Australia's TGA has completed its review of the Clause 14E exclusion for digital mental health tools. The exemption remains unchanged for now, with a regulatory options paper due for public consultation in 2026. Here is what the review found, what has not changed, and what manufacturers should prepare.
Published 26 October 2026, 19:36 — Category: Technical and Regulatory Guidance
Review complete, rules unchanged
On 19 October 2026, the Australian Therapeutic Goods Administration (TGA) updated its page on the review of the exclusion for certain digital mental health tools. The conclusion: the review has been completed, and its findings will inform a consultation paper on regulatory change options that will be released for public comment within 2026.
That statement needs to be read carefully. A completed review does not mean the rules have changed. The framework currently applied remains item 14E of Schedule 1 to the Therapeutic Goods (Excluded Goods) Order 2018, and the decision pathway set out by the TGA has not moved. What has changed is that the exclusion is now officially characterised as possibly no longer fit for purpose, and the matter moves into a public consultation phase.
What Clause 14E actually excludes
Under the TGA position, software meeting the definition of a medical device in section 41BD of the Therapeutic Goods Act 1989 is regulated in Australia unless it falls within one of the 15 categories of excluded software in Schedule 1. Item 14E is one of those categories and is specific to digital mental health tools.
The provision states that digital mental health tools (including cognitive behavioural therapy tools) that are based on established clinical practice guidelines, where those guidelines are cited in the software and displayed in a manner that users can access, need not be regulated by the TGA and therefore need not be entered in the Australian Register of Therapeutic Goods (ARTG).
The assessment is reduced to four questions:
- Is the software for mental health purposes?
- Does it follow established clinical practice guidelines?
- Are those guidelines cited within the software?
- Is the citation displayed so that users can clearly see it?
Where all four answers are yes, the exclusion may apply.
The TGA guidance page draws two further boundaries. Software that uses psychological methods to address physiological problems falls outside the exclusion — for example, a cognitive behavioural therapy app for managing diabetes symptoms. Novel therapies still in the clinical trial stage also fall outside and require a separate exemption application.
The gaps the regulator itself identified
The findings section of the review page is direct. Since the exclusion was introduced, the number and complexity of digital mental health tools have risen substantially, including products incorporating automated and algorithm-driven functionality. The exclusion criteria, however, do not consider a product's intended purpose, its user population, its output type, its clinical claims, or the consequences should it fail.
The conclusion is that higher-risk products may now qualify for the exclusion, which reduces regulatory coverage and, in turn, weakens user protection. The TGA also acknowledges a second gap: consumers generally assume that products of this kind have been independently checked for safety and performance, whereas excluded products are precisely those outside TGA oversight.
One data point is worth noting. Information gathered through the review indicates that few products actually rely on 14E for supply. That information was provided voluntarily by stakeholders for policy purposes, and the review did not carry out a detailed assessment of individual products. The nature of the problem is a mismatch between criteria and risk, not widespread use of an exemption pathway.
How the evidence was generated
Commissioned market research
The first strand was commissioned market research, comprising a literature review, market mapping, focus groups with 98 consumers and 25 health software developers, and a survey of 1,550 consumers.
The findings were as follows. Around one third of Australians have used health software; of these, half had not discussed it with their own health professional, and one third used it to address mental health issues. Three quarters of consumers considered the benefits to outweigh the risks, but many assumed the products had been checked for safety and performance, which may lead them to underestimate risk. The risks identified included misdiagnosis, ineffective treatment, health anxiety, and privacy and data security concerns.
Survey responses
The second strand was a questionnaire that received 121 responses from users and 34 from developers and suppliers, including service providers certified against the National Safety and Quality Digital Mental Health Standards. The results were consistent with the market research and exposed a common issue: limited understanding of the regulatory requirements applicable to digital mental health tools.
Expert and stakeholder input
The third strand involved experts and stakeholders. An expert panel of approximately 20 members covered mental health, product development and use, the consumer perspective and the digital health industry, and included representatives of the Australian Commission on Safety and Quality in Health Care, the National Mental Health Commission, and the Mental Health and Suicide Prevention Division of the Department of Health, Disability and Ageing. The TGA separately sought input from its technical reference group on software as a medical device and advanced algorithms, and from the Medical Devices Consumer Working Group.
What happens next
In the TGA's words, it will use the information gathered through the review to publish an options paper addressing these issues, with participation details to be announced on the TGA consultation platform. The stated timeframe is within 2026.
The implication for companies is straightforward. No change to registrations is required now, but preparation of supporting materials should begin. Once the options paper is published there is normally a comment period, and that is the only window in which to influence the shape of the final provisions. Waiting until the provisions are settled leaves only compliance cost.
What has not changed
Three points remain as they were. Item 14E is still in force and is still assessed against the same four questions. Entry in the ARTG is still required before supply in Australia unless a valid exclusion or exemption applies, and there is no relaxation of that requirement. And a guideline written in-house does not constitute an established clinical practice guideline — the TGA guidance states that guidelines must be widely accepted in Australian clinical practice and issued by an organisation or body representing health professionals; a single research paper will generally not qualify.
The date boundary also needs to be stated clearly. The TGA page carries an update date of 19 October 2026, but the text does not give a specific release date for the options paper and does not list the proposed options. Any statement claiming to know the content of those options currently goes beyond what has been officially published.
AIMEILI regulatory interpretation
The review outcome should be read as a policy signal rather than a regulatory change. The TGA has concluded that the design of item 14E is no longer aligned with the risk profile of the products now on the market — particularly software that generates outputs, makes clinical claims or is directed at populations with different risk exposures — yet it has deliberately left the provision intact pending consultation. That sequencing matters: the compliance obligation today is identical to what it was before 19 October 2026, and the exposure going forward lies in the transition, not in the current text.
Two features of the review are worth flagging for regulatory strategy. First, the TGA's own framing separates the scale of the problem from the direction of travel: it states that few products rely on 14E, while simultaneously concluding that the criteria are risk-blind. This suggests that the eventual options are likely to focus on tightening the qualifying conditions — for example by introducing intended-purpose, claims or output-based limitations, or by requiring some form of self-assessment or notification — rather than on removing an exclusion that is heavily used in practice. Second, the identified consumer misperception, where users assume excluded products have been independently verified, is the type of evidence that historically drives the TGA toward narrowing exclusions rather than retaining them.
Equally important is what the review does not do. It does not create a new exemption category, does not alter the section 41BD device definition, and does not change the requirement for ARTG inclusion where no exclusion applies. Products outside the four-question test — including psychological tools addressing physiological conditions and therapies still under clinical investigation — were never covered by 14E, and those positions are unaffected.
Business impact
For manufacturers and suppliers of digital mental health tools, the immediate action is a documented eligibility assessment. Each product should be mapped against the four 14E questions, with the evidence held on file: which established clinical practice guideline is relied on, who issued it, how it is cited in the software, and how the citation is displayed so that users can access it. Where any of the four elements is weak, the product should be treated as a candidate for ARTG inclusion rather than as an excluded good.
For distributors and local sponsors, the commercial risk crystallises at the point of supply. If the exclusion is narrowed in 2027 or later, products currently supplied without ARTG inclusion would need to transition, and transition timelines, technical documentation and conformity assessment evidence take time to assemble. Distributors should confirm now, in writing, the basis on which each mental health software product is supplied in Australia, and should track which suppliers are relying on 14E rather than on ARTG inclusion.
For regulatory affairs teams and CROs, the consultation window is the principal lever. Once the options paper is released, submissions can be supported with product-level evidence on risk classification, intended purpose and clinical claims, which is the type of input that shapes final provisions. Preparing that evidence base while the criteria are still unchanged is materially cheaper than retrofitting a regulatory strategy after the provisions are settled.
Finally, communications and labelling merit review. Because the review found that consumers assume excluded products have been independently verified, claim wording that could imply TGA approval, registration or assessment should be checked, particularly for products that are not ARTG-registered.
Sources and scope of verification
- TGA — Review of the exclusion for certain digital mental health tools (page updated 19 October 2026): https://www.tga.gov.au/products/regulations-all-products/tga-reforms/medical-devices-reforms/medical-devices-reforms-software-regulation/review-exclusion-certain-digital-mental-health-tools
- TGA — Understanding the digital mental health tool software conditional exclusion (four-question assessment and boundary examples), 1 February 2026: https://www.tga.gov.au/resources/guidance/understanding-digital-mental-health-tool-software-conditional-exclusion
- TGA — Medical devices reforms: software regulation (background on software and intelligent systems regulation reform), 1 February 2026: https://www.tga.gov.au/products/regulations-all-products/tga-reforms/medical-devices-reforms/medical-devices-reforms-software-regulation
Verification scope and access date: all three TGA pages above were reviewed in full, including the findings, review process and next steps sections of the review page, and the quotation of item 14E, the four assessment questions and the illustrative examples on the guidance page. Access date: 26 October 2026. Provision references (section 41BD of the Therapeutic Goods Act 1989; item 14E of Schedule 1), research sample sizes (focus groups with 98 consumers and 25 developers; 1,550 consumer survey responses; 121 user and 34 developer/supplier questionnaire responses; expert panel of approximately 20 members) and all percentages are taken from the text of those official pages.
Scope note: this article interprets publicly available regulatory information and does not constitute a conclusion or undertaking in respect of any specific product, company or registration application. The item 14E exclusion continues to apply under the current provisions, and the TGA has not published the proposed options or a legislative timetable. The statement that the review is complete refers to the conclusion of the review work and does not mean the rules have changed. Whether a specific product falls within the exclusion, and whether ARTG inclusion is required, must be determined on the official text and the facts of the individual case. Information may change with subsequent official updates.
Original date: 2026-10-19
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