Should the FDA regulate certain medical apps?

Over the last five years cell phones have become so popular they are like an extension of the body for some people.  With this popular technology came “apps” or easy-to-use computer applications that serve as mini programs at users fingertips.  The phrase, “There’s an app for that,” may in need be true.  There are apps for just about anything you can think of including one for erectile dysfunction.  Now the U.S. Food and Drug Administration is proposing guidelines to “oversee” certain kinds of medical apps.

The medical app craze
“Today, mobile medical apps include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device,” a statement released by the FDA stated.  According to Research2Guidance 2010, 500 million smartphone users worldwide will be using a health care application by 2015.  This is just one of the many smartphone debates that is going on, including one about cell phones hurting your vision.

The proposed guidelines
“The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”

Only a small portion of apps will be regulated under these guidelines.  The apps regulated would be:
*Apps that are used as an accessory to medical device already regulated by the FDA

* Apps that transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.  (For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).

Public input
The U.S. Food and Drug Administration is seeking public input on these guidelines.  Should a government agency regulate medical apps?  Should they be allowed to govern some apps you want on your phone?  You can submit your comments online here.

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