2019 BIO International Convention: Current and Future Regulatory Environment for Digital Health
Pennsylvania Convention Center
1101 Arch St.
Philadelphia, PA 19107
Bradley Merrill Thompson, Member of the Firm, will present "Current and Future Regulatory Environment for Digital Health" at the 2019 BIO International Convention, which runs from June 3 to 6.
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.
For more information, visit BIO2019.com.