Health Apps Don’t Have to Do What They Say They Do
When the app says it is counting calories, we assume that it is. Ditto if he promises to alert you to interactions between medications and supplements, or if he says he can tell you what’s going on this week during your pregnancy. But manufacturers are not required to confirm any of these claims.
This is because the FDA is seeking evidence that a health app only works if it qualifies as a medical device using hardware components such as a camera or sensors and could cause it will hurt you if something goes wrong.
On the other hand, if an app tells you the wrong amount of calories and disrupts your diet, the FDA doesn’t care. Or, if an app is supposed to help you cope with depression or anxiety disorder, but is actually giving you bad advice and making it worse, that too is not in their hands. Even apps that exist to provide correct information – such as apps that tell you when you’re at risk for an asthma attack, or that tell you which smoking cessation methods work best – are not required to show the FDA that they are doing their job. …
You can read the full list of applications that the FDA is not interested in here . The FDA describes this huge gray area as “discretion of coercion,” which means they have the power to enforce regulations, but have chosen not to. Here are just a few of the categories:
- Mobile apps that help patients with diagnosed mental illness (eg, post-traumatic stress disorder (PTSD), depression, anxiety, obsessive-compulsive disorder) maintain their behavioral coping skills by providing the Skill of the Day behavioral technique or audio messages that the user can access when experiencing increased anxiety;
- Mobile applications that provide periodic educational information, reminders or motivational advice to smokers trying to quit smoking, drug recovery patients or pregnant women;
- Mobile apps that use GPS location information to alert asthmatics to environmental conditions that may cause asthma symptoms or to alert an addicted patient (drug addict) when they are near a predetermined high-risk location;
- Mobile apps that use video and video games to motivate patients to do physical therapy exercises at home;
- Mobile apps that prompt the user to indicate which herbs and medications they would like to take at the same time, and provide information on whether interactions have been seen in the literature and a summary of what type of interaction has been reported;
- Mobile apps that help asthmatics track inhaler use, past episodes of asthma, the user’s location during an attack, or factors causing an asthma attack in the environment;
Lying about what the app does is still illegal and the FTC can take action if it wants to. These applications can also be the subject of other legal issues. New York’s attorney general recently struck a deal with three app developers forcing them to soften their claims and pay fines to the state. However, all apps are still available: they include the Cardiio heart rate monitor, the running Runtastic app and a fetal heart monitor called My Baby’s Beats.