Module 8 - Part 4: Proposed Frameworks for Digital Health

Dr. Sakshi Sardar discusses some of the frameworks that are currently being utilized for working with digital health technologies. The first one will be the V3 framework, which represents Verification, Analytical Validation, and Clinical Validation.
This module is part of the educational series “Model-Informed Drug Development (MIDD): Methods Advancing Medical Products to Patients”. The educational content was developed for regulatory scientists by experts in the field in partnership with the Critical Path Institute and funded by FDA CDER Office of Translational Sciences. As part of Multidisciplinary Education and Exchange initiatives, CDER’s Quantitative Medicine Center of Excellence is making this resource accessible to all, supporting community-wide educational enrichment.
Disclaimer: The presentations in this educational series reflect the views of the presenters and should not be construed to represent FDA’s views or policies.