About the exclusion review
Digital mental health tools (DMHTs) are software products, like apps and websites, that offer assessment, therapy, or self-management strategies to support mental health care. These tools are generally regulated by the TGA when they are used for diagnosis, prevention, monitoring, prediction, prognosis or treatment of a person and therefore meet the definition of a medical device. However, some DMHTs are 'excluded' (removed) from TGA regulation if they are based on established clinical practice guidelines that are displayed in a way that can be reviewed by the user.
In 2024, we reviewed our legislation for software, including artificial intelligence (AI), to determine if our approach to regulating these products is appropriate and if there were ways we could improve. One finding was that the DMHT exclusion may no longer be fit-for-purpose and should be reviewed.
The exclusion review involved:
- Market research to map the broad health software landscape
- Surveys of people who use, recommend, or develop DMHTs
- Meetings with experts and stakeholders.
The review is now complete and has informed the consultation paper on potential options for regulatory change. The consultation paper will be released in 2026 for public comment.
What we found
Since the exclusion was introduced, the availability and use of DMHTs have increased significantly. Products have become more diverse and complex compared to when the exclusion was put in place for example by using AI.
However, the exclusion criteria do not account for a tool’s intended purpose, user groups, output types, clinical claims or the consequences if it doesn’t work as intended. This means higher-risk products might now qualify for the exclusion, reducing regulatory oversight and therefore protection for users.
Consumers generally expect DMHTs to have been independently checked to ensure they are safe and effective. But excluded products are not subject to TGA oversight, so this expectation isn't being met.
Information gathered during the review suggests only a small number of DMHTs are supplied under the DMHT exclusion. The information was provided voluntarily by stakeholders to inform policy, and the review did not include detailed assessment of individual DMHTs.
The review process
Health software market research
We commissioned market research to better understand the Australian health software landscape more broadly, including consumer and developer attitudes. It included a literature review, landscape mapping, focus groups with 98 consumers and 25 health software developers, and a survey of 1,550 consumers.
Overall, 1 in 3 Australians used health software. Of these, half used it without talking to their health professional and one-third used it for their mental health.
Consumers valued the convenience and cost savings of health software, with 3 in 4 believing the benefits outweigh the risks. But many assumed software products were checked for safety and effectiveness, which may have led them to underestimate the risks.
The research found risks of health software include misdiagnosis, ineffective treatment, health anxiety, and privacy and data security risks.
Consumers felt that software developers, government authorities, and app stores share responsibility to ensure health software is safe and effective.
Developers engaged with software regulation in widely different ways. Some followed the rules, while others chose not to, or didn't know they had to. The research identified barriers to complying with regulations, such as limited awareness and resources, misunderstanding or deliberately misinterpreting the rules, and a perception that meeting TGA rules is not important.
Stakeholder surveys
We sent out surveys about DMHTs to understand:
- the types of DMHTs available in Australia,
- how much the exclusion is used as a pathway to supply DMHTs, and
- user behaviours and expectations.
We received 121 responses from DMHT users and 34 from developers and suppliers, which included some service providers accredited to the National Safety and Quality Digital Mental Health Standards.
Overall, the survey findings aligned with the broader health software research data. The survey responses also suggested that only a small number of DMHTs are supplied under the DMHT exclusion. More broadly, the surveys showed that there was a general lack of understanding of DMHT regulation.
Visit the DMHT user survey page for more detailed findings.
Expert group and stakeholder engagement
A dedicated expert group informed this review. The group is made up of around 20 members with expertise in mental health, development and use of DMHTs, consumer perspectives, and the digital health industry. It also includes representatives from the Australian Commission on Safety and Quality in Health Care, the National Mental Health Commission and the Mental Health and Suicide Prevention Division within the Department of Health, Disability and Ageing.
Discussions suggested the exclusion may create a gap in regulatory oversight because its criteria don't account for the growing range, complexity, and risks of available DMHTs. The expert group provided insight into options for regulation, the risks of DMHTs, and how to balance safety, access and innovation.
We also sought advice from the Technical Reference Group on Software as a Medical Device and AI and the Medical Devices Consumer Working Group, and regularly engage with regulators from other countries.
What's next
Using the information collected as a part of the review, the TGA will publish a consultation paper on options to address what we heard. More information on how to participate in the consultation will be available on the TGA consultation hub.
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Original publication
Original publication