Digital Health Technologies Document Outlines Framework for FDA

FDA released the framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development on March 23, 2023. The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

The DHT program will:

• engage stakeholders and include workshops and demonstration projects
• establish internal processes to support DHT evaluation for use in drug development
• promote shared learning and consistency for DHT-based policy, procedure, and analytic tool development
• facilitate the publication of relevant guidance documents.

Further, DHTs can help conduct decentralized clinical trials, where data can be remotely recorded and analyzed directly from participants as a part of everyday tasks at places such as school, home, work, or outdoors. DHTs can also benefit with data collection from participants who are unable to report their experiences, like infants or cognitively impaired individuals. This kind of data collection can expand access to underrepresented and diverse patient populations and improve trial retention rates by improving convenience for trial participants and reducing caregiver burden.

Source: FDA