Happtique, which runs a marketplace for mobile health applications, has released its draft guidelines on medical app development.
Described as a "Good Housekeeping" seal of mobile apps by Happtique CEO Ben Chodor, the App Certification Program specifies which types of apps satisfy standards on operability, privacy, security and content, the company reported.
Happtique is a unit of GNYHA Ventures, the business arm of the Greater New York Hospital Association. It launched the App Certification Program Jan. 17 and released its draft on July 11.
The draft dictates that apps need to operate reliably, according to Chodor.
"There are tens of thousands of medical, health and fitness apps on the market, and their sheer number makes it difficult for health care professionals and consumers to locate apps that operate reliably, are based on valid information and safeguard users' information," Chodor said in a statement. "Happtique's App Certification Program will address an important need in the m-health field by evaluating apps along these dimensions."
In a similar process, the FDA published its guidelines on medical health apps in July 2011. The FDA plans to regulate apps that work as accessories to FDA-regulated devices or that turn smartphones into medical devices to monitor conditions such as abnormal heart rhythms.
Happtique's operability standard would mandate that apps run effectively on mobile devices, and are able to connect properly to peripherals as well as WiFi or cellular networks. Speed would also fall under operability standards, though the document doesn't mention how fast an app would need to operate on a network.
To satisfy the privacy standard, a mobile app would have to make clear who will receive a patient's information prior to the user downloading the software. The app also must disclose resources that would be used, including how many Short Message Service (SMS) or Multimedia Message Service (MMS) messages would be sent per month, how many emails would be sent and which Bluetooth profiles would be used.
As far as security, mobile apps would need to ensure that they don't contain viruses, worms, spyware, adware, rootkits or other threats.
The content standards would require that the app is current and gets its data and documentation from a "recognized source." In addition, content would be need to be written in layperson's terms, according to Happtique.
A panel of experts made up of a doctor, nurse, biotechnology scientist and patient advocate developed the guidelines.
Happtique is looking for feedback from the medical, health and fitness community, including app owners, developers and patients, according to Dr. David Lee Scher, chair of Happtique's App Certification Program Blue Ribbon Panel.
"Our goal is to produce a set of rigorous standards that will give both health care professionals and consumers a solid basis for selecting apps," Scher said in a statement.
"We believe the certification process will lead to the identification of truly high quality apps, thereby giving health care professionals and consumers alike the confidence they need in the apps they are recommending or using," said Chodor.
Happtique is accepting comments until 5 p.m. ET on Aug. 17 at its certification Web page.