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FDA To Scrutinize Mobile Medical Apps 142

Posted by timothy
from the because-regulation-is-always-good dept.
mikejuk writes "It looks like 'first do no harm' is coming to an app near you. The US Food and Drug Administration (FDA) is seeking input on its proposed oversight of some health-related mobile phone apps. It is almost too easy to create an app that aims to help people detect or manage some condition or other — but should programmers play the role of doctor even in seemingly harmless areas?"
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FDA To Scrutinize Mobile Medical Apps

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  • because if there is a word 'health' in it, that's it, you are not your own person, you are property of your government and even when there is cancer treatment that can help you, created by a guy back in 1976, you can't have that treatment because the government says so [burzynskimovie.com] and you can't choose to exercise your freedoms, you are not your own person.

    • Where's Dr. Bob, DC when we need him? I'll bet antineoplastons cause subluxations. Just sayin'
      • No, you have got it all scrambled. Neoplastons cause subluxations. Antioneoplastons are the good guys in this let's-bash-the-FDA-and-cronies psychotic (but unmedicated) mind view.
        • I'd still feel better if I heard it from Dr. Bob. He has a way of explaining complex medical issues that I find very reassuring.
          • Well, if Dr. Bob won't come to you, I suppose you could use the magic of the Internet to go to Dr. Bob [worldchiro...liance.org] (or his therapeutic equivalent).
        • Oh, and just so I don't wander off into total snark ville - The FDA is really just looking for comments on things that either are used directly by a medical provider to view images or is attached to a medical device (like a glucometer). Makes perfect sense although why the FDA is so wound up about PACS (Picture Archival and Communication System - just a glorified version of a image viewer and database) is beyond me, but that's the FDA for you.

          As for all of the other 'Alternative / natural / homeopathic a
          • by ceoyoyo (59147)

            Those images are major diagnostic tools. They need to be stored securely, both against loss and theft, and displayed accurately so nobody misses anything or sees something that isn't there.

          • by flink (18449)

            There's a lot more to a PACS than "just" a DB of images. For example, a lot of times radiology has their own registration system, so you have two different patient identities you have to correlate, possibly through an MPI. You also want to make sure that relevant medical history or notes are available to the doc reading the film. And then at the end of the day, you may want to package the film and the read up into a clinical document and ship it off to an XDS or some other document system.

            If any of that g

    • If the 'antineplastons' are so wonderful, how come this MD PhD scientist type hasn't offered to rid some other country of the scourge of cancer? Europeans, Africans, Asians - they all get cancer and have money.
    • by Anonymous Coward

      There's a difference when you go beyond yourself to serving others.

      And as serving others is what the app market is about, I don't see a reason for you, or anybody else to have an unrestricted freedom to do what you want unto others in this regard.

      You'll have to find another set of circumstances if you want to be convincing that there's something outrageous going on.

    • by ChromeAeonium (1026952) on Sunday July 24, 2011 @02:05PM (#36863852)

      Protecting me from snake oil salesmen (like your Burzynski [quackwatch.org] quack [scienceblogs.com]) who have the one true cure for cancer is exactly why I want the government involved in health. You shouldn't be able to make shit up and pass it off as medicine, and you bet I want someone looking over real science before something goes to market where it can do real damage either if it is dangerous or if it just doesn't work and prevents people from getting real treatment. Could this lead to a a legitimate treatment being overlooked due to those big bad close minded doctors who just can't see the brilliance of (insert probable pseudoscience but possible real treatment here)? Maybe. But it's better than the alternative, and it is much more likely that they'll be preventing lots of bad treatments rather than suppressing a few good ones.

      And it's funny that the people always bashing the FDA (usually because their favorite quackery didn't get approval) are always the same ones hating on the pharma companies. Uh, hello, who the hell do you think is keeping those guys in line? You really want them running amok?

      • by superwiz (655733)
        You are already protected from snake oil salesmen. You are protected from them in the same way that you are protected from people selling land Chernobyl as "exclusive quite rural land in pristine woods." Fraud is fraud. You don't need a special case of medical fraud vs investment vs any other kind of fraud. And don't even bother saying that an average judge isn't able to distinguish a proper medical claim from a fraudulent one. We have family courts. We allow courts to decide on complicated intellectua
      • by superwiz (655733)
        Oh, and you NOT protected from snake oil salesman. Atkins diet, anyone? So you get all the negative sides of an overreaching regulatory agency and very few of the positive ones.
        • by superwiz (655733)
          Oh and,

          But it's better than the alternative, and it is much more likely that they'll be preventing lots of bad treatments rather than suppressing a few good ones.

          you got any statistics to back that up? Because Milton Freedman's analysis of their incentive structure showed the opposite to be the case -- their built-in bias is against approval.

          And it's funny that the people always bashing the FDA (usually because their favorite quackery didn't get approval) are always the same ones hating on the pharma companies. Uh, hello, who the hell do you think is keeping those guys in line?

          Pharma companies are unsung heroes of our time. They separate us from the misery of the natural world. Natural life if brutish, painful and short.

          • by superwiz (655733)
            buh.. his name is Milton Friedman, of course. (not Freedman)
          • you got any statistics to back that up?

            Look at how many so-called alternative medicines turn out to be just quackery, and how many turn out to be vindicated. There is a heavy skew toward bad ones.

            Pharma companies are unsung heroes of our time. They separate us from the misery of the natural world. Natural life if brutish, painful and short.

            Hey, I love living free of polio, measles, mumps, rotovirus, ect. courtesy of the pharmaceutical sector. I like that there's all kinds of helpful medications for things that were once a death sentence developed by the drug companies. I'm not trying to say they're this big evil cabal or anything like a lot of conspiracy nutters make them out to be, ju

      • by sjames (1099)

        Now if they would just protect us from the very expensive and occasionally deadly snake oil that comes out of big pharma. Or from the gray area cases where the prescription "drug" turns out to be a fantastically expensive minor variation on a cheap generic dietary supplement.

        Meanwhile, in the midst of the food contamination scares, the FDA was busy raising the approved levels of the contaminants and seizing e-cigs in defiance of a federal judge rather than helping to solve an actual problem.

        So, there's the

      • Having never heard of Dr. Burzynski, I took the liberty of reviewing your posted links.

        None of the posted information in the links discusses the therapy *or* the evidence, it only discusses the physician and in an uncomfortably bad light. They take the evidence of his credibility and dismiss it out of hand.

        For instance, the 2nd link points out that he is an MD and a PHD. Rather than take the obvious stance of "this is a trained scientist, perhaps we should examine his claims", they state this:

        "First, he rea

    • Did you read the article? This FDA oversight makes perfect sense.

      [Draft guidelines] specifies the following two categories of mobile medical apps:
      a: those used as an accessory to medical device already regulated by the FDA. (For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet)
      b: transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices. (For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).

      I'd rather my doctor not use apps with his approved devices that are unregulated. Although, I'm sure the free-market would sort it all out.

      • by mysidia (191772) *

        I'd rather my doctor not use apps with his approved devices that are unregulated. Although, I'm sure the free-market would sort it all out.

        I'd rather the FDA regulate the use of the combination of the app and the attachment in the case of (b). And require a standard of testing for the combination of app on tablet and attachment together. The tablet or app itself shouldn't need to be regulated or certified as an individual unit.

        But (I suppose) a consequence of this, would be workers would have to use sp

    • by ceoyoyo (59147)

      Sounds like you could use someone to protect you. If you want to take "antineoplastons" you're welcome to do so (they seem to be found in urine). Governments regulate people who give you medical advice and prescribe treatment.

      I do like how your "evidence" prominently includes a Dr Oz endorsement though.

    • by shentino (1139071)

      Gotta keep that pharmaceutical lobby going.

    • You know I sort of agree on this. Let the libertarians and "alternative medicine" kooks get their non-FDA approved medicine. Bring a little Darwin back into our idiot-safe modern world >:-)

      • by roman_mir (125474)

        Whatever you want to call it, get rid of government monopolies on drugs and there will be more drugs. Many of them will not help you, many of them will help you, and the market will sort it out. The way it's done now is ridiculous, apparently you are not your own person, you are property of your government, which decides for you what is it that you need and are allowed or not.

  • by NoNonAlphaCharsHere (2201864) on Sunday July 24, 2011 @01:49PM (#36863750)
    Nope, never played a roll, but I have baked them.
  • Bad Summary (Score:5, Insightful)

    by microcars (708223) on Sunday July 24, 2011 @01:57PM (#36863798) Homepage
    This only applies to apps that are used to communicate with an external device of some sort.

    It isn't planning to oversee all health apps - just those medical apps that could present a risk to patients if the apps don’t work as intended.
    It specifies the following two categories of mobile medical apps:
    a: those used as an accessory to medical device already regulated by the FDA.
    (For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet)
    b: transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.
    (For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).
    The FDA wants interested parties including software creators to comment on its proposals during the next 90-days.

    • by Trepidity (597)

      I can see that being a good idea in some cases, like monitoring for heart attacks, but I'm worried that the definitions will be too broad. As a private individual, it seems like I should be able to hook up a smartphone to a sensor and install an app that, say, monitors my sleep patterns. Maybe I'm "self-treating" some sort of sleep disorder; but maybe I'm just curious; or maybe I'm collecting data for an art installation based around my sleeping patterns. Either way it doesn't really seem like it should be

      • Either way it doesn't really seem like it should be the government's business to regulate it, unless it's actually being sold as a medical product.

        They're not. They are going after real 'medical devices'. If you claim that your device is not intended to cure or diagnose disease then you get a free pass. Just don't try to sell it with advertising suggesting that it's a real medical device.

  • Now is probably a bad time to point out to the FDA that the last time they tried regulating this, it was because the computer diagnostic program didn't have a license to practice medicine. They ignored the fact that the program was better at diagnosing medical conditions than the doctors that asked for its removal.

    I fail to see how giving people the resources to diagnose their own problems is a public health concern, any more than providing people with information about how to fix their own cars. Yes, some

    • by hedwards (940851)

      There's a significant amount of researching and testing that has to be done before you're allowed to advertise something as having a medical use. With good reason, while a pillow might really treat certain types of sleep apnea you would have to do the trials necessary to back it up.

      I'm guessing that the issue wasn't solely about not having a license to practice medicine. Personally, I'd rather have somebody that's been trained working on me than some random quack. I have had a lot of luck with complementary

    • If you knew anything about medicine, you would know that no computer has come close to out-diagnosing an experienced clinician. Computers are great at giving lists of possibilities, but real medicine is all about risk and uncertainty, where intuition and clinical skills play a big part. How do you think a computer would even be able to form a reliable diagnosis without an experienced clinician performing an examination?
  • If you use it for a real medical issue and hurt yourself, its your own damned fault.

    I can see an 'app czar' coming soon :(

  • by decora (1710862) on Sunday July 24, 2011 @02:07PM (#36863866) Journal

    could they go after the '1 secret to trim belly fat' or 'dermatologists hate this woman' ads first?

    those are out and out fraud, but more than that, im sick of looking at them.

    • by ceoyoyo (59147)

      I was curious what kind of woo was behind the belly fat ads so I followed the link until it wanted to charge for a PDF, then went and found the document on the pirate bay. Once you cut through all the crap, basically the secret is "exercise."

  • Medical apps are just one step in a trend that will redo the way we manage health.

    Health care is broken in the US. The problem is that the system is so unbelievably entrenched that it's impossible to dislodge. Health insurance companies that make billions, safety rules that require half a billion investment to test a drug, physicians' inability to make exceptions... everything is frozen in bureaucracy that will not change.

    Any entrenched fixed system will eventually be overtaken by smaller innovative solutio

  • should programmers play the role of doctor even in seemingly harmless areas?

    As a programmer, not only am I not interested in doing that, but I'm not qualified either, and no user would have reason to trust me even if I did it. So the answer (in my case) is obviously no.

    But that's irrelevant anyway, because someone already mentioned the FDA. The question is now, "Should government use force to prevent people from using programs written by people who play doctor?"

    You might think that answer is just as clear

  • leads me to conclude that some corporation wants the FDA to eliminate competition to some of its medical apps. After this plays out, and we see which corporation is still peddling medical apps, we'll know who paid the FDA to go after the others.

    It's such a common problem these days. Every government agency is headed by a former corporate CEO or lawyer, and when their term expires they return to the corporate world, being replaced by the CEO they replace. This goes on unchecked because Congressmen and

    • by Trepidity (597)

      Indeed, they're hoping to come out of this with the best of both worlds. They want to sell devices using commodity iPad / iPhone hardware, greatly lowering their costs compared to the low-production-run custom stuff that medical devices have typically been, but they still want to sell them in these "certified" packages w/ software for high medical-device prices without any commodity competition.

  • The fees to get a product 501k approved are $4000 if you are a large business or $2000 if you are a small (and small to them is $100,000,000/yr) and a yearly $2000 fee.

    now, easy for gaxosmithkline to afford but not for a two person indie shop. The large companies haven't innovated at all in the mobile market, almost all top apps in the Appe Medical App Store are from small shops

    bravo FDA for destroying the innovators in the market reducing health care costs.
  • but should programmers play the role of doctor even in seemingly harmless areas?

    That's a stupid generalization. A doctor can hire a programmer to create an app but a that still does not make the programmer a doctor.

    • Although.. what IS a doctor (MD), really?

      A person who has spent the better part of a decade cramming as many (hopefully correct and up-to-date) facts into his head and relating them all to each other in such a way that they will have quick access to the important ones for each patient he is presented with.

      In other words, an MD is a medical database in organic form! One that has to be built from scratch on each new piece of hardware running it. (and one whose pruning algorithm is a little aggressive....)

      Fr

  • We don't need government involvement in apps, websites or other sources that are simply informative in purpose. If you getting close to medical advice the creators should just tell you: this is not medical advice, if in doubt contact your doctor, do not use for diagnosis etc. If people are stupid and use it for it, why not, some believe and practice lot of old wive tales about medical things, some even believe in homeopathy, faith healing etc., government involvement over those things is simply encroaching

  • Everything at all related to food and drugs is FUCKED UP IN THE U.S.A.. The FDA is one of the major causes of this. They feed on our own money and drop their excrement on us.

    Improve the physical and economic health of America by doing whatever you can to take those motherfuckers down.

  • In every other industry there is an acknowledged trade off between quality and cost.

    This at least the low-hanging fruit to become cheap and affordable.

    But not in the healthcare industry. There, you just mention the world quality and it must be done. Driving up the cost and preventing people from getting cheaper affordable treatment.

    No, we're talking about someone hacking you up to do brain surgery at low cost. But the low-hanging fruit.

    I've been on the same thyroid medication for years. Yet I always hav

  • "but should programmers play the role of doctor even in seemingly harmless areas"

    No, obviously no one other than a doctor should play the role of doctor. But this is a red herring. We're not talking about medical apps that claim to be equivalent to doctors. No one is practicing medicine without a license here.

    It should be obvious to anyone that an app can be written by someone who does not have a medical degree or any relevant experience. Now, if these apps were claiming to be written by doctors or to
  • by clifyt (11768) <sonikmatter@gm a i l . com> on Sunday July 24, 2011 @08:15PM (#36866384) Homepage

    I use to write medical applications and instruments years ago, and one of the most expensive things was testing the work, and running it past lawyers -- who tested the work one more time with a different team.

    And my products were generally known as being good, accurate, and scientifically tested. ...

    And then I would see competitors put out similar works that was not tested, and often times inaccurate. And much cheaper. Hell, one of my competitors put a disclaimer and lawyerly notice with the same guys I had been working with and I asked them if it was a conflict of interest...my guys said that if they were involved, they couldn't talk about it because of client lawyer priv...but then came back and said they could talk about it because they never heard from the guy. And yet, people thought his work was as scientifically tested and rigorous mine.

    In my case, I was doing mostly psychological work...I was careful about my clients. I only licensed my software to legitimate psychologists or MDs with the appropriate background. My competitors didn't care...schools would try to buy my work to test kids to see if they were psychos or needed kicked out...and wants software that could take the place of a trained professional (where as I actually took out a few automations that would have been easier to diagnose, BUT it made it easier for people that had no right to diagnose, nor actually understood the ramification of doing this...I wanted the diagnosis to come from a licensed psychologist).

    The whole point is, there is too much unregulated work in this world. Too many people that think they are experts, just because they have a book with equations and knowledge of programming. Too many people that are willing to put their name on a product for a percentage of the sales without ever looking at it. I spend the money on making certain things were right -- and it cut into my profit A LOT -- but it was the right thing to do. Everything I hear from this law is that it will actually make the law a little more uniform and a lot of stuff that we had to guess at is now concrete and no guessing needed. It will be actually cheaper to do this than what I paid before...the only people complaining are those that took shortcuts and didn't really care about your health.

    (and sadly, these days I have the credentials to do the work...and yet I do no programming any more).

Faith may be defined briefly as an illogical belief in the occurence of the improbable. - H. L. Mencken

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