July 11, 2012
New York, NY – Happtique, a mobile health application store and total app management solution, today released a draft of the standards that it will be using to certify medical, health, and fitness apps under Happtique’s App Certification Program. The purpose of the program is to help users identify apps that meet high operability, privacy, and security standards and are based on reliable content. The draft standards are the product of several months of deliberations by a Blue Ribbon Panel—consisting of a physician, nurse, biotechnology scientist, and patient advocate—that was formed by Happtique to oversee the development of the certification program’s standards and operating procedures.
Happtique is developing this program in response to the many health care organizations and clinicians who expressed a need for a way to identify technically and substantively valid apps. “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,” said Happtique CEO Ben Chodor. “Happtique’s App Certification Program will address an important need in the mHealth field by evaluating apps along these dimensions. 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.”
The Certification Program is a voluntary program for apps intended for use in the U.S. Initially, the program will focus on English language apps with additional languages expected to be added in the future. The draft standards, while not designed to determine clinical efficacy, address four areas: Operability, Privacy, Security, and Content. Each area consists of multiple standards and associated performance requirements. In developing the standards, Happtique met with and received feedback from a number of private organizations and federal agencies, including the Association of American Medical Colleges (AAMC), Mobile Marketing Association (MMA), GSM Association (GSMA), mobile Healthcare Information and Management Systems Society (mHIMSS), Association for Competitive Technology (ACT), U.S. Food and Drug Administration (FDA), Federal Communications Commission (FCC), Federal Trade Commission (FTC), and the Office of the National Coordinator for Health Information Technology (ONC). For the critical areas of privacy, security and usability, the standards draw heavily on work that has been done by MMA, GSMA, mHIMSS, and ACT on these issues. Finally, the standards are explicitly designed to be consistent with any guidance or rules promulgated by U.S. regulatory agencies such as the FDA, FCC, FTC, and ONC. While the draft standards reflect the very valuable feedback provided by these organizations and agencies to date, it does not represent their approval or endorsement. Further input from these entities along with input from others who have not seen earlier drafts is anticipated and welcome.
Happtique’s App Certification Program Blue Ribbon Panel is composed of the following recognized leaders in mHealth, health care technology, health care certification and accreditation programs, and patient advocacy:
- David Lee Scher, M.D., Panel Chair – former practicing cardiologist and mHealth authority
- Franklin Schaffer, EdD, RN, FAAN – Chief Executive Officer, Commission on Graduates of Foreign Nursing Schools
- Shuvo Roy, Ph.D. – Director, Biomedical Microdevices Laboratory and Associate Professor, Department of Bioengineering and Therapeutic Sciences, School of Pharmacy, University of California, San Franciso
- Dave deBronkart (“ePatient Dave”) – well-known spokesman for patient engagement
“We are pleased to invite public comments on the draft App Certification Program Standards, and we welcome feedback from organizations and professionals in the medical, health, and fitness community; app owners, developers, and publishers; patients; and consumers. 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,” said Dr. Scher, the Panel’s Chair.
Comments on the draft standards can be submitted until 5:00 p.m. (Eastern Time) on Friday, August 17, 2012 at http://www.happtique.com/app-certification/.
During the comment period, the Panel will be finalizing the Certification Program’s operating policies and procedures. In general, each app submitted for certification will first undergo technical testing to determine its compliance with the Operability, Privacy, and Security Standards. Those that pass the technical assessment will proceed to content review. App reviewers will have credentials relevant and appropriate to the content being reviewed (e.g., cardiologists will review cardiology apps, nurses will review nursing apps, dieticians will review diet and nutrition apps, certified personal trainers will review fitness apps). Details of the full App Certification Program process, including but not limited to submission requirements, review procedures, feedback and resubmission opportunities for developers whose apps don’t qualify for certification, length of certification, re-certification requirements, procedures for assuring compliance with the standards between certification reviews, fees, and procedures for updating the standards will be released in the coming weeks. The program is expected launch in the fall of 2012.
Happtique is a mobile health application store and app management solution that helps healthcare providers, physicians, and patients easily integrate mHealth into treatment. It offers medical enterprises—like hospitals, continuing care facilities, and physician practices—the ability to create individually branded, secure, multi-platform application stores for staff and patient use. Happtique is a subsidiary of GNYHA Ventures, Inc., the business arm of the Greater New York Hospital Association.
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