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

Dallas (SMU) 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.

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."


Contact: Denise Gee
Southern Methodist University

Related medicine news :

1. The Business of Beauty is Booming in Bonita
2. Pump Up Your Gym’s Marketing Muscles with Mobile Marketing: CallFire's Health & Fitness Webinar Week – July 28th to August 1st
3. Memorial Hermann Physician Network Launches Physician Mobile Communication Solution Throughout Houston
4. SIMpalm Launched Updated Forte Mobile Payment App on iPhone and iPad for Its Client
5. Diet-to-Go Introduces New Online and Mobile Weight-Loss Tools, with Apps for iPhone and Android
6. Cloud BaaS / Mobile BaaS Market Expected to Reach $7.7 Billion by 2017 – Report by MarketsandMarkets
7. Gold Mobile Partners With United Preference To Deliver Incentives For GoMo Health Mobile Engagement Platform
8. FashionLoyal Unveils Fashion’s Social Currency Platform with Mobile App
9. Mobile Health Solutions Market to Grow at 34.88% CAGR by 2018, Says a New Research Report at
10. IBM i ISVs Can Now Easily Integrate Mobile-Based Two Factor Authentication to Increase Security of Solutions
11. Heterogeneous Mobile Processing & Computing Market Worth $61.70 Billion by 2020 – New Report by MarketsandMarkets
Post Your Comments:
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... ... use in Final Cut Pro X. With ProSidebar: Fasion, video editors can easily ... use ProSidebar as a minimalist title opener. Utilize presets featuring self-animating drop zones, ...
(Date:11/27/2015)... ... November 27, 2015 , ... Consistent with the ... 2016 Building Better Radiology Marketing Programs meeting will showcase some of ... 6, 2016, at Caesars Palace in Las Vegas with a pre-conference session on ...
(Date:11/27/2015)... ... 2015 , ... A simply groundbreaking television series, "Voices in America", which is ... an array of issues that are presently affecting Americans. Dedicated to providing the world ... is changing the subjects consumers focus on, one episode at a time. , ...
(Date:11/27/2015)... Bangalore, Karnataka (PRWEB) , ... November 27, 2015 ... ... the world, Health-E-minds, an innovative online platform for mental health and wellness consultation, ... KleverKid. , This partnership will bridge the knowledge gap experienced by parents and ...
(Date:11/27/2015)... IL (PRWEB) , ... November 27, 2015 , ... ... of the largest, most successful and prominent nonprofit healthcare organizations in the country. ... governance involvement with various organizations, and helped advance the healthcare industry as a ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... November 26, 2015 ... adds "Global Repaglinide Industry ... Report on China Repaglinide Market, 2010-2019" ... data and information to its online ... . --> ...
(Date:11/26/2015)... 26, 2015 Research and Markets ( ... "2016 Future Horizons and Growth Strategies in ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging Opportunities" ... --> --> This new ... Italian therapeutic drug monitoring market, including emerging tests, ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... has announced the addition of the  ... in the European Cell Surface Marker ... Emerging Opportunities"  report to their offering.  ... announced the addition of the  "2016 ...
Breaking Medicine Technology: