KKB Partner Suzan Onel will be speaking at the Food and Drug Law Institute’s Virtual Digital Health Technology and Regulation During COVID-19 and Beyond Conference on September 10, 2020. This virtual conference will focus on developments in digital health regulation pre-and post-COVID-19, including significant enforcement discretion policies and exemptions FDA has implemented over the past six months. We will discuss the implications of these policies on industry, and speakers will utilize examples to explore strategies for obtaining permanent clearance or approval for digital health products holding emergency use authorizations (EUAs) during COVID-19. Speakers will also discuss the current regulatory status of clinical decision support (CDS) software and its use during and after the COVID-19 pandemic, FDA’s regulation of artificial intelligence/machine learning (AI/ML) and an update on its use in health care, and lessons learned from digital health cybersecurity and privacy breaches.
More information on the conference can be found here.