title: Regulatory frameworks for mobile medical applications.
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.
authors: Department of Technologies and Health, Istituto Superiore di Sanità, Viale Regina Elena 299, Roma 00161, Italy.
authors: Federica
authors: F
authors: Censi
authors: Eugenio
authors: E
authors: Mattei
authors: Michele
authors: M
authors: Triventi
authors: Giovanni
authors: G
authors: Calcagnini
mesh_terms: D054626:Consumer Health Information / Q000379:methods*; D018795:Device Approval; D004864:Equipment and Supplies; D005062:European Union; D006801:Humans; D063731:Mobile Applications; D012648:Self Care / Q000379:methods; D000068997:Smartphone; D012984:Software; D014481:United States; D014486:United States Food and Drug Administration
keywords: European directives; FDA guidelines; medical device; mobile application; regulatory framework