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AI in Australian healthcare

Healthcare is Australia's most regulated setting for AI. The TGA treats AI software as a medical device whenever its intended purpose is clinical, Ahpra holds practitioners personally accountable for AI outputs, and health information attracts the strictest privacy rules in the Privacy Act. Reforms flagged by the TGA's AI review are in progress, and AI scribes are an active compliance focus.

TGAAhpra / National BoardsOAICDept of HealthACSQHC

Last reviewed August 2026. Every entry links to its official source.

The rules

What applies today

The TGA regulates AI-enabled software as a medical device under the Therapeutic Goods Act whenever its intended purpose is diagnosis, prevention, monitoring, prediction, prognosis or treatment. The framework is technology agnostic: intended purpose, not the presence of AI, triggers regulation, and regulated devices must be in the ARTG before supply. The guidance covers scope creep (an update adding clinical features can turn a non-device into a device), off-label use, evidence expectations for training data and limits on synthetic validation data.

Who this affects: Developers and suppliers of AI software with a clinical purpose, including LLM chatbots and clinical decision support.

Latest updates

What changed recently

  1. The Australian Alliance for AI in Healthcare launched its third National Policy Roadmap for AI in healthcare, covering governance, workforce capability, regulation and AI safety. An industry and academic advocacy document rather than a regulator instrument.

    AAAiH: 3rd National Policy Roadmap

  2. The National AI Centre published updated implementation guidance for its Guidance for AI adoption, the voluntary six-practices governance framework that evolved the Voluntary AI Safety Standard.

    Guidance for AI adoption (industry.gov.au)

  3. The TGA published updated guidance on AI and medical device software regulation, clarifying when AI products including LLM chatbots and clinical decision support are medical devices, and how scope creep and off-label use trigger regulation.

    TGA AI guidance

  4. The TGA updated its digital scribes guidance: transcription-only scribes are not devices, but scribes adding diagnostic or treatment suggestions are, and must be in the ARTG before supply.

    TGA digital scribes guidance

Getting ready

Compliance checklist

  • Classify every AI tool against the medical device definition by its intended purpose, and confirm ARTG inclusion before deployment if it qualifies. See the rule

  • Re-assess after every software update. A new feature, like a scribe that starts suggesting diagnoses, can change intended purpose and require TGA approval before rollout. See the rule

  • Keep practitioners accountable and in the loop: human judgment applied to every AI output, and tools tested for fitness for purpose before clinical use. See the rule

  • Obtain and record informed patient consent where AI tools take patient data as input, especially consultation-recording scribes. See the rule

  • Do privacy due diligence before adopting any AI product: no health information in public AI tools, a valid basis for secondary use, and a privacy policy that discloses AI use. See the rule

  • Stand up organisational AI governance: an accountable owner, a risk treatment plan, pre-deployment testing and incident monitoring including notifiable data breaches. See the rule

  • Equip clinicians with the ACSQHC AI Clinical Use Guide and its ambient-scribe safety scenario, and check professional indemnity insurance covers AI use. See the rule

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