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Medicine Software Politics

Should Medical Apps Be Regulated? 254

Posted by Soulskill from the what-could-possibly-go-wrong dept.
maximus1 writes "There's a tidal wave of medical-related apps coming to smartphones and tablets that will be used by doctors and patients alike. But how should the medical establishment deal with them? Neurologist Steven Levine, currently working on an app for stroke victims, thinks they should be treated like new medicines: developed using scientific peer review and subject to regulation by the government or professional associations. Obstetrician Kurian Thott, developer of an app called iRounds that helps communication between doctors, thinks they should be released quickly and the market should decide which take off. What do you think?"
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Should Medical Apps Be Regulated? More

Should Medical Apps Be Regulated?

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  • We no longer regulate ads and mail order products. (Score:5, Interesting)

    by Kenja ( 541830 ) on Tuesday August 21, 2012 @02:05PM (#41071837)
    So why regulate apps? You can more or less claim your snake oil does anything you want, so long as you hide a disclaimer some place that your claims have not been confirmed by the FDA. If we're going to regulate medical self help and remedies then it should be all inclusive, not limited to apps.

    • Re:We no longer regulate ads and mail order produc (Score:5, Insightful)

      by mr1911 ( 1942298 ) on Tuesday August 21, 2012 @02:09PM (#41071903)

      So why regulate apps?

      Because regulation artificially narrows the supply, making the profits more lucrative for the incumbents. You did notice the guy pushing for regulation was a doctor already doing apps. Once he's in, regulation is good for him.

      Oh, I misunderstood your question. You were looking for a good reason to regulate apps. Sorry, I can't help you there.

      • Re:We no longer regulate ads and mail order produc (Score:5, Insightful)

        by ColdWetDog ( 752185 ) on Tuesday August 21, 2012 @02:37PM (#41072375) Homepage

        Uh, the other guy who DIDN'T think that regulations were needed was - also a doctor.

        Personally, I don't think you should regulate these. Who's going to do it? How many friggin 'lawyer' screens are you going to create (hint: more than we already have)?

        Do you then regulate every 'medical' website? Most of these apps either could be duplicated by a web site or already have been.

        Where, exactly, do you stop?

        What happens when doctors or even medical professional societies disagree (think stroke treatment with clot busting drugs - the American Academy of Emergency Physicians and the American Neurologic Society (or whatever prof society the neurologists hang out on) disagree pretty vehemently. That's fine, it's expected but how do you 'regulate' that?

        • Re:We no longer regulate ads and mail order produc (Score:4, Insightful)

          by jhoegl ( 638955 ) on Tuesday August 21, 2012 @03:01PM (#41072745)
          Actually Medical apps need to be regulated because their accuracy needs to be verified.
          If an app takes metrics, the metrics must be authenticated because that metric could mean life or death.
          Those are the apps we are talking about here, not the calorie counters or shit where you input the info.
          • Absolutely. In fact, this is a question which has already been answered by codified law (21 CFR) and has an entire branch of the FDA already involved in software (CDRH - center for devices and radiological health).

            When is software a device?

            'an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

            - recognized in the official National Formulary, or the United States Pharmacopoeia, or any s

          • Actually Medical apps need to be regulated because their accuracy needs to be verified. If an app takes metrics, the metrics must be authenticated because that metric could mean life or death. Those are the apps we are talking about here, not the calorie counters or shit where you input the info.

            Actually, Medical advice needs to be regulated because your friends and relatives' accuracy needs to be verified.
            If a family member takes your temperature, it must be authenticated because that measurement could mean life or death.
            Those are the people we are talking about here, not the Weight Watchers or self help books.

        • Re: (Score:3)

          by TheCarp ( 96830 )

          > Uh, the other guy who DIDN'T think that regulations were needed was - also a doctor.

          Well saying that one person or groups recomendation is self-interested doesn't make any specific claim about every member of the group or profession. It can be self interested, and still not supported by everyone who would benefit. (this is what always perplexes me about people who simplify down to "why should they be against welfare, they recieve it, they would lose out if it went away".... yes... but that doesn't mean

        • I don't know why the US can't accept "on license" and "off license" variants of things like restaurants, medicine, etc.? As a customer of an off-license product, you're basically saying: The regulatory agency hasn't approved this and I don't care. If M.D.s want to put their malpractice insurance to the test and use off license apps, let them.

        • "Personally, I don't think you should regulate these."

          See, this is a really tricky topic because almost unlike any other category, people's lives are at stake. I know it's fun to joke about "snake oil" (see posts above) but "old school legit doctors" are pretty good, so an app they use could directly affect a patient's life. Remember, this was "Medical Apps", not just "communication between people who happen to be doctors". So I'd want a review of a "Medical App" because so help me if it includes "advice to

      • Comment removed based on user account deletion
        • Doctors, with the exception of high-volume neurosurgeons and orthopedic surgeons, don't have houses in the Hamptons unless they live there year-round. Most family physicians would love to break $200k.

        • Patients have been self-diagnosing for as long as doctors have existed. I'm guilty of it myself, and won't usually see a doctor unless I think the doctor will actually be able to do something. (no point in seeing a doctor for a runny nose, it's probably just allergies or a cold... if it's allergies the doctor can't do anything other than give me the antihistamines I'm already taking, and if it's a cold, no self-respecting doctor will give me anti-virals for something my body can heal on its own in a few day

      • Re:We no longer regulate ads and mail order produc (Score:5, Insightful)

        by Sir_Sri ( 199544 ) on Tuesday August 21, 2012 @02:58PM (#41072673)

        Because regulation artificially narrows the supply

        And artificially strips out dangerous or faulty procedures, chemicals etc. before they experience the joys of the free market on the public who have to enjoy the burdens of what's happening. Because your medical information is *private* and letting anyone have at your private medical information without any regulation means that information could be used against you.

        Because letting people take random chemicals to see if some of them cure whatever disease they have definitely isn't a good idea, but it's cheap, so we could do that.

        It does however depend a lot on what apps actually do. I'm not sure you need to highly regulate the applications used by medical professionals to handle payroll or scheduling or room booking. There are custom software packages for a lot of those because all hospitals face similar problems and so on, so it makes sense then to not have to completely re-engineer your payroll system just because your hospital is not the hospital one block over. But if you're talking about tracking a patient's blood sugar and providing advice based on that tracking you're into a whole collection of privacy rules (how secure is this data? Who am I sending the data to?) and providing medical advice from something that isn't a medical professional.

        Which tends to show they're talking past each other a bit. The one doctor is making an app to deal with strokes, that's almost certainly into the category of medical advice (at least potential medical advice) and tracking a lot of deeply private medical information. The other guy is helping doctors communicate information between rounds, so there are privacy implications, but he's not necessarily intending that information to ever actually see a patient.

      • If apps make claims to have a certain medical benefit, and do not provide that benefit, then of course there is a good reason to regulate. Medicine isn't all about markets. I'd say the litmus test ought to be - if the app fills a similar role to medicine - it is a part of a patient's treatment plan with medically significant impact - then it needs to be regulated. If the app is purely for convenience, entertainment, or education - then there is no need.

    • Re:We no longer regulate ads and mail order produc (Score:4, Insightful)

      by RobFrontier ( 550029 ) on Tuesday August 21, 2012 @02:11PM (#41071935)
      If the app impacts diagnosis in any way it is no longer just an app, it's a medical device, and subject to regulation. This doesn't even begin to speak to patient data stored locally in an app and current HIPAA regulation.

      • Re: (Score:3)

        by Kenja ( 541830 )
        If a pill advertised on TV can claim to rebuild damaged joints or convert your fat into muscle (these claims have not been verified by the FDA) and in fact do nothing, an app should be able to as well. If the app can't (and it should not be able to) then neither should the sugar pills.

        • Re: (Score:3, Insightful)

          by RobFrontier ( 550029 )
          We are talking about apps in the hands of doctors potentially using them for diagnosis. There is a huge difference between that and an app in the hands of a consumer for self diagnosis (a sugar pill). The consumer can do that now with WebMD et al.

      • HIPAA only matters if the app is storing PHI and it is being used by a covered entity. So apps targets at patients won't run afoul of HIPAA. They can keep every bit of PHI that you put into them and not have to run any special protections. It also means that if such an app were on the iPhone there's no legal issue if this data is backed up on the iCloud. Apple would not have to suddenly meet new data storage requirements to meet HIPAA standards.

        Lawyers aren't covered entities either so if your personal inju

      • Re:We no longer regulate ads and mail order produc (Score:5, Insightful)

        by Harvey Manfrenjenson ( 1610637 ) on Tuesday August 21, 2012 @02:47PM (#41072501)

        If the app impacts diagnosis in any way it is no longer just an app, it's a medical device, and subject to regulation.

        This doesn't even begin to speak to patient data stored locally in an app and current HIPAA regulation.

        The DSM-IV, which is simply a list of diagnostic criteria for psychiatric disorders, is available in e-book format as an "app". Is that app a medical device? What about a paper copy of the DSM-IV that I carry around in my pocket? Is that a medical device, too?

      • Using your justification all web browsers are medical devices.

    • Re:We no longer regulate ads and mail order produc (Score:5, Insightful)

      by JackieBrown ( 987087 ) on Tuesday August 21, 2012 @02:23PM (#41072107)

      We are on our way to regulating everything, anyways.

      I can't even be astonished by new cries for regulation. It is a very sorry world we are creating. We push aside religion for being too invasive and controlling and then ask the government to be even more invasive and controlling than the religion could ever hope to be.

      • Ideology *is* a religion, or at least it is for the masses. The sociopaths preaching the holy writ of Party platforms are just using it as a tool.

      • It is a very sorry world we are creating. We push aside religion for being too invasive and controlling and then ask the government to be even more invasive and controlling than the religion could ever hope to be.

        Nobody expects, er, remembers the Spanish Inquisition!

        The "government" is the electorate, and the electorate's demand for regulation is in response to the unregulated's history of abusive practices.

      • You mean, you'd rather have a free-for-all abuse and exploitation based on your "free market" religion, instead of science-based regulation agreed upon by the consent of the electorate. Yup. The gubbermint is out to get you. Obviously

  • FDA (Score:5, Informative)

    by RobFrontier ( 550029 ) on Tuesday August 21, 2012 @02:06PM (#41071869)
    Speaking as someone who works as a mobility specialist in the medical products industry, the FDA already issues guidance in this area. It won't be long before the guidance turns into regulation.
    • There is very little grey area as long as the apps are seen as an extension of current methods and regulated as such. Unfortunately I have serious doubts that the FDA will take this pragmatic approach and over regulation will be their approach.

    • Re: (Score:2)

      by tgd ( 2822 )

      Speaking as someone who works as a mobility specialist in the medical products industry, the FDA already issues guidance in this area. It won't be long before the guidance turns into regulation.

      Speaking as someone who works as a mobility specialist in the medical products industry, the FDA already issues guidance in this area. It won't be long before the guidance turns into regulation.

      There are plenty of categories of medical software that already require FDA certification.

    • They can try to regulate apps, but they will run smack dab full tilt into the fan blades of First Amendment law if they try.

      If money is free speech, then so is code.

      • Re: (Score:2)

        by green1 ( 322787 )

        If money is free speech, then so is code.

        your code is only speech if your money speaks loudly enough...

  • no? why should the communication you're using for non-emergencies be regulated? (actually you're phone is supposedly regulated so that anyone can call 911 with it).

    the apps that are just glorified pamphlets shouldn't be reviewed any different than regular pamphlets, of course, but it's not like you're going to eat the application and if it gives some wrong advice then you're as publisher on the same hook as if you produced a snake-oil pamphlet I suppose.

    I don't think the paper that came with my glucose mete

  • In a word: yes. (Score:5, Informative)

    by Samantha Wright ( 1324923 ) on Tuesday August 21, 2012 @02:09PM (#41071909) Homepage Journal
    Yes, they absolutely should; for the consumer, to prevent abominations like this [baltimoresun.com]. I would say that anything more interactive than a reference document or log book. For more real medical software (i.e. patient monitors or diagnostic tools), just because it's on a smartphone and not a dedicated box doesn't mean it suddenly stops being a medical tool.

    • I don't know if that's the right approach. I'd treat it like any ol' website: if you just believe what the first site you find says about some complex medical issue, that's your own problem. I'd appreciate if the official government agencies have some guidelines on how to identify scammy apps and which apps are useful, but other than that, I'm comfortable with the idea that it's just information in a snazzy new package, and as such, cannot and should not be controlled.

      That said, anything that is officially

      • I left pure reference works out, actually. That's be analogous to your "any ol' website" statement. I don't think that expanding the Darwin Awards is a very noble ulterior motive, however. Gene Roddenberry would disapprove.

    • AcnePwner was downloaded 3,300 times at a cost of 99 cents in the Android Marketplace.
      There were about 11,600 downloads of AcneApp from the iTunes store, which cost $1.99.

      According to the settlement, Koby Brown and Gregory W. Pearson of DermApps are required to pay $14,294,
      and Andrew N. Finkle of Acne Pwner must pay $1,700.

      $2,800 sales revenue - $1,700 fine = $1,100 profit
      $16,158 sales revenue - $14,294 fine = $1,864 profit

      Not the most profitable fraud.
      They should have gone into finance.

    • Re: (Score:3)

      by moeinvt ( 851793 )

      Wouldn't that already fall under the provisions of existing law? AFAIK, fraudulent misrepresentation of a product is already a crime. It seems like damages arising from the use of an app would fall under provisions of tort law.

      If some medical service provider is going to deploy a smart phone app as a diagnostic or treatment tool, then it's up to the app developer and the user to negotiate a contract and the terms of liability issues. I don't see why Big Brother needs to be involved.

      • Yes, that example already very clearly fell under such a law (since it already got shot down!). I pulled it out because it was high-visibility and has already happened. Consider this program [apple.com]. It measures your heart rate through minute differences in brightness. What if you, as a home user and not a medical service provider, have a heart attack because there was a bug in the code? Most of the FDA's work regarding complex devices involves code verification to ensure this doesn't happen. Some kind of certifica

  • Why not just release new apps without any regulation, then have them voluntarily certified by a trusted party.
    Then medical professionals can choose between new, as-yet-uncertified apps and ones that have been certified.

  • Yes and No (Score:5, Insightful)

    by hsmith ( 818216 ) on Tuesday August 21, 2012 @02:14PM (#41071973)
    "Medical Apps" is a broad range of things. Apps that make medical decisions for you certainly should be. Are they making a diagnosis? Telling you treatment? Yes.

    On the other hand, Apps that help you track things (Say your glucose levels) or tracks your prescriptions - don't need that added cost / regulation.

    I'd be curious to see - are the big companies pushing for this? FDA approval isn't cheap OR fast. Small innovators are able to disrupt this market which has been held strongly by the giant medical firms - who can't be quick and innovate.

    We have a fine line to walk between stifling innovation and regulation.
    • Having spent the last year developing an app that falls strictly into the later category (tracking) I was operating under the impression that the division you described is how things currently operate. The idea I received from our client was that as long as we did not encourage decisions or try to promote behavior we didn't have to worry about going through FDA regulation. This didn't save us from developing to the same standards as we would have for FDA submission, since the client has plans to expand the

    • "Medical Apps" is a broad range of things. Apps that make medical decisions for you certainly should be. Are they making a diagnosis? Telling you treatment? Yes.

      On the other hand, Apps that help you track things (Say your glucose levels) or tracks your prescriptions - don't need that added cost / regulation.

      So, in one case, you're basically calling for the regulation of what amounts to medical advice (also known today as WebMD.com), and yet, you do not find it necessary to regulate the app that tracks if you've had your meds today or not?

      Seems to me an problem in the software in either situation could prove equally as deadly. Either choose to regulate them or do not, but half-assing it is simply asking for liability to come your way.

      • Re: (Score:2)

        by hsmith ( 818216 )
        So, you think the FDA should also regulate notepads, since - you know - people also write down when they take medications, no? Please, describe to me how logging what medications you took could prove deadly. I'd love to hear.

  • Hippa rules do you really want apple to have a backdoor to your medical info?

  • popular != quality (Score:3)

    by Skapare ( 16644 ) on Tuesday August 21, 2012 @02:19PM (#41072031) Homepage

    Kurian Thott, developer of an app called iRounds that helps communication between doctors, thinks they should be released quickly and the market should decide which take off.

    I'd rather have medical professionals who are also coders looking at the source code to make such decisions, rather than the ignorant public that is too easily influenced by marketing tactics.

  • It's not like an unregulated marketplace, with limited liability, will mind if a few patients die due to a coding error.

    After they privatize the profit, stuff it in their kids trust funds and retirement funds, and walk away while people die.

    Socializing the risk and lifetimes of pain and misery on the rest of us. ... oh. ... wait ... It is.

  • app for stroke victims

    What is that? A ebook, a sleazy spreadsheet app, or a MRI remote control app with special features for head scans?

    Some apps are basically just an ebook. They should be regulated as much as medical book publishing (in other words, none at all).

    I suppose someone could build a X-ray controller app that zaps patients. That needs a intense regulation, as much as the xray machine itself. There's a long history of killing people with buggy medical device software.

    Then there's relatively sleazy stuff in the mid

  • .. then some government agency needs to step in and verify that said software is safe for use, whether it's an app that diagnoses a heart condition in your grannie, or a pilot who relies upon an iPad for flight manuals. It was a few years before the FAA permitted iPads to be used in the cockpit and not just because of the supposed electronic interference.
  • The story is casting too wide a net in simply saying "Medical Apps". Apps which help me record or log or communicate should not be strongly regulated (other than following HIPAA guidelines). They are no different than if I were to manually keep a journal or call the doctors office. There is nothing "new" about them other than the convenience. But apps which attempt to diagnose, analyze, or treat an illness should be regulated. Bugs or outright fraud in their capability can directly and seriously impac

  • I can't see why we can't go with a simple compromise, and have unapproved apps present big huge warning labels saying they hadn't been approved by the FDA, and once they do, they can put a big huge FDA logo of approval.

    I know some people will, on their own risk, ignore those warnings, but I think that's something they need to realize on their own.

    So, yes, I think they should be regulated, but only insofar as to allow people to make informed decisions on their risks.

  • "Neurologist Steven Levine, currently working on an app for stroke victims, thinks they should be treated like new medicines: developed using scientific peer review and subject to regulation by the government or professional associations."

    Of course. He's afraid of competition. Government regulation will slow that down. We wouldn't want to empower people!

    • Re: (Score:2)

      by geekoid ( 135745 )

      Actual he want's people to get accurate information for their health.
      He is developing the App from a grant for PCORI.
      But, you keep with your crazy conspiracy nonsense. Sure, you would stop innovation that would help people for money, but don't assume everyone else would.

  • Next question, I'm on a roll.

  • They have enough problems getting their phones and tablets working with the legit medical apps put out by EHR companies. They don't need unregulated random medical apps floating around on top of that. (Hell, we've had doctors have trouble sending email through Outlook on a workstation. They usually make their PAs do that sort of thing for them.)

  • If a medical person uses an app and takes an action (or chooses not to act) on the basis of information they got from an app, who's liable for anything that goes wrong? I would expect that the medic in question would get the blame and I'd also be surprised if their professional insurance would kick in to pay for any damages that ensued.

    I would also expect that any professional organisation would be advising its member to NOT use any app that had not passed some sort of approval regime. So on that basis, ig

  • As a person coding a project going through the FDA clearance process, we have 1000+ pages that show that they *are* regulated.

  • I helped write code for the Plex-ID system, which among other things can identify every virus and bacteria in your spit by their genetic profile; spit in the tube, put it in the machine and wait an hour. CE (European Union) and FDA have similar requirements for a diagnostic device. But the FDA is pro-active and monitors development as it happens, where as CE takes a look at the paperwork once you are done and doesn't get in the way unless something goes wrong (in which case they come down hard, is what I

  • if the app is turning your phone, or whatever, into a medical device. A random heart rate monitor app is fine unregulated, but if it's being used to monitor a patents heart rate for medical purposes then yes it must be regulated. In this case regulation is intended to give you devices that meet minimum guidelines. If it's important that a doctor know your heart rate within 20bpm but the app has a 100bpm margin of error then it's worthless as a medical device, and the regulation is to enforce the guideline

  • They should be subject to provisions of existing law, such as fraudulent misrepresentation of the product. For instance, I read about an app that claimed it could make your phone cure acne or something. That's no different than digital snake oil.

    Creating an FDA type process for apps? Forget it.

  • Just add a fitting punishment for life-threatening failures. Like the CEO of the affected company must sit in a vat of spiders (imported from Australia), until he promises to fix the problem.

  • Regulation is necessary on a good many things.

    However, the degree of regulation must be carefully weighed.

    In any industry, adding regulation means:

    1. Higher cost to the consumer
    2. More boredom of paperwork for employees, so often lowered standards
    3. More bureaucrats and other unimaginative people in power

    If we regulate anything, we should make our rules short and clear and the approval process fast and supportive of industry, or we shoot ourselves in the foot.

    • Re: (Score:2)

      by geekoid ( 135745 )

      "so often lowered standards"
      no, that's false.

      " our rules short and clear "
      except life and science isn't 'short and clear' . Making short in clear your goal cost in terms of conciseness.
      I can say 'eat better' but what does that really mean scientifically?

  • Take the obvious route (Score:3)

    by gman003 ( 1693318 ) on Tuesday August 21, 2012 @03:33PM (#41073179)

    Any app that claims to either itself be a cure/treatment, or which directly interfaces with a system that is (or is already subject to regulation), gets regulated. So a "game" that claims to treat dementia, or an app that interfaces with a medical records system needs to be regulated, or an app that connects to a pacemaker for diagnostics, would need regulation.

    Anything that simply offers medical information or rudimentary "advice" is fine. So a WebMD-type app would need no regulation, although it could still cause liability if it's wrong to the point of causing physical harm.

    Basically, replace "app" with "book" and see if it makes sense.
    "This book contains a list of diseases, cross-indexed by symptom. It does not need to be regulated."
    "This book contains the complete medical history of everyone who has ever visited this hospital. It should be subject to basic regulation regarding patient privacy."
    "This book allows the doctor to control an implanted medical device. It should be strictly regulated, including stringent testing and controlled distribution."

  • People taking advice from medical (and "medical") websites are pretty similar, internet is the ultimate app after all. But in a sense, all mass media give medical advice, sometimes just ads disguised as them. Should be all regulated? If so, what you do with other countries websites and/or media? In any case, you end in doing media control without control on your side (and that includes promoted medical advice to push products from paying companies, is not like that never happened in a way or another).

    Inst

  • there should be 'Official Approved Scientific Based' process.
    You don't have to get it, but getting it means you have been vetted by the proper specialists.

    Medical apps are far to wide of a area to classify them all. O I need scientific vetting for my app the emails my Dr.? no.
    Should I get one that's giving me, or my Dr, advice on my medical condition? IN many case, yes.

  • If the app causes harm to somebody and there appears to be obvious negligence, e.g. advised the incorrect drug. All professionals need to worry about this whether in person or in an app.

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