Saturday, 19 October 2013

Does my mobile health app need regulation?

If you're a developer starting to look into the growing demand for mobile health apps and have a great idea for one, you're probably going to eventually have to look into regulatory questions about making your own mobile health app.
Unlike traditional medical routes like hospital care, mental health etc. the new frontier of mobile health apps have not really been subject to any legislation.
There's two sides to his argument as to whether med health apps should be more tightly controlled, on one side as an app entrepreneur you don't want to have your brain child sit through years of FDA approval and countless medical regulatory hoops, on the other you don't want, either as a dev or a consumer to have an app promising medical benefits and either not delivering or even worse being harmful.
Many(most?) people use a smartphone or tablet to access the web nowadays, and many health apps (such as WebMd) are often consulted, for the ease and convenience that mobile apps bring.
Whichever part of the mobile health spectrum you're on, consumer or creator, here's some guidelines for what can and can't, would or could be done:
Not falling under regulations: Wellness Apps
When is an app a wellness app? Quite simply when no danger is posed to the user the app will fall out of the FDAs remit( beyond advice or request level) and fits the following criteria:

  • The app can :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.
  • Are the rough criteria for a non regulated wellness app.
Now what mobile health apps should be regulated?
Criteria for Mobile Health App needing FDA approval:
  • You'll need to seek FDA approval for your mobile health app if your app fulfills any/all of these criteria:
  • 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.

Of course if you're a professional developer of apps for healthcare and do fit these criteria these hoops can also be seen as a good way of legitimizing the credentials of your med health app. We're sure that you want to be seen as above board and don't just recommend a deep tissue massage in chicago  for every ailment so would probably welcome FDA approval of your app!

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