Mobile health ? Not so quick as FDA, FTC and Apple go after mobile health apps

imagesJust about two years ago, the FDA first announced its intention to begin regulating medical apps and soon thereafter released its draft guidance for how it would do so. A few months later, the FTC jumped into the fray and took action against applications that claimed to treat acne with light therapy from an iPhone.  More recently, the FDA took another step forward and put app developers on notice that it is serious about medical apps following regulations with its letter to the makers of Ucheck Urine Analyzer.  In lieu of the FDA’s recent inquiry into the uCheck urine analyzer app, it appears Apple might be tightening restrictions on medical app developers.

Apple is only accepting apps with dosage information from the “the medications manufacturer” which has led to some developers leaving iOS and instead concentrating on Android.  The ability to look up a drug dosage on a mobile device is one of the main reasons healthcare professionals use a mobile device. At this point, it’s unclear if apps like Epocrates or Medscape are free from the Section 1.2 rule since they could argue they are using dosage information from the medicine’s manufacturer. But how does Apple confirm the dosages are correct?

Let’s be honest here.  Yes mobile health is going to become important but we are still a long way from take an app and  call me in the morning.  The idea that apps can increase compliance and adherence maybe well founded but taking a pill or capsule is a lot easier than using a lot of health apps which are deleted with 60 days of downloading.  In addition Pew Internet clearly showed that the majority of health apps downloaded by the public were apps related to diet and exercise not medications or health conditions.



Right now the market for health applications and medications is primarily used by physicians not patients.  Smartphones and tablets allow physicians to get information on dosing when they are writing Rx’s for their patients.  Yet there are websites and people who would have you believe that pharma needs to develop and launch health apps.  Bull !!

Like any good marketer the first thing I would ask is “what is the need ?” and “can we develop and maintain an app that will find utility with our users?”.  Then of course there is the development of the apps in iOS, Android and Windows formats.  While some apps are indeed good I would argue that 95% of them are a waste of money sold into clients who believe the hype around mobile health.

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3 thoughts on “Mobile health ? Not so quick as FDA, FTC and Apple go after mobile health apps

  1. The medical apps idea is very innovative, however, the fact that the app expires after a couple of months made me realize that it would be very expensive. Besides, doctor-patient meeting is still the best.

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