With all the work underway on the Food and Drug Administration’s (FDA’s) Digital Health Software Precertification (Pre-Cert) Program and the broader agency agenda on digital health regulation, this session will focus on learning more about this program and directionally where FDA is headed. Industry leaders will provide their perspective on the program and describe the goals and objectives behind Pre-Cert, followed by a discussion on the impact of the program on health IT regulations and broader healthcare initiatives.