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Alan W. Silberberg

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Mobile App for Lifesaving Technology? Or Regulated Industry?

Posted: 05/18/2012 9:19 am

I have been following closely the debate surrounding the FDA's call to regulate apps like you use on your smartphone as a device, like a heart monitor or diabetes test kit.

Is this the right thing to do? I am all for regulation of industries to ensure safety and make sure no one dies because a product was used. But this is a whole new era. Is an app a device? Is it a life-saving tool or is it the new shiny toy on your smartphone about which you know nothing about the reliability or specificity of how it works? This debate has been roiling the device/app/regulated industry market for a long time already, but is really heating up this week due to pending legislation currently being "worked up" in the U.S. House of Representatives.

There are many legitimate questions at stake. Capitalism and how it relates to government regulated industries in a rapidly changing world for one. Health and safety of any "tool" -- whether device, software, hardware, application or just a bandaid -- when it comes to being used on humans? Should the government stifle innovation efforts by regulating apps for your smartphone exactly as a medical device? Are small companies -- who are the primary developers of most apps still -- being shut out of a marketplace controlled by only the largest and most set in place corporations and being assisted through legislative and regulatory ruling? What happens when one of these apps is used in a "cloak operation" and is actually something like a private information/financial information thief?

Wait, what did I just say? The harsh reality is the FDA even admits that the "device approval" is one of the hardest processes they put any company through, outside of actual drug approval. Just ask any device manufacturer about their recent run-ins with the PMA (premarket approval). You will get an earful.

But translate this to medical smartphone apps and the FDA. Who builds apps? As stated above, mostly small companies with small numbers of employees (obviously there are clear exceptions.) If the apps are to be regulated exactly as devices, then it subjects these companies to lengthy, even multi-year engagements just to get approval prior to selling anything. This flips the market dynamics of most app companies; that are used to making their money off short development/lead time cycles, and short sales cycles. How can most small companies survive this? They can't, and it's back to the question of stifling innovation in small businesses through the FDA on behalf of the few companies with the bucks to last out this process.

I would suggest the FDA look at how software and hardware is approved under FIPS for example. (FIPS are requirements issued by the National Institute of Standards and Technology that apply to federal government computer systems.) Additionally I would suggest the FDA create a tiered regulatory system, one for devices, one for aps. Clearly this debate is not going away without a fight.

 

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