Medical apps and mobile health regulation

This story first appeared in the November 2013 issue of Pulse+IT Magazine.
The explosion of apps for the medical and wellness sectors has been noted by many, and the problem of developers making medical claims about their apps is also a growing issue. Both the US FDA and Australia’s TGA have released guidance on what software constitutes a medical device, so app developers are urged to consult with regulators about the claims being made for their apps.

With an ageing population, the increase in the number of people with chronic diseases and an ever reducing health dollar, we need to find smarter ways to manage the health needs of Australians. In response to the looming demand for care, we are seeing the rapid adaptation of existing medical devices, and the development of new applications for monitoring and treating health conditions in the home, that can respond to this demand. An explosion in the use of smartphones has driven the development of mobile applications for everything and anything, including lifestyle and medical apps. These apps can provide an innovative solution for the self-management of a range of health problems.

However, in some cases developers of these apps unwittingly make medical claims about health management that could constitute the app being regulated as a medical device. Although the use of apps is often viewed as a bit of fun, apps making medical claims could prevent individuals from seeking medical attention through reliance on the app to manage a disease state.

A wide range of health and medical apps can be downloaded for use on smartphones. Intel’s global director of health innovation, Eric Dishman, uses the term “consumerisation of medical devices” to explain how a simple object such as a phone can include embedded sensors and assist in healthcare. Many “medical” apps are misclassified and it is impossible to determine how many real (i.e., validated and reliable), medical apps actually exist.

Medical apps for smartphones can be purchased by both medical professionals and consumers. There is concern about the use of medical apps that have not been validated by clinicians, as a large number of mobile health apps are targeted at doctors to facilitate and improve patient healthcare, for example to perform calculations, assist with differential diagnosis or monitor the progress of patients.

A separate concern is the purchase of apps by patients who are less likely to have the ability to assess whether an app is able to do what it claims. Consumers may have a preference for monitoring medical conditions using a smartphone app. Any app that provides medical advice may result in harm to the consumer if the advice is misleading or incorrect.

To read the full story, click here for the November 2013 issue of Pulse+IT Magazine.

Posted in Australian eHealth

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