Mobile Health Apps Flooding Unregulated Market, Is That A Good Thing?

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Over 31,000 health, fitness, and medical apps are on the market with no government oversight or vetting by private companies

HealthLeaders Media reported early this year “the healthcare app industry is a boomtown generating hundreds of new apps each month with most designed for use on mobile devices.” It also quotes Mark Anderson, CEO of healthcare IT consulting firm The AC Group, as saying “There are hundreds of apps that really work and are completely legitimate. But there are also a lot of apps manufactured by snake oil salesmen who promote them with a lot of misleading information.” Despite the uncertainty as to the validity of any particular app, recent surveys indicate physicians see real value in them.

Health Populi shared the results of an eClinicalWorks survey that revealed “A vast majority – 9 in 10 physicians – like mobile health (mHealth) apps, especially when tied to electronic health records (EHRs).” The survey results (click here so see an infographic with more information) were distributed in conjunction with the news that eClinicalWorks was releasing a free mobile app that “will connect patients to their EHRs and enable provider-patient communication.”

Last month, the University of California, San Francisco launched an “online cardiovascular study that harnesses the power of mobile technology to monitor patients using their smartphones and send the information to doctors who can analyze the data and provide instant feedback.” The study aims to enroll 1 million people and will allow participants to submit data via a secure online survey and uses smartphone technology to measure a participant’s heart rate, blood pressure and pulse rate.

InformationWeek Healthcare compares the study to the Framingham Heart Study and points out that, “unlike the Framingham trial, which collected data on patients only once every two years, the UCSF study will gather information from its subjects' mobile devices several times a day.”

Two days after the UCSF announcement, MobiHealthNews reported The Cleveland Clinic released Cleveland Clinic Today, the hospital’s 10^th app. MobiHealth notes “anyone can download the app, (but only) Cleveland Clinic patients can access its full feature set, including resources to navigate the provider’s network to find a doctor, access contact information, or request an appointment.”

Despite physician’s enthusiastic support, health care apps still need to overcome some hurdles, specifically the U.S. Food and Drug Administration. The Columbus Dispatch quotes Bakul Patel, a policy advisor in the FDA’s Center for Devices and Radiological Health, as saying mobile health devices carry “a potential risk to patients if they do not work as intended, which makes FDA oversight important.” Patel went on to say the FDA, which released draft guidelines concerning medical apps in July 2011, is working with app developers to find the best way to ensure patient safety of the apps while not impeding innovation.

Marketplace Tech reports the FDA as saying most mobile medical apps won’t need approval unless they control the delivery of insulin or are used in any way that depends on their accuracy. They also note that “Costs for lawyer’s fees and testing can run into the hundreds of thousands” and that some “in the industry say the red tape is stifling.” They quote attorney Gerry Hinkley as saying the process may discourage developers who could “go off and develop a killer game instead of something that is going to cure cancer.”

UPI.com editorializes there are benefits to the health care app boom, “But to take full advantage of these benefits, there needs to be a change in the regulatory policies that foster the growth of the mobile medical industry.” MobiHealth News also sees a need for regulation saying “Without professional guidance, health and medical apps risk falling into the “for amusement purposes only” category, and if physicians aren’t willing to help their patients understand how certain apps fit into the overall picture of health, then we are just building another silo in an oversiloed industry.”

Healthcare IT News writes that, whatever the outcome, mHIMSS doesn’t see any containment of the exploding health care app market. It quotes mHIMSS executives Tom Martin and David Collins as saying the future of healthcare apps, and their developers, couldn’t be brighter and that “Valuations of these innovative companies will continue to grow. The breadth and depth of patient engagement will also continue to grow with these apps.”