Happtique, an mHealth solutions company, recently announced the publication of the final standards it will use to certify apps under the Happtique Health App Certification Program (HACP). The HACP will help healthcare providers and consumers easily identify medical, health, and fitness apps that deliver credible content, contain safeguards for user data, and function as described. The final Certification Standards and associated Performance Requirements, which assess operability, privacy, security, and content, can be read at www.happtique.com/app-certification/.
Happtique also announced that the Association of American Medical Colleges (AAMC), CGFNS International, and Intertek will serve, according to their respective subject matter expertise, as HACP Partners responsible for the evaluation of health apps against the Certification Standards.
"The vast sea of mobile health apps—over 40,000 across all platforms—can be overwhelming," said Ben Chodor, CEO of Happtique. "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."
In July 2012, Happtique released a set of draft Certification Standards and associated Performance Requirements that were developed under the direction of a Blue Ribbon Panel with input from many private organizations and representatives of key Federal agencies whom Happtique met with, including: mHIMSS, US Food and Drug Administration, Federal Communications Commission, Federal Trade Commission, and the Office of the National Coordinator for Health Information Technology. While the final Certification Standards reflect this valuable collective feedback, and input provided during the public comment period, it does not represent their approval or endorsement.
"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, Inc and managing director of Happtique. "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."
Internationally Recognized Organizations to Collaboratively Conduct Mobile Health App Evaluation
AAMC, CGFNS International, and Intertek have partnered with Happtique to serve as HACP Partners responsible for the evaluation of apps against the Certification Standards.
"We are honored to partner with such prestigious organizations," said Chodor. "The involvement of AAMC, CGFNS International, and Intertek will provide healthcare providers and consumers added assurance that Happtique Certified apps have undergone testing and review by experts in their respective fields."
The testing of the Technical Standards will be conducted by Intertek, a global leader in the provision of testing, inspection, certification and auditing services. Intertek was selected as the HACP Technical Testing Partner after an extensive RFP process.
App evaluation for the Content Standards will be conducted under the auspices of internationally recognized thirty party organizations, including AAMC and CGFNS International, and performed by clinical specialists selected based on the mobile app's specific subject matter. Happtique will continue to expand its HACP Content Review Partners and is currently in discussions with a number of organizations with various areas of clinical expertise.
After an app successfully meets all of the Happtique HACP Standards and associated Performance Requirements, it will be granted Happtique Certification. Certification is valid for a two-year period and is specifically associated with the app version that was submitted for evaluation.
App developers planning to submit their medical, health or fitness app(s) should register for a HACP Submission Form. As soon as Happtique and its Program Partners are ready to accept submissions, registrants will receive a link to the HACP Portal where they can submit their application.