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Health-Related Smart Phone Apps Subject to FDA Regulation

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The FDA is focusing on regulating smartphone apps that are meant to help patients with their at-home healthcare.  While there are hundreds of applications from app makers to receive FDA approval, only 40 have been approved.  The specific apps that the FDA is most concernd about regulating are those that could have a harmful effect on patients if they do not work as intended.  There are a limited number of these types of apps, with low-risk apps making up the majority of the ones available.  The small number of apps subject to stricter FDA restrictions are those already linked to regulated medical devices.  These apps allow patients to check heart rhythms like an EKG machine, or submit medical images or charts to physicians for a diagnosis.  Another app allows people to test their food for allergens (provided they have the necessary equipment attached to the phone as well).  The FDA regulations will not extend into the sale of smartphones, nor will it be able to regulate mobile app distributors such as iTunes.

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