Table 7 Sample developer guidance: Australian medical device laws and global best practices [33]

Is the focus of the app ANY of the following?

 • A specific disease, injury or disability? [This DOES include medical diagnoses and conditions (e.g. depression, eating disorder). It does NOT include symptoms or conditions that are not classified as a medical disease (e.g. stress, trouble concentrating, difficulty sleeping).]

 • An anatomical or physiological process? [This DOES include things like the sleep cycle. It does NOT include general well-being.]

 • Control of conception

Yes: go to next question. No: it is unlikely that your app is a medical device.

Does the app claim that the output from the device can prevent or treat a specific disease, injury or disability or directly influence an anatomical or physiological process? Answer no if the app ONLY provides tips and advice on prevention or treatment.

Yes: go to next question. No: it is unlikely that your app is a medical device.

Does the app collect user-generated data*?

Yes: go to next question. No: it is unlikely that your app is a medical device.

Does the app deliver individualised health messages on the basis of user-generated data?

Yes: it is likely that your app is medical device; go to next question to assess its likely risk-categorisation and regulatory requirements.

No: it is unlikely that your app is a medical device.

Does the app allow direct diagnosis or monitor a vital physiological process?

Yes: Your app is likely a Class IIa (low-medium risk), Class IIb (medium-high risk) or Class III (high risk) medical device. All of these apps must be assessed by the Australian Therapeutic Goods Administration or must hold an equivalent certificate from a European Notified Body.

No: Your app is likely a Class I (low risk) medical device.You must conform to the Australian Therapeutic Goods Administration’s Essential Principles for safety and performance but unless your app has a direct measuring function (e.g. wearables) your app does not require external assessment by the Therapeutic Goods Administration . You must be able to provide evidence of conformity to the Therapeutic Goods Administration upon request.

*USER GENERATED DATA is any information entering the app that comes from the user. Apps may rely on user-generated data to generate tailored messages to users via algorithms, calculators, coaches or other means. If an app delivers tailored health messages, it may be classified as a medical device. Example health messages include:

 • Diagnosis: e.g. The user has…

 • Prognosis: e.g. The user is at risk of …

 • Monitoring: e.g. The user’s disease is getting better / worse, or is stable / unstable

 • Advisory: e.g. The user should pursue a particular behaviour or use a product or service in a particular way (eg specifying dose or timing)

Tips: An app is unlikely to be classified as a medical device, if the app only ever:

 • Indicates the risk that a population group has of developing a disease

 • Provides general advice about a “healthy lifestyle” (such as limiting smoking and alcohol use, getting sufficient exercise);

 • Provides links to support groups

 • Gives generic advice to “seek help”

 • Provides education about disease, anatomy or physiology

 • Reminds users to take medications

 • Monitors general health, fitness, wellbeing or the menstrual cycle (except if it investigates a specific physiological process)

 • Stores user-generated data for later review by a health professional