Why are some mobile apps classified as medical devices and why does it matter? An article from Vitalograph details considerations when using a device for remote monitoring of respiratory conditions, including regulatory compliance, performance, privacy, and hygiene.
From the article:
In general, there are two approaches to using telehealth apps in remote monitoring systems.
1. In the first approach, the app is not classified as a medical device because the medical device functionality is completed by the medical (monitoring) device.
2. In the second approach, an app completes some of the medical device functions (eg controls the device and/or processes the raw data) meaning that the app and associated mobile platform become a medical device and require validation as such. Therefore, where the mobile platform performs medical device functions, the user’s own mobile platform should not be used without validation