Digital Health: Innovation Meets Regulation

11:00 AM - 12:15 PM, Thursday, June 11, 2020 ・ Track Pacific
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Wearables, apps, sensors and smart tech products hold vast potential to transform the way sponsors develop medicines and positively impact patients. The excitement about deploying these tools in medical product development is tempered, however, by the uncertainty in the regulatory environment.

This session will seek to explore broad regulatory questions such as: How should FDA regulate digital health medical products? Are the current regulatory frameworks for evaluation of medical products appropriate for digital health products? What do patients expect from digital tech in medicine?
Moderator
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Group Director, US Regulatory Policy
Genentech
Speaker
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Director, Division of Digital Health, Center for Devices and Radiological Health
FDA