Digital mental health tools (DMHTs) are software products including apps, websites, or platforms offering assessments, therapy, or self-management strategies that support mental health care.
When we regulate digital mental health tools
We regulate DMHTs when they:
- meet the definition of a medical device under section 41BD of the Therapeutic Goods Act 1989 and
- do not meet the exclusion criteria for certain DMHTs described in Item 14E of Schedule 1 in the Therapeutic Goods (Excluded Goods) Determination 2018.
A DMHT is likely to meet the definition of a medical device if it is intended to:
- diagnose or screen for a mental health condition
- monitor symptoms or treatment
- provide therapeutic interventions, such as cognitive behavioural therapy.
Software developers, manufacturers and sponsors must ensure DMHTs that are regulated by us comply with all relevant regulatory requirements.
When digital mental health tools are not regulated
Software, including DMHTs, is not regulated by us when functionality is strictly limited to non-clinical purposes.
This includes software that only:
- displays clinical guidelines or health information
- registers users or schedules appointments
- records or tracks symptoms without analysis
- facilitates telehealth consultations
- generates or updates digital health records.
Similarly, software is not regulated when it only:
- replicates published clinical practice guidelines or checklists without diagnostic, monitoring or treatment functions
- enables uploading of results to a database for later review, without interpreting or acting on the data.
If the software does only these things – and does not diagnose, monitor, or treat – it will not meet the definition of a medical device and will not be regulated by us.
Digital mental health tools exclusion
DMHTs that meet certain specific conditions are excluded from regulation by us. Learn more about the conditional exclusion for certain digital mental health tools.
Mixed-function software
When a software product meets the definition of a medical device it will be regulated by us, even if it combines regulated and non-regulated features.
We assess medical device components and ensure non-regulated features do not compromise safety or performance.
Technology-agnostic regulation
Whether the intended purpose of the software meets the definition of a medical device determines whether it is regulated by us, not the kind of technology type the device uses.
Chatbots, mobile apps, cloud-based systems and desktop software can all meet the definition of a medical device if they are intended for a therapeutic purpose.
Examples of regulated digital mental health tools
Digital mental health tools can be regulated in different ways depending on what they do and how they do it. Many consumer and general advice apps do not meet the definition of a medical device and are not regulated by us.
The following examples are intended to show you when a DMHT will be regulated as a medical device.
Example 1 – Web-based diagnostic tool
A web-based tool consumers log into and provide information about themselves and particular symptoms they are experiencing. The tool provides feedback on the information provided including diagnosis for mental health conditions including depression and suggested treatment options for mental health conditions such as cognitive behavioural therapy.
The consumer is invited to regularly provide symptom updates; the tool analyses the consumer’s information and responses over time, providing charts showing progress and adjusting treatment based on the progress observed.
The tool references a standard for depression diagnosis but doesn’t disclose the basis for the treatment provided.
Explanation for Example 1
The product is a regulated medical device because it diagnoses depression and suggests treatment.
It is not excluded because it does not show that the algorithm is based on a clinical practice guideline. The device needs to be included in the ARTG before it is made available.
Example 2 – Cloud-based monitoring
An app that can be prescribed by healthcare practitioners to patients who have been diagnosed with a condition, such as severe depression.
The app works with a cloud-based database and rules engine. It allows patients to log their daily symptoms and provides healthcare practitioners with a dashboard where they can monitor patients.
If a patient’s condition deteriorates rapidly or they are assessed as being at risk, the app sends a real-time urgent alert to the healthcare provider’s pager, phone, or practice system.
The algorithm used to monitor patients and issue alerts is not disclosed.
Explanation for Example 2
The product is regulated as a medical device because it monitors the patients in real time and provides alerts based on a diagnostic process.
It is not excluded because it does not show that the algorithm is based on an established clinical practice guideline. The device needs to be included in the ARTG before it is made available.
Example 3 – Self-reported monitoring
An app that monitors self-reported symptoms of anxiety and collects pulse rate data via a connected smartwatch.
The app diagnoses mental health conditions (displaying RANZCP guidelines) and diagnoses cardiac disease.
Explanation for Example 3
This app combines multiple features. The mental health function of the app meets the conditions of exclusion and is therefore not regulated. The diagnostic feature for cardiac disease is not excluded and will be regulated as a medical device.
The app will be regulated as a medical device and will need to be included in the ARTG before it is made available.
Digital mental health services
The Australian Commission on Safety and Quality in Health Care (the Commission) has developed the National Safety and Quality Digital Mental Health (NSQDMH) Standards.
These standards guide service providers in the delivery of safe and high-quality digital mental health care services.
- Accreditation to the Standards is usually voluntary but may be required by regulators or funding bodies.
- The Standards apply to service providers, not individual tools or products.
We are working with the Commission to ensure safety and performance of digital mental health products and services in Australia while minimising regulatory burden through clarification of our respective roles.
- Regulation of products: We regulate medical devices which may include software products or tools, such as websites, apps or packages that deliver a mental health service, unless excluded.
- Accreditation of service providers: The Commission’s Standards are used to assess the safety and quality of digital mental health service providers.
| Organisation | Oversight type | Focus |
|---|---|---|
| TGA | Mandatory | Product regulation (medical devices) |
| The Commission | Voluntary or mandatory | Service provision |
Providers must determine which framework applies to their product or service. In some cases, both may apply.
How we regulate digital mental health tools
If a DMHT meets the definition of a medical device and does not meet the conditional exclusion in the Therapeutic Goods (Excluded Goods) Determination 2018, it will be regulated in the same way other medical devices (including software based medical devices) are regulated.
It will need to be included in the ARTG by the sponsor of the device and meet all relevant regulatory requirements for medical devices. For more information see our guidance on How we regulate software products.
Privacy and data protection
All digital mental health tools must comply with Australian privacy and data protection laws, including the Privacy Act 1988, regardless of whether they are regulated as medical devices. Visit the Office of the Australian Information Commissioner for more information.
For consumers
Consumers should be aware not all DMHTs available in Australia are regulated by us. Many are not regulated because what they’re intended for doesn’t meet the definition of a medical device. Others do meet the definition of a medical device but they have been excluded from regulation when they meet specific exclusion criteria.
When a product doesn’t meet the definition of a medical device or has been excluded from our regulation, it means we have not assessed its quality, safety or performance. These kinds of products and tools can still be helpful, but it's important to understand that their performance may not have been independently verified.
How to stay safe when using digital mental health tools
Whether or not a DMHT is regulated by us, there are things you can do to help you use DMHTs safely:
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Be cautious of bold claims
Avoid tools that promise quick fixes, guaranteed results, or claim to cure mental health conditions.
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Check for Australian Register of Therapeutic Goods (ARTG) inclusion
If a tool claims to diagnose or treat a mental health condition, check whether it is included in the ARTG.
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Protect your privacy
Make sure the tool has clear privacy policies and complies with Australian privacy laws. Be cautious about sharing sensitive personal or health information.
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Talk to a health professional
Use DMHTs to support, not replace, advice from qualified mental health professionals.
Report any concerns
If you have concerns about a DMHT such as misleading claims, safety issues, or misuse of your data, you can report it to us. Reporting helps protect others and ensures that unsafe or inappropriate tools are investigated and appropriate action is taken.
You can also speak to your healthcare provider or contact the Office of the Australian Information Commissioner (OAIC) if your privacy has been breached.
Contact us or the Commission
If you have questions or would like to have a discussion, contact us at: Digital.Devices@tga.gov.au.
General medical device enquiries
devices@tga.gov.au
1800 141 144
Australian Commission on Safety and Quality in Health Care Advice Centre
AdviceCentre@safetyandquality.gov.au
1800 304 056