We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Feedback can be provided through our Consultation Hub while the survey is open.
After the closing date, submissions will be reviewed, and a summary will be available on the same consultation page.
About this survey
There is growing interest in using software and artificial intelligence (AI) in healthcare settings, including where it is used to support people with mental health conditions.
The TGA’s AI Review Report published earlier this year found that the regulation of certain low-risk digital mental health tools (DMHTs) is no longer appropriate, and urgent review is required. In response, we are reviewing the regulations that apply to software-based medical devices – including DMHTs – that are used to screen, diagnose, monitor and/or treat patients experiencing mental health conditions.
To assist in this work, we are seeking information about DMHTs currently available in Australia. We are seeking input from stakeholders responsible for developing, deploying or supplying DMHTs to help us better understand these tools, including the:
- types of DMHTs available
- intended users
- mental health conditions DMHTs are used for
- functions performed by DMHTs.
Your responses to the survey will ONLY be used for the following purposes:
- to consider if further refinements to regulatory framework are needed; and
- as a point of contact for future consultation on refinements that may impact you.
Information collected in this survey will not be used for conducting compliance or enforcement activities.
More detail about this consultation is provided at the TGA consultation Hub.