Abstract

http://ssrn.com/abstract=2284448
 


 



The Mobile Health Revolution?


Nathan Cortez


Southern Methodist University - Dedman School of Law

June 24, 2013

UC Davis Law Review, Vol. 47, 2104
SMU Dedman School of Law Legal Studies Research Paper No. 128

Abstract:     
Rarely does a class of technologies excite physicians, patients, financeers, gadgeteers, and policymakers alike. But mobile health — the use of mobile devices like smartphones and tablets for health or medical purposes — has captured our collective imagination. Observers predict that mobile health, also referred to as “mHealth” or “medical apps,” can save millions of lives, billions in spending, and democratize access to health care. Proponents argue that mobile health technologies will transform the ways in which we deliver, consume, measure, and pay for care; disrupting our sclerotic health care system.

This Article evaluates mobile health and its many ambitions. Given the significant hype surrounding mobile health, I try to provide a relatively sober, dispassionate review of the many claims here. I begin by surveying the universe of mobile health technologies, offering a typology of products based on their functions, many of which have regulatory significance.

The Article then considers the federal government’s posture towards mobile health. To date, Congress and over half a dozen federal agencies have addressed mobile health. Contrary to the prevailing wisdom, federal regulators are sympathetic, not hostile, to these technologies. However, I demonstrate how one agency, the U.S. Food and Drug Administration (FDA), is repeating the same mistakes that it made when it first confronted medical device software 25 years ago, relying on nonbinding guidance documents that are largely weak and unenforceable. I argue that, somewhat counter-intuitively, mobile health will only reach its immense potential if regulators like the FDA provide meaningful oversight. Otherwise, users will be flooded with mobile technologies that are ineffective, or worse, unsafe.

Number of Pages in PDF File: 58

Keywords: mobile health, mHealth, medical apps, mobile apps, FDA, FCC, FTC, device regulation, medical devices, medical software, device software

Accepted Paper Series


Download This Paper

Date posted: June 24, 2013 ; Last revised: April 21, 2014

Suggested Citation

Cortez, Nathan, The Mobile Health Revolution? (June 24, 2013). UC Davis Law Review, Vol. 47, 2104; SMU Dedman School of Law Legal Studies Research Paper No. 128. Available at SSRN: http://ssrn.com/abstract=2284448 or http://dx.doi.org/10.2139/ssrn.2284448

Contact Information

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)

Feedback to SSRN


Paper statistics
Abstract Views: 831
Downloads: 223
Download Rank: 77,635

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo4 in 0.266 seconds