Experts express concerns about FDA precertification program for health apps

In a new commentary published in Annals of Internal Medicine, experts suggest that the FDA’s Digital Health Software Precertification Program may lead to less rigorous FDA oversight and studies of safety and effectiveness of marketed digital health apps, with uncertain patient outcomes.

“The [FDA’s] Digital Health Software Precertification (Pre-Cert) Program is designed to expedite regulatory review for companies that demonstrate quality and organizational excellence in software development,” Theodore T. Lee, BA, from Yale University, and Aaron S. Kesselheim, MD, JD, MPH, from Brigham and Women’s Hospital and Harvard Medical School, wrote. “Although Pre-Cert is intended to promote the worthy goals of access and innovation in digital health, many questions have been raised.”