Apple's iOS App Store has drawn lots of criticism for strict policies that the company forces developers to accept when creating apps for the iPhone and iPad. The criticism is particularly frustrating when the company appears to enforce its mandates inconsistently and capriciously. These bans can have far-reaching consequences.
That's definitely the case for the most recent spate of app rejections. Identified earlier this week by iMedicalApps, Apple has been rejecting medical and health apps that provide information about prescription and over-the-counter medications. The rulings appear to target drug reference guide apps that provide both on- and off-label dosage guidelines.
In rejecting these apps, Apple has cited a section in its developer requirements that states that the company will only accept dosing instructions within an app if that app is being produced by a drug's manufacturer. Apps that provide dosing schedules or guidelines for medications that are not created by drug makers are subject to rejection.
This is a big deal when you consider that doctors and nurses increasingly rely on mobile devices to serve as diagnostic and treatment reference tools. Studies have shown that this one of the most common uses of an iPhone, iPad, or a non-Apple mobile device in clinical settings.
A recent Black Book study showed that the federal government's push for electronic records has driven clinicians to use mobile devices as primary tools across a number of specialties, with Primary Care and Internal Medicine physicians taking the most interest. The study also confirmed a strong preference for iOS devices that was found in past studies. In fact, iPhones were used by doctors and medical providers more than twice as often as all other smartphones combined.
When it came to using mobile devices and mobile apps as reference sources, 51% said that they relied on tablets as a reference resource.
The extent of the ban isn't yet clear. iMedicalApps stated that it provided only limited information in an effort to protect the developer that initially raised the concern, but said that "more than one" app has been banned.
MobileHealthNews notes that this isn't the first incident in which medical app developers have become frustrated by Apple's rules and rejections. The site notes incidents beginning as far back as a year ago.
The issue comes as the FDA remains unclear about what role it will eventually take with respect to regulating medical apps, though the agency did begin enforcement proceedings with a letter to the developer a urinalysis app Uchek. The FDA has classified Uchek, which must used with a urinalysis test strip and can be used with or without additional hardware that the company sells, as a Class I medical device and therefore subject to regulation.
Several well known medical reference apps remain available in the App Store, including the extremely popular Epocrates reference app, which includes drug reference and treatment guidelines as well as a medical calculator and a feature that allows a clinician to identify a medication by taking a picture of a pill or tablet and/or entering a description of the medication. That could indicate that some developers are operating with special dispensation from Apple or, more likely, that they have been able to reach agreements with drug makers to provide and verify dosing guidelines.
With the explosion of medical and health-related apps, Apple may simply be taking the safest road available at this point while waiting for the FDA to issue official guidance on the regulation of content, use, and sale of health-related apps. As Apple has created separate categories for "health and fitness" and "medical" apps, it would appear that the company is striking the best middle of the road approach available to it at this time.
As with any developer running afoul of Apple's approval process, one avenue open to medical app developers is to create an HTML 5 web app that can be used on iOS devices as well as other mobile and desktop platforms.