FDA Regulation of Mobile Health Technologies

Authors

Nathan Cortez, Southern Methodist University, Dedman School of LawFollow
I. Glenn Cohen, Harvard University Law SchoolFollow
Aaron S. Kesselheim, Brigham & Women’s Hospital Department of Medicine Division of Pharmacoepidemiology & PharmacoeconomicsFollow

Abstract

Mobile health (“mHealth”) is the use of portable devices such as smartphones and tablets to improve health. This report discusses the public health benefits and risks of mHealth and the challenges facing the FDA in regulating this technology.

Publication Title

New England Journal of Medicine

Document Type

Article

Keywords

mobile health, FDA, liability, congress, premarket, postmarket

Recommended Citation

FDA Regulation of Mobile Health Technologies, 371 New England Journal of Medicine 372 (2014) (with I. Glenn Cohen and Aaron S. Kesselheim)