Digital Health Monthly: FDA DHT Guidance

Digital Health Monthly: Scientific Webinar Series

Sensor-based DHTs are shedding an illuminating light on how people function in their real-world environments. Drug developers, researchers, patients, and regulators are realizing the multifaceted value sensor-based DHTs can bring to clinical research.

As their adoption continues to grow, the ActiGraph team is excited to continue ‘Digital Health Monthly’, a monthly series of science-focused webinars to share the latest high-impact developments in clinical research from innovators in the digital health field. Each month, we feature brief data-driven presentations from clinical researchers, data scientists, and biostatisticians on a focused topic with dedicated time for audience Q&A. We believe that together, we can move the digital health technology field forward faster, and we are excited for this opportunity to facilitate important discussions on the latest research with members of the digital health community.

Navigating the FDA DHT Guidance: Perspectives from Across the Industry

This Digital Health Monthly webinar focuses on the practical implications of FDA’s final guidance of the use of Digital Health Technology (DHT) for remote data acquisition in clinical investigations. This 1-hour session begins with an overview of key points from the guidance followed by a roundtable-like discussion with speakers from different industry stakeholder groups sharing perspectives on the impact of the recommendations in this guidance and implications for the future of DHT use in clinical trials.

Main Topics:

Summary of key points covered in the guidance
Background and intentions of the guidance from a regulatory perspective
Impact of the guidance for clinical trial sponsors who want to include DHTs in their study
Opportunities for DHTs to address healthcare gaps today and in the future