How Happtique plans to certify health apps

By: Brian Dolan | Jul 12, 2012        

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Brian Dolan, Editor, MobiHealthNewsThis week Happtique, the healthcare-specific appstore and mobile app prescription technology vendor, published its draft document for the mobile health app certification process its panel of advisors has been developing over the course of the past few months. Happtique is looking for public comments on its draft, which certainly seems a lot like the process the FDA used for its draft guidance on the regulation of some mobile medical apps as medical devices. The FDA’s draft guidance document published last summer and the agency has yet to publish a final guidance document.

Happtique’s effort is less focused on the safety risks associated with a given app and more so on the app’s operational integrity, security, privacy policies, and content. Happtique’s panel of advisors for the certification process includes Franklin Schaffer, EdD, RN, FAAN, the CEO of the Commission on Graduates of Foreign Nursing Schools; Shuvo Roy, Ph.D., a director at the School of Pharmacy at the University of California in San Franciso; and Dave deBronkart (“ePatient Dave”) a prominent spokesman for patient engagement. While the original panel included Dr. Howard Luks, an associate professor of orthopedic surgery at New York Medical College, as its chairman, Happtique appointed Dr. David Lee Scher, a former practicing cardiologist and mobile health consultant as the panel’s new chairman after Dr. Luks had to bow out due to other commitments.

Happtique says it culled best practices and received guidance about mobile security, privacy, and usability from a number of government agencies and other organizations, 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).

Those areas of the draft guidance appeared substantial and based on similar efforts previously undertaken by some of the groups listed above. Some of the requirements bulleted out in the content section of Happtique’s draft guidance appear to be more novel. Here are five content-related requirements that I found worth considering:

> “The app is based on one or more credible information sources such as an accepted protocol, published guidelines, evidence-based practice, peer-reviewed journal, etc.” (So, no certified apps will be making use of a new and innovative practice that leverages this new technology?)

> “The date/source of the app’s content is provided through an ‘About’ section (tab, button or equivalent).” (All certified apps will then need an “About” section or the equivalent? How many health apps have this kind of section today?)

> “For any app derived from a third-party source that does not contain the original source’s complete content, the app provides a link, reference, or other appropriate method to enable the user to locate the complete content.”

> “Information in any app that constitutes advertising is denoted by the message ‘This is an advertisement’ or equivalent.”

> “The content of an app that is intended primarily for use by laypersons is designed and written in a way that is readily understood by the target audience (e.g., appropriate use of technical terminology).” (This will be an interesting one to judge. Which words do laypersons not understand? Aren’t some laypersons more tech-savvy than others?)

Happtique is crowdsourcing feedback on its draft certification requirements over the course of the next month. Read the full certification requirements draft over at Happtique’s site here. (PDF)

  • http://www.ecardio.com/ Aly

    Hi Brian – I think regulating mobile health apps is a good thing. And it was really the only way the industry was going to go. I just hope the regulations will find a happy balance between protecting patients and promoting innovation. It’ll be interesting to see how the FDA regulations play out, as well as Happtique’s own certification guidelines. 

    Anyhow, thanks for sharing! – Aly

  • Wfuture

    The devil is in the details. As one who has worked in evaluation research projects and programs the criteria, transparency, methodology, baseline to assess health apps, and many many more points needs to be developed and accredited etc. Its noble cause but many landmines around the topic. Lawrence

  • MelvinR

    I think you misunderstood ‘technical’ wrt the last requirement.  it comes in the content section so relates to (medical) professional terms and jargon – not technology.

  • David Lee Scher, MD

    I appreciate you discussing Happtique’s draft standards, Brian.  I would like to address a few points if I may. 1. While I am no longer a practicing cardiac electrophysiologist, I have extensive experience in both the regulatory and reimbursement arenas of medicine as well, and continue to hold a faculty appointment as Clinical Associate Professor of Medicine at Penn State University College of Medicine.2. I am not clear on the point you are trying to make regarding the informational sources of the apps.  This is a critical component of the review as it goes directly to the credibility of claims made by the app or of the source of information it is based on.3.The date/source of the content is important because it refers to the timeliness of the app. As you state, not many apps have this today. However, that is no reason why they shouldn’t.  4.Users have a right to know, as in any publication, whether something is presented as fact or advertisement. In health and medicine,the differentiation is sometimes difficult and we think it is proper to present an easy way for users to know this. 5.The reference to layperson language is important. As a former human research subject committee chair for 18 years, this is a critical issue when reviewing information presented to patients and families. While the definition of layman’s terms can be defined (8th grade reading level), it will be the subject of multiple reviewers who must be unanimous in their determination. 6. The certification process is not mandatory (though there are good reasons why an app owner would want it certified: http://davidleescher.com/2012/07/13/five-reasons-why-medical-apps-will-want-to-undergo-certification/). Finally, the standards represent a fluid document, presently open to public comment, which might change over time with technology, regulatory and technical developments, and healthcare practice.