FDA Regulation of Mobile Health Technologies

370 New England Journal of Medicine 372 (2014)

Harvard Public Law Working Paper No. 14-40

Posted: 22 Oct 2014 Last revised: 4 Dec 2014

See all articles by Nathan Cortez

Nathan Cortez

Southern Methodist University - Dedman School of Law

I. Glenn Cohen

Harvard Law School

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School; Harvard University - Edmond J. Safra Center for Ethics

Date Written: October 20, 2014

Abstract

Mobile health (“mHealth”) technologies that employ portable devices such as smartphones and tablets for medical purposes are rapidly transforming the medical profession. Yet adapting existing regulatory processes to ensure the safety and efficacy of this new set of products has proved challenging for the U.S. Food and Drug Administration (FDA). In this Article, we highlight issues encountered by the agency in applying its authority and its established approval and monitoring processes to this new genre of medical devices. After reviewing legislative proposals and recommendations by the FDA as to the appropriate scope of agency oversight of mHealth products, we present policy recommendations for updating the FDA’s authority. We conclude that preserving the FDA’s premarket and postmarket authority and providing the agency with additional funding and expertise provide a more promising solution than strictly limiting FDA’s authority, which could impede the agency’s ability to adapt to future innovation by tying it to existing products.

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

Suggested Citation

Cortez, Nathan and Cohen, I. Glenn and Kesselheim, Aaron S., FDA Regulation of Mobile Health Technologies (October 20, 2014). 370 New England Journal of Medicine 372 (2014) ; Harvard Public Law Working Paper No. 14-40. Available at SSRN: https://ssrn.com/abstract=2512458

Nathan Cortez (Contact Author)

Southern Methodist University - Dedman School of Law ( email )

P.O. Box 750116
Dallas, TX 75275
United States
(214) 768-1002 (Phone)

I. Glenn Cohen

Harvard Law School ( email )

1525 Massachusetts Avenue
Griswold Hall 503
Cambridge, 02138
United States

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School ( email )

1620 Tremont St
Suite 3030
Boston, MA 02120
United States
617-278-0930 (Phone)
617-232-8602 (Fax)

HOME PAGE: http://www.drugepi.org/portal

Harvard University - Edmond J. Safra Center for Ethics ( email )

124 Mount Auburn Street
Suite 520N
Cambridge, MA 02138
United States

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