• Expert Rev Med Devices · May 2015

    Review

    Regulatory frameworks for mobile medical applications.

    • Federica Censi, Eugenio Mattei, Michele Triventi, and Giovanni Calcagnini.
    • Department of Technologies and Health, Istituto Superiore di Sanità, Viale Regina Elena 299, Roma 00161, Italy.
    • Expert Rev Med Devices. 2015 May 1; 12 (3): 273-8.

    AbstractA mobile application (app) is a software program that runs on mobile communication devices such as a smartphone. The concept of a mobile medical app has gained popularity and diffusion but its reference regulatory context has raised discussion and concerns. Theoretically, a mobile app can be developed and uploaded easily by any person or entity. Thus, if an app can have some effects on the health of the users, it is mandatory to identify its reference regulatory context and the applicable prescriptions.

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