Digital Mental Health Tools User Survey

The Therapeutic Goods Administration (TGA) sought input from users of digital mental health tools (DMHTs) through a survey conducted between 17 December 2025 and 11 February 2026.

The survey was open to individuals who use DMHTs themselves (consumers), and professional users, like health professionals and service providers.

The purpose of the survey was to better understand how DMHTs are being used in Australia. Specifically, we asked for feedback on:

• the types of DMHTs used and how they are accessed
• how users decided whether a DMHT is safe and effective
• what information supports decision-making when choosing a DMHT
• how DMHTs have influenced clinician-patient interactions
• any concerns about the safety or effectiveness of DMHTs
• expectations for the regulation of DMHTs in Australia

A total of 121 responses were received: 42 consumers (35%) who use DMHTs and 79 professional users (65%), including healthcare professionals, service providers, and others working in organisations that recommend DMHTs.

Consumer response summary:

Consumers described DMHTs broadly as any digital products that support their mental health and wellbeing. Examples spanned from general health and wellbeing apps, biometric and mood tracking tools, mindfulness and meditation apps to generative AI (artificial intelligence) tools. These tools were claimed to be used primarily for support or monitoring (29 responses), followed by information seeking (22 responses) and treatment or management (18 responses). Most consumers accessed DMHTs via online app stores or websites (32 and 20 responses, respectively).

When deciding whether to use a DMHT, the information most commonly looked for was cost, reviews and ratings, who developed the tool, and whether it works. Many respondents (51%) indicated that their healthcare professional was not involved in their use of DMHTs. The strongest factor for building trust was feeling better after using a tool (25 responses).

Consumers indicated they expect DMHTs to be subjected to oversight to ensure safety, quality, and performance. Most respondents (78%) considered that DMHTs should be checked or approved before being made publicly available and favoured a moderate, risk-based regulatory approach.

While consumers wanted flexibility and choice, only 6 respondents felt they had a share in the responsibility to assess whether DMHTs are safe. Responsibility for this was primarily attributed to the Australian Government (23 responses), followed by the companies that develop and supply DMHTs (19 responses). Respondents preferred information about quality, safety and performance to be provided through a simple, recognisable visual indicator, similar to the Heart Foundation’s tick (29 responses). A publicly available database or a list of government-endorsed DMHTs were also supported (19 and 18 responses, respectively).

When ranking priorities, consumers placed safety and prevention of harm highest, followed by expert‑based advice, regular expert review, ease of access and use, and broad availability.

Professional user response summary:

Professional users included healthcare professionals, service providers, and others working in organisations that recommend DMHTs. The 3 most common conditions professional users targeted with DMHTs were anxiety, depression, and general mental health/wellbeing (62, 57, 50 responses, respectively).

When selecting DMHTs, professional users prioritised evidence of effectiveness, alongside privacy and data protection considerations, intended use and recommendations from colleagues or professional bodies. Most respondents indicated they assessed effectiveness through review of published evidence (57 responses), alignment with clinical guidelines (56 responses), and feedback from patients or clients (40 responses). 

Professional users identified privacy and data breaches, incorrect advice or diagnosis (including overdiagnosis) and deterioration in a person’s mental health as the most significant risks associated with DMHTs. Sixteen respondents (22%) reported having observed or experienced an adverse event with a DMHT.

Professional users most strongly attributed responsibility for ensuring DMHT safety and performance to the Australian Government (58 responses), followed by companies who supply or make the tools available (55 responses) and software developers who create them (52 responses). Consistent with consumer responses, professional users (97%) wanted to know if a DMHT was independently assessed for safety and performance, with a recognisable visual mark rated most highly. Public databases or clear statements of approval status on the app stores or websites, were also supported.

When ranking priorities for DMHT safety and regulation, professional users placed safety and prevention of harm first, followed by effectiveness, alignment with best‑practice clinical guidelines, and ease of access and use.

Insights from this survey will inform the TGA’s review of DMHTs, being undertaken as part of implementing the outcomes of TGA’s legislative review report, Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI), published in July 2025.

The review will assess whether current software exclusions and oversight for DMHTs remain appropriate. This work is being undertaken in collaboration with experts who provide input on risks associated with DMHTs and the need for any regulatory refinements. Findings from this work may be used to inform a future public consultation on potential refinements to the current software exclusions framework.