Perspective On The FDA's Final Digital Health Technologies Guidance

By Christine Guo, Ph.D.

The landscape of clinical research and healthcare is significantly shaped by regulatory guidance, and last month marked a milestone with the release of the FDA guidance titled "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations." This culmination follows a decade of exploration with wearable sensors in industry research and decades of application in academic research.

For the benefit of clinical researchers, we have crafted a practical guide that dissects the FDA's final guidance on the use of Digital Health Technologies (DHT) in clinical investigations. The guide not only provides insights but also offers a checklist to assist study teams in navigating considerations when determining the appropriateness of a sensor-based DHT and evaluating clinical endpoints derived from DHT data.