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.”
In their commentary, Lee and Kesselheim assess the benefits and risk of the Pre-Cert program and the debates on regulating health-related software as a medical device.
Apple, Samsung, Verily, Johnson & Johnson, Roche, Fitbit, Pear Therapeutics, Phosphorus and Tidepool were chosen to participate in the Pre-Cert pilot program. The nine companies were required to share quality management information with the FDA, collect and report postmarket data and allow visitation from the FDA, according to the authors.
Lee and Kesselheim note that instead of medical devices, Pre-Cert focused on free-standing software, mainly apps designed to diagnose or treat disease.
There is concern that developers may not be appropriately incentivized under the Pre-Cert program to review software products regarding safety and efficacy before patients access them, according to Lee and Kesselheim. Many patients and physicians may believe that marketed products have been rigorously evaluated; therefore, the program may also cause confusion, they wrote.
Regulatory flexibility is necessary because the apps could be frequently updated, they wrote.
“Given limited resources, the FDA cannot review every health app undergoing constant iterations,” Lee and Kesselheim concluded. “However, for medical software devices that purport to diagnose or treat disease, adequate study of safety and effectiveness is needed at some point in their lifecycle regardless of developers’ internal quality processes. Without that, the Pre-Cert approach will ascribe FDA validation to more new products that have not established actual clinical benefits.” – by Alaina Tedesco
Lee reports consulting for Bain & Company. Kesselheim reports receiving grants from Laura and John Arnold Foundation, Harvard Program in Therapeutic Science and Engelberg Foundation.