1. FDA Regulation of Mobile Health Technologies.
- Author
-
Cortez, Nathan G., Cohen, I. Glenn, and Kesselheim, Aaron S.
- Subjects
- *
MOBILE health , *HEALTH information technology , *HEALTH policy , *MEDICAL laws - 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.
- Published
- 2014
- Full Text
- View/download PDF