Unpacking New FDA Draft Guidance on Digital Health

Insights from THREAD to Help Understand and Navigate the FDA’s Latest Recommendations Around Digital Health Technologies and Remote Data Collection in Clinical Trials

Following the explosion in demand for decentralized clinical trial (DCT) approaches caused, at least in part, by the COVID-19 pandemic keeping people away from healthcare facilities, the U.S, Food and Drug Administration has issued new guidance around the use of digital health technology in research.  

In THREAD’s latest white paper, we walk you through the FDA’s guidance covering: 

• The selection of Digital Health Technologies 
• Verification and Validation of Digital Health Technologies 
• The Use of Digital Health Technologies to Collect Trial Endpoints 
• Risk Considerations for the Use of Digital Health Technologies, Along with Informed Consent 
• Record Protection and Retention 
• Training 

In this paper, THREAD offers insights to help sponsors understand the new guidance while providing insights for implementing compliant new processes.