Wellness & Mental Health App Development in Sydney & Melbourne

It depends on what the app is intended to do. A general wellness app that does not diagnose, treat or monitor a condition may not be a medical device at all. On 16 March 2026 the TGA clarified an exclusion for some digital mental health tools, described in the next answer. Confirm your position with the TGA or a regulatory adviser before you build.

As reported by regulatory advisers, the TGA's 16 March 2026 clarification of item 14E says digital mental health tools, including CBT apps and websites, need not be on the ARTG if all four conditions are met: the tool is intended to support mental health, it is based on established clinical practice guidelines, the guidelines are clearly referenced in the software, and users can access them inside the product. Verify the detail with the TGA.

We build apps that support people, not apps that replace clinicians. Programs and advice should come from your qualified clinical advisers, and the app should say clearly what it is and is not. If you want clinical features, such as assessment or treatment claims, that changes the regulatory position, so decide it at the start. We are engineers, not clinicians, and we work with yours.

It should be designed for it, not surprised by it. We build safety rails: clear crisis options shown immediately, such as Lifeline on 13 11 14 and Triple Zero (000) for emergencies, a path to a human where your service has one, a record of safety events for clinical review, and honest wording that the app is not an emergency service. The National Digital Mental Health Standards expect systems to recognise and respond to acute deterioration.

Collect only what you need, ask for clear consent, encrypt data, let people delete their data, and be careful with analytics and advertising tools that could share health-related information with third parties. Health information is treated as sensitive information under the Privacy Act, so get legal advice on consent and disclosure. We do not describe any build as compliant or certified.

Possibly. The OAIC's Children's Online Privacy Code is due to be registered by 10 December 2026, with the start date not yet confirmed, and the draft says health services as defined in the Privacy Act would not be subject to it. Whether your app counts as a health service is a legal question. eSafety's industry codes also cover AI companion chatbots. Ask an adviser if under-18s may use your app.

It is possible, but it is the highest-risk feature in this category. eSafety has raised concerns about AI chatbots and self-harm content involving children. If you want one, we recommend a constrained design: answers drawn from clinician-approved content, no diagnosis, crisis hand-off, logging and human review. Sometimes the right advice is not to build it. Automated decision rules from 10 December 2026 may also apply.

It depends on the number of features, the content and clinician workflows, integrations and the safety work the risk calls for. A focused tracking or program app is a smaller build than a practitioner-connected platform. We scope before quoting.