Digital therapeutics

DTx are evidence-based software products that deliver medical interventions intended to prevent, manage or treat a disease, disorder or injury.

They can be used on their own or in combination with medicines, medical devices or other therapies to support patient care and improve health outcomes.

DTx are a type of software as a medical device (SaMD).

We regulate software and mobile apps that meet the definition of a medical device under Section 41BD of the Therapeutic Goods Act 1989.

As DTx are a type of software-based medical device, they are regulated under the medical device framework.

DTx products must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia, unless they are excluded or exempt.

DTx are distinct from general health and wellness apps such as fitness trackers or calorie counters which are not medical devices and are not regulated by us.

DTx are not wellness apps

DTx are designed for specific medical purposes and are regulated accordingly. In contrast, wellness apps – such as fitness trackers or meditation tools – are designed to support general health and wellbeing.

Wellness apps are not intended to treat, diagnose or manage medical conditions, and therefore are not regulated by us.

Examples of DTx

DTx leverage different kinds of technology and digital capabilities and can be used for a wide variety of applications including:

• patient monitoring and self-management
• digital behavioural interventions
• artificial intelligence and machine learning
• apps connected to sensors and wearables
• gaming and virtual reality.

Patient monitoring and self-management

Patients can use DTx to manage their healthcare by tracking their health status, symptoms and treatment progress. They can share data with their healthcare professionals who can follow up as needed.

Examples of patient monitoring and self-management DTx

• apps for managing pain in irritable bowel syndrome
• supportive care tools for cancer patients
• AI-enabled apps for glucose monitoring and insulin dosing.

Digital behavioural interventions

DTx can be used to modify behaviour and improve health outcomes.

Examples of digital behavioural inventions

• cognitive behavioural therapy (CBT) apps for substance use disorders
• web-based CBT programs for anxiety.

Artificial intelligence and machine learning

DTx can use AI and machine learning algorithms to enhance digital health interventions.

Examples of artificial intelligence and machine learning

• real-time treatment recommendations based on patient data
• adaptive interventions that personalise care.

Apps connected to sensors and wearables

DTx can use sensors and wearables to track and monitor health metrics, collect real-time data on biomarkers and patient behaviours.

Examples of apps connected to sensors and wearables

• inhaler tracking apps for asthma
• migraine management tools with behavioural therapy modules.

Gaming and virtual reality

DTx can be an extension to digital behavioural interventions that work by providing patients with a game or virtual reality-based experience.

Examples of gaming and virtual reality

• video game-based therapy for children with attention deficit hyperactivity disorder
• virtual reality system for chronic pain management using CBT techniques.

All DTx products must include clear information about:

• their intended purpose
• how to use them safely
• the manufacturer and sponsor.

This information may be provided in printed form or electronically, such as through an app interface or website.

Because they are accessible and can be integrated into care management, DTx are becoming an important part of healthcare delivery.

They can:

• support patient self-management
• extend the reach of clinical care
• encourage engagement and adherence
• integrate with other therapies and care plans.

Patients may access DTx through smartphones, tablets, laptops or other digital platforms.

Healthcare professionals' responsibilities when using DTx

As a health professional, you remain responsible for delivering safe, ethical and high-quality care, regardless of the technology used.

The Australian Health Practitioner Regulation Agency (Ahpra) expects practitioners to:

• understand the purpose, limitations and clinical application of DTx
• use DTx appropriately within their scope of practice
• support informed consent and patient understanding when using DTx as a part of treatment
• maintain accountability for clinical decisions and outcomes.

For more information, see Ahpra’s guidance on Meeting your professional obligations when using artificial intelligence in healthcare.

Note 

In this section, we use the term consumers to refer to people who use, or are considering using, DTx products, whether independently or as part of their healthcare.

What to consider before using a DTx product

Before using a DTx app or software, talk to your healthcare professional and consider:

• Is the product included in the Australian Register of Therapeutic Goods (ARTG)?
• Do I understand what the app is telling me and what to do with the results?
• Will I need support to interpret the information or take action?

Reporting problems or concerns

If a DTx product doesn’t work as expected or causes a problem, you can:

• contact the sponsor or manufacturer listed in the product information
• speak to your healthcare professional
• report the issue to us
• also call 1800 809 361 or email IRIS@health.gov.au for help with reporting.

Your responsibilities

If you are developing or have developed a DTx product for the Australian market, you must:

• determine whether your product meets the definition of a medical device based on its intended purpose
• understand the applicable classification rules and regulatory requirements
• ensure the product complies with the Essential Principles for safety and performance
• maintain documentation and evidence to support the product’s intended purpose and claims.

Manufacturers, developers and sponsors are responsible for understanding and meeting the regulatory requirements for medical devices in Australia. You should make sure you are familiar with the relevant legislation and guidance.

For more information, see How we regulate software-based medical devices.