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Mhealth app guidelines released by FDA

10/01/201309/28/2013 Jorge Gonzalez

The Food and Drug Administration has now issued its final guide for applications of a medical and health nature. The Food and Drug Administration (FDA) has now released a final mhealth guide that shows just how medical and health apps are going to be regulated within the United States. The FDA has also decided that they will not be enforcing under the Federal Drug and Cosmetic App. The FDA has come to the conclusion that the majority of health and medical apps don’t pose very much of a risk to…

Mhealth apps generate concerns among lawmakers in the US

03/14/201303/13/2013 Jesse Collins

These worries have been voiced to the FDA, regarding the taxing of the mobile applications. Republican House Energy and Commerce Committee members have voiced concerns to the U.S. Food and Drug Administration (FDA) regarding whether or not it plans to regulate mhealth apps for smartphones and tablets which could deem them medical devices under the rules of the Affordable Care Act. The new healthcare law has imposed a excise tax on medical devices but it is unclear if apps are among them. Six members of the committee wrote a letter…