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FDA to Regulate Smartphone Health Apps

By Admin on September 24, 2013 | Last updated on March 21, 2019

The U.S. Food and Drug Administration (FDA) has released a press announcement stating that it will begin regulating smartphone health apps.

With the continuing popularity of smartphones such as the Apple iPhone, Android mobile devices, and various tablets, a whole new slew of health applications have hit the market designed to keep users' health in check. Medical applications such as calorie counters and heart monitors are easily downloadable, and many users rely on them to serve their designated functions.

Despite these benefits, there could be potential health consequences if an application is faulty or used improperly. Enter the new FDA regulations:

What Types of Applications?

There is a huge variety of different mobile medical apps currently on the market. Some can diagnose abnormal heart rhythms or even function as a glucose meter for those with diabetes. However, just because an app serves some type of health or medical function doesn't mean the FDA's new regulations will apply.

The FDA states in its press release that the focus will be on the following types of apps in particular:

  • Apps that are intended to be used as an accessory to a regulated medical device (e.g. an application that allows a doctor to diagnose by viewing an image from a picture archiving and communication system); or
  • Apps that can transform a mobile platform into a regulated medical device (e.g. applications that serve as a device to detect abnormal heart rhythms or measure glucose)

Regulations Focused on Functionality

The FDA also does not plan to regulate any general consumer functions of smartphone apps such as sales, settings, or where they are sold (through iTunes or Google Play, for example). Nor will they plan to regulate personal wellness apps, such as those that allow a user to track her daily calorie consumption.

According to the director of the FDA's medical device division, as stated in the press announcement, regulation of an application ultimately depends on that app's primary functions and its risks. He states that, for example, if a heart device that is used in a hospital is regulated, then the mobile app version will of course also be regulated. A faulty application can be just as dangerous as a faulty medical device.

Basically, "[i]t's not about the platform. It's about the functionality."

These products will first need to be cleared by the FDA before being released into the market. The average review time could take up to a couple of months, and the apps will be regulated according to the same standards for medical devices.

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