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How MHealth Apps Are Regulated


Mobile Health Applications allow users with and without medical degrees to track, diagnose, record, and find treatments for themselves, their family, and their friends. The problem with this technology is that users don’t possess all of the knowledge and equipment to truly determine if their health assessment is correct. In the worst circumstances these apps could lead to health repercussions when users begin the wrong treatment. With the danger that medical apps can have to users, it was only a matter of time before the Food and Drugs Administration stepped in to lay down some guidelines that all health apps must follow.

What Apps Are Regulated?

As a web developer, a member of the health profession, or a health app enthusiast, you may be wondering how the FDA will determine if an app will be regulated. The FDA has ruled that they will regulate apps if the application:

  • Transforms the handheld device into a mobile medical application.
  • Is meant to be used in a medical capacity.
  • Could cause danger to the patient if the app malfunctions.
  • Displays, transfers, stores and converts patient medical data from a connected device.
  • Connects to a medical device or tool to control the operation, function, or energy source of that tool.

What Apps Aren’€™t Regulated?

Don’t panic. The majority of medical apps don’t require FDA regulation. They fall within the health niche, but they are not considered dangerous to the user. These apps are more properly considered wellness apps. Wellness apps are exempt from mHealth App regulation. Although the FDA does have the right to request that the developers fix a problem or remove the app if a concern is found. An app is considered a wellness app if they allow the user to:

  • Self-manage a disease without delving into suggesting treatments.
  • Organize and track health conditions.
  • Gain easy access to health information.
  • Document potential medical conditions for healthcare providers.

What Does FDA Regulation Entail?

Are you a medical app designer? Do you have an app that is currently in the works or on the market? If you answered yes to both questions, you should make sure that you are following all of the regulations set out by the FDA. The FDA requires that mobile health app developers must:

  • Annually registered medical health with the FDA.
  • Submit a premarket approval application or a Premarket Application 510(k) submission before they are put on the market. The type of application you must submit will depend on the type of app you are looking to approve.
  • Receive approval from the FDA and the Institutional Review Board before unapproved devices are tested in clinical studies.
  • Comply with the labeling regulations.
  • Comply with Quality System Regulations. QS Regulations are meant to ensure that the app is safely distributed, installed and operated.
  • Report any injuries or deaths that occurred when the device was used. This is meant to determine why the accident happened and how another accident can be avoided.
  • Correct any problems with the app. In extreme cases the FDA can request that an app be removed from the market.
  • Report the correction of problems to the FDA.

For an application developer, it can be annoying to have to jump through hoops to get your product out to your intended audience. The aim of medical application regulations is not to stifle creativity, but to create a framework that will ensure that safety of all users. The FDA regulations and exemption laws will ensure that medical and wellness apps can be used without worrying about faulty or dangerous products.

Written By

Connor Ewert is just a fun loving guy who can't get enough technology.

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