Health Apps Don’t Have to Do What They Say They Do
When an app says it counts calories, we assume it actually does. Same if it promises to alert you about interactions between drugs and supplements, or if it says it can tell you what’s going on this week in your pregnancy. But the makers don’t have to back up any of these claims.
That’s because the Food and Drug Administration only asks for proof that a health app works if it qualifies as a medical device, using hardware components like the camera or sensors and having the potential to harm you if things go wrong.
On the other hand, if the app tells you the wrong calorie counts and ruins your diet, the FDA doesn’t care. Or if an app is supposed to help you manage your depression or anxiety disorder, but actually gives you bad advice and makes it worse, that’s out of their hands too. Even apps that exist to give correct information—like apps that tell you when you’re at risk of an asthma attack, or that tell you which quit-smoking techniques work the best—aren’t required to show the FDA that they’re doing their job.
You can read the full list of apps the FDA doesn’t care about here. The FDA describes this massive gray area as “enforcement discretion,” meaning that they have the authority to enforce the rules, but have chosen not to. Here are just a few of the categories:
- Mobile apps that help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder (PTSD), depression, anxiety, obsessive compulsive disorder) maintain their behavioral coping skills by providing a “Skill of the Day” behavioral technique or audio messages that the user can access when experiencing increased anxiety;
- Mobile apps that provide periodic educational information, reminders, or motivational guidance to smokers trying to quit, patients recovering from addiction, or pregnant women;
- Mobile apps that use GPS location information to alert asthmatics of environmental conditions that may cause asthma symptoms or alert an addiction patient (substance abusers) when near a pre-identified, high-risk location;
- Mobile apps that use video and video games to motivate patients to do their physical therapy exercises at home;
- Mobile apps that prompt a user to enter which herb and drug they would like to take concurrently and provide information about whether interactions have been seen in the literature and a summary of what type of interaction was reported;
- Mobile apps that help asthmatics track inhaler usage, asthma episodes experienced, location of user at the time of an attack, or environmental triggers of asthma attacks;
Lying about what an app does is still illegal, and the Federal Trade Commission can crack down if they like. These apps are also subject to other types of legal challenges. New York’s Attorney General recently settled with three app makers, forcing them to tone down their claims and to pay penalties to the state. The apps are all still available, though: they include heart-rate monitor Cardiio, running app Runtastic, and a fetal heart monitor called My Baby’s Beats.