Two doctors at Brigham and Women’s Hospital in Boston are advocating for the creation of a mobile health (mHealth) app review and certification organization for apps that don’t get regulated under official Food and Drug Administration (FDA) authority.
David Bates, M.D., chief quality officer at Brigham & Women’s and former Chair of the FDA’s Safety and Innovation Act (FDASIA) and Adam Landman, M.D., CMIO for Health Information Innovation and Integration and an emergency medicine physician at the hospital, wrote the article for a recent issue of The Journal of the American Medical Association (JAMA). They argue that a good percentage of the more than 40 000 health, fitness, and medical apps available would not be regulated under the FDA, as per the agency's guidance.
“Although the FDA has focused on safety, it has largely left the review and certification of apps to the marketplace,” the physicians write in the article, saying the market reviews have focused on “personal impressions,” rather than an “evidence-based, unbiased assessments of clinical performance and data security.”
They say an organization would be desirable because the apps are typically expensive and free, and users are unlikely to care as much about their investment as an expensive electronic health record (EHR) system. Thus, the user review, which is what KLAS does for EHRs, is not viable.
The organizations could begin by reviewing and assessing the most popular mHealth apps over a range of categories including safety, accuracy, and security. Safety could be determined through a certification process. They could also focus on the clinical effectiveness of these apps, the authors note.
“People are increasingly turning to their smartphones for assistance in improving their health, but are having difficulty determining which apps are the securest and most effective. We hope that our article will instigate action that will enable clinicians and patients to make more effective use of mHealth apps,” Powell, lead author of the article, said in a statement. “We foresee a potential future in which physicians will be able to confidently prescribe apps to their patient, and will have the tools that they need to interpret the resulting data. The establishment of an unbiased app certification and review process will play a key role in getting us there.”