Digital Health Technologies (DHTs) in Clinical Trials: Key Points from the FDA’S Important Draft Guidance

Date Published:
Whitepaper

Signant’s Bill Byrom discusses the FDA’s most recent guidelines regarding 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
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