Digital Mental Health Tools Regulatory Environment Survey

Overview

There is growing interest in using software and artificial intelligence (AI) in healthcare delivery, 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.

Why your views matter

This survey aims to gather information about DMHTs currently available in Australia, including how these tools are developed, supplied and used.

Please complete the survey only if you are involved in:

• the development of DMHTs
• supplying DMHTs for other people to deploy
• deploying DMHTs for use through publicly available platforms like app stores, websites, or in healthcare settings for use by professionals.

PLEASE NOTE – Your responses will ONLY be used for the following purposes:

• to inform further refinements to our regulatory framework; 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.