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United States Medicine Technology

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

Posted by samzenpus
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.
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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 Jawnn (445279)

      If the federal government cannot keep up, then farm it out to private firms who are then audited by the Federal Government.

      Yeah. Look how well that's worked out for the pharmaceutical industry.

      • This is exactly how they do it for FIPS 140-2 cryptographic module certification. They farm it out to private certification firms.

        • This is exactly how they do it now for software in medical devices. Except that that 'private firms' are the manufacturers. It's ludicrous for them to claim that a certification process that basically amounts to asking the manufacturers to promise that they've tested it really well 'won't scale'.
    • 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 rhsanborn (773855)
        Unfortunately, companies like Apple are developing services to aggregate health data from things like wifi BP cuffs, scales, activity trackers, pulse oximeters, etc. And, physicians and regulators are already looking at ways to integrate that information into a broader plan of care. So, regardless of it's novelty, it's going to be used for very real medical decisions. At the very least, there needs to be better education about the lack of oversight and the potential for wildly inaccurate data, and I don't g
        • Unfortunately, companies like Apple are developing services to aggregate health data from things like wifi BP cuffs, scales, activity trackers, pulse oximeters, etc. And, physicians and regulators are already looking at ways to integrate that information into a broader plan of care. So, regardless of it's novelty, it's going to be used for very real medical decisions. At the very least, there needs to be better education about the lack of oversight and the potential for wildly inaccurate data, and I don't get the feeling that's happening.

          I honestly doubt physicians will base medical decisions on data from non-FDA approved devices. That is an enormous opening for the trial lawyers and their malpractice lawsuits.

          Similarly I doubt Apple will be promoting its consumer oriented devices for use in patient care, well in the medical data acquisition and telemetry sense, as opposed to doctors accessing data/records via iPads. Apple will probably "prohibit" such use in its licensing agreement. Apple's pockets are way too deep and they would just m

          • by tlhIngan (30335)

            I honestly doubt physicians will base medical decisions on data from non-FDA approved devices. That is an enormous opening for the trial lawyers and their malpractice lawsuits.

            And that is what would regulate the market in the meantime.

            The FDA doesn't want to regulate because not only is it going to be hard, but it's going to stifle what is a tremendous source of innovation that's happening.

            But even better is that the industry will either self-regulate, or will call on rules after a few court cases come out.

            • by perpenso (1613749)

              I honestly doubt physicians will base medical decisions on data from non-FDA approved devices. That is an enormous opening for the trial lawyers and their malpractice lawsuits.

              And that is what would regulate the market in the meantime.

              That is not how the trial lawyers work. They are not defacto regulators in most cases. The are far more often just parasites and are very much like the patent trolls, just using the legal system to extort money. They will sue doctors who did receive correct data from a device and who made a medically well informed decision. They will use the fact that the device is not FDA certified to sow FUD and confuse and mislead a jury who is clueless about medicine and devices. Every once in a while they will find a g

              • by tlhIngan (30335)

                That is not how the trial lawyers work. They are not defacto regulators in most cases. The are far more often just parasites and are very much like the patent trolls, just using the legal system to extort money. They will sue doctors who did receive correct data from a device and who made a medically well informed decision. They will use the fact that the device is not FDA certified to sow FUD and confuse and mislead a jury who is clueless about medicine and devices. Every once in a while they will find a g

                • by perpenso (1613749)

                  Why do you assume a doctor will be using this data?

                  Because the post I responded to said "And, physicians and regulators are already looking at ways to integrate that information into a broader plan of care." :-)

    • The upside to a certification program, even if privatized, allows the assignment of liability which supersedes the bullshit in the EULA. The idea is to create a "seller beware" instead of "buyer beware" market and to empower the consumer in such a way as to scare off the majority heap of charlatans. Further the cost of entry of certification clears a lot of that out anyway. Certainly the spam crap apps out of China and India.

      It also gives a registered address to send the legal summons and other such when
    • by Anonymous Coward

      Why? They've literally admitted the free market is too fast for them to manage without stiffling development. What sense does it make to demand they manage it somehow regardless? Staying out of people's hair is a good thing, not a bad one.

  • this does beg the question: if they're so popular without any FDA approval already, does this have any meaningful impact? i somehow doubt it.

    ed
    • by Anonymous Coward

      Popularity isn't the issue. Lots of dangerous stuff would be remarkably popular if given a chance.

      Short term pleasure, long term price.

      • Re: (Score:3, Insightful)

        by fustakrakich (1673220)

        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.

        • stuff

        • Re: (Score:3, Insightful)

          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 Mikkeles (698461)

            It's a good point, but the problem is to recognize the good one amongst all the bad ones. A bad one slipping through could cost even more lives.

      • Re: (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.
  • by Anonymous Coward on Sunday July 06, 2014 @08:53PM (#47396247)

    Nothing in the Constitution gives the federal government permission to have the FDA.

    Shut it down.

  • by Anonymous Coward

    ... or a drug?

    Why is the government involved in devices? If you want to market a device that measures BP (or whatever), great! If your customers would like some proof that it's good for the purpose, get Underwriter's Labs (or equivalent private organization for your country) to certify it.

    Government neither needed nor wanted here.

    • Why is the government involved in devices? ... get Underwriter's Labs .... to certify it.

      From the WP entry on UL - "UL is one of several companies approved to perform safety testing by the US federal agency Occupational Safety and Health Administration (OSHA)". If UL started handing out certs without doing the work then their license will be pulled and they will go out of business overnight.

      Very few "free markets" spontaneously arise and prosper, the government creates them with the judicious use of regulation, the most basic of these regulations is property law, the saftey cert market is

  • You can get heart rate monitors from sporting goods stores; these aren't FDA regulated either. As long as they don't make medical claims (like being suitable to diagnose or monitor a medical condition) it's not illegal to measure pulse or blood pressure.

    • What I find astounding is that the FDA doesn't even try to regulate Electronic Health Records. Large, expensive, complex programs that do monitor and help diagnose medical conditions. I'm much more leery of EHRs than random iPhone apps.

      It would be a major challenge to do this, but you might actually make a difference.

  • So, this info will become a part of The Health Administration's dossier? Move away from your e-gadgets....
  • Is this something that would respond to crowd-sourcing? I'm asking because I really don't know.

    I've noticed that the reviews for apps have become much less reliable. Apple and Google have even started making it harder to break out the low-rated reviews on apps in their stores now, and there's so much manipulation of the reviews that it's impossible to fully trust them. And Apple and Google are far from blameless in this.

    I wouldn't mind seeing some independent site that had sort of "wiki-reviews" of apps

    • by spauldo (118058)

      A friend of mine works in a lot of internet marketing and used to do things like search optimization and whatnot. Trust me, no matter what user-based system you set up, people will work day and night to subvert it to push their products. Any sort of review or rating system would be corrupted very quickly.

      And really, user reviews aren't a good source for medical data anyway. Half the people who leave reviews think streptococci is on special at the fancy italian place downtown.

      Personally, I think the FDA j

      • by PopeRatzo (965947)

        A friend of mine works in a lot of internet marketing and used to do things like search optimization and whatnot. Trust me, no matter what user-based system you set up, people will work day and night to subvert it to push their products. Any sort of review or rating system would be corrupted very quickly.

        So the system is inherently flawed.

        I can't believe there's no way to design a more robust system of review that isn't prone to corruption. Maybe the FDA is that system, but it's an expensive and inefficien

  • Dear Mr. Obama, we're sorry to inform you that our current Data Centers are at maximum capacity storing the complete browsing history and Porn Site usage of all American Tax Payers and cannot accommodate tracking medical app usage in the iTunes or Google Play App Store. Perhaps if you could be so kind as to take a shit on and then wipe your ass with the Constitution on Fox Cable News and proclaim this a Nation of God under Martial Law, we could come to an agreeable compromise.
  • This is an area that needs to be free from the constraints of the FDA for awhile.
  • This is a very good sign on the whole as it shows that out-innovating the regulatory state is not only possible, but actually happening right now. Our regulatory regime is stuck in the 19th century centralized command-and-control model, and it will stay there. Better to let it fail so that a useful and effective method of necessary oversight can come to replace our gilded age government with an information age government.
    • by spauldo (118058)

      I don't see an "information age" government happening for another twenty to thirty years, and that's probably optimistic.

      Those in power tend to be older and more conservative (in general terms, not talking about politics). They're often lawyers, who are used to working on months- or years-long projects where rapid response isn't possible or (to their mind) necessary. Getting them to accept that drastic change is necessary is difficult. When they do try to implement change, there are levels upon levels of

  • Copper & magnetic bracelets and a whole bunch of other snake oil that motivated the formation of the FDA in the first place are rampant.
  • I am glad the FDA can't keep up with health apps. Can you imaging how much it would stifle innovation? The health monitor that comes installed with Samsung Galaxy smart phones is wonderful. It quietly monitors my daily walking and lets me know when I hit my goal. I could hope for other biomonitors too, like something that can monitor blood chemistry and the like. We can have independent bodies rate how well these things work, and also how please the current users are with them. And actually, we have a lot
  • The FDA hinders too much medicine as is... just ask the people that actually make the medicine or the machines that save your life. They'll tell you that while the FDA means well they tend to just screw things up.

    Currently they're creating several drug shortages in the US by interfering with the manufacturing process to no particular purpose.

  • Do they really because I've only seen apps for monitoring blood pressure readings, readings taken by an external device. How is an app supposed to measure blood pressure?
  • iPhones have cult status all over the globe. It is one of the most pride possessions. Publishing of magazines to such a popular device through Magazine Apps for iPhone gives an advantage to increase reach out capacity to a great extent.
  • by Lehk228 (705449)
    ITT: libertardian circlejerk
  • It would be just one more thing the "pay to play" FDA has no business being involved in.

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