Mobile app store vendor Happtique has released the draft standards that it will be using to certify medical, health and fitness apps under its certification program.
The program, announced in January, is intended to provide a grading system to all apps that Happtique sells in its apps store, meaning the company not only will sell apps, but it also will certify their efficiency. The standards address an app's operability, privacy, security and reliability of content.
"There are tens of thousands of medical, health and fitness apps on the market and their sheer number makes it difficult for healthcare professionals and consumers to locate apps that operate reliably, are based on valid information, and safeguard users' information," Happtique CEO Ben Chodor said in a statement. "We believe the certification process will lead to the identification of truly high quality apps, thereby giving healthcare professionals and consumers alike the confidence they need in the apps they are recommending or using."
Happtique is accepting comments on the draft standards until August 17 on its website.
Happtique's draft standards are different from those created by the U.S. Food and Drug Administration (FDA), which is charged with regulating medical devices, and which published its own draft guidance for mobile apps nearly a year ago today. The FDA's focus is on the oversight of mobile apps that perform a medical function and present the greatest risks to patients when they don't work as intended. The agency's draft guidance applies in most cases only to mobile apps that either transform a mobile platform into a medical device, or control an existing device's use, function, modes or energy source.
To learn more:
- here's Happtique's announcement
- read their draft guidance (.pdf)