Foley April 3, 2023
On March 23, the U.S. Food and Drug Administration (FDA) published a framework to guide regulatory decision-making on the use of digital health technologies (DHT) in clinical drug trials.
DHTs include a wide array of technologies, including software applications that run on a phone, wearables, and environmental sensors, among others. As DHT becomes more sophisticated, the technologies have the potential to play an even larger role in health care, including clinical research.
The framework builds upon FDA’s draft guidance, DHT remote acquisition of clinical trial data (December 2022), and is a step toward fulfilling FDA’s commitment under the Prescription Drug User Fee Act VII (PDUFA VII) to clarify its stance on DHTs’ use in drug, device, and biologics product development....
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