Current and Future Regulatory Environment for Digital Health

4:00 PM - 5:00 PM, Monday, June 3,2019 ・ 118A, Level 100
Digital health technologies are increasingly being used for drug discovery, development, evidence generation (RWE/RWD), monitoring adherence, and to increase product quality. As a result there is a need for a clear regulatory framework to enable use of digital health technologies for new innovative products. Recently, the FDA has taken on initiatives such as the Digital Health Software Precertification program and the Framework for Prescription–Use Related Software to provide regulatory clarity, share the FDA’s thinking, and provide a mechanism to explore and evaluate possible models for regulatory review of these technologies moving forward. This session will bring together FDA and Industry to provide an overview of recent regulatory advances within the digital health technologies space as well as existing barriers for the use of digital health technologies and potential solutions.
Speakers
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Associate Director for Clinical Methodology, Office of Medical Policy
Center for Drug Evaluation and Research (CDER), FDA
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Head of US Regulatory Policy
Roche Diagnostics
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Member of the Firm
Epstein, Becker, Green