Navigation Links
Booming mobile health app market needs more FDA oversight for consumer safety, confidence
Date:7/28/2014

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
dgee@smu.edu
214-768-7658
Southern Methodist University
Source:Eurekalert

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 Sandlerresearch.org
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:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... Beach, CA (PRWEB) , ... June 25, 2016 , ... ... UCLA with Magna Cum Laude and his M.D from the David Geffen School of ... Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at the ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June ... with. The article goes on to state that individuals are now more comfortable seeking ... common operations such as calf and cheek reduction. The Los Angeles area medical group, ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain ... for a minimum wage raise to $12 an hour by 2020 and then adjusting it ... the lost value of the minimum wage, assure the wage floor does not erode again, ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... SAN FRANCISCO, Calif. , June 24, 2016 ... GBT ), a biopharmaceutical company developing novel therapeutics ... significant unmet needs, today announced the closing of ... shares of common stock, at the public offering ... shares in the offering were offered by GBT. ...
(Date:6/24/2016)... , June 24, 2016 The Academy ... of recommendations that would allow biopharmaceutical companies ... with entities that make formulary and coverage decisions, a ... "value" of new medicines. The recommendations address ... not appear on the drug label, a prohibition that ...
(Date:6/24/2016)... , June 24, 2016 According ... by Type (Standard Pen Needles, Safety Pen Needles), Needle ... GLP-1, Growth Hormone), Mode of Purchase (Retail, Non-Retail) - ... This report studies the market for the forecast period ... reach USD 2.81 Billion by 2021 from USD 1.65 ...
Breaking Medicine Technology: