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Regulation of medical mobile apps

What constitutes a medical app? Does anyone keep an eye out as to whether a medical app lives up to what it claims to do or ensure that it does not endanger users?  Should anyone?

Oversight of mobile apps, in general, varies by platform.  Historically, Apple’s app store is a much more regulated marketplace with each app being reviewed by Apple and required to meet certain standards before being allowed to enter the store.  Google takes a more laissez faire approach to their Android Play store, though in August of this past year they did add some guidelines for developers to follow.  But for both companies, their app development rules do not provide oversight over quality of content.   While for some categories of apps this may not matter much, for apps that bill themselves as “medical,” for use either by healthcare providers or consumers to make decisions related to health, lack of content oversight may be worth considering.

Over the last couple of months there has been quite a bit of discussion over whether or not medical apps should be regulated and who, if anyone, should do that regulation.  Often this debate splinters between whether or not apps developed for consumers versus those for professionals should be treated differently – the logic here being that consumers may need more protection as providers should be able to evaluate the quality of an app on their own.  Some might recall in 2011 when the FTC brought a settlement against two different developers of apps that claimed to be able to cure acne that were being sold in both Google and Apple’s app stores.

While the FTC was the organization responsible for bringing that particular settlement against those particular apps that were built around unsubstantiated claims, the FDA is mentioned most often as the body best suited to provide this type of oversight, as they already regulate medical devices.  Currently, the FDA does provide regulatory oversight to a subset of mobile medical apps – those that are in some way “an extension” of a medical device or effectively transform a mobile device into a medical device.  An example of an app that falls into this category that received FDA approval last month was an ECG monitor that works with an iPhone.

Last July NPR spoke with a representative from the FDA who indicated they did not plan on reviewing most medical or health related apps beyond those described above.  Some developers of apps are nervous that this stance could change or that the line between an app that acts enough like a medical device versus a regular old app could blur.  Recently, United States Representative Mike Honda introduced a bill in the House, The Healthcare Innovation and Marketplace Technologies Act (HIMTA).  Amongst other aspects of the bill, it proposes to establish an Office of Wireless Health within the FDA that would be responsible for providing recommendations on “how to develop and maintain consistent, reasonable and predictable regulatory framework on wireless health issues.”  In 2013 we will continue to see development in this area of regulation as this bill makes its way through Congress.

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