TGA Digital Mental Health Tools Consultation Update
Australia’s TGA digital mental health tools consultation has moved from open surveys to published user feedback and clearer exclusion guidance. Developers and sponsors of apps that screen, diagnose, monitor, or treat mental health conditions now have a denser TGA primary record on when software is a medical device—and when Item 14E can carve it out.
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Key Takeaways
- TGA’s developer/supplier DMHT survey ran 7 October 2025–11 February 2026 after an 18 December 2025 extension from the original 1 December close.
- A parallel user survey (17 December 2025–11 February 2026) drew 121 responses; 78% of consumers wanted pre-market checks or approval.
- TGA regulates DMHTs that meet the medical-device definition under section 41BD and do not meet Item 14E exclusion conditions.
- March 2026 guidance restates Item 14E: guideline-based DMHTs with referenced, displayed, reviewable clinical practice guidelines may be excluded from ARTG.
TGA DMHT review at a glance
| Field | Detail |
|---|---|
| Regulator | Therapeutic Goods Administration (TGA), Australia |
| Topic | Digital mental health tools (DMHTs) as software-based medical devices |
| Supplier survey | 7 Oct 2025 – 11 Feb 2026 (extended 18 Dec 2025) |
| User survey | 17 Dec 2025 – 11 Feb 2026; 121 responses published |
| Trigger | TGA AI Review Report: low-risk DMHT rules no longer appropriate |
| Key exclusion | Item 14E, Therapeutic Goods (Excluded Goods) Determination 2018 |
| Next signal | Possible future public consultation on software-exclusion refinements |
What did the TGA open for feedback?
On 7 October 2025, TGA published that it is reviewing regulations for software-based medical devices, including DMHTs used to screen, diagnose, monitor, and/or treat mental health conditions, according to TGA’s news article seeking DMHT input.
The linked Survey on Digital Mental Health Tools consultation page asked developers, deployers, and suppliers about DMHT types, intended users, mental health conditions, and functions. TGA said responses would inform whether the regulatory framework needs refinement and create a contact list for future consultations—not for compliance or enforcement.
Page history on that consultation shows an 18 December 2025 update extending the end date to 11 February 2026 from 1 December 2025. The hub also points to the July 2025 AI software review report as the policy backdrop.
What did users and clinicians say?
TGA’s Digital Mental Health Tools User Survey feedback page (feedback updated 10 June 2026) summarises the 17 December 2025–11 February 2026 user survey. It received 121 responses: 42 consumers (35%) and 79 professional users (65%).
Consumers most often used DMHTs for support or monitoring, information seeking, and treatment or management, and mainly accessed tools via app stores or websites. Most consumers (78%) said DMHTs should be checked or approved before public availability and favoured a moderate, risk-based approach. Only six consumer respondents felt they shared responsibility for assessing safety; most pointed to government and suppliers.
Professional users most often targeted anxiety, depression, and general mental health or wellbeing. They prioritised evidence of effectiveness, privacy, intended use, and peer recommendations. Sixteen professional respondents (22%) reported observing or experiencing an adverse event with a DMHT. Nearly all professional users (97%) wanted to know if a tool was independently assessed for safety and performance.
TGA says insights will inform its DMHT review under the AI legislative review report, and that findings may support a future public consultation on refinements to software exclusions.
When does TGA regulate a DMHT?
TGA’s product page on digital mental health tools (DMHTs) (last updated 11 February 2026) states TGA regulates DMHTs when they meet the medical-device definition under section 41BD of the Therapeutic Goods Act 1989 and do not meet Item 14E exclusion criteria in Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018.
A DMHT is likely a medical device if intended to diagnose or screen for a mental health condition, monitor symptoms or treatment, or provide therapeutic interventions such as cognitive behavioural therapy. Software limited to displaying guidelines, scheduling, symptom recording without analysis, telehealth facilitation, or health-record updates is not regulated as a device on that page’s examples.
TGA also separates product regulation (TGA/ARTG) from the Australian Commission on Safety and Quality in Health Care’s National Safety and Quality Digital Mental Health Standards, which focus on service providers. Both frameworks can apply.
How does the Item 14E exclusion work?
Guidance published and last updated 16 March 2026, Understanding the digital mental health tool software conditional exclusion, walks sponsors through Item 14E. Exclusion may apply if the software is for mental health, follows an established clinical practice guideline, references that guideline, and displays the reference so users can review it.
TGA warns that novel treatments still in clinical trials are not excluded and may need an exemption pathway. The guidance includes worked examples, such as a CBT website that links RANZCP guidelines and can therefore be excluded if other conditions are met.
For APAC digital-health teams, the practical test is documentation: if the algorithm or therapy path is not visibly tied to an established Australian clinical guideline inside the product, ARTG inclusion is the safer planning assumption.
What remains open after the surveys?
The supplier survey page said a summary would appear on the same consultation page after close; the user-survey hub already publishes aggregate feedback. TGA has not, in these pages, announced final legislative text changing Item 14E. It has signalled that survey evidence will guide advice to government and may precede further consultation on exclusion refinements.
Claims about specific commercial apps’ ARTG status are out of scope here unless listed on ARTG. Sponsors should map intended purpose against section 41BD and Item 14E before Australian supply.
Related NovaPharma coverage includes TGA Australia drug-approval coverage, Nektar pipeline regulatory context, and Leqembi real-world LEADER study notes.
Frequently Asked Questions
What did the TGA ask about digital mental health tools?
From 7 October 2025 to 11 February 2026 (extended from 1 December 2025), the TGA surveyed developers, deployers, and suppliers of digital mental health tools (DMHTs) about product types, intended users, conditions treated, and functions, to inform whether software medical-device rules need refinement.
What did DMHT users tell the TGA?
In a user survey open 17 December 2025–11 February 2026, TGA received 121 responses (42 consumers, 79 professionals). Most consumers (78%) said DMHTs should be checked or approved before public availability; 97% of professional users wanted to know if a tool was independently assessed for safety and performance.
When is a DMHT excluded from TGA regulation?
Under Item 14E of the Therapeutic Goods (Excluded Goods) Determination 2018, software that is a DMHT (including CBT tools) based on established clinical practice guidelines that are referenced and displayed in a user-reviewable way may be excluded from ARTG inclusion. Novel treatments still in clinical trials are not excluded.
Primary Sources
- TGA: Survey on Digital Mental Health Tools (consultation)
- TGA Consultation Hub: Digital Mental Health Tools User Survey feedback
- TGA: Digital mental health tools (DMHTs) product guidance
- TGA: Understanding the DMHT software conditional exclusion (Item 14E)
- TGA news: seeks input on Digital Mental Health Tools (7 Oct 2025)
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