(Cth) Ensure AI-Enabled Digital Mental Health Tools are Regulated by the TGA
Author: Jake Young, Max Richter-Weinstein, Alex Day, Shera Subba & Dynuk Devamulla | Publish date: 24/9/2026
Content Warning: Mental Health (Psychosis and AI-generated psychological support content)
P: In Australia, some Artificial Intelligence (AI) digital mental health tools are excluded from therapeutic goods regulation as medical devices.
S: The Minister for Health should repeal Item 14E of Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018 (Cth), to ensure all digital mental health tools using AI-driven features are regulated as medical devices by the Therapeutic Goods Administration.
E: Jen Nixon, National Mental Health Consumer Alliance (2026): ‘Digital Mental Health Tools should be subject to regulation by the Therapeutic Goods Administration’.
Problem Identification:
Under the Therapeutic Goods Act 1989 (Cth), the Therapeutic Goods Administration (TGA) regulates Digital Mental Health Tools (DMHTs) as medical devices. However, according to the National Mental Health Consumer Alliance (NMHCA), which advocates for mental health service users, this is only the case when they are ‘intended for diagnosis, prevention’ and other similar purposes. Additionally, Item 14E of Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018 (Cth) excludes ‘digital mental health tool[s that are] based on established clinical practice guidelines’.
The TGA noted that this means that some DMHTs used in clinical practice ‘have therefore not been assessed for quality, safety or performance before deployment and use.’ According to the NMHCA, ‘this regulation model leaves out several AI and digital tools such as AI minute takers, Chatbots and other tools that can be used for mental health supports.’ The TGA further stated that the exclusion of DMHTs is ‘no longer appropriate and urgent review is needed’.
Context:
DMHTs refer to ‘software products including apps, websites, or platforms offering assessments, therapy, or self-management strategies that support mental health care.’ They may take the form of online therapy portals, AI chatbots, virtual reality (VR) programs and more, and ‘incorporat[e] AI driven features’ (e.g. mental health apps with AI-based mood analysis). The NMHCA explained that ‘there is currently no transparent or reliable mechanism for users to identify whether a DMHT has been subject to regulation’.
The TGA stated that it follows a risk-based regulation process where ‘regulation is only used where absolutely needed’. They assess therapeutic goods ‘before the product can be made available in Australia and [provide] safety monitoring once it is available’ based on a product's associated risk. They added that this ‘risk-based approach to regulation allows greater effort to be directed to those therapeutic goods which pose greater risks to a patient's health’.
The Australian Commission on Safety and Quality in Health Care has also set out voluntary National Safety and Quality Digital Mental Health Standards (2020).
Arguments:
The NMHCA argued that AI-enabled DMHTs may provide ‘potentially incorrect and harmful information’, ‘exacerbat[ing] … pre-existing conditions’ and ‘worsen[ing] mental health and wellbeing’. Talkspace, an online mental health platform, noted that AI DMHTs generate responses from training data and lack the ‘lived experience, clinical training and intuition [of] a human therapist’. A news article on a 2025 Stanford University study reported ‘that AI therapy chatbots … could also contribute to … dangerous responses’. Additionally, academic Keith R. Head, LMSW, (2025) revealed that users of AI tools often ‘anthropomorphize [sic] AI systems, forming parasocial attachments that can lead to delusional thinking, emotional dysregulation and social withdrawal.’ An ABC News article reported that a WA woman was hospitalised with psychosis after an AI chatbot ‘enabled some of [her] more harmful delusions … [including that] all her friends were “preying on [her] downfall”.’
Castro and McLaughlin (2019), from the Information Technology and Innovation Foundation, argued that regulating emerging AI broadly could ‘limit innovation and discourage adoption’ and recommended instead ‘sector-specific’ regulations to ‘prevent specific harms’. However, Jen Nixon from the NMHCA stated that ‘given the potential for harm that these tools can inflict on users, safety is paramount’. The Australian Medical Association (AMA) added that ‘even low-risk software can pose patient harm.’
Advice/Solution Identification:
Jen Nixon, the National Policy and Research Manager of the NMHCA (2026), has called for ‘Digital Mental Health Tools [to] be subject to regulation by the Therapeutic Goods Administration’. The NMHCA further stated that ‘harm can be minimised if the developers of AI and AI-enabled DMHTs embed key ethical and legal principles’.
Precedent:
If Australia were to enact this reform, it would be world-leading to the best of the authors’ knowledge.
Public Support of the Solution:
(This list reflects publicly stated positions and should not necessarily be taken as endorsement of this specific brief.)
Jen Nixon - National Policy and Research Manager at NMHCA (see acknowledgements)
Broad Support
The Royal Australian and New Zealand College of Psychiatrists - They have recommended ‘the creation of an AI healthcare oversight body’ and a regulatory framework with evaluation and error-reporting mechanisms for AI tools in mental healthcare. However, they have not explicitly called for AI DMHTs to be brought under TGA regulation.
Avant Mutual - They have advocated for mandatory minimum standards for ‘AI tools used in healthcare that fall outside the [TGA's] regulatory framework … [covering] privacy and security, risk management and insurance.’ However, they have not explicitly called for AI DMHTs to be brought under TGA regulation.
News Coverage:
The Conversation - “Digital mental health programs are inexpensive and innovative. But do they work?” This article discussed how digital mental health programs improve access to affordable mental health support, where many people struggle to access traditional support systems. However, it should complement traditional face-to-face care and not replace it. By: Bonnie Clough, Aarthi Ganapathy and Lou Farrer | 14 March 2025 - Read the article here.
The Medical Republic - “Digital mental health tools in TGA crosshairs”. This article mentioned that the TGA was considering stronger regulation of digital mental health tools to ensure their safety and effectiveness while maintaining their accessibility. By: Lincoln Tracy | 11 December 2024 - Read the article here.
Psychiatry Online - “Digital Mental Health Apps Need More Regulatory Oversight”. This article argued for the FDA to regulate digital mental health apps. By: Nick Zagorski | 22 November 2023 - Read the article here.
ABC News - “Mental health apps are largely unregulated in Australia. Some experts fear vulnerable users could be harmed”. This article argued that the lack of regulation of mental health apps was concerning and should be addressed to ensure no harm to users. By: Sam Nichols | 2 June 2023 - Read the article here.
InSight+ - “Framework for digital mental health services”. This article mentioned that regulation should support the integration and coordination of digital mental health services within a broader support system. By: Helen Christensen, Natalie Reily, Caitlin Connell, Dunkan Yip and Sam Harvey | 9 August 2021 - Read the article here.
Where to go to learn more:
(2025) Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI) | Therapeutic Goods Administration - This review found the DMHT exclusion is ‘no longer appropriate’, and the need for a review of both TGA AI tool regulations as well as international AI tool regulations. View the report here.
(2023) Understanding digital mental health device rules | Therapeutic Goods Administration - This report explained the current Item 14E exclusion and when a digital mental health tool is regulated as a medical device. View the webpage here.
(2025) Digital futures in mind: Why lived experience collaboration must guide digital mental health technologies | Gilbert et al. - This article argued that lived-experience collaboration must guide the design and regulation of DMHTs. View the article here.
(2025) Safe and Responsible Artificial Intelligence in Health Care – Legislation and Regulation Review, Final Report | Department of Health, Disability and Ageing - This report provided the whole-of-government context for the TGA's review. View the report here.
(2020) National Safety and Quality Digital Mental Health (NSQDMH) Standards | Australian Commission on Safety and Quality in Health Care - This report outlined the voluntary safety and quality framework that currently sits alongside the exclusion. View the standards here.
Therapeutic Goods (Excluded Goods) Determination 2018 (Cth) - Read the full Determination here.
Human Perspective:
CW: mental health issues, anxiety and panic attacks
Sam is a university student who has been struggling with anxiety and severe stress. Looking for support, he downloaded a popular mental health app with a chatbot that promised personalised therapy and evidence-based treatment. Reassured by the app's advertising and accessibility, he began relying on it daily instead of speaking to a doctor or counsellor. In the weeks that followed, Sam found it increasingly difficult to concentrate in class, meet assignment deadlines and maintain friendships. Although he regularly told the app's chatbot he felt overwhelmed and hopeless, the advice it provided only made his depression worse. It did not refer him to an appropriate service for him to access adequate support. Sam thought he was taking the right steps and continued to use the app until a panic attack during an exam forced him to seek professional help. When he finally met with a psychologist, he learned that his symptoms had become more severe over several months and required a level of support the app was not equipped to provide. Sam didn’t know that the app wasn’t regulated and was unable to deliver the support he needed.
To protect the anonymity of those involved, this is a fictionalised account drawn from an amalgamation of real-life stories, experiences and testimonials gathered during the research process for this brief. Any resemblance to actual individuals is purely coincidental.
Conflict of interest/acknowledgment statement:
Nixon, J. allowed for her statement on the necessity of DHMTs being regulated by the TGA to be used in this brief, with permission granted on 28th May 2026.
Support
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Disclaimers
Please review all FORE disclaimers here.
Reference list:
Australian Commission on Safety and Quality in Health Care. (2020). National Safety and Quality Digital Mental Health Standards. https://www.safetyandquality.gov.au/sites/default/files/resources/attachments/national-safety-and-quality-digital-mental-health-nsqdmh-standards.pdf
Australian Medical Association. (2024, October 22). AMA submission to the TGA consultation on clarifying and strengthening the regulation of Artificial Intelligence.
Castro, D., & McLaughlin, M. (2019, February 4). Ten Ways the Precautionary Principle Undermines Progress in Artificial Intelligence. Information Technology and Innovation Foundation. https://itif.org/publications/2019/02/04/ten-ways-precautionary-principle-undermines-progress-artificial-intelligence/
Head, K. R. (2025). Minds in Crisis: How the AI Revolution is Impacting Mental Health. Journal of Mental Health & Clinical Psychology, 9(3), 34–44. https://www.mentalhealthjournal.org/articles/minds-in-crisis-how-the-ai-revolution-is-impacting-mental-health.html
Kalle, P. (2026, January 23). Digital mental health technologies and the changing face of regulation. Pharmaphorum. https://pharmaphorum.com/digital/digital-mental-health-technologies-and-changing-face-regulation
McLennan, A. (2025, August 12). AI chatbots accused of encouraging teen suicide as experts sound alarm. ABC News. https://www.abc.net.au/news/2025-08-12/how-young-australians-being-impacted-by-ai/105630108
National Mental Health Consumer Alliance. (2026). AI and Digital Mental Health Tools in Australia: Risks, Regulations and Consumer Leadership. https://nmhca.org.au/__static/jdj5jdewjgtjnnyzugvqodniljcztvbr/position-paper-ai-and-dmht-in-australia-final.pdf
Talkspace. (2026, April 22). Is AI Therapy Safe? Exploring the Potential Dangers. https://www.talkspace.com/blog/is-ai-therapy-safe/
Therapeutic Goods Administration. (2026). Digital mental health tools (DMHTs). Department of Health, Disability and Ageing. https://www.tga.gov.au/products/medical-devices/software-and-artificial-intelligence-ai/overview/types-software-based-medical-devices/digital-mental-health-tools-dmhts
Therapeutic Goods Administration. (2025). Report: Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI). Department of Health, Disability and Ageing. https://www.tga.gov.au/resources/consultation/consultation-clarifying-and-strengthening-regulation-artificial-intelligence
Therapeutic Goods Administration. (2015). Product regulation according to risk. Department of Health, Disability and Ageing. https://www.tga.gov.au/products/regulations-all-products/regulation-essentials/regulation-basics/product-regulation-according-risk
Therapeutic Goods (Excluded Goods) Determination 2018 (Cth). https://www.legislation.gov.au/F2018L01350/latest/text
Wells, S. (2025, June 11). Exploring the Dangers of AI in Mental Health Care. Stanford University, Human-Centered Artificial Intelligence (HAI). https://hai.stanford.edu/news/exploring-the-dangers-of-ai-in-mental-health-care
Young, J., Maclean, C., Do, A., Nixon, J. (2026). Meeting regarding regulating AI DMHTs [Video interview with National Policy and Research Manager, NMHCA]. 2026, June 19.
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