Perspective On The FDA's Final Digital Health Technologies Guidance
By Christine Guo, Ph.D.
![GettyImages-638646884 medical team meeting GettyImages-638646884 medical team meeting](https://vertassets.blob.core.windows.net/image/ca141384/ca141384-7c41-4024-b2c9-d63e50a7abf7/375_250-gettyimages_638646884_medical_team_meeting.jpg)
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.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Clinical Tech Leader? Subscribe today.