Medical Apps Get an Examination from the FDA

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You can unleash some built –up aggression with Angry Birds, test your knowledge of the English dictionary with Words with Friends and now your doctor can check you for skin cancer, as long as he has the app for it.

These “mobile medical apps” have become increasingly prominent in the health field, so much so that the FDA (Food and Drug Administration) recently began seeking input on proposed guidelines to regulate this growing market. The federal agency has defined this category as any app for a smartphone, tablet or personal digital assistant that aids in diagnosing, treating or preventing a disease or medical condition.  

Though analysts estimate there are over 17,000 medical applications available currently, the FDA doesn’t plan on controlling all health apps. Instead the administration plans to focus on those that could be used as “an accessory to a regulated medical device” or that “transform a mobile platform into a regulated medical device.”

An example of an app that will be examined by the FDA is one that displays radiological images, as such images on a mobile device could be negatively affected by the smaller screen size and uncontrolled ambient light. Also apps that use attachments or sensors to convert mobile devices into regulated medical equipment, such as a stethoscope, will come under the new guidelines. 

However, the FDA dances on the deciding line, claiming that an app designed to give off light and illuminate an object does not qualify, though if it’s marketed as a light to examine patients it would.

As the FDA attempts to “protect the public health,” they hope to hear from manufacturers and the public. After the comment period, which closes in three months, the rules will become final. 




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