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

Posted by samzenpus on from the hard-work-is-hard dept.

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.

3 of 123 comments (clear)

  1. Re:FDA shouldn't even exist in the first place by Hungus · · Score: 1, Troll

    How does the existence of radium products grant a power to the Federal Givernment? {spelling intentional). I was under the impression that we had things called laws that laid out what the government could and could not do .. but I already said that when I went into the difference between regulative and normative.

    Maybe you are an ends justifies the means kind of person.. I am a deontologist.

    --
    Bad Panda! No Bamboo for you! In matters of importance ACs will not be responded to. Want to say something critical,OK
  2. Re:Charge what it costs to certify by Rockoon · · Score: 1, Troll

    He is a full blow Statist willing to make things up to justify his Statist position, rather than form a position based on actual information.

    perhaps he thinks that his Statist position is so solid that the information he is unaware of must support his position, so feels free to just make it up because hey it must be true.

    --
    "His name was James Damore."
  3. Re: does it mean anything though? by smittyoneeach · · Score: 1, Troll

    One thing we know is that absence of regulation == total chaos.
    Just ask a bureaucrat.
    Furthermore, we know that people are stupid, and absolutely incapable of operating above caveman level without kindly bureaucrats.
    In summary, ensuring Total Regulation is a basic national security requirement.

    --
    Get thee glass eyes, and, like a scurvy politician, seem to see things thou dost not.--King Lear