| Literature DB >> 25644202 |
Federica Censi1, Eugenio Mattei, Michele Triventi, Giovanni Calcagnini.
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.Entities:
Keywords: European directives; FDA guidelines; medical device; mobile application; regulatory framework
Mesh：
Year: 2015 PMID： 25644202 DOI： 10.1586/17434440.2015.1007125
Source DB: PubMed Journal: Expert Rev Med Devices ISSN： 1743-4440 Impact factor: 3.166