It has been predicted by many technology pundits that smartphones will be in everyone's hands within the next few years. Of course there will be different flavors of smartphones to adjust to different consumer ranges, but the way of the numpad flip-phones will be left to the late 90s and the 2000s.

Part of what makes these smartphones so "smart" is their ability to function as mini-computers with their wide offering of applications ("apps" for short). Apple and Google have essentially claimed joint dominance of the app market (with the iTunes App Store and Android Market respectively) as many others like Blackberry (AppWorld) fall behind. As a former Android user, a current iPhone user, and app enthusiast, I acknowledge that the draw to use and create applications is great; however, with great power comes great responsibility.

A large segment of the app market is the medical app genre [Health & Fitness, Medical, etc.]. This can encompass fitness apps (the Nike+ app for example), dieting apps (such as the wildly popular and successful SparkPeople application), or even medical devices as examples. That's right folks, smartphone apps can be considered medical devices. The issue at hand? Many developers haven't the faintest idea that they are now regulated by the FDA.

Let's take a look at a top ten list of questions to answer from app developers and marketers. Sure, it's great to understand the competitive landscape, an exit plan, message of the application, which market you expect to enter [iPhone, iPad, Android], and other business-related questions listed in the article. The problem is that none of those top ten questions include any regulatory considerations.

I'd be lying to you if I told you the FDA didn't have its hands full with changes in leadership, revisions in policy, uproar over its approval processes, and an increase in potentially regulated technology. I would also be lying to you if I told you that mobile applications weren't on their radar. Additionally, the FDA isn't the only regulator out to get app developers. Earlier this year, I cited a case where the FTC fined two app developers who claimed that their light therapy would treat acne. Applications on the fence, such as patient logs, need to be prepared for questioning by the FDA.

This blog series on mobile medical apps will be full of examples and guidance regarding the regulation of mobile medical apps. A good synopsis of the recently released FDA guidance can be found here. Happy developing!

-RTK

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