2023 Digital Health Conference Agenda Why AttendPreliminary Agenda Location & CLEAgenda Subject to Change All Times Listed in Eastern Time Wednesday, January 31 10:30–11:15 AM | FDLI Welcome, Introductions, and Keynote Address Christine Simmon, President & CEO, Food and Drug Law Institute Sonja Fulmer, Deputy Director, Digital Health Center of Excellence, FDA 11:30 AM–12:30 PM | Navigating Laws and Regulations Globally in the Artificial Intelligence and Machine Learning Era12:45–1:45 PM | More than Medical Devices: Development and Use of Companion Apps for Pharmaceutical Products and Beyond1:45–2:30 PM | Break 2:30–3:30 PM | Securing the Future: Cybersecurity in Medical Devices 3:45–4:30 PM | Safeguarding Data and Privacy in Digital HealthThursday, February 1 11:00 AM–12:00 PM | FDLI Welcome, Panel Discussion: The New Era of Clinical Decision Support Software (CDS): Risks and Unknowns FDLI Welcome Bianca Cardona Melendez, Assistant Director, Educational Programs, FDLI Panel Discussion: The New Era of Clinical Decision Support Software (CDS): Risks and Unknowns 12:15–1:15 PM | Exploring the Regulatory Terrain of Decentralized Clinical Trials1:15–2:00 PM | Break 2:00–3:00 PM | Enforcement and Litigation Trends: Hot Topics3:15–4:00 PM | Evolving Expectations for Proposed Rules on Laboratory Developed Tests (LDTs): How LDTs and Software Interact4:00 PM | Closing Remarks and Adjournment Hannah Brown2023-09-22T14:53:14-04:00