Digital Mental Health Tools Regulatory Environment Survey

Closes 1 Dec 2025

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Overview

We are currently reviewing the regulation of digital mental health tools (DMHTs) in Australia. As part of our work, we are seeking more information about:

  • the types of tools that are available
  • who these tools are intended for
  • the mental health conditions these tools address
  • what these products do.

This survey is intended for people who:

  • develop DMHTs
  • supply DMHTs for others to deploy or use
  • deploy DMHTs 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.

Definitions

These definitions are intended to clarify our meaning in the context of this survey only and may differ from official TGA policy or legal definitions.

For legislative definitions of these terms and how they apply in the regulation of software-based medical devices, please consult our How the TGA regulates software-based medical devices guidance.

Deploy/Deployer/Deploying/Deployment:

The entity responsible for deciding to use or incorporate DMHTs as part of clinical practice or workflow. Deployers may be:

  • health facilities that make a DMHT available to clinicians as part of a standard clinical workflow or policy
  • individual clinicians who choose to use a DMHT as part of their clinical practice.

Develop/Developer/Developing/Development:

See ‘Manufacturer’.

Manufacturer:

Refers to the person or company responsible for developing a software product. The manufacturer is responsible for engaging in or arranging the design, production, packaging and labelling of software. This term may be used interchangeably with software ‘developer’.

For the legal definition of ‘manufacturer’ as relevant to the regulation of therapeutic goods, please refer to Section 41BG of the Therapeutic Goods Act 1989 (the Act).

Supply:

The act of making arrangements for, or actively facilitating access to, your software product, including by consumers.

For the legal definition of ‘supply’ as relevant to the regulation of therapeutic goods, please refer to Section 3 of the Act.