With the transition period for updated regulations around Software as a Medical Device (SaMD) in Australia well and truly over, it’s a timely reminder of the need for users of software medical devices – including health-related apps – to know what these products are, and why they’re required to meet strict criteria.
SaMD is not a new concept, and in fact some of the first uses of computers were in medicine, so we have had medical device software for a long time, even if we were not calling it that.
However, the idea of regulating it remains somewhat controversial.
Significant advances in mobile phone technology has made software as a medical device far more accessible to the general population, and those same technological advances have also resulted in big changes to the way software is developed and distributed.
What has changed?
In 2002, when the medical device framework was first introduced, software was still made by large companies and distributed on physical disks.
Now anyone can make software and distribute it easily through an app store or website and this includes the increasing development of SaMD apps.
Which health-apps are regulated?
It’s important to highlight that apps that simply provide health or medical information, or are used as a tool to manage a healthy lifestyle are not regulated by the Therapeutic Goods Administration (TGA) and so are required to be included in the Australian Register of Therapeutic Goods (ARTG).
However, apps that have the intended purpose of diagnosing, monitoring, predicting or treating disease, injury or disability, claim to prevent disease, or control or support conception for example, must be registered.
Examples include baby movement apps, apps that track a person’s health information and analyses it to diagnose diabetes, or provide a percentage risk of the user having diabetes, or software that analyses skin images to screen for melanoma.
Why do we regulate these apps?
The reason for regulation is to prevent harm to the end user and ensure that the product does what it says it does and that it has been tested and evaluated properly by the developer.
It’s important to note that harm prevention isn’t just around the risk of physical harm. Software-based medical devices could potentially pose other risks if not regulated correctly. Often this is a risk of missing a diagnosis (false negative) or relates to the management of personal medical records or identification data.
What can I do?
It is for this reason that users should be demanding more information, and asking questions if they answer yes to any of the following;
- Is the app or software assisting to manage my health and/or condition?
- Has the app or software been recommended by a doctor or health practitioner?
- Is the app or software making health claims?
- Is the app or software being used to diagnose a particular condition?
- Is the app asking me to provide information about my medical history or personal health?
- Is the app controlling a device that is used to manage my health?
A recent study showing influencers promote misleading information about medical tests on social media is a timely reminder of the need for consumers to be informed, and particularly around SaMD.
In the same way that people are now more exposed to so-called ‘influencers’, there’s a real need to be thinking about what information you’re consuming online. Consumers should also be thinking about the types of apps they’re using and whether they need to be included in the ARTG.
While the register is publicly accessible, users also have an important role to play in reporting illegal apps and products and assisting the Government to stay on top of this issue. In practice, it is the end consumer who will always have more visibility over what health-apps are being sold, and what claims are being made.
If consumers are demanding more information from app developers and vendors, and not using SaMD that isn’t registered, it sends a clear and powerful message.