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Regulatory frameworks for mobile medical applications.

作者信息

Censi Federica, Mattei Eugenio, Triventi Michele, Calcagnini Giovanni

机构信息

Department of Technologies and Health, Istituto Superiore di Sanità, Viale Regina Elena 299, Roma 00161, Italy.

出版信息

Expert Rev Med Devices. 2015 May;12(3):273-8. doi: 10.1586/17434440.2015.1007125. Epub 2015 Feb 3.

DOI:10.1586/17434440.2015.1007125
PMID:25644202
Abstract

A 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.

摘要

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