19 mobile health apps earn new certification seal
By Kari Jensen
December 4, 2013
The HACP seal
Great Call, Power 20 and eight other medical and healthcare application developers' apps are the first in the United States to meet new health certification standards.
The 19 medical and healthcare apps earned the Health App Certification Program or HACP seal, developed by Happtique, a mobile healthcare app aggregator. Happtique developed a certification process for medical and health apps with a goal of helping app developers ensure safety and effectiveness.
One of the biggest challenges to app integration in healthcare is knowing which apps to select/offer," said Corey Ackerman, president and chief operating officer of Happtique, New York. "Happtique created its certification program as a first step toward addressing that issue."
While the number of mobile health-related apps continues to grow and use is climbing as well, a significant portion of the apps do not fall under regulatory oversight.
This presents potential issues for marketers and developers as well as consumers, in terms of apps' stated benefits and their effects on consumers' health and wellness.
The first apps to be certified include ones for monitoring diabetes, exercise and food intake. One of the Tactio Health Group apps tracks a user's weight, blood pressure and activity level. Others help users manage their weight and track their fitness levels.
Happtique estimates there are more than 40,000 medical and healthcare apps, and the numbers of apps and app users are growing.
According to industry estimates, 500 million smartphone users worldwide will be using a health care app by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications.
These users include health care professionals, consumers and patients.
The U.S. Food and Drug Administration issued final rules covering the development of mobile medical apps in September, saying it would focus its oversight on those apps that have the potential to harm consumers if they do not function properly (see story).
The FDA also had cleared about 100 apps at that time, according to its Web site.
That leaves the majority of the mHealth apps unregulated and untested.
Happtique intends to help the healthcare market self-regulate. HACP is structured to complement the U.S. Food and Drug Administration oversight.
The 19 HACP certified apps
Developers voluntarily submit their apps to HACP for testing. The submissions must include privacy policies, proof of FDA approval if applicable and documentation of content sources.
After passing technical testing, the apps are submitted for content review, which is conducted by independent, licensed experts. To maintain objectivity, Happtique requires reviewers to disclose potential conflicts and reassigns apps as necessary.
Once certified, developers can display the HACP seal on their apps, Web pages and data sheets. The seal is meant to instill consumer confidence, according to Happtique.
IHealthVentures was unable to comment on this by press time.
The HACP seal is meant to help consumers determine if an app will protect their personal information, operate as promised. In addition, it ensures that the clinical information included in the app has been documented and verified.
"The healthcare industry, generally, is highly regulated for the purpose of protecting patients, and we believe that app developers and publishers entering the space will benefit from the transparency created by self-regulation and review processes," Mr. Ackerman said.
Kari Jensen is staff writer at Mobile Marketer, New York
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