Devices

Digital Health Technologies Capture Real-Time Info: Column

FDA Digital Health Center of Excellence director Rick Abramson says that digital health technologies (DHTs), especially those enabled by artificial intelligence, can continuously capture information about a person’s health in real time and in the context of their everyday life. Writing in an FDA Voices column, Abramson says DHTs also enable earlier detection of treatment effects or safety signals and may facilitate decentralized clinical trials.

Given the potential of DHTs, he writes, the agency’s medical product centers have published a white paper highlighting key considerations drawn from existing guidances for the development and use of digitally derived measures (DDMs) as outcomes in clinical investigations.

He says DDMs are measures derived from data collected using DHTs. “Depending on the intended use,” he says, “they may serve as clinical outcome assessments, biomarkers, or components of composite endpoints derived from multimodal data. Their potential is significant.”

Abramson writes that one of the white paper’s central messages is that the development of a DDM should not begin with the sensor, algorithm, or device. Rather, he says, it is helpful to begin with the meaningful aspect of health that researchers seek to understand. From there, developers should clearly define the concept of interest, the target population, and the intended context of use.

He concludes that the next challenge is not just technological, but scientific. “We need,” he says, “to determine how to translate these capabilities into measures that are trustworthy, interpretable, meaningful, and appropriate for the decisions they are intended to support.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome