Finally, FDA Reveals Its Regulation Plans On Mobile Health Apps

[] Mobile health developers have been waiting for more than two years to get some clarity on how and what the US Food and Drug Administration (FDA) plans to regulate regarding mHealth apps. has finally released its final guidelines its guidelines after more than two years of issuing its draft guidance on the focusing on the various regulations around mobile health apps.

Today, there are approximately 40,000 mHealth related apps available for download on iPhone, Android and other smartphones. But most of these apps were developed outside the scope of FDA regulation. With the release of final guidelines, mobile health developers can now align themselves with agency’s regulation plans.

The FDA said its oversight will apply to two broad categories of apps:

  • Those intended to be used as “an accessory to a regulated medical device” – for example, an app that enables a healthcare provider to diagnose a condition by viewing a medical image from a picture archiving or communication system on a smartphone or tablet; or
  • Apps that “transform a mobile platform into a regulated medical device” – for example, apps that turn smartphones into an electrocardiography (ECG) machine that can detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

The FDA will evaluate apps falling under those categories using the same regulatory standards that it applied to other medical devices. The agency also clearly stated that it does not regulate sale or general consumer use of smartphones and does not regulate mHealth app distributors like Apple iTunes and Good Play Store.

The mHealth economy has grown enormously over the past few years and still continues to grow at a rapid pace. According to MarketsandMarkets, the mHealth apps & solutions market is estimated to be worth $20.7 billion by 2018. Several restrictions due to regulations and uncertainty have somehow affected the growth and innovation in the mHealth industry. The release of the final guidance should give the industry some of the clarity it’s been waiting for since a long time.

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3 thoughts on “Finally, FDA Reveals Its Regulation Plans On Mobile Health Apps

  1. Pingback: HealthIT+ Newsletter – October 2013 Issue Is Out! | HealthIT Plus

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