The Therapeutic Goods Administration (TGA) is considering changes to the regulation of digital mental health tools after a review found that some higher-risk products, including those using artificial intelligence, could be exempt from medical device oversight.
The review found that existing exclusion criteria may no longer be fit for purpose as digital mental health products become more widely used and increasingly complex.
Under current regulations, some digital mental health tools, including apps and websites offering assessment, therapy or self-management support, are excluded from TGA regulation if they are based on established clinical practice guidelines that users can review.
However, the TGA found that the exclusion criteria do not account for a product’s intended purpose, target users, clinical claims, outputs or the potential consequences of a malfunction.
This means higher-risk products could qualify for exclusion, leaving them outside the regulator’s oversight.
The review also found that consumers generally expected digital mental health tools to have undergone independent checks for safety and effectiveness, even when the products were not subject to TGA regulation.
The findings follow a broader review of software regulation, including AI, undertaken in 2024, which identified the digital mental health exclusion as an area requiring further examination.
One in three Australians using health software
Research commissioned by the TGA found that one in three Australians had used health software. Of those, half had used it without consulting a health professional and one-third had used it for their mental health.
The research included a survey of 1550 consumers, focus groups involving 98 consumers and 25 health software developers, a literature review and market mapping.
Three-quarters of consumers surveyed believed the benefits of health software outweighed the risks, with convenience and cost savings among the main attractions.
However, many assumed the products had been independently assessed for safety and effectiveness.
The research identified potential risks including misdiagnosis, ineffective treatment, increased health anxiety and privacy and data security issues.
It also found varying levels of regulatory compliance among developers. While some understood and followed the requirements, others were unaware of their obligations or chose not to comply.
Barriers included limited resources, poor understanding of the regulations and a perception that TGA compliance was not important.
Consultation planned for 2026
As part of the review, the TGA surveyed 121 users of digital mental health tools and 34 developers and suppliers, including some providers accredited against the National Safety and Quality Digital Mental Health Standards.
The responses suggested that relatively few products were being supplied under the existing exclusion, although the TGA noted that the information was voluntarily provided and individual products had not been assessed in detail.
The review was also informed by an expert group of around 20 representatives from mental health, digital health, consumer and regulatory organisations.
These included the Australian Commission on Safety and Quality in Health Care, the National Mental Health Commission and the Department of Health, Disability and Ageing.
The TGA said the findings would inform a consultation paper outlining potential changes to the regulation of digital mental health tools, to be released for public comment later in 2026.
No regulatory changes have yet been announced.
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