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mHealth: Regulation and How to Avoid Practicing Medicine on the Web

During this session panelists will discuss strategies for navigating the potential legal risks associated with the practice of telemedicine and the rules governing the commercialization of mobile medical devices. This session will introduce FDA's regulation of mobile medical devices, mHealth applications ("apps") for use on smartphones and other portable devices, and accessories to such devices. Panelists will also discuss the status of FDA's 2011 Draft Guidance document focused on the regulation and commercialization of mobile medical apps. Attendees will learn various the various factors to consider when evaluating data security and data privacy. Issues related to medical practice licensure, corporate practice restrictions and reimbursement will also be considered.

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