The Association of Clinical Research Professionals

Digital Health: A Clinical & Regulatory Update

Software as a Medical Device (SaMD) is performing a larger and more impactful role in patient care than ever before, and new technologies present new regulatory and development challenges. This presentation explores Digital Health technologies and the challenges and opportunities they present to industry, health care providers, and global regulators. After a brief review of the regulatory approaches used for Digital Health technologies across multiple international venues, the US FDA’s Digital Health Precertification Program will be explored. The underlying principles, philosophy and challenges to digital health tech development will be presented, the real and potential “value” of SaMD will be defined, and implications for research and regulatory professionals will be discussed.


This program is a recorded session from ACRP 2019