Why Mobile Health Applications Require FDA Regulation
If a medical device like a pacemaker was to be installed through surgery and hadn’t been thoroughly vetted by the proper agency, what patient would ever allow their doctor to go through with the surgery? It’s likely no such patient exists and healthcare advocates expect all medical devices to undergo the relevant approval process before being marketed to healthcare providers.
If so, why do consumers continually download and utilize mobile health applications that haven’t undergone due inspection by the Food and Drug Administration (FDA)? Current policies on tracking the safety and benefits of mHealth applications are lackluster in the United States.