This is an update on my previous post which dealt with Apple’s rejection of an update to the EP Mobile app because it contained drug dose calculators. According to a clause buried in the App Store Review Guidelines (section 22.9, to be precise),
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.
EP Mobile has included such dosage calculators from its very first version, but for some reason the current update (which just added the D’Avila algorithm [PACE 1995;8:1615-1627] for determining accessory pathway location) triggered the discovery that the app was in violation of this rule. I was unaware of this rule, and I don’t think the rule was extant when I submitted the first iOS version of the app in 2012.
I submitted an appeal to Apple stating that as physicians have to calculate drug doses every day there does not seem to be any reason a physician-programmer should not be permitted to write an app to calculate drug doses. A drug company could only produce an app for their specific drug, so they could not duplicate the functionality of having multiple drugs from different companies in one app. I don’t see any incentive for a hospital, insurance company, or university to develop this kind of app, though I suppose it is possible they could. As a physician I developed the app because it was useful in my daily work. It makes figuring out drug doses for certain anti-arrhythmic drugs or anticoagulants much easier. As far as I know that specific functionality is not duplicated in the App Store.
Apple stuck to their guns and maintained the app update could not be approved. On Twitter a colleague tweeted this article from iMedicalApps of June 2013 which discusses the problems that Apple has with drug dosage apps. Apple is probably concerned about the FDA’s potential scrutiny of medical apps and possible legal liability for drug dose calculators that could give erroneous information. In any case this article points out that the Medscape app also provides drug dosing information (though only as written information, not as a calculator — I’m not certain, but it appears that the App Store Review Guidelines may have changed from banning dosing information altogether to just banning dose calculators). Medscape is owned by a private company (WebMD) and is neither drug company, hospital, insurance company nor university.
If the Medscape model for presenting drug dose information is legitimate in Apple’s eyes (as opposed to a violation that just hasn’t been noticed yet), it would be possible to retool my app to provide a creatinine clearance calculator followed by the specific dosing information for each drug. This is not as slick as having the answer just pop up in a dialog box, but on the other hand does show exactly what the dosing criteria are and removes the computer from the decision making process. However if I go that route there is no way to save one of my favorite parts of the app, the warfarin dose calculator. It is an implementation of an algorithm from this paper and provides suggested dosing changes for patients on chronic warfarin based on their INR, INR target, weekly total dose, and tablet size. It suggests how many pills the patient should take each day of the week. Whoever makes generic warfarin is not likely to develop a warfarin dose calculator like this, nor is anyone else.
At this point I have requested further information from Apple. Apple has rejected the update to EP Mobile, but they have not requested I withdraw the current version of the program (which still has all the drug calculators in it). Certainly they might do so. In the hopes that their position will change, I have decided to withdraw the update and leave the app as is, unless Apple tells me otherwise. This is not a good long term strategy as I like to update the app frequently to keep it up to date with what is going on in electrophysiology, and I am now blocked from making any updates that don’t remove the drug calculator functionality. If I do release an update that does not contain the drug calculators, I will announce it well ahead of time on Twitter and on this site to give users the option not to update the app. I should also point out that the Android version of the app has not been challenged (Android is very hands off compared with Apple).
I am hoping that Apple will consider this further, based on this section of their App Store Review Guidelines:
This is a living document, and new Apps presenting new questions may result in new rules at any time. Perhaps your App will trigger this.