TGA seeks input on Digital Mental Health Tools

Survey link: Digital Mental Health Tools Regulatory Environment Survey

Survey open: 7 October 2025 - 1 December 2025

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 Therapeutic Goods Administration (TGA) is reviewing the regulations that apply to software-based medical devices – including digital mental health tools (DMHTs) – that are used to screen, diagnose, monitor and/or treat patients experiencing mental health conditions.

We are seeking information about DMHTs currently available in Australia, including the:

• types of DMHTs available
• intended user groups
• mental health conditions DMHTs are used for
• functions performed by DMHTs.

Information collected in this survey will not be used for conducting compliance or enforcement activities.