This 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is looking for public comments on its draft, which certainly seems a lot like the process the FDA used for its draft guidance on the regulation of some mobile medical apps as medical devices. The FDA's draft guidance document published last summer and the agency has yet to publish a final guidance document.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Those areas of the draft guidance appeared substantial and based on similar efforts previously undertaken by some of the groups listed above. Some of the requirements bulleted out in the content section of Happtique's draft guidance appear to be more novel.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)