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How Regulators are Setting Standards for Digital Health Technologies

Expert Insights from ADDS Atlanta 2026

ADDS 2026 - Regulatory Session Panel

Regulatory standards are quickly adapting to keep pace with digital health technologies and clinical research innovation. In this featured session from the ADDS 2026 conference, leading regulatory authorities from the U.S. Food and Drug Administration (FDA), alongside industry leaders, share data-backed insights on developing digital health technology (DHT) and pre-competitive consortia intelligence towards clinical research adoption.  

Across four featured presentations, selected oral abstracts, and an regulatory panel discussion, these exclusive on-demand presentations highlight new opportunities and collaborative pathways to build regulatory-ready solutions.

Register to watch the Featured Presentations and Panel Discussion and hear how industry leaders are applying official guidance, generating rigorous evidence, and using pre-competitive strategies for real-world clinical trial assessments.

Regulatory Session Featured Presentations

Michelle Campbell

Advancing Regulatory Science for Clinical Outcome Assessments: Applying Guidance to Develop Novel Digital Endpoints


Michelle Campbell, PhDMichelle Campbell, PhD
U.S. Food and Drug Administration (FDA)

Sylvain Zorman

Regulatory Engagements as a Pre-Competitive Consortium: DECODE Perspective



Sylvain Zorman, PhD

Sylvain Zorman, PhD
Ametris

Jeremiah Trudeau

Why DECODE-Obesity: Qualitative Evidence Supports Sensor-based Outcomes for Physical Function



Jay Trudeau, PhD

Jay Trudeau, PhD
Eli Lilly & Company

Collin Hovinga

Finding Needles in a Haystack: Where we are with a Regulatory-Endorsed Digital Endpoint for ALS



Collin HovingaCollin Hovinga
Critical Path Institute (C-Path)

AI Session Panel Discussion

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Watch the full session to hear how industry leaders are turning AI-driven insights into scalable, regulatory-ready solutions for modern clinical research and development.

Register to Watch Regulatory Session Videos