Follow Slashdot stories on Twitter

 



Forgot your password?
typodupeerror
Check out the new SourceForge HTML5 internet speed test! No Flash necessary and runs on all devices. ×
Medicine Software Government

FDA Will Regulate Some Apps As Medical Devices 130

chicksdaddy writes "In an important move, the U.S. Food & Drug Administration (FDA) has released final guidance to mobile application developers that are creating medical applications to run on mobile devices. Some applications, it said, will be treated with the same scrutiny as traditional medical devices. The agency said on Monday that, while it doesn't see the need to vet 'the majority of mobile apps,' because they pose 'minimal risk to consumers,' it will exercise oversight of mobile medical applications that are accessories to regulated medical devices, or that transform a mobile device into a regulated medical device. In those cases, the FDA said that mobile applications will be assessed 'using the same regulatory standards and risk-based approach that the agency applies to other medical device.' The line between a mere 'app' and a 'medical device' is fuzzy. The FDA said it will look to the 'intended use of a mobile app' when determining whether it meets the definition of a medical 'device.' The Agency may study the labeling or advertising claims used to market it, or statements by the device maker and its representatives. In general, 'when the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease, or it is intended to affect the structure of any function of the body of man, the mobile app is a device.'"
This discussion has been archived. No new comments can be posted.

FDA Will Regulate Some Apps As Medical Devices

Comments Filter:
  • Woohoo! (Score:0, Troll)

    by geek ( 5680 ) on Tuesday September 24, 2013 @04:06PM (#44940623) Homepage

    Nanny State to the rescue! Did someone appoint Bloomberg to the FDA?

    • Re:Woohoo! (Score:0, Flamebait)

      by Anonymous Coward on Tuesday September 24, 2013 @04:09PM (#44940665)

      why don't you move to Somalia, you jack off.

    • Re:Woohoo! (Score:5, Insightful)

      by ColdWetDog ( 752185 ) on Tuesday September 24, 2013 @04:12PM (#44940691) Homepage

      So you want an app that's controlling an IV pump to be written to the same standards as your average fart app?

      That's what this is about. The FDA neither has the time nor energy to look at every stupid 'medical' app in the store. They're only going to deal with ones that have an interaction to hardware that can cause problems or if the app is really, egregariously touting some medical benefit that it can't possibly provide.

      • Re:Woohoo! (Score:5, Insightful)

        by geek ( 5680 ) on Tuesday September 24, 2013 @04:14PM (#44940751) Homepage

        So you want an app that's controlling an IV pump to be written to the same standards as your average fart app?

        Why the fuck would you use a mobile app to control an IV pump? That's like running a production database for a fortune 500 company off of Arch Linux.

        You don't use something that isn't stable to run something as important and life critical as an IV pump. Nor would any hospital do so and any individual that tried would simply be a victim of natural selection.

        • Re:Woohoo! (Score:4, Insightful)

          by bill_mcgonigle ( 4333 ) * on Tuesday September 24, 2013 @04:22PM (#44940857) Homepage Journal

          Why would you put a poorly-tested embedded bluetooth stack in a pacemaker that crashes under fuzzing? Crazy, right?

          If it's anything like it was when I was in medical software, the FDA is more concerned with process than specifics of implementation. If you're practicing good software development and QA methodologies and you can impress your ISO9001 auditor, then the FDA won't be too tough. Then again, "those were the days", so maybe somebody can update this - last time I flew to FDA for a development seminar was the first time I got wanded by TSA.

          • Re:Woohoo! (Score:4, Insightful)

            by Artraze ( 600366 ) on Tuesday September 24, 2013 @04:45PM (#44941109)

            These days they have ISO 13485 [wikipedia.org]. It's a lot like ISO 9001, but drops the more marketing continual improvement and customer feedback and adds additional requirement for creation of requirements, something more-or-less non existent in 9001.

            So theoretically, 13485 would require you to recognize risks (e.g. fuzzing) and add mitigation (e.g. not crashing) to your requirements, which would then be tested and all the in a similar matter to 9001. I'd say that as a result it's about as good as can really be expected. The only real other steps would be for the FDA to bring in experts to verify the considered risks and possibly verify the testing, which starts to become unrealistic.

            For completeness it's worth mentioning that when it comes to diagnostic software (I believe this started in the last couple years) they also require clinical trials to verify effectiveness somewhat like they do for medicine. Therefore if you write an application that, say, helps determine if someone is concussed (the case which started diagnostic software, IIRC) then you actually have to collect data for concussed and non-concussed people (verified by traditional means) and prove that it can provide a meaningful diagnosis.

            • by TapeCutter ( 624760 ) on Tuesday September 24, 2013 @07:44PM (#44942899) Journal

              The only real other steps would be for the FDA to bring in experts to verify the considered risks and possibly verify the testing, which starts to become unrealistic.

              Yes, in many cases the only 'experts' are the people who wrote the code. All you can really do is minimise risks by erecting procedural walls and testers between the experts, the accountants, and the patients. Sure it slows things down, bumps up costs, and is still not 'failsafe'. But that's the price of working under the motto "first do no harm".

              Aside from that, in most western nations if your software does kill or injure someone, your 'principle engineer' better be able to demonstrate due diligence such as adherence to government mandated standards, ie: adherence to the law. If not he will find himself charged with the local equivalent of "negligent homicide". Why do people think there was so much fuss over Y2K? Why would an insurer not cancel a public liability policy if the insured was not Y2K "compliant", who would the coroner hold responsible if there was an accident? Y2K was not a "beat up", it was proof that software engineers can and do act like real engineers when risks are identified.

              To the rest of the world a software engineer that ignores mandated standards is just as criminally reckless as the (veteran) Italian train driver who recently crashed his passenger train into a concrete embankment because he took a bend at twice the posted speed.

        • by khb ( 266593 ) on Tuesday September 24, 2013 @04:27PM (#44940921)

          A wide variety of medical devices currently use Windows (often XP) to provide the client interface. Most Doctors have smart phones, so getting the buggy, unreliable, insecure Windows box out of the picture may appeal to some ... and leveraging the technology that the staff already have is not unreasonable (yes, there's some OTHER computer actually monitoring the flow. But setting the rates? Receiving alerts? ... why not use the smartphone?).

          As to whether the FDA does a good or bad job (or a bit of both), it neither seems odd that some people would want to leverage the control (think Cochlear implant devices and programming adjustments) that folks already have, to manage their devices (durable, not just hospital based). Nor, if one accepts that the FDA has a role of any sort, why they should not be involved JUST because something is a software app as opposed to the software running in the otherwise regulated device.

          • by K. S. Kyosuke ( 729550 ) on Tuesday September 24, 2013 @04:44PM (#44941103)

            A wide variety of medical devices currently use Windows (often XP) to provide the client interface.

            I hope that the Feds on Drugs Administration has thoroughly tested those Windows as well. I can't imagine a medical device having anything COTS-related that wouldn't be isolated in some safe way that would make testing the front-end at least less important, if not completely meaningless. You don't prevent Therac-25-like incidents by vetting an XP client that controls everything, you prevent them by minimizing the implementation into a single-purpose controller with bulletproof interface to the XP client. Likewise, I can't see how a cell phone or tablet could even communicate with a trustworthy medical device without either 1) the cell phone having an simple but reliable add-on port hardware to connect to the device, or 2) the device having a common wireless communication equipment such as WiFi or BT. The former makes it a non-app (as in, not a downloadable file, but a physical device with a SW client, and therefore a medical device in the old sense), the latter would be extremely braindead given the complexity of the WiFi and BT stuff, and the potential bugs therein.

          • by TapeCutter ( 624760 ) on Tuesday September 24, 2013 @08:32PM (#44943243) Journal
            My mum is in her late 70's and has a $6k hearing aid that is tuned on a PC. The FDA don't want to prevent people tuning their hearing aid with their mobile phone, they want to ensure they can't accidentally blast their brains out with a 130db screech in the pitch of a 6yo girl. They will also want to look at the hearing aid to ensure it can't be used as an audio torture device in the first place.

            It's well known that principles are expensive. The majority of the $6k for the device and software represents the cost compliance with the "first do no harm" principle that has been central to western medical practice for over 2000yrs, money well spent IMHO.

            Pre-emptive "free market" retort: Hearing aids and the software that interacts with them are tested, certified, and sold as a standalone "system". Everyone is "free" to play in that "market", although individuals and groups have varying degrees of influence on how the market works, they are not "free" to dictate the rules of trade that constitute the market itself, that's the role of government.
        • Re:Woohoo! (Score:5, Insightful)

          by reebmmm ( 939463 ) on Tuesday September 24, 2013 @04:29PM (#44940949)

          Why the fuck would you use a mobile app to control an IV pump?

          The point is really two-fold. First, we already regulate medical devices like infusion pumps and radiology information systems. Under the proposed regime, one does not simply avoid regulatory scrutiny and obligations by offloading them to an app.

          Second, if a app makes claims to do things things that would ordinarily be regulated, you don't escape the regulatory regime simply by saying, I'm just an iPhone app.

          Both prongs make some sense if you accept the basic assumption that FDA regulation of devices makes sense at all.

          • by rshol ( 746340 ) on Tuesday September 24, 2013 @05:42PM (#44941733)

            you don't escape the regulatory regime

            Exactly. Ever. And that is the root of the problem.

          • by tlhIngan ( 30335 ) <slashdot@wo[ ]net ['rf.' in gap]> on Wednesday September 25, 2013 @10:55AM (#44948331)

            you don't escape the regulatory regime

            Exactly. Ever. And that is the root of the problem.

            The FDA came about this because there were a HUGE number of apps that did medical quackery.

            Yes, quackery, as in back to the snake oil days. You may recall many apps claimed to do stuff like cure acne and analyze your skin for stuff like melanoma and things like that.

            The problem was the first claimed to do it by "exposing the acne to a special light", which ended up just being a specific color of the screen. And there was no evidence whatsoever that said a particular color of light would cure acne, nor was there any evidence that even a smartphone screen could generate the required light.

            Of course, that app sold a ton of copies because it appealed to a huge market who generally tend to own such devices.

            The second kind of app is positively dangerous if it makes a wrong diagnosis. If it's a false positive, not generally a problem since your doctor (who you need to go through in order to get treatment anyways) will probably discover it's not melanoma.

            But if it's a false negative, then there's a big problem because someone may wait far too long with it (thinking it isn't melanoma) before deciding they really need to seek treatment. By then, the cancer may have spread and (in the best case) make for a complex series of treatments, or be completely inoperable and terminal.

            And then there's a whole new set of apps that are designed for doctors to aid in diagnosis and many that patients use to send medical data to their doctors. If there's ever a case for privacy protection - sensitive information like this would be it. It would make apps stealing your contacts list seem trivial by comparison if a developer decides they want to get your medical information and sell it to people who shouldn't get it.

        • by Anonymous Coward on Tuesday September 24, 2013 @04:31PM (#44940987)

          Arch Linux is not stable enough to run anything

          • by Urza9814 ( 883915 ) on Tuesday September 24, 2013 @08:57PM (#44943389)

            I run Arch on my desktop and laptops and it requires *orders of magnitude* less maintenance than the Mandriva system it replaced...not that that's saying much. Of course Mandriva still beat Ubuntu -- I could never manage to get an Ubuntu system fully working in the first place! (granted, the last time I tried was probably six years ago when it was a fairly new distro...)

        • Re:Woohoo! (Score:4, Insightful)

          by icebike ( 68054 ) on Tuesday September 24, 2013 @04:36PM (#44941043)

          You don't use something that isn't stable to run something as important and life critical as an IV pump. Nor would any hospital do so and any individual that tried would simply be a victim of natural selection.

          From your mouth to God's Ears.

          But just in case someone was thinking of doing this the FDA is going to step in and set guidelines.
          Why: Because people are re-purposing cellphones for all sorts of stuff, most of it not well thought out.

          You can find examples which contain unvetted information on the Google Play store. Some of this might find its way into actual use in the field, because in all too many cases doctors and computers live in two different worlds, and may come to trust something that looks approximately right, only to find out its horribly wrong in some places:

          Examples (with no allegations of incorrectness or danger, simply to show examples that already exist):
          https://play.google.com/store/apps/details?id=com.shahlab.anesthesiologist [google.com]
          https://play.google.com/store/apps/details?id=net.klier.blutdruck [google.com]
          https://play.google.com/store/apps/details?id=com.qxmd.calculate [google.com]
          https://play.google.com/store/apps/details?id=com.mobisystems.msdict.embedded.wireless.mcgrawhill.ivdh [google.com]
          https://play.google.com/store/apps/details?id=com.sekos.dosagecalc [google.com]

          So yeah you might thing such doesn't exist, and these might be harmess infomation apps, but who's to know when nobody is watching.
          And with NFC built into every phone these days, who's to say someone won't find another use for it?

          • by Anonymous Coward on Tuesday September 24, 2013 @05:06PM (#44941373)

            A lot of those examples are more akin to books. AFAIK there is not a similar review process for that scenario at least.

            I think people should only be afraid of over reach. When I think of over reach I am more concerned with things like the kickstarter eeg projects.

            Apps that actually can injure someone due to malfunction IS different than someone being stupid and trusting questionable information.

        • by raymorris ( 2726007 ) on Tuesday September 24, 2013 @04:43PM (#44941097) Journal

          That's exactly when the FDA should step in, and when they have, historically. It doesn't make any sense to try to cure diabetes with lizard tails. If you sell lizard tails as a diabetes cure, the FDA may come knocking. If you sell a magnet hat as brain cancer protection, the FDA may want to talk to you. If you sell a strobe light app as a cure for emphysema, same thing.

          Really this is just another case of "on a computer doesn't change anything". If you sell a "cure" for a disease, the FDA may want to have a look.

        • by mspohr ( 589790 ) on Tuesday September 24, 2013 @04:49PM (#44941147)

          I agree that the software should be stable and tested (and that is the purpose of these regulations).
          As to "why use a mobile app to control an IV pump"... let me count the ways.
          Use your imagination.
          - patient is in isolation... don't touch the pump
          - nurse can monitor and control a lot of pumps from one application
          - the application can check for problems with the pump
          - the application can check for drug interactions
          - the application can check for drug overdoses
          - the application can check lab values and recommend changes in dosage
          --- these are just a few off the top of my head...

          It's not hard if you have a little imagination.

        • by jklovanc ( 1603149 ) on Tuesday September 24, 2013 @04:51PM (#44941189)

          How about the following?
          1. An app that interfaces with a glucose reader that calculates what dose of insulin and when to administer but miscalculates and over/under prescribes.
          2. An app that displays ECGs for cardiologists but mis-displays and life threatening illnesses are missed.
          3. A portable ECG that mis-records? I used to work at a company that uses puck sized ECGs with USB interfaces.
          4. An app that interfaces with a blood pressure cuff and attempts to diagnose high blood pressure.

          A smart phone makes a great display and data recorder and they can get into areas where mistakes can cause death or disability.

        • by mjr167 ( 2477430 ) on Tuesday September 24, 2013 @04:58PM (#44941283)

          By your logic we should never do anything because it is not safe.

          The world is moving on and us kids will happily get off your lawn and take our new mobile shinies with us. We are moving into a world where the data gets shot through the air and my device fits in my pocket. You can bitch about it or you can help us make it work. The IV pump you mention CAN accept its inputs from mobile apps. But between the app and the IV pump should be something that is going to validate the inputs coming from the app. And the IV pump is going to perform the same validations that it currently performs against the nurse fiddling with the knobs/buttons/whatever manually.

          Yes it's not safe because it gets shot through the air, but smart software engineers will build in fail saves and checks and security. Oh noes! We will have to test and validate our code! The horror!

        • by Luciano Moretti ( 2887109 ) on Tuesday September 24, 2013 @05:34PM (#44941627)

          What would probably happen is the actual logic and safeties would be written in an embedded board on the IV pump, and then the app would be a remote display app, with a touchscreen interface allowing you to adjust settings within predefined limits.

          I used to work in medical imaging, and people floated the idea of display apps on iPads for doctors to view images, but the display quality wasn't good enough for medical diagnosis. Even our monitors on our equipment had a disclaimer that they weren't for medical diagnosis: usually that was offloaded onto a dedicated workstation with a super-high resolution monitor (usually grayscale)

          Other potential uses would be remote display of ECG/Vitals, but then you have to make sure that alarms come across your network correctly to the device, and that data isn't delayed or incorrectly displayed (which could cause misdiagnosis).

          That said, when I left about a year ago we were still selling a device that had Windows 95 on it.

        • Re:Woohoo! (Score:4, Interesting)

          by Alternate Interior ( 725192 ) <`moc.roiretnietanretla' `ta' `todhsals'> on Tuesday September 24, 2013 @05:37PM (#44941677) Homepage

          Speaking as a Diabetic- yes I do.

          I wear an infusion pump already. And a continuous monitor. They're plastic screens and buttons I clip to my belt. They have to be easily accessible because there is so much variance day-to-day.

          Having everything talk via ANT or BT or something. Having one controller for it all. It'd be wonderful. I think your point is that it's too dangerous to put all that burden on a single piece of commodity hardware. And that's a valid point, in theory. But in reality, if I can replace the pump UI and CGM UI with a phone **that I'm already carrying** I end up with a whole lot fewer widgets to keep track of. Also, by virtue of commoditization, I could replace the software stack infinitely easier than a purpose-built controller, Dangerous? Sure. But understand the position we're in now:

          1. Taking too much insulin is deadly.
          2. It's easy to take too much insulin.
          3. Since 2009, pumps and CGMs have been available in much of the world which automatically stop delivering insulin when your blood sugar is low.
          4. The FDA has not allowed this technology in the United States.

          I don't care if it's dangerous or voids the warranty or puts the FDA boogey-man on me. If a development like this occurs in the future and the FDA impedes it, I would like the opportunity to get it. Running on an open stack, even a quasi-open stack, is the only viable way for that to happen. And for today, smartphones are the best way to make that happen.

        • by c ( 8461 ) <beauregardcp@gmail.com> on Tuesday September 24, 2013 @05:45PM (#44941775)

          Why the fuck would you use a mobile app to control an IV pump?

          An IV pump, probably not. In fact, you'd be silly to run hospital gear with a phone.

          A personal device like an insulin pump... yep, I could see it. They've already got pumps that wirelessly communicate with glucometers, and a user interface written on a mobile has to be less confusing than the nests of modal menus on a pump.

        • by pscottdv ( 676889 ) on Tuesday September 24, 2013 @06:50PM (#44942439)

          But perhaps they want to regulate devices such as this:

          http://hardware.slashdot.org/story/13/09/21/1341212/turning-a-smart-phone-into-a-microscope [slashdot.org]

          From the article:

          For example, doctors in remote regions could use the technique to measure HIV viral loads in patients' blood samples, allowing the doctors to easily monitor disease progression and determine the best course of treatment."

      • Re:Woohoo! (Score:2, Interesting)

        by cayenne8 ( 626475 ) on Tuesday September 24, 2013 @04:16PM (#44940771) Homepage Journal
        I'm guessing it is also a nice move to allow more tax revenue to be gathered due to be being categorized as a medical device....another nice little by product of obamacare (the increased taxation of medical devices).
      • by Anonymous Coward on Tuesday September 24, 2013 @04:20PM (#44940813)

        So you want an app that's controlling an IV pump to be written to the same standards as your average fart app?

        That's what this is about. The FDA neither has the time nor energy to look at every stupid 'medical' app in the store. They're only going to deal with ones that have an interaction to hardware that can cause problems or if the app is really, egregariously touting some medical benefit that it can't possibly provide.

        But the government can't possibly do anything right! Surely we are better off just letting our corporate fart-app overlords have final say over what we are allowed to use as a medical device, instead.

      • by Jack Quack ( 1352327 ) on Tuesday September 24, 2013 @06:40PM (#44942345)

        Here are two examples of how an app on it's own can pose significant risk to a patient, if the app is intended to make a diagnosis.

        1) a medical professional prescribes an intervention that is influenced by the app's diagnosis. If the diagnosis is inaccurate, the prescribed intervention may be very harmful to the patient.

        2) If the diagnosis leads to a treatment that is incorrect, the patient may be delayed from receiving the best treatment for that particular case, and this delay may be very harmful to the patient.

      • by TapeCutter ( 624760 ) on Tuesday September 24, 2013 @07:00PM (#44942565) Journal
        Agree, just the fact the FDA have announced they are looking at them will deter some quacks from peddling their brand of crazy as an app. Also the FDA is used as a global standard, it's one of the few admirable institutions within your health system. You guys should reinvent it as a UN agency so that you're not the only ones paying for it.
        • by ColdWetDog ( 752185 ) on Wednesday September 25, 2013 @10:04AM (#44947659) Homepage

          You guys should reinvent it as a UN agency so that you're not the only ones paying for it.

          Are you kidding? If that happened, then the small fraction of the US that doesn't think the FDA is a Big Pharma plant will get all riled up because the AYERABS and COMMIES will control their meds.

          Which, on reflection, might not be such a bad thing ...

      • by dywolf ( 2673597 ) on Wednesday September 25, 2013 @08:27AM (#44946659)

        actually i saw it more as a preemptive move on the FDAs part. since we dont really have tons of diagnostic sensors in our mobile devices yet...but someday we might ("Lab on a chip", etc), aka, Tricorders. so this is just them saying, if we get to that point, these apps better work, and will be regulated.

        ie, none of that "You might be diseased. Click here to find out" shennanigans.

        • by DeadCatX2 ( 950953 ) on Wednesday September 25, 2013 @05:32PM (#44953479) Journal

          Except this is not preemptive. FDA has already been regulating medical applications on mobile platforms (quote, FTA: "The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years"). This guidance is saying that certain medical applications are now exempt from regulation.

          • by dywolf ( 2673597 ) on Thursday September 26, 2013 @12:23PM (#44961265)

            i cant see any current apps being used as "medical devices". not that i know a lot about medical apps, but i dont yet know of any mobile phones being used to perform tests and provide control over treatment. far as i know the lab on a chip is still theoretical.

            • by DeadCatX2 ( 950953 ) on Thursday September 26, 2013 @12:47PM (#44961521) Journal

              That's why FDA issued this guidance. Because they were being forced to heavily regulate simple things unnecessarily. Up until now, if you wanted a doctor to use your app, you had to get it FDA approved. Now, assuming your app meets one of the exemptions, doctors can use your app more easily without potential liability (doctors tend to be paranoid about what they'll use on patients).

    • by Anonymous Coward on Tuesday September 24, 2013 @04:15PM (#44940755)

      I saw him on CNN on July 4th saying that this date reminds us of all the freedoms we enjoy as Americans.
      What a turd.

    • by Artraze ( 600366 ) on Tuesday September 24, 2013 @04:28PM (#44940939)

      The important fine print omitted by the summary (and very nearly the article; way to push the important information to the last third ya damn flamebaiters masquerading as journalists) is that they targeting apps

      when the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease, or it is intended to affect the structure of any function of the body of man

      Now, we'll have to see how it plays out, to be sure. Certainly I think that their interest in targeting apps that interface with medial devices is a little disconcerting because it would make, say, a free/cheap pulse monitor simply impossible. However, they generally allow anything with sufficient (and reasonable) disclaimers (e.g. for research purposes only) so I'm not too concerned yet.

      So while I loathe nanny state type policies and don't like everything that the FDA does, I view stuff like this to actually be rather important. Basically, think of it as a proactive enforcement of truth in advertising (vs reactive which requires a lawsuit). If I say my app diagnoses X, the FDA wants to make sure it actually does that. Coupled with the ability for the developer to avoid that by saying 'this is not approved to actually do anything' it makes for a valuable tool for consumer choice.

      • by skids ( 119237 ) on Tuesday September 24, 2013 @04:48PM (#44941139) Homepage

        a free/cheap pulse monitor simply impossible

        I don't think phones need to be attached to anything to do that, but that's beside the point, as how I read the document things such as this heart rate monitor [f-droid.org]

        ...might be considered a device that needs to register, but might not, and what makes the difference is entirely how it is marketed, that is what claims are made of it. In which case small demo apps like this might be able to just get away with disclaimers that state "for demo purposes only." Which, without some level of QA, is pretty much all you should be using them for.

      • by SonnyDog09 ( 1500475 ) on Tuesday September 24, 2013 @07:57PM (#44942973)

        Right. But since being overweight has just been re-classified as a disease, any app that lets you track you weight can be interpreted as being one that is involved in the "treatment or prevention of disease." Don't you think they won't.

        The other thing I like about this is that they have a scheme for registering and tracking these devices. See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm [fda.gov] for details.

        This is the Globally Unique Device Identifier (GUDID), which they are pronouncing "Good ID". Who says that the government can't market its stuff.

      • by Urza9814 ( 883915 ) on Tuesday September 24, 2013 @09:08PM (#44943441)

        Certainly I think that their interest in targeting apps that interface with medial devices is a little disconcerting because it would make, say, a free/cheap pulse monitor simply impossible.

        Every treadmill I've ever seen includes a heart rate monitor. Usually when I try to use them I get readings of 0...or 500...or some other equally absurd number. Clearly things like heart rate monitors are not very strictly regulated.

    • by Dahamma ( 304068 ) on Tuesday September 24, 2013 @05:23PM (#44941543)

      Totally! We all agree that the FDA is one of the most ridiculous, intrusive examples of a nanny state imaginable.

      Signed,
      - Monsanto, Pfizer, GlaxoSmithKline, Philip Morris, Tyson, and 100s of other companies fined for marketing and selling tainted, dangerous, or untested products to consumers

    • by Anonymous Coward on Tuesday September 24, 2013 @05:37PM (#44941681)

      The FDA is protecting traditional medical device manufacturers an their exorbitant, overpriced tech to prevent vastly cheaper apps from disrupting the high cost of health care and allowing the average person to monitor their health at home for pennies a day.

    • Re:Woohoo! (Score:4, Insightful)

      by mcgrew ( 92797 ) * on Tuesday September 24, 2013 @06:32PM (#44942269) Homepage Journal

      Nanny State to the rescue!

      Bullshit, regulating medical devices isn't being nanny-state, outlawing marijuana is. I, for one am damned glad that the FDA had to approve the device they inserted surgically into my eyeball. I'm damned glad that drugs are regulated, so I won't underdose or overdose on a needed medicine because a supplier is incompetent or dishonest.

      Do you scream "nanny state" when the cops go after armed robbers? Did you scream Nanny State when they jailed Madoff?

      Sorry, kid, but your comment is just brain-dead stupid. Read a little history, look up "patent medicine" and "snake oil". Read Upton Sinclair's The Jungle (public domain, it's at gutenberg).

  • by rolfwind ( 528248 ) on Tuesday September 24, 2013 @04:13PM (#44940713)

    Stating the app is only for entertainment/educational purposes only.

  • by oDDmON oUT ( 231200 ) on Tuesday September 24, 2013 @04:16PM (#44940775)

    Or just be another black hole that taxpayer dollars funnel into?
    [Think medical device fraud via Medicare/Medicaid that is STILL rampant]

  • by Anonymous Coward on Tuesday September 24, 2013 @04:17PM (#44940787)

    Just as certain applications for other specific fields may need to pass testing and scrutiny before being available for general use (flying and the FAA comes to mind), so it is reasonable for the FDA to step in here.

  • by Anonymous Coward on Tuesday September 24, 2013 @04:23PM (#44940869)

    App to app app gets apped after app kills 500 people, causing app apper to app apps.

  • by PseudoCoder ( 1642383 ) on Tuesday September 24, 2013 @04:24PM (#44940887)

    Would they then be subject to the O-care medical device tax? Let's not forget what it was all about to begin with.

    http://www.youtube.com/watch?v=r2Kevz_9lsw

    http://www.youtube.com/watch?v=BLiexzoAq7E

  • by Anonymous Coward on Tuesday September 24, 2013 @04:25PM (#44940903)

    How many software applications can say that?!

    "My Days"

    Helps track ovulation cycles to aid (or prevent) pregnancy.

    Also helps track when the horrible PMS monster will emerge.

    • by raymorris ( 2726007 ) on Tuesday September 24, 2013 @04:49PM (#44941163) Journal

      Same here. Margaritas also played a key role.
      Had I been smarter, I would have made my own fertility app that said "its time" whenever _I_ wanted to have some romance .

    • by DeadCatX2 ( 950953 ) on Wednesday September 25, 2013 @05:26PM (#44953389) Journal

      While I use My Days to track my wife's cycle, you can have improved accuracy using an LH strip. It's a "pee in a cup, stick strip into pee for three seconds, let dry for five minutes" test.

      The beautiful thing is that the LH surge happens very reliably, 24-48 hours before ovulation. (see the third chart in this link and note how narrow the blue peak is compared to the other charts: http://upload.wikimedia.org/wikipedia/commons/c/c8/Hormones_estradiol%2C_progesterone%2C_LH_and_FSH_during_menstrual_cycle.svg [wikimedia.org] )

      I've also read (Amazon reviews, so take with appropriate amounts of salt) that if a woman has polycystic ovarian syndrome, she may not ovulate, even if she menstruates. The LH surge can tell her when she actually ovulates.

      Using the LH strip in combination with My Days, you can reliably avoid or become pregnant. After a few cycles, you can tell whether My Days is correctly predicting ovulation (my wife is usually right on or a day late). Since sperm lasts up to five days, and there's some natural variations in the cycle, we generally avoid 8 days before and four days after ovulation is supposed to start. No condoms, no pill, no spermicide, and still no babies, four years running.

  • by PseudoCoder ( 1642383 ) on Tuesday September 24, 2013 @04:33PM (#44941001)
    Witnessed this myself at the birth ward when my wife gave birth last month. Took a photo of a health monitor BSOD while giggling in the hallway, but haven't posted it anywhere. Isn't there a website where you can post BSOD's in funny places?
  • by BetaDays ( 2355424 ) on Tuesday September 24, 2013 @04:35PM (#44941019)
    I think Apple's terms of service says it all and that all medical apps need tossed out since they would break the tos of the device. Or am I missing something. http://www.apple.com/legal/sla/docs/iOS7.pdf [apple.com]

    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.
  • by fastgriz ( 1052034 ) on Tuesday September 24, 2013 @04:50PM (#44941169)
    Can't have cheap apps cutting into the business of big campaign donors.
  • by Anonymous Coward on Tuesday September 24, 2013 @04:53PM (#44941215)

    So what if I create a free software app that serves some medical purpose? Am I required to get FDA approval first? What if I refuse and the FDA tries to initiate an enforcement action against me and forces me to stop distributing it? How have the courts been ruling on free software as a free speech issue?

    • by trevmar ( 188523 ) on Tuesday September 24, 2013 @05:10PM (#44941413) Homepage

      You need to differentiate between apps distributed in the USA and those elsewhere in the world. FDA only has control over the US of A. They will claim control (and to the best of my knowledge they have control) over the distribution of free-software (described by this final guidance) within the USA.

    • by Anonymous Coward on Tuesday September 24, 2013 @05:25PM (#44941559)

      So what if I create a free software app that serves some medical purpose? Am I required to get FDA approval first? What if I refuse and the FDA tries to initiate an enforcement action against me and forces me to stop distributing it? How have the courts been ruling on free software as a free speech issue?

      You can make your app, but unless you get FDA approval your options for marketing said app will be limited (you can't claim it cures any medical conditions). Also no doctor will touch for nontrivial uses as they'd be exposing themselves to malpractice liability if they trusted your app and as a result failed to treat someone's condition, or made their condition worse.

  • by Anonymous Coward on Tuesday September 24, 2013 @04:55PM (#44941237)

    I have a blood glucose meter that works fine all by itself (for a one day reading), if you plug it in to an iDevice you can get all of the readings, graphs, reports, etc.

    Should that app be regulated? I think it is today, but does it need to be? It is only a convenience, it does not control anything or provide recommendations or diagnosis.

    I'd like to get the raw data to build my own plots, the vendor response is that the FDA will not let them do that, the best they can export is a pdf.

    I need the government out of my business. I don't see how this regulation helps.

  • by Kazoo the Clown ( 644526 ) on Tuesday September 24, 2013 @05:43PM (#44941747)
    What if I open source my DIY ultrasound code? Or my STL files of the 3D printed parts? Should I be expecting a gag order?
  • by nurb432 ( 527695 ) on Tuesday September 24, 2013 @05:52PM (#44941877) Homepage Journal

    is the first step to eliminating it.

  • by deadlydiscs ( 1505207 ) on Tuesday September 24, 2013 @06:04PM (#44941985)
    Comes to mind.... http://en.wikipedia.org/wiki/Biofeedback [wikipedia.org]
  • by llamahunter ( 830343 ) on Tuesday September 24, 2013 @11:17PM (#44944265)
    I can certainly understand wanting to qualify a mobile app that controls an insulin pump or something like that (Appendix C), but Appendix B indicates the FDA intends to regulate applications that "are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness" such as meal logs, calorie counters, exercise activity, brain games, etc. Sounds like you can kiss a whole bunch of useful apps goodbye as they get regulated out of existence.
  • by melstav ( 174456 ) on Tuesday September 24, 2013 @11:34PM (#44944383)

    DISCLAIMER: I am, (among other hats) a software developer for a medical device manufacturer in the United States.

    Seriously, people. The FDA's stance has *ALWAYS* been that if something has a medical purpose or is an accessory to a medical device, then it *IS* a medical device, even with software. See: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices [fda.gov], dated 2005.

    For the purposes of this document, we refer to devices that contain one or more software components, parts, or accessories, or are composed solely of software as “software devices,” including:

    • firmware and other means for software-based control of medical devices
    • stand-alone software applications
    • software intended for installation in general-purpose computers
    • dedicated hardware/software medical devices.
    • accessories to medical devices when those accessories contain or are composed of software.

    This guidance applies to software devices regardless of the means by which the software is delivered to the end user, whether factory-installed, installed by a third-party vendor, or field-installed or -upgraded.

    So, yes, apps with a medical purpose are medical devices, just like any other piece of software.

    Which means they *ARE* subject to the "Obamacare Tax" -- Which is *NOT* a "sales tax" to be paid by the consumer. It's an "income tax" to be paid by the manufacturer / developer.

    This also means that if your app is categorized as a medical device, you (the developer) have to register with the FDA as a device manufacturer, which costs a couple thousand dollars a year, and means that every few years, the FDA sends someone out to review your quality control system, which includes your testing methodologies, what complaints you've received and how you've handled them, how you document your development process, etc.

    AND what your software does determines what kind of medical device the FDA calls it. And the kind of medical device determines whether you are required to get the FDA's permission before you distribute it. (even if you distribute it for free) And yes, applying for that permission costs money, whether it's approved or not.

    And, by the way: Each country makes its own rules about what makes a medical device and what you're required to do to be able to legally distribute it in that country. And in most countries that includes software.

  • by DeadCatX2 ( 950953 ) on Wednesday September 25, 2013 @05:37PM (#44953541) Journal

    It seems that literally nobody can be bothered to actually understand what happened ("nanny state" "snuffing" "innovation" with "unnecessary regulations"). The FDA's guidance, released this past Monday, is RELAXING regulations - it is EXEMPTING whole categories of applications from regulation.

    FTA: "The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years"

    FDA has ALREADY been regulating medical apps. For a long time. The problem is, even if all your app does is draw pretty graphs, you still needed to go through e.g. 510K certification for your application. This guidance by FDA is aimed at reducing the barriers to entry for non-critical medical applications.

Every program is a part of some other program, and rarely fits.

Working...