U.S. Food and Drug Administration Precertification pilot program for digital health software: weighing the benefits and risks.
Approach to Improving Safety
Innovation is a valuable process in health care. However, when innovations are rapidly deployed, efforts to proactively identify and address safety concerns may fall short and lead to unintended consequences. This commentary describes a new program to expedite the review of digital health software and summarizes the benefits and potential harms that could result from the program.