Apple gets tough on medication dosage apps

By: Brian Dolan | Jun 6, 2013        

Tags: | | | | | | | | | |  |

Brian Dolan, Editor, MobiHealthNewsApple’s review process for the apps angling to get into the AppStore has long been a pain point for developers. This week physician-led medical app review site iMedicalApps pointed out that a number of medical app developers have received rejection notices from Apple because they included medication dosage information in their app, and Apple says it only accepts medical dosage information submitted by the medicine’s manufacturer.

While it’s tempting to suggest, as iMedicalApps did, that this is a sign of some kind of response from Apple to the recent attention the uChek app has received for its letter from the FDA, Apple has actually been sending these kinds of rejection letters to drug reference app developers for at least a year now — long before uChek got into its regulatory imbroglio two weeks ago.

Back in July 2012 one frustrated developer anonymously recounted their experience of repeated rejections of a medical app: “First I tried referencing the FDA website directly, then I tried removing the brand names and only use the generic. Still, Apple rejected and in the last correspondence they told me that unless I manufacture the drugs I cannot make an app that references them.” The last line might be overstating it, but you get the point. Based on his posts in the forum, in December 2012 this developer gave up on his medical app after six months of fighting Apple on an appeal and went back to creating games and other non-medical apps.

By January 2013 another medical app developer has posted about a similar saga. Vitaliy Salnikov shared his experience trying to get his latest drug reference app into the AppStore on his medical app software company’s blog. Salnikov also posted his rejection letter from Apple, which cited the same section of the developer agreement that Apple used as a reason to reject the others:

“We found that the Seller and/or Artist names associated with your app do not reflect the name of the manufacturer of the medicine referenced in your app or its metadata, as required by the iOS Developer Program License Agreement,” Apple wrote. It also noted: “We can only accept medical dosage calculators submitted by the medicine’s manufacturer.”

Notably, Salnikov’s development shop, Anaesthsoftware already has two drug reference apps up for sale in the AppStore, which appear to offer very similar features. The app that got rejected, Pocket Intensive Care Assistant (PICA), was first submitted to the AppStore in November and was rejected six times, Salnikov writes on his company’s blog.

Of course, Android apps don’t receive the kind of scrutiny that Apple iOS ones get. PICA is actually up for sale in the Google Play store right now. The PICA app is billed as “medical software that contains all [the] features that [an] ICU doctor needs” and it helps users “calculate the infusion rate of inotropic drugs, vasopressors and vasodilatators.” The app boasts a user-friendly interface that lets users “change the infusion rate of medication (mL and mcg/kg/min simultaneously) by simply moving his finger in a circle.”

Just a few weeks ago a Spain-based medical app developer posted a similar story and a similar rejection letter from Apple, which stated: “We can only accept medical dosage information submitted by the medicine’s manufacturer.”

As it is notoriously secretive, Apple doesn’t make it easy to understand what’s going on here, but the passage it continuously cites from its developer agreement to explain the rejection is not new. The original intent of this section was to ensure that developers contracted by companies to create an app on their behalf were not the ones submitting the app for review. The company that hired them has to do it. (When this rule first went into effect in July 2011 it made things difficult forĀ some do-it-yourself build your own app tools.)

By stretching this rule to drug dosage information, Apple appears to be taking a more active role in determining whether a medical app is providing trustworthy information. That is a slippery slope and one that will likely require Apple to hire a considerable amount of medical expertise to execute.

In the meantime, you likely won’t hear too much from rejected medical app developers — at least from those that want to continue to develop apps for iOS. Here’s Apple’s advice to developers whose apps get rejected, from the developer agreement they all must sign:

“If your app is rejected, we have a review board that you can appeal to. If you run to the press and trash us, it never helps.”

  • Dolly Parikh

    IMO, this is short sighted approach from Apple’s part considering that there are multiple medicine manufacturers and they have vested interest in representing their products. Medication adherence is a consumer challenge and a huge one in the domain of wellness.

    Apple may want to control the quality and filter the amount of apps they have and they can’t have enough resources to manage that but that should not stop the developers to launch on Android and if they are good, some day Apple may reconsider.

  • PhillyCooke

    This is leading down a very strange path. It appears everyone developing third-party dosage apps is fine in Android, but barred from iOS. Yet, doctors overwhelmingly prefer iOS. So, the platform physicians prefer is less likely to have the apps they need.
    Has Apple commented on whether they would reject the apps if they received FDA clearance as 510(k) medical devices?

  • shangmaster

    So why do doctors prefer that platform? It’s not because it has the apps they need, so why? I have been asking physicians why, myself, and the answer is often “because my friend/colleague suggested it”. That’s it (which is not unlike how most of us buy many things). So it’s not a technical reason, but a social one. So let’s just say that if Apple doesn’t allow the apps that physicians need on their devices, then maybe the physicians should look for another device that supports their needs.

  • Praxiteles

    None of the top medication prescribing Apps are published by the medication manufacturers: ePocrates, Medscape, Lexicomp.

    How did Apple respond to asking why those are let through?

  • Mike S

    I agree with Praxitleles, seems like a double standard going on here…

  • Matthew Holt

    This is obvious question!

  • Ester

    A few days ago Pediatric Support has appeared in the Apple Store. A new application about drug dosage and other useful functions for pediatric advanced life support (PALS). It must be very good for Apple has approved

  • Arieh

    Depending upon the nature of the App, if the app has direct impact upon patient safety from which data provided by the App has direct impact upon patient care, it is likely that the App maybe considered a medical device. Problem with use of Smartphones is that they have to be careful that such patient care apps can’t be compromised or corrupted such that the App may provide incorrect information thereby having a direct upon patient safety. Apple and other smartphone manufactures are not in a position to have their devices declared as a medical device as there is no way that they can control the smartphone, also the liability that would come with it.
    Special review by Apple for medical related Apps, especially those that have direct impact upon patient safety is warranted by Apple. It is one thing to embed a complete drug dose PDF file that can be looked up on a smartphone which provides the drug dosages and equation for specific drug, its is another to have an App perform the calculation. Ensuring patient safety is critical.