The US FDA is seeking public feedback on advancing the use of digital health technologies in drug trials, according to reporting on an agency request that frames new guidance needs across CBER and CDER. The effort is intended to help sponsors use DHTs more effectively while addressing regulatory expectations for safety, data quality, and oversight. The initiative arrives as DHT adoption accelerates across endpoints, remote monitoring, and real-world measurement workflows, raising questions about standardized validation and interoperability across systems. For biotech, the consultation is a signal that regulators are actively revisiting the evidence framework for DHT-derived data in clinical programs. Sponsors relying on eCOA, wearables, or other digital measures may need to align study designs to the anticipated guidance. Overall, the FDA’s move suggests near-term changes in how trials incorporate patient-facing technology without losing rigor.