Why are smartphone health apps so hard to regulate?
When is a device not a device? When it’s an app
Australia’s drugs and devices watchdog has spent years grappling with the issue of how to regulate smartphone apps.
At present, the TGA has no overall mandate to regulate apps, as they are rarely devices in the true sense of the word.
However, last week, the need for more robust regulation came to the fore after a problem was found with the Accu-Chek Connect Diabetes Management app that is used in conjunction with Accu-Chek Aviva Connect and Accu-Chek Guide blood glucose meters.