Exclusive: Apple now asking app developers to provide sources of medical information

Iltifat Husain MD (@iltifatMD) contributed to this piece

Recently there have been signs Apple is taking the reliability and content of medical apps sold through the App Store more seriously.

iMedicalApps recently reported that medical apps containing drug dosages were being rejected from the App Store. Further information has now become available that suggests Apple is now looking to ensure the information contained in each medical app is appropriately validated.

It appears a number of developers have had requests to release or update medical apps rejected on the basis of incomplete metadata as per the screenshot below. Specifically, Apple is requesting information regarding the source of the medical information contained in the app.

apple requesting information

This is an exciting development from Apple as it suggests they are concerned about the potential for misinformation contained in medical apps. By asking developers to verify the information contained in the app, Apple will encourage developers to cite the sources of the information contained — similar to how medical journals are written. Whether or not Apple has the ability to accurately assess the validity of the sources cited remains to be seen.

We’re also hoping this will curb the medical plagiarism currently rampant in the App Store, something we highlighted last week.

On the whole — this has the potential to be  a game changer and dramatically improve the medical content in the app store.  It’s our opinion at iMedicalApps that every medical app should cite the resources they use when appropriate.

If you submitted a medical app recently and received this prompt from Apple, we’d love to hear from you — and to hear what you did to improve your app.

Author:

Tom Lewis

Editor, iMedicalApps.com

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27 Responses to Exclusive: Apple now asking app developers to provide sources of medical information

  1. Balu Kadiyala September 18, 2013 at 10:23 am #

    Hi,

    We developed and released a medical App called BrainAttack back in Dec 2012. BrainAttack App helps ER doctors treat stroke patients by determining tPA eligibility. Back in December we were requested source of the medical criteria that is used by the App to determine tPA eligibility. I am in fact surprised that such is being reported only now. After we responded back to apple with relevant sources, they approved the App without any hassles. We also heard that the best practice is to cite sources within the App and that helps get the App approved faster. Thanks for sharing information about the dosage though, it may impact us in our future planned release. Do you think citations can help with dosages as well?

    thanks,
    Balu.

    • Iltifat Husain, MD September 18, 2013 at 9:13 pm #

      I think citations would help, but multiple developers have told us that even by mentioning citations they aren’t able to get through.

      When you added sources to BrainAttack, did it get the app approved? Also, what sources did you end up citing?

      It’s interesting this hasn’t been reported already, it makes us think Apple might not be applying the policy broadly to everyone.

  2. James Wilson September 18, 2013 at 10:47 am #

    I have released two apps, Be*Healthy & Be*Healthy Pro. Both applications are Health Risk Assessments. Apple did not ask for sources of medical information in either app. Be*Healthy lists the sources of information in what is equivalent to an “About Box”. Be*Healthy Pro was in review for weeks on end. I ended up asking them to expedite the review of Be*Healthy Pro and suggested that if their HR department does Health Risk Assessments they would be able to help them in the review process.
    I suspect that they may have difficulty reviewing medical apps for content.

  3. Adam September 18, 2013 at 10:50 am #

    I wonder… if Apple approves an app that contains incorrect information.. Say the app says take 400mg on a blood pressure medication instead of 40mg. Does this make Apple libel? I can’t really see the whole rule about providers aren’t responsible for their users content protecting Apple on this. That really only works if you don’t “police” the content to begin with. Is Apple going to validate every claim in a medical app for accuracy? This is almost saying “I’m Apple and I approve this message” sort of thing for them.

    • Iltifat Husain, MD September 18, 2013 at 9:15 pm #

      Yea, it’s really a muddy situation overall. At the end of the day a Physician should know what sources to trust and what not to trust. I think it’s harder for patients to figure out what to trust and what not to trust.

    • Zach R January 12, 2014 at 4:48 pm #

      Well here’s the problem though, Adam. Anything published on the AppStore has to go through Apple to get there. If Apple passes an app with false information, especially medical information, lawsuits can arise. People can say what I’ve said above, and blame Apple for supplying false info. This would make Apple at fault, and they can get sued. By using citations, the risk of misinformation can decrease dramatically. The only problem is if Apple has people, or even programs if they’re that technical, good enough to check all those sources, how could they keep up with the demand of app proposals Apple is bombarded with each day? It would be very hard, but not impossible. My theory is, unless the tech company has specifically said that they want sources, if any used for the content of a dev’s apps, from all apps, then I think they are in a testing phase of how they can check the sources. I hope if it is, they never stop doing it for medical apps, because I’m thinking of downloading one for personal use. But, if Apple is doing this permanently for medical apps, they will eventually extend the citation part of the AppStore to other apps. Good luck Apple; you’re gonna need it.

  4. Tom Mariner September 18, 2013 at 10:53 am #

    Maybe I’m off base here, but all medical device companies operate under regulations that generally stem from ISO 13485 which enforces how products are developed, tested, distributed and documented. Hospitals, doctors, countries rely on these risk-based regs. Apple could just ask for conformance with the standards, rather than trying to figure it out themselves.

    If a software company doesn’t know what 60601, 14971, 62304 or 62366 are, they probably shouldn’t be publishing apps that affect patient care.

    • Iltifat Husain, MD September 18, 2013 at 9:16 pm #

      Good point — I would say that almost all of the software companies publishing medical apps don’t know those standards. It’s mostly one to a few developer teams for them.

  5. Marc-Emile Plourde September 18, 2013 at 10:17 pm #

    I have no idea how they will “enforce” something like this. As much as we would like to believe we have strong, evidence based guidelines, it’s just not true. Just ask 100 docs on what is a good starting morphine dose, or if they should recommend prostate Ca screening… I agree with Iltifat that the physician are responsible in evaluating the quality of the information they trust, just like we do with other sources.

    @ Tom Mariner . I have heard about the ISO standard “thing”, but I don’t really know what they mean. However, I believe the apps I publish are quality apps that contains quality medical information. I would be really surprised that many authors or respected publishers are aware of them either, judging from my personal experiences in dealing with them.

    For the patient though it’s a different story, but trying to regulate health apps and trying to regulate the internet is very similar, and not as easy as quoting a reference or two.

    • Iltifat Husain, MD September 19, 2013 at 10:38 am #

      Good points as usual Marc-Emile. I think have some sort of expectations for quality is important. E.g. Speed limits are necessary, but not everyone follows them. Obviously, enforcement leaves much to be desired. Either way, some sort of basic standards like referencing source material are essential.

      • Marc-Emile Plourde September 20, 2013 at 1:22 am #

        I agree that quoting references should be the bare minimum, but it is still far from guaranteeing quality content.
        Apple asked me to quote the source of the medical info contained in the app I’m responsible for, but there’s plenty of links to the references (with direct links to pubmed and to the article via Read app), so my best bet is that they just have no clue what they’re doing.

        • Iltifat Husain, MD September 23, 2013 at 6:01 am #

          wow! i’m aware your app has the references cited, but they asked anyways? So then, they don’t really know?

  6. Frank September 20, 2013 at 7:19 am #

    It is even getting more interresting of you use an iOS Device together with a Medical Device
    and the app is controlling the medical device .As a manufacturer you need to involve apple in your design and risk management process ? How will they solves this ? How does FDA and CE look at this?

    • Tom Mariner September 23, 2013 at 2:19 pm #

      App controlling the medical device is a medical device. 510(k), etc. etc. etc.

      The only question here is if medical decisions are made using the app means the app needs approvals. Currently no, but I think you’re nuts if you don’t at least make a gesture in that direction.

      • Frank September 23, 2013 at 3:23 pm #

        In my opinion not only the app is considered part of the medical system or medical device but also the platform(tablet) its running on. Meaning that it will have to be compliant with medical device regulations e.g. EMC. We all know that tablets / pc etc.. have a lousy emc behavior compared to medical devices – thats why a separate standard has been created for them :-)

        • Tom Mariner September 23, 2013 at 3:44 pm #

          Frank — Interesting — the big deal for the electrical standards is whether the instrument is used in the patient vicinity. if so, then IEC 60601-1 — and the present version standard is “complete” and big. The real deal is if one is specifying the device (tablet, phone, wristwatch, etc.) as a part of the “system” if so, then simple EMI / EMC when the system is being tested. Actually since there is generally no galvanic connection, it is a lot easier.

          Hey, what am I giving all this stuff away for free? I get paid a tiny portion of a gazillion dollars to get safe, effective products shipped. (A stupid, rhetorical question — in any give and take session like this with a lot of smart, motivated people, I learn more than I blabber.)

  7. Dissent September 22, 2013 at 9:03 am #

    How is Apple determining what is a “medical app?” What about self-help apps such as for managing anxiety or OCD? Is Apple only looking at apps for MDs and nurses or are they doing with this apps giving non-medication health-related intervention advice?

  8. josh September 23, 2013 at 5:50 am #

    Is Harper-Collins or Penguin Publishing liable if they publish a book on child rearing or heart attack prevention and the content is wrong? Of course not.

    It’s really surprising that somehow Apple would be held to a higher standard by any court. App is not different than a website. Websites are full of all sorts of specious quasi-medical info.
    –JSt

  9. josh September 23, 2013 at 5:56 am #

    That said, it’s not a bad thing that Apple make a gesture towards quality info.

    I have never been asked for details about the veracity of medical content. But each of my 13 medical apps has “References” as the 5th tab along the bottom. Now of course, Apple does not have the expertise to evaluate whether I have presented the 2010 CDC guideline on preventing invasive GBS infection faithfully. Hell, Apple wouldn’t know GBS from GPS! I could stick a citation on strep throat in there and how would Apple know. So the whole thing is kinda silly.

    Still, it’s not a bad thing.

    If Apple wants to promote quality, I’d recommend cleaning the garbage out of the “Medical” category altogether. There’s tons of stuff in there labelled as Medical or Healthcare (never defined labels) which are neither.
    –JSt

    • Marc-Emile Plourde September 23, 2013 at 8:31 am #

      I agree 100% with you Josh. The only reason I can imaging Apple is doing this is to weed out the mass junk developers (quizz apps, fake anatomy apps…) by assuming they won’t answer the call for references and move on to another category to spam.

      • josh September 23, 2013 at 9:38 am #

        It’s a strange move on Apple’s part. I wonder from medicolegal point of view if it is wise. If you take the stance of your average publisher or website host, you print anything and take no responsibility for its accuracy and what happens when people use the info. But if you take Apple’s stance, now you are acknowledging that quality matters and that you are taking steps to ensure quality info. Now if bad app guidance leads to harm, would Apple be held accountable? After all, they have admitted and acknowledged that they care about accurate quality information, they have incurred a duty because of it, and perhaps that leaves them at risk of failing in their duty if the info in an app is crappy and causes harm.

        Glad I’m not a lawyer.
        –JSt

        • James Wilson September 23, 2013 at 10:00 am #

          I believe Apple’s intent is to demonstrate concern for their customer’s experience with their products. They want to convey a high quality produce with quality apps. I think all they are trying to do is to keep out things that are obviously junk, nothing more than that.

  10. Penm September 25, 2013 at 9:00 am #

    Hi all,

    I had am app rejected because it contains drug dosages. Can any one confirm that if the dosages are referenced appropriately that it will get accepted?

    Ps. our first submission had every dose referenced and got rejected. Just wondering if it was worth re-submitting now.

    • josh September 26, 2013 at 2:57 pm #

      I have drug doses in several reference apps, all explicitly referenced from major guidelines (IDSA, ATS, ACCP, ACC, CDC, ACOG, etc.). Although many were approved months or years ago, my Pneumonia Guide was updated and approved as recently as late August 2013 with no problems.

      Sorry you’ve had trouble.
      –JSt

    • Raul July 1, 2014 at 10:19 am #

      Hi, I recently had an app rejected because it contained drugs dosage.
      It is not enough that the app is published by a physician and that all references were included.
      This is what they’re saying now:
      “22.9: Apps that calculate medicinal dosages must be submitted by the manufacturer of those medications or recognized institutions such as hospitals, insurance companies, and universities”.

      • Iltifat Husain, MD July 2, 2014 at 1:19 am #

        what type of app was it? have you tried resubmitting it?

        • Raul (iOS Developer) July 2, 2014 at 3:06 am #

          The app name is “CVVH & Drugs: your assistant for dose calculation”.
          It helps to manage the drug doses to be administered to a patient who is under renal replacement techniques, either by convection (CVVH), diffusion (CVVHD) or mixed (CVVHDF).
          We made an appeal telling that the drugs were generic, and therefore don’t belong to any manufacturer. We also sent the reference documentation used to calculate the dosages, but Apple response was that the original rejection was correct.
          We haven’t tried to resubmit it.

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