We’re all still waiting for the FDA to explain how they plan to regulate mobile health apps. Here’s a critical question/equation that will determine how the FDA will regulate this space:
mobile device + mobile health app = a medical device ?If the combination of a mobile device plus a mobile health app results in a “medical device,” then the FDA will be involved in regulating these types of apps. So, is a symptom checker running on a smartphone considered a medical device?
How does Section 201(h) of the Federal Food, Drug, and Cosmetic Act define a medical device?
“… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or] intended to affect the structure or any function of the body of man...”Based on this broad definition, it would seem that computers and smartphones will be classified as medical devices if physicians are using computers to diagnosis or treat a disease.
To take things further, there are mobile health apps that are making health claims like, “use this app to lower your blood pressure.” Or, you may see, “use this app to improve your diabetes control.” At what point will the FDA step in and send warning letters to app developers who are making these types of health claims?
One of the biggest challenges is the fact that many mobile health apps are being developed in other countries. These apps are showing up on the Apple App Store, Android Market, or BlackBerry App World and some are even written in foreign languages. If a Korean person living in the United States uses a Korean mobile health app that she finds on the Apple App Store, does the FDA need to regulate that Korean app?
Experts are predicting that 500 million people will be using mobile health apps by 2015. Are we ready to see the FDA regulate such a rapidly growing market of mobile health apps? There are so many complex questions regarding the regulation of mobile health apps. The technology is moving so fast than regulatory agencies like the FDA can’t keep up with all the evolving technology. By the time the FDA releases regulatory guidelines, they may be obsolete.