Article | March 12, 2024

Key Insights From The FDA's DHT Guidance

Source: Medable

By Cindy Howry, VP, eCOA Science


The FDA's latest guidance, issued on December 23, 2023, marks a significant step towards the integration of Digital Health Technologies (DHTs) into clinical trials. This guidance, encapsulated in the "Framework for the Use of DHTs in Clinical Trials," lays down a comprehensive road map for how technologies like wearable devices, implantable and ingestible sensors, environmental monitors, and mobile phone applications can be leveraged to enhance clinical research. The potential of DHTs to streamline data collection, improve participant engagement, and yield more accurate results is immense.

Here's a breakdown of the key areas covered in the FDA's guidance:

  • Considerations for DHT Selection
  • Design and operation of DHTs
  • Use of participant's own DHT and/or technologies
  • DHT submissions
  • Verification, Validation, and Usability
  • Evaluation of endpoints involving DHT data
  • Record protection and retention
  • Other considerations for sponsors and investigators

Access the full article below for a summary of each section contained above, as well as insights for sponsors and investigators when using these innovative tools.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Life Science Leader? Subscribe today.

Subscribe to Life Science Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Life Science Leader