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. Learning Objectives:
Identify at least 3 different types of digital technologies that are being developed today and their potential impact on patient health and healthcare.
Discuss how the “value” of a digital technology is assessed.
Describe FDA PreCert regulatory framework for the development and approval of digital health technologies.
MSN, CPNP, RAC, CCRA,
WW Vice President, Clinical & Medical Strategic Operations ,
Johnson & Johnson Medical Devices
Credits: None available.
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