Silver Spring, MD-Ambitious technological innovation and the US healthcare system are two things that do not often logically go together. Young startups and large corporations are both facing substantial obstacles in the field of mobile health apps, or mHealth apps. Creating mHealth apps that encourage patients to take control of their health while following the stringent FDA regulations is a challenge. As a result, many apps are hitting the market without much testing or regulation. Now many professionals are calling for increased regulation for mobile health apps.

The confidence that consumers have in the Android and Apple marketplaces make newly emerging health apps easy to download and use. Without FDA guidance, we face the possibility of patients believing in false or inaccurate health and wellness information, however, with too much guidance or restriction, innovation may be heading for a plateau.

Mobile health apps are growing in popularity, yet only about 100 out of 100,000 mHealth apps available in the marketplace today have been FDA-approved. This is due largely to the fact that getting an mHealth app approved requires a long approval process and large sums of money.

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. –Nathan Cortez, Associate Dean for Research at Southern Methodist University

Balancing safety and technological innovation in the production of mHealth apps is a burgeoning challenge for both tech companies and the FDA. Nonetheless, these challenges are not slowing down the rate of adoption for consumers.

According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications. -FDA

Posted By: Zach Gerber

About the Author:

As Managing Director of Innovation and Insights for Syneos Health Communications, Leigh is responsible for building and scaling a global team of healthcare experts who together help life science leaders better understand the complex lives, influences and expectations of their customers. Specifically, they uncover actionable insights that fuel empathy and creativity; lead co-creation events that let marketers learn from peers, trends, and new possibilities; and help clients identify the most valuable and useful new customer experiences to create.

Leigh has worked with Fortune 1000 companies to craft their digital, mobile, social and CRM strategies for nearly 20 years.She’s worked for category-leading agencies in retail, public affairs, B2B technology, and higher education. Prior to moving to Syneos Health Communications, she held several leadership roles at our largest agency, GSW.  There, she founded an innovation practice fueled by the zeitgeist and spearheaded digital and innovation thinking across the business.

Leigh has taken a special interest in complex healthcare products that can change lives in meaningful ways. She was recently a strategic lead on the 3rd largest launch in pharmaceutical history: Tecfidera. Before that she had keys roles with Eli Lilly Oncology, Abbott Nutrition, Amgen Cardiovascular, and Eli Lilly Diabetes.

A critical part of Leigh’s work is trends and new ideas. Every year, she convenes a group of trend watchers from across our global network to identify the shifts most critical to healthcare marketers. This year, she led over 250 experts to experts to focus on the most important changes in the commercial, consumer, marketing, digital and healthcare landscapes. (See reports at

Leigh is a sought-after writer and speaker. Recognized as one of the most inspiring people in the pharmaceutical industry by PharmaVoice and Top 10 Innovation Catalysts of 2017 by MM&M, Leigh also was recognized  as a Rising Star by the Healthcare Businesswomen's Association (HBA) for her overt passion, industry thought leadership and significant contributions in new business, strategy and mentoring.