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Why Doctors Want the FDA to Regulate Health and Fitness Apps

Why Doctors Want the FDA to Regulate Health and Fitness Apps

Technology is shaping the future of healthcare, and while technology has brought a number of innovative healthcare solutions, healthcare professionals are worried about the impact of unregulated health and fitness apps.

There are a number of healthcare apps that are helpful to users, but there is a growing number of apps that are untested and unregulated by the FDA. Wired spoke to Iltifat Husain, an ER doctor who points out the dangers of health and fitness apps. He offers the example of an app called Instant Blood Pressure, which claims to take a user’s blood pressure without a cuff and deliver the results via an iOS device. Instant Blood Pressure is one of the top paid Health and Fitness apps in the Apple App Store and the developers affiliate the app with John Hopkins University, but when questioned about the app, the university had never heard of it.

Instant Blood Pressure holds no scientific basis, claiming its technology is under wraps due to competition, and the app doesn’t overtly alert users to the fact that the data could potentially be false. There is a warning, but it’s buried deep down in a menu where most people never take time to look. Therefore, it could mean that many people are taking apps like Instant Blood Pressure at face value and inherently trusting the data.

The danger doesn’t come from using the app itself; it’s how users interpret the data. If false data causes keeps someone from going to the doctors, health issues could grow into a larger problem that could have been fixed with early detection. Doctor Husain has written an entire blog post about the app, and the dangers of a number of other applications lurking within the Health and Fitness categories of the Apple App Store and Google Play. But he also profiles the benefits of technology in healthcare, supporting the idea that there is a positive and productive side to health IT.

The FDA has responded as more doctors and health professionals begin to raise serious questions about the legitimacy of health and fitness apps. In a press release by the FDA, Director of the FDA’s Center for Devices and Radiological health, Jeffrey Shuren, M.D., J.D., states, “Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation.” 

But the FDA has released guidelines for monitoring healthcare apps, and notes that it plans to focus on apps that are “intended to be used as an accessory to a regulated medical device,” and “transform a mobile platform into a regulated medical device,” according to a press release.

Since releasing that statement less than a year ago, an entire list of the types of apps the FDA intends to monitor can be found on its website. The list includes, but is not limited to, apps that diagnose psychiatric disorders, give information about drugs and herbs, diagnose based off symptoms, allow users to track diet and exercise, act as a replacement to an approved medical device, and many more.

Even with the promise of regulation from the FDA, the number of apps that enter the market every day is overwhelming and PBS points out that the FDA doesn’t plan to evaluate every single app that falls under the Health & Fitness. In fact, PBS states that as of early July, the FDA had evaluated some 100 apps, while about the same amount find their way into the Apple App Store and Google Play store each month.

While the FDA may be keeping an eye on as many apps as it can, it also released federal regulations that essentially allow developers to continue creating heath and fitness apps. These guidelines separate Health IT and medical devices, freeing up confusion for developers, and even letting apps that “straddle the line” slide.

The bottom line is: downloader beware. Everyone should take the time to consider the science behind an app, and dig into it a little deeper. And its important to remember that although there are a number of apps that are unregulated and questionable at best, there are also a host of apps that can help users maintain a healthy lifestyle. Apps like HeathTap, Couch-to-5K, MapMyRun, and MyFitnessPal let users have access to healthcare professionals, train to run a 5K, GPS map a workout, and track calories and exercise, which can all lead to a healthier lifestyle. But when it comes to apps like Instant Blood Pressure, which offer an “easy” solution for serious health conditions, users should take a closer look at the fine print. Users should also remember to consult a physician before starting out on any journey to better health, and then use the apps as motivation to track their success.