Final standards released for mobile apps

Happtique, a New York-based developer of mHealth solutions, on Feb. 27 unveiled the final draft of standards that will be used to certify mobile applications through the Happtique Health App Certification Program (HACP). Those standards, which had been fine-tuned since their draft release last June, will be used by organizations designated as HACP partners to assess operability, privacy, security and content.

"The vast sea of mobile health apps – over 40,000 across all platforms – can be overwhelming," said Ben Chodor, Happtique's CEO, in a Feb. 27 press release. "Healthcare professionals and consumers need third-party certification to verify that the app they are prescribing or downloading delivers credible content, contains safeguards for user data, and functions as described."

Speaking by phone earlier this week, Chodor, HACP Director Sandy Maliszewski, and Tammy Lewis, the company's chief marketing and strategy officer, said Happtique has received a wide range of comments since releasing the draft standards in June 2012. Chodor said the feedback has been "amazing."

"There's a lot of recognition for the need for these types of [standards]," said Maliszewski. She pointed out that some of that feedback helped them to modify certain criteria, adding in language for interoperability, better defining secure document lifestyle processes and making the user experience standards more objective.

The release of final standards comes with the healthcare industry poised to meet next week in New Orleans at the HIMSS13 Conference and Exhibition and the U.S. Food and Drug Administration poised to announce its final draft of regulations for mobile medical apps.

"We're entering a different world," said Chodor, who sees app standards as moving from a "nice-to-have" resource to a "must-have" resource in light of the fast-paced adoption of mHealth tools and services. As healthcare providers and consumers move onto this platform, he said, "they [will] want to know where these apps are from."

As part of the Feb. 27 announcement, Chodor said the Association of American Medical Colleges (AAMC), CGFNS International and Intertek will serve as HACP partners responsible for evaluating apps against the certification standards. Intertek, described as "a leader in the provision of testing, inspection, certification and auditing services," will test technical standards. The AAMC, representing all 141 accredited U.S. medical schools, and about 400 teaching hospitals and health systems and 90 academic and scientific services, will handle content evaluation. CGFNS International, described as a "global authority on credentials evaluation of the education, registration and licensure of nurses, healthcare and other professionals worldwide," will focus on mobile nursing applications.

Happtique officials said they're in discussions with other organizations to add content review partners.

Those wishing to submit their apps must first register for a HACP submission form. As soon as Happtique and the HACP partners are ready to review submissions -- Chodor expects this to occur this spring -- registrants will be directed to the HACP portal to submit their applications.

If an app meets all standards and associated performance requirements, it will be designated as certified by Happtique for two years.

Maliszewski and Chodor said the standards were originally developed by a panel of experts in the field, with input from many private and public concerns, including mHIMSS, the U.S. Food and Drug Administration, the Federal Communications Commission and the Office of the National Coordinator for Health IT. Chodor pointed out that while the final standards reflect input from federal representatives, it doesn't mean those entities have approved or endorsed the standards.

That panel was chaired by David Lee Scher, MD, owner of DLS Healthcare Consulting and a regular blogger on digital health issues.

"It was an educational and stimulating privilege to chair the Blue Ribbon Panel that developed the Happtique Health App Certification Standards," Scher said. "They were developed with the focus on the provider and consumer, as evidenced by the participation of physician, nurse and patient advocate members. I look forward to these standards as paving the way for apps becoming an important piece of the healthcare landscape."

"With mHealth's footprint and importance rapidly expanding, we can expect a proliferation of health apps that will need careful review from expert stakeholders," said Lee Perlman, president of GNYHA Ventures and managing director of Happtique, in the press release. "The Happtique Certification Standards will not only complement the objectives of key federal agencies involved in the regulation of mobile health apps, but also raise the bar for a growing segment of apps that are currently not subject to heightened regulatory oversight."

That segment, said Chodor, included the rapidly growing -- and loosely defined -- field of health and wellness, which can run the gamut of healthcare, nutrition, exercise, holistic health and many more areas.

"Someone needs to put a Good Housekeeping Seal on these types of apps," he said.

The draft standards can be accessed here.