Suppose you are developing an app that aims to provide general health management content or track an individual’s health information. In that case, you must consider if the software you are developing will be deemed a medical device by the Therapeutic Goods Administration (TGA). There are instances where software is deemed a medical device and must be regulated by the TGA. This article sets out a high-level overview of some preliminary questions that you should consider when developing your application.
Intended Purpose of the Software
The first question to ask is to consider the purpose of the software that you are developing.
Under the Therapeutic Goods Act 1989 (Cth) (Therapeutic Goods Act), the intended purpose of the software is what you intend to use it for as stated in:
- information provided with the device;
- instructions for use;
- any advertising material; or
- any technical documentation describing the mechanism of action of the device.
Suppose the intended purpose includes one or more of the following. In that case, it has a therapeutic use as deemed by the Therapeutic Goods Act:
- diagnosis, monitoring, prediction, prognosis, treatment or alleviation of disease, injury or disability;
- prevention of disease;
- compensation for an injury or disability;
- investigation, replacement or modification of the anatomy or pathological process or state; or
- control or support of conception.
Intended Purpose is Medical
If the software you are planning to develop has one or more of the intended purposes stated above and any of the following functions, it may be excluded from being a medical software:
- consumer health life-cycle prevention, management and follow-up that do not provide specific treatment or treatment suggestions;
- digital mental health tools including cognitive behaviour therapy tools;
- enabling technology intended to support telehealth, remote diagnosis, healthcare or dispensing;
- digitisation of paper-based or other published clinical rules or data including simple dose calculators and Electronic Patient Records;
- population-based analytics that does not drive outcomes for individuals; and
- laboratory information management systems and information systems.
If the software works directly with data obtained in vitro, it is considered an in vitro diagnostic (IVD medical device). Separate regulations would apply.
Continue reading this article below the formIs My Software Exempt?
Exempt software refers to medical devices not required to be included in the Australian Register of Therapeutic Goods. Unlike excluded software which is unregulated by the TGA, exempt software must still adhere to certain legal requirements. This includes reporting adverse events to the TGA, following the advertising code of conduct and notifying the TGA of the exempt devices itself. Depending on the type of software, the criteria for exemption may change.
For example, a clinical software that supports and enables clinical practice will be exempt if it meets all three of the following criteria:
- the manufacturer intends it to be for the sole purpose of providing or supporting a recommendation to a health professional about preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons;
- the manufacturer does not intend to directly process or analyse a medical image or signal from another medical device; and
- the manufacturer does not intend it to replace the clinical judgement of a health professional concerning making a clinical diagnosis or decision about the treatment of patients.
With an exempted clinical decision support software (CDSS), approval by the TGA and registration of the device is not required. However, sponsors and suppliers must notify the TGA of their exempt CDSS devices and do so using TGA’s notification form.
There are other requirements to consider. Accordingly, it is recommended to speak to an expert for further advice on this point.
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Other Considerations
It is important to note that if your software is not a medical device, it is deemed a consumer product. Thus, the TGA does not regulate it. Regardless of whether the TGA applies or not, you will still need to ensure compliance with the requirements imposed by the Australian Competition and Consumer Commission.
Key Takeaways
It is important to note that this article provides a high-level overview of some of the preliminary considerations when developing software in the health space. This is not a comprehensive list, and you must consider further aspects to determine if your software is regarded as a medical software under applicable laws.
Suppose your intention is not to develop software as a medical device. In that case, we recommend taking the time to consider the preliminary questions and to speak to an expert for further guidance. Our experienced contract lawyers can assist as part of our LegalVision membership. For a low monthly fee, you will have unlimited access to lawyers to answer your questions and draft and review your documents. Call us today on 1300 544 755 or visit our membership page.
Frequently Asked Questions
Software can be seen to have therapeutic use when its intended purpose includes diagnosis, monitoring, prediction or alleviation of disease, injury or disability, prevention of disease, compensation for an injury or disability, investigation, replacement or modification of the anatomy or pathological process or state or control or support of conception.
No. Please note, however, that there is a level of oversight retained by the TGA over exempted software. Even if the TGA does not regulate your software, you would still need to ensure that it complies with all relevant legislation.
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