Whose FDA Is It, Anyway?

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watchmen_smiley_dannybirchall.jpgI was rather happy to see a news headline touting that the FDA would begin regulating safety and security in medical software.  Upon reading the full story, however, I have to say that I'm rather disappointed.

Why disappointed?  Because mobile platforms are not designed to do anything critical.  Take for example this excerpt from the End User License Agreement of iOS 7:

"""
7.5 YOU FURTHER ACKNOWLEDGE THAT THE iOS SOFTWARE AND SERVICES ARE NOT INTENDED OR SUITABLE FOR USE IN SITUATIONS OR ENVIRONMENTS WHERE THE FAILURE OR TIME DELAYS OF, OR ERRORS OR INACCURACIES IN, THE CONTENT, DATA OR INFORMATION PROVIDED BY THE iOS SOFTWARE OR SERVICES COULD LEAD TO DEATH, PERSONAL INJURY, OR SEVERE PHYSICAL OR ENVIRONMENTAL DAMAGE, INCLUDING WITHOUT LIMITATION THE OPERATION OF NUCLEAR FACILITIES, AIRCRAFT NAVIGATION OR COMMUNICATION SYSTEMS, AIR TRAFFIC CONTROL, LIFE SUPPORT OR WEAPONS SYSTEMS.
""

So basically we have it that the platform is not designed for use as a medical diagnostic device, and yet the FDA is going to regulate apps built upon that platform?

Something seems wrong here.

My sincere hope is to start seeing the FDA enact and enforce security in devices which are certified for use as life-dependent technologies.  Why are our automated heart defibrillators and insulin pumps allowed to operate in a way that makes them open to malfeasance and misoperation? 

But as a first step, it would be nice to see the FDA either publicly acknowledge or publicly condemn the use of 'smart' devices that are not licensed for use as medical diagnostic equipment. 

There is an implicit 'publicly acknowledge' taking place with this most recent announcement.  It makes me wonder: what will happen if a misdiagnosis results from a smart device app?  From the EULA, it appears that the doctor would be liable (he or she agreed not use the device for this purpose), but the FDA announcement is simply muddying the water.

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This page contains a single entry by giminy published on September 24, 2013 2:08 PM.

Schneider Doesn't Fix a Thing was the previous entry in this blog.

Carte Blanche: A Social Experiment is the next entry in this blog.

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