Featured Research

from universities, journals, and other organizations

Booming mobile health app market needs more FDA oversight for consumer safety, confidence

Date:
July 28, 2014
Source:
Southern Methodist University
Summary:
While the mobile health apps market offers tremendous potential, several health law experts say that more oversight is needed by the US Food and Drug Administration to ensure consumer confidence and safety. Out of 100,000 mHealth apps on the market, only about 100 have been cleared by the FDA, which opponents see as a deterrent to innovation and profit. But it doesn't have to be.

Smart phones and mobile devices are on the cusp of revolutionizing health care, armed with mobile health ("mHealth") apps capable of providing everything from cardiac measurements to sonograms.

Related Articles


While tremendous potential exists to broaden access to medical treatment and control costs, several health law experts say in a just-published New England Journal of Medicine (NEJM) report that more oversight is needed by the U.S. Food and Drug Administration (FDA) to ensure consumer confidence and safety. Out of some 100,000 mHealth apps on the market, only about 100 have been cleared by the FDA, while opponents see the FDA as deterrents to innovation -- and profits.

"Consumers will be spending a lot of money on these products, and venture capital is flying into the industry," says the article's lead author, SMU Dedman School of Law Associate Dean of Research Nathan Cortez, adding that by 2017 mHealth apps are expected earn $26 billion -- up from $2.4 billion in 2013.

The FDA needs "additional funding and in-house technical expertise to oversee the ongoing flood of mHealth products," the authors note. An under-regulated mobile health industry could create "a Wild West" market, says Cortez, who has conducted extensive research into FDA regulation of mobile health technologies.

"Most consumers take mobile health app claims at face value, and think that because they're available through a trusted retailer like the iTunes Store, they must have been reviewed by the FDA, which isn't usually the case," Cortez says.

Cortez, who also serves as an associate professor in SMU's Dedman School of Law, co-wrote the NEJM article with Harvard Law School Professor I. Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics and author of Human Subjects Research Regulation: Perspectives on the Future (MIT Press, 2014) and Aaron S. Kesselheim, Associate Professor of Medicine at Brigham and Women's Hospital/Harvard Medical School.

"Although the vast majority of mHealth products are very low-risk, some apps make promises they can't fulfill, and others make errors that could harm patients," Cortez notes, pointing out that life-threatening technical mistakes are not only possible -- they also have occurred.

One of several examples cited in the study includes Sanofi Aventis' 2012 recall of a diabetes app that miscalculated insulin dosages.

Several Congressional bills have been proposed to strengthen FDA jurisdiction over mHealth products, with one proposing the creation of a new Office of Wireless Health Technology within the administration, the article notes. Meanwhile, more restrictive bills also have been introduced to keep the FDA from regulating "clinical software" or "applying a complex regulatory framework could inhibit future growth and innovation in this promising market."

"The conventional wisdom is that FDA regulation will stifle innovation, and that's a very short-term way to think about this," Cortez says. "Most Silicon Valley firms aren't used to much federal regulation, and Internet technologies have been subject to very little federal oversight."

If dangerous errors and disproven product benefits are allowed to proliferate, "some very useful products will be undermined by widespread consumer distrust," Cortez contends.

"We're trying to push lawmakers to empower the FDA, not hamstring it," he says. "Clarity will help the industry create products more helpful than harmful."


Story Source:

The above story is based on materials provided by Southern Methodist University. Note: Materials may be edited for content and length.


Journal Reference:

  1. Mary Beth Hamel, Nathan G. Cortez, I. Glenn Cohen, Aaron S. Kesselheim. FDA Regulation of Mobile Health Technologies. New England Journal of Medicine, 2014; 371 (4): 372 DOI: 10.1056/NEJMhle1403384

Cite This Page:

Southern Methodist University. "Booming mobile health app market needs more FDA oversight for consumer safety, confidence." ScienceDaily. ScienceDaily, 28 July 2014. <www.sciencedaily.com/releases/2014/07/140728123850.htm>.
Southern Methodist University. (2014, July 28). Booming mobile health app market needs more FDA oversight for consumer safety, confidence. ScienceDaily. Retrieved October 24, 2014 from www.sciencedaily.com/releases/2014/07/140728123850.htm
Southern Methodist University. "Booming mobile health app market needs more FDA oversight for consumer safety, confidence." ScienceDaily. www.sciencedaily.com/releases/2014/07/140728123850.htm (accessed October 24, 2014).

Share This



More Science & Society News

Friday, October 24, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola Fears Keep Guinea Hospitals Empty

Ebola Fears Keep Guinea Hospitals Empty

AP (Oct. 23, 2014) Fears of Ebola are keeping doctors and patients alike away from hospitals in the West African nation of Guinea. (Oct. 23) Video provided by AP
Powered by NewsLook.com
Despite Rising Death Toll, Many Survive Ebola

Despite Rising Death Toll, Many Survive Ebola

AP (Oct. 23, 2014) The family of a Dallas nurse infected with Ebola in the US says doctors can no longer detect the virus in her. Despite the mounting death toll in West Africa, there are survivors there too. (Oct. 23) Video provided by AP
Powered by NewsLook.com
Academic Scandal Shocks UNC

Academic Scandal Shocks UNC

AP (Oct. 23, 2014) A scandal involving bogus classes and inflated grades at the University of North Carolina was bigger than previously reported, a new investigation found. (Oct. 23) Video provided by AP
Powered by NewsLook.com
Chameleon Camouflage to Give Tanks Cloaking Capabilities

Chameleon Camouflage to Give Tanks Cloaking Capabilities

Reuters - Innovations Video Online (Oct. 22, 2014) Inspired by the way a chameleon changes its colour to disguise itself; scientists in Poland want to replace traditional camouflage paint with thousands of electrochromic plates that will continuously change colour to blend with its surroundings. The first PL-01 concept tank prototype will be tested within a few years, with scientists predicting that a similar technology could even be woven into the fabric of a soldiers' clothing making them virtually invisible to the naked eye. Matthew Stock reports. Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Science & Society

Business & Industry

Education & Learning

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins