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FDA Regulation of Mobile Health Technologies.

Authors :
Cortez, Nathan G.
Cohen, I. Glenn
Kesselheim, Aaron S.
Source :
New England Journal of Medicine. 7/24/2014, Vol. 371 Issue 4, p372-379. 8p.
Publication Year :
2014

Abstract

The article discusses challenges facing the U.S. Food and Drug Administration (FDA) in regulating mHealth or the use of mobile devices such as smartphones and tablet computers to improve health. Topics addressed include proposed bills in the U.S. Congress to change FDA jurisdiction over mHealth products, mHealth's clinical utility and risks, the FDA's plan to focus on mHealth's intended functionality and not the mobile platform, and the FDA's framework for mobile software.

Details

Language :
English
ISSN :
00284793
Volume :
371
Issue :
4
Database :
Academic Search Index
Journal :
New England Journal of Medicine
Publication Type :
Academic Journal
Accession number :
99367758
Full Text :
https://doi.org/10.1056/NEJMhle1403384