Digital Tools and Medical Devices used for mental health – is yours a regulated medical device?

The Therapeutic Goods Administration (TGA) recently released guidance on digital tools and medical devices for the mental health sector (Guide).[1] The Guide aims to clarify whether software-based medical devices, products, services and tools used in the mental health sector (collectively, digital mental health products) are regulated by the TGA.

Prior to the Guide, information about whether digital mental health products were regulated was somewhat scattered. The Guide brings together this information in the one place, sets out the obligations with which providers of digital mental health products must comply, and outlines the intersection of the Australian Commission on Quality and Safety in Health Care (Commission) and TGA in regulating such products.

What is regulated by the TGA?

The TGA’s medical device regulations capture any kind of technology intended to be used for:

• diagnosis, prevention, monitoring, prediction, prognosis or treatment of a disease, injury or disability;
• alleviation of or compensation for an injury or disability;
• investigation of the anatomy or of a physiological process; or
• control or support of conception.

The majority of digital mental health products will be captured by the above and subject to TGA regulation, unless it meets all of the following criteria for exclusion:

• the software follows established clinical practice guidelines;
• the guidelines are referenced and the reference to them is displayed in the tool; and
• the user can clearly view the guidelines.

Where a digital mental health product meets the definition of a medical device and it does not meet all exclusion criteria, the digital mental health product will need to be included in the Australian Register of Therapeutic Goods (ARTG).

What is not regulated by the TGA?

The TGA does not regulate software:

• used simply for display of guidelines, information or resources;
• used for registration or viewing, or recording or tracking of results;
• used to facilitate telehealth consultations; or
• used to generate or update a digital health record.

If a digital mental health product has multiple functions and combines TGA-regulated and non-regulated features, the whole product must be included on the ARTG.

Where does the Commission come into this equation?

Both the TGA and Commission are involved in the regulation of digital mental health products.

The Commission assesses the safety and quality of digital mental health service providers against its National Safety and Quality Digital Mental Health Standards (Standards).[2] The Standards only apply at the level of the service provider – they do not extend to the tool or product. That is where the TGA steps in.

What does this all mean for your tools and devices?

Suppliers of digital mental health products need to assess whether the TGA regulates or Standards apply to their product, or both.

Where a digital mental health product is regulated by the TGA, that product must comply with medical device regulations and be included in the ARTG.

On the other hand, the Standards are generally voluntary. The Standards can become mandatory, for instance if a state health department directs a funded service to undergo accreditation or where accreditation is required for a digital mental health service to qualify for public funding.

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Authored by:

Kelly Griffiths, Partner
Clare Smith (Cullen), Associate

[1] Australian Government, Department of Health and Aged Care, Therapeutic Goods Administration (May 2023) Digital tools and medical devices: a guide for the mental health sector <https://www.tga.gov.au/resources/resource/guidance/digital-tools-and-medical-devices>.

[2] Australian Commission on Safety and Quality in Health Care (2020) National Safety and Quality Digital Mental Health Standards <https://www.safetyandquality.gov.au/standards/national-safety-and-quality-digital-mental-health-standards>.