Digital Health Technology and Regulation Conference

February 26–27, 2025 | Virtual Event

February 26–27, 2025 | Virtual Event

Preliminary Agenda

Agenda Subject to Change
All Times Listed are Eastern Time

Wednesday, February 26

10:00–10:50 AM | FDLI Welcome & Fireside Chat

FDLI Welcome
Christine M. Simmon, President and CEO, FDLI

Fireside Chat: FDA, FTC, and DOJ Digital Health Leadership
Troy Tazbaz, Director, Digital Health Center of Excellence, CDRH, FDA
Moderated by Marian J. Lee, Chief Counsel, FDA & Regulatory, McKesson Corporation

11:00 AM–12:00 PM | The Next-Gen Regulatory Arena

12:10–1:10 PM | LDTs: Companion and Complementary Diagnostics to Clinical Decision Support Software

Son Nguyen, Special Counsel, Cooley LLP

1:10–2:10 PM | Lunch Break

2:10–3:10 PM | An Automated Future Handmade by Human Intelligence

3:20–4:20 PM | AI Market Readiness

Thursday, February 27

10:00 AM–11:00 AM | FDLI Welcome and Striving for a Globally Integrated Digital Health Approach

FDLI Welcome
Lauren-Caroline Tadros Potter, Assistant Director, Educational Programs, FDLI

Striving for a Globally Integrated Digital Health Approach
Hester Borgers, Senior Associate, Bird & Bird

11:10 AM–12:10 PM | Patient-Driven Cybersecurity Measures

12:10–1:10 PM | Lunch Break

1:10–2:10 PM | Predetermined Change Control Plan Guidance: A Pipeline Towards What?

2:20–3:20 PM | Bytes to Rights: First Amendment and Regulation of Output from Prescription Drug Use-Related Software Guidance

3:30–4:30 PM | Exercising AdPromo Enforcement Discretion: Recent Actions and Priorities in the New Administration

Moderated by Sonia W. Nath, Partner, Cooley LLP

4:30 PM | Closing Remarks and Adjournment