Digital Health Technologies (DHTs) in Clinical Trials: Key Points from the FDA’S Important Draft Guidance

Signant’s Bill Byrom discusses the FDA’s most recent guidelines regarding digital health technologies (DHTs), such as sensors and wearables as well as general computing platforms, when collecting health data from clinical trial patients.

Readers will learn:

• The FDA’s position on BYOD in the context of DHTs
• The evidence supporting the use of sensors & wearables
• Data integrity considerations in the context of minimizing missing data and device, firmware, or software update