Consultation: Reviewing the exclusion for certain digital mental health tools

Overview

We want your feedback on options for the future regulation of certain digital mental health tools (DMHTs).

Digital mental health tools (DMHTs) include apps, websites and chatbots that provide assessment, therapy or self-management strategies for mental health conditions. They are playing an increasingly important role in how Australians access mental health care.

Many DMHTs are regulated by the Therapeutic Goods Administration (TGA) as medical devices. However, some are currently excluded from regulation. To qualify for the exclusion, a DMHT must be based on established clinical practice guidelines. These guidelines must also be referenced and displayed within the software in a way that users can review.

Since the exclusion was introduced in 2021, DMHTs have become more diverse and complex. They now include a broad range of mental health conditions such as depression, anxiety and attention deficit hyperactivity disorder. Some also offer more advanced functionality, including personalised recommendations and artificial intelligence (AI).

Some DMHTs can be accessed directly by consumers without the involvement of a health professional. They may improve access to mental health support. However, they may also increase the potential risks associated with inaccurate outputs, recommendations or advice.

We are seeking feedback on 3 options for the current exclusion for certain DMHTs: keeping it, removing it or modifying it.

Download the consultation paper linked at the bottom of this page under "Related". 

Why your views matter

Your feedback will help us understand the potential benefits and impacts of each option, for consumers, health professionals, developers and other stakeholders.

It will inform our advice to the Australian Government on the future regulation of DMHTs.

The consultation paper is linked at the bottom of this page under "Related".