Governance · Australia
Digital mental health tools: TGA review points to possible regulatory change
TGA’s completed review is informing consultation options for digital mental health regulation.
The review considers whether the existing exclusion remains appropriate as products become more complex, including through AI. Consultation options are being developed; the review itself does not repeal the exclusion.
Before relying on an exclusion, record the tool’s intended purpose, clinical claims and evidence against current criteria. Assign a reviewer to monitor consultation and any later legal changes. Do not describe proposed policy options as requirements already in force.
Official source
TGA · Source updated:
NORMIX editorial summary and practical commentary. Check the official source for scope and current requirements.
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