Is a Mobile App a Medical Device? The FDA Clears Things Up with “Yes,” “No,” and “Maybe” on mHealth solutions

The FDA Clears Things Up with “Yes,” “No,” and “Maybe” on mHealth solutions...

It’s not every day the FDA issues a statement that amounts to pretty good news for pharmaceuticals communications teams. But that’s just what the agency did with its recent on “General Wellness: Policy for Low Risk Devices.” The guidance is an attempt to define when a mobile application may be regulated as a medical device, since the number of medical and wellness apps for smart phones has boomed in the last few years.


  • Since the beginning of 2015, the total number of mHealth apps grew 57 percent to a total of 259,000 apps.
  • In 2015, approximately three billion mobile health (mHealth) apps were downloaded onto Android and Apple devices.

Obviously, mobile apps in the healthcare environment deserve the attention of pharma marketers, but there’s more to the story than just the numbers. mHealth solutions are an effective way for pharmaceuticals companies to enhance consumer engagement, such as by offering such relevant, information on where to find a provider or streamlining prescription renewals. Marketing departments can use mHealth solutions to reach providers as well, by offering apps to simplify patient communication and improve adherence to medication and treatments. Through these connections, pharma also gains insight on patient and practitioner behavior, to help them better serve their target audience.


Still, we all know how pharma tends to move at a glacial pace when it comes to innovative technology, and mHealth certainly does fall within that category. Pharma PR execs tend to refrain from developing medical apps due to regulatory precautions and a lack of clear guidelines that explain the thinking of the FDA. And that’s where the good news comes in: The recent Guidance and supporting documents have clarified the mHealth areas where the FDA will assume oversight, dividing these apps into three groups.


  1. YES: The FDA will enforce regulations…where the mHealth app or solution is a “device” under existing rules. Apps that connect to a pacemaker or similar equipment would be included, as would the amazing “smart pill” technology – a pill that actually has a chip in it to communicate with healthcare providers via smart phone.


  1. NO: The FDA will not oversee… apps that are “low risk,” as defined by the recent Guidance. Factors to consider are whether the app is invasive or involves an unacceptable risk to health or safety. The low risk category includes apps like calorie counters, fitness trackers, and appointment reminders.


  1. MAYBE: The FDA may exercise regulatory discretion… on a case-by-case basis to determine whether an app could potentially be a medical device. The question may come down to how the app is marketed and to whom. For instance, an LED light is helpful for the average consumer who needs to navigate in the dark. But if it’s marketed as a light doctors use to examine patients, that may make it a “device” like an ophthalmoscope.


Hopefully, this explanation of the FDA’s position on medical apps will help pharmaceuticals communications teams get over their fear of developing mHealth solutions. Competition in this space will continue to explode, making it more difficult to stand out and boost those download figures. With hundreds of new mobile health apps released every day, you have to approach developing an app as you would a product launch in a saturated market. Play it safe by discussing your mHealth development plan with your legal department, and keep in mind the FDA’s “Yes,” “No,” and “Maybe” rules on mHealth solutions.


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