The FDA’s thinking on Digital Health Technologies (DHT) continues to evolve. They released the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development in March.

This publication, a PDUFA VII commitment, will “guide activities such as

(1) defining objectives for workshops and demonstration projects,

(2) developing methodologies for evaluating DHTs proposed as measuring key (primary or important secondary) endpoints or other important measures ( e.g., for safety monitoring or baseline characterization) in clinical trials,

(3) managing submissions with extensive and continuous data ( e.g., in order to develop acceptable approaches to capture adverse events), and

(4) developing a standardized process for data management and analysis of large datasets from DHTs.”

It includes valuable summaries of the available guidance and information on the subject.

Download a copy and submit your comments here.