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United States Medicine Technology

FDA: We Can't Scale To Regulate Mobile Health Apps 123

chicksdaddy writes Mobile health and wellness is one of the fastest growing categories of mobile apps. Already, apps exist that measure your blood pressure and take your pulse, jobs traditionally done by tried and true instruments like blood pressure cuffs and stethoscopes. If that sounds to you like the kind of thing the FDA should be vetting, don't hold your breath. A senior advisor to the U.S. Food and Drug Administration (FDA) has warned that the current process for approving medical devices couldn't possibly meet the challenge of policing mobile health and wellness apps and that, in most cases, the agency won't even try. Bakul Patel, and advisor to the FDA, said the Agency couldn't scale to police hundreds of new health and wellness apps released each month to online marketplaces like the iTunes AppStore and Google Play.
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FDA: We Can't Scale To Regulate Mobile Health Apps

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  • by Anonymous Coward on Sunday July 06, 2014 @08:43PM (#47396185)

    Just charge what it costs to certify that an application/ device does what it claims to do. I know it is a novel concept of fee for service, but things are far more transparent that way. If the federal government cannot keep up, then farm it out to private firms who are then audited by the Federal Government.

  • by fustakrakich ( 1673220 ) on Sunday July 06, 2014 @09:03PM (#47396287) Journal

    With the FDA infected with industry worms a lot of dangerous is given a chance, while less harmful substances are outright prohibited from even studying.

  • by Impy the Impiuos Imp ( 442658 ) on Sunday July 06, 2014 @09:05PM (#47396301) Journal

    I'll tell you what -- all it'll take is the FDA causing the delay for one year of a decent cancer or heart disease or diabetes drug, and boom! They've cost more lives than they will have saved since 1938.

  • by perpenso ( 1613749 ) on Sunday July 06, 2014 @09:12PM (#47396337)
    I expect these new mobile devices/apps coming onto the scene will be considered some sort of novelty devices by the FDA not medical devices. Like ancient digital watches.

    The info they provide will be considered more trivia or a novelty than medical info. Much like ancient digital watches that could show a pulse, novelty info, not to be used for medical purposes. Or ancient digital watches that could show pressure, novelty info, not to be used for aircraft altitude or depth when scuba diving. I actually used one for scuba diving but it was secondary to my actual depth gauge made for scuba diving. It was surprisingly close. And when driving up to the mountains it will surprisingly close to the altitude markers along the highway, assuming I calibrated. I knew my altitude at home. And when diving, I was at sea level on the beach/boat. As reasonably accurate as it was, it was still a novelty device, or a last resorts back if my actual device failed.
  • by Hungus ( 585181 ) on Sunday July 06, 2014 @09:20PM (#47396393) Journal

    In other words, provide no oversight at all while an "independent" firm rubber stamps all the industry's apps for a completely legal fee which ends up going to the executives of the fake company via bonuses, then let it fold and start up a new one.

    Privatized enforcement is no enforcement. If it can't be overseen by the government it needs to either be banned. You can open up the question of if it needs to be regulated at all, but providing the illusion of safety and regulation when there is none is far worse.

    Nowhere does the OP say that, you are jumping way down an argument and not providing your work in between. How I read the OP is that private contractors do the heavy lifting and then the FDA comes back in and audits the results. If you audit one in 3, then see a group fails to catch something so you audit their entire batch, that is still substantial oversight.

    I also would be willing to jump in and say the FDA is overstepping what little role it should have and might be provided by the ICC (Article I, Section 8, Clause 3) and would even be willing to say that it may only regulate the actual commerce and not the actual products, however I think the OP is a step in the right direction.

  • by Bing Tsher E ( 943915 ) on Sunday July 06, 2014 @09:58PM (#47396633) Journal

    That is completely garbage. The Underwriter's Laboratory is a private for-profit organization and does a very good job of assuring fire and electrical safety for a huge sector of industry. When something is UL listed you can be certain it meets stringent safety standards.

  • by sycodon ( 149926 ) on Sunday July 06, 2014 @11:12PM (#47396997)

    Because INS, "Homeland" Security (What a freaking Totalitarian sounding name), and the TSA are doing such a bang up job.

    Dickheads like you are the ones shutting down Lemonade stands run by six year olds because they don't "meet regulations".

Adding manpower to a late software project makes it later. -- F. Brooks, "The Mythical Man-Month"