation recordings. Diagnostic imaging AI analyses patient scans. The OAIC has issued dual AI guidance for developing and using AI products. APP 8 governs cross-border data flows to offshore AI providers. The National Health Privacy Rules 2025 add new requirements for claims information, and My Health Record mandatory breach notification applies to the OAIC and System Operator.

The Australian Commission on Safety and Quality in Health Care released pragmatic AI guides for clinicians in August 2025. The guides build on the NSQHS Standards and recommend a "before-while-after" governance approach: confirm the clinical use case before implementation, build on existing patient safety and digital health governance during deployment, and maintain ongoing monitoring. 88% of consultation respondents said healthcare AI decisions should always have a "human in the loop."