Silicon Valley technology firms investing heavily in mobile medical devices and apps are increasingly confronting the challenges of clearing U.S. regulatory approval processes.
Although FDA has said it is not interested in regulating most medical apps that simply track calories or help manage prescriptions, FDA will regulate apps that measure and display physiological parameters, such as blood glucose, or allow active, remote monitoring, such as the progress of labor, as medical devices, according to guidance issued last year. Meanwhile, developers of mobile medical apps have asked for clarification of federal HIPAA rules in the context of rapidly changing health IT, arguing "the risks of potential disclosure should be weighed again against the anticipated benefits of wider sharing and easier access to crucial health data."
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