Health and Wellness Apps May Collect Health Info, Unbeknownst to Users

"If your app carefully sidesteps claiming any kind of medical intervention, then it's a health and wellness app and not a medical device -- and it is not regulated."

The founder and director of Rice University’s Medical Futures Lab believes that “the boundaries between medical and nonmedical environments are dissolving” due to the rise of health and wellness mobile apps, and the public should be wary of that.

Kirsten Ostherr says that such programs make people’s daily lives part of “experiments ‘in the wild’,” often without their knowledge. Applications of all types often gather and compile data on their users to be leveraged later. In the case of health and wellness applications, of which there are tens of thousands in the Apple App Store alone, that data can have myriad uses.

Information derived from such applications offers terrific research opportunities for those looking to learn about health habits of users in their daily lives, rather than in controlled clinical studies. It becomes problematic when participants are unwilling to share their data and do not know it is being collected, particularly since most apps are not considered medical devices and the data they collect is not subject to privacy laws. Because of these conditions, Ostherr believes it is unlikely that the data collected by apps will be used for any medically beneficial purpose.

"If your app carefully sidesteps claiming any kind of medical intervention, then it's a health and wellness app and not a medical device -- and it is not regulated," by the FDA, Ostherr said in a statement. Still, some of what they capture might be considered personal health information were the apps classified as medical devices.

Software cannot make any claims of medical or therapeutic benefit in the absence of FDA approval as a medical device. The process of receiving that approval can be long and rigorous, and typically requires the app makers to prove efficacy, though Ostherr notes that for some companies, that could be of benefit. She will be giving a speech on the topic next week at the Department of Health and Human Services’ "Data Privacy in the Digital Age" symposium.

For its part, the FDA is looking into streamlining its certification program. Last month, it announced a pilot program for health software development that will include major players like Apple, Fitbit, and Samsung, alongside growing entities like Pear Therapeutics. Pear just became one of the first companies to gain FDA approval for an application to be used as a treatment for substance abuse disorder.

Images courtesy of Rice University and ThinkStockPhotos.com.