When questioning how to accomplish just about anything, one is quick to wonder, "Is there an app for this?" Technological applications ("apps") available on a variety of mobile devices can provide valuable information at the touch of a button. However, when certain apps remain unregulated, patient safety may be put at risk.
The market hosts a countless number of apps related to exercise, nutrition and patient health. However, many experts and regulators are concerned that various apps, many of them seemingly well-meaning, may ultimately put patients at risk for dangerous drug interactions, risky behaviors and other complications as a result of amateur advice.
Because of these concerns, many are questioning whether or not the Food and Drug Administration should assume responsibility of regulating patient health-related apps.
First, the Federal Department of Health and Human Services (HHS) will study the issue of health-related apps and potential FDA oversight of them. After that period of study, the agency may or may not be given broad control to regulate apps aimed at individuals with health concerns. There is speculation however, that the FDA has been granted provisional authority by Congress to explore potential regulations for these apps even before the HHS study has concluded.
What would FDA oversight mean for mobile medical apps? Ideally, regulations would be enacted to prevent patients from making unsafe choices as a result of amateur advice provided by apps. At minimum, if apps provide medical advice, they will be required to disclose that the advice is not of a professional nature.
At that time, consumers can make an informed decision on whether to seek the advice of a licensed physician, nutritionist, pharmacist or physical trainer, or to proceed with the advice given by the app without double-checking the information's accuracy or interaction risk.
In a world ruled increasingly by touch screen technology, some government oversight of endless medical apps may be just what the doctor ordered.
Source: Health Tech Zone, "Should FDA Regulate Mobile Health Apps?" Braden Becker, June 21, 2012
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