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Summary:

After more than two years of waiting, mobile health app developers are finally getting some clarity from the U.S. Food and Drug Administration on what it plans to regulate.

mobile health
photo: iadams

More than two years after issuing its draft guidance on the regulation of mobile health apps, the U.S. Food and Drug Administration has finally released its final guidelines.

By some counts, there are about 40,000 health-related mobile apps available for download on the iPhone, Android devices or other smartphones. The vast majority of these apps exist outside the scope of F.D.A regulation, but mobile health app developers have still been waiting for the agency’s final word on where it plans to focus.

On Monday, the F.D.A. 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.

Apps that fall into those categories will be evaluated using the same regulatory standards that the F.D.A. applies to other medical devices. The agency also emphasized that it does not regulate the sale or general consumer use of smartphones or tablets and it said it does not regulate mobile app distributors like Apple’s iTunes App Store or Google’s Play Store.

Over the past few years, the mobile health app economy has been growing rapidly –  by 2017, market research firm Research2Guidance estimates the mobile health market will be worth $26 billion. But some say that the threat of regulation and uncertainty has been impeded innovation. This final guidance should give the industry some of the clarity its been waiting for.

  1. It’s great to see this now final as it clears up lots of uncertainty. One now only really has to worry about 21 CFR 820 for a very small percentage of apps. It means the door is wide open for apps (and app store deployments) for most of Health IT (EMR, eSource, ePRO, PDC) and Health 2.0

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  2. This is more FDA crap. Now we get regulated on how we analyse the data in a picture etc! This is more of their suppression of innovation. We need to get them out of this.

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