FDA will not regulate all healthcare mobile apps. Health and wellness apps that aim to help individuals improve their health but do not include capabilities meant to diagnose, cure, mitigate, treat, or prevent diseases will not be regulated. Other mobile solutions like e-books, mLearning solutions, office tools, and personal health record systems are out of the loop too.
So, who’s in? FDA will regulate mobile apps the same as medical devices if they store, transmit, display, control or analyze medical patient data. These include mobile medical imaging solutions (teleradiology, telecardiology, medical simulators, etc.), mobile solutions that analyze, assess or interpret electrocardiograms or electroencephalograms; solutions that control medical devices that monitor vital statistics with or without attachments (blood pressure, heartbeat, sleep patterns, etc.); and apps that offer functionalities similar to medical devices. Mobile applications that suggest treatments based on a users’ inputs fall under FDA purview too.
Why FDA regulation?
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