The FDA has been adding some statements about mobile apps since the release of its report back in late March. Specifically, on 6/11/14 it released more clarification on what would fall under enforcement discretion – or those that it will leave up to other entities to enforce. According to mHealth they pretty much described Apple’s health app:
“Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a health care provider, or upload it to an online (cloud) database, personal or electronic health record.”
So what does the Apple health app have included? Well, again according to mHealth, they have several diagnostic functions, including number of times fallen, galvanic skin response, and body heat flux. They have weight and activity related metrics – the ability to track body fat percentage, steps taken, calories burned. Then the nifty basal calories burned – those pesky calories burned while you sit and do nothing. And just in case you need it – the blood alcohol content results. Along with the expected medications functions – reminders, alerts to interactions, etc. Nutrition, sleep, and vital signs seem to be included.
What really interests me about the app is that is appears to be designed to work with other products more than as a stand-alone. That makes sense as it really isn’t a medical device and where else could it get most of the medical data if it did not interact? So in my mind this puts the app out there as more of a medical record for me. Then I circle back around to where does the data go?
If you are just waiting on this fall for the release of the app you might want to do some research beforehand and order your extra device for that blood alcohol content monitor, Breathometer (as seen on Shark Tank), or your Nike+ fuel monitors.