FDA's Digital Health Technologies Framework Addresses Important Challenges

By Chad Landmon and Gabriella McIntyre

Government agencies are in a constant race to keep up with the ever-quickening pace of innovation, particularly with respect to medical technologies and especially as industry increasingly utilizes nascent AI-based tools.

In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.” This framework goes part of the way in satisfying the FDA’s commitments promised under the PDUFA VII and addresses a few important challenges associated with the use of DHTs in drug, device, and biologics product development. Here is what you need to know.