Stakeholders debate best approach for mHealth app assessment, certification

The issue of mobile medical app review and certification is spurring a healthy professional debate between physicians and highlighting pros and cons in how best to tap such tools while ensuring patient safety and data security.

The discussion kicked off in late March with a paper written by Adam C. Powell, Ph.D., president of Payer+Provider Syndicate, and Adam B. Landman and David W. Bates, both of Harvard Medical School, Brigham and Women's Hospital and Partners Information Systems. In the paper, published in Journal of the American Medical Association (JAMA), the authors opined that mHealth apps require an unbiased review and certification process.

That paper sparked a response from Steven R. Chan, M.D., and Satish Misra, M.D., who believe that certification is not a scalable strategy given the tens of thousand of apps available, and a better approach would be empowering end users to become app literate. That strategy, the physicians wrote in a response published in JAMA on Sept. 17, "is a quicker and more viable large scale solution."

But Powell, Landman and Bates don't agree and in a response to Chan and Misra, stated it would be problematic to require patients and clinicians to "fend for themselves" when evaluating apps.

The debate comes as industry groups and lawmakers are also discussing potential mHealth regulations and oversight. Last week, two congressmen wrote to the U.S. Department of Health and Human Services, requesting that the agency develop "clear, easily accessible and up to date regulatory guidance", as well as help update online technical compliance guidance to help developers adhere to the Health Insurance Portability and Accountability Act. The lawmakers' effort was at the request of ACT-The App Association, which wants to drive change in the regulatory environment regarding mHealth app development.

In the end, the mHealth app assessment, review and regulatory realm could very well wind up a multi-pronged strategy, Landman told FierceMobileHealthcare in an email interview, as different sorts of mHealth apps may lend themselves to different styles of review.

"Just as medical evidence is developed by a combination of academic journals, professional societies, and for-profit organizations, it is quite possible that evidence of apps will be developed by a variety of stakeholders as well," Landman said. "Multiple stakeholders may be considered in the review process, including the patient, the clinician, and society at large. It is unclear that consumers could ever truly review all apps on their own due to the clinical knowledge sometimes required.

For more information:
- read Chan and Misra's post in JAMA
- read the counterpoint response by Powell, Landman and Bates

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