Happtique Health App Certification Program

Helping providers and patients identify health apps with credible content

The Happtique Health App Certification Program (HACP) is intended to 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 HACP Standards and associated Performance Requirements were developed under the direction of a Blue Ribbon Panel composed of recognized leaders in mHealth, health care technology, health care certification and accreditation programs, and patient advocacy along with input from health care and information technology organizations and representatives of key Federal agencies. The Standards address four areas: Operability, Privacy, Security (collectively referred to as the “Technical Standards”), and Content (“Content Standards”). Each of these areas consists of multiple Standards and associated Performance Requirements that seek to specify how each Standard will be applied with respect to the application being assessed. The final Standards reflect input received after Happtique released a set of draft Certification Program Standards for public comment.

The Happtique Certification Standards and associated Performance Requirements are explicitly designed to not only complement the objectives [existing regulations and guidelines] of key Federal agencies – namely, the 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) – involved in the regulation of mobile health applications, but also raises the bar for a growing segment of apps that are currently not subject to heightened regulatory oversight. Therefore, the Happtique Certification Standards should be interest to all app developers who create products for the mobile health market.

Who conducts the certification evaluation?
Happtique has partnered with internationally recognized third party organizations to serve as Health App Certification Program (HACP) Partners for the evaluation of apps against the Certification Standards, based upon each organization’s subject matter expertise.

The testing of the Technical Standards will be conducted by Intertek, a global leader in the provision of testing, inspection, certification, and auditing services. Apps that meet all of the Technical Standards will then be evaluated for the Content Standards, which will be conducted under the auspices of internationally recognized third party organizations, such as the Association of American Medical Colleges (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.

• AAMC, represents all 141 accredited U.S. medical schools, nearly 400 major teaching hospitals and health systems and nearly 90 academic and scientific societies, will conduct the content evaluation for apps related to medical education
• CGFNS International, a global authority on credentials evaluation of the education, registration and licensure of nurses, health care and other professionals worldwide, will conduct the content evaluation for mobile nursing applications

Only after an app successfully meets all of the Happtique HACP Standards and associated Performance Requirements, will it be granted the Happtique Certification. Certification is valid for a two-year period and is specifically associated with the app version that was submitted for evaluation.

What determines if an app qualifies for submission?
The Happtique Health App Certification Program (HACP) is a voluntary program. In order to qualify for submission, an app’s content must be written in English, run natively on iOS, Android, Blackberry or Windows devices, be intended for sale or use within the U.S., and pertain to at least one of the following areas:

• Provision of healthcare
• Health monitoring and management
• Advancement of healthcare or medical knowledge

Additionally, apps that require any public or private certification, registration, clearance or similar approval must obtain those approvals prior to submitting an application for Happtique Certification.

What is the Happtique certification seal?
The Happtique certification seal (Seal) is a symbol of confidence and assurance for consumers and healthcare providers when selecting or prescribing mobile health apps. The Seal helps easily identify apps that deliver credible content, contain safeguards for user data, and function as described. The Happtique certification seal is only awarded to those apps that successfully meet the Happtique Health App Certification Program’s operability, privacy, security and content Standards and associated Performance Requirements. The Certification and Seal is valid for a two (2) year period and is specifically associated with the app version that was submitted for evaluation.

How is the Happtique Seal used?
The app owner/developer may use the Seal in promotional, advertising or marketing activities so long as the Certification is valid and such use is in compliance with Happtique’s Seal Use Guidelines. All active seals will contain a link back to the Happtique Certified App Directory that includes pertinent information about the app and its certification.

How do I apply for Happtique Certification?
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.

A Summary Overview of the Draft vs Final Standards and Side-by-Side Comparison are available.