Technology & Data U.S. Food and Drug Administration · December 22, 2023 · National (U.S.)
FDA finalizes guidance on digital health technologies for remote data acquisition in clinical trials (external link to U.S. Food and Drug Administration)
FDA's final guidance "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations" covers using DHTs — wearables, sensors, apps, and other connected tools — to collect trial data from participants remotely. It addresses selecting technologies that are fit-for-purpose, verification and validation, participants' own devices versus sponsor-provisioned ones, defining endpoints from DHT-derived data, and where source data resides when measurements flow from a device into a durable electronic repository, along with expectations for managing transmission, storage, and access.
Why it matters
Remote acquisition moves data management upstream: fitness-for-purpose, provenance, and transmission integrity get decided before first patient in, not fixed during cleaning. The guidance gives data managers standing to join DHT selection early, and its treatment of source data and durable repositories is exactly the kind of detail that should shape the data management plan for any study using sensors or bring-your-own-device designs.
Federal agency final guidance · Topics: digital health technologies, wearables and sensors, source data, decentralized trials · Checked September 1, 2026 · Read the original at U.S. Food and Drug Administration (external link)