Lexology February 18, 2022
Spurred by the realities of the COVID-19 pandemic, FDA has taken a number of regulatory actions to advance the use of digital health technologies (“DHTs”) in clinical trials. DHTs provide sponsors with opportunities to capture a broader array of information from study subjects than is typically available through traditional study designs. This includes information from activities at home, work, school, outdoors, and while sleeping. DHTs also enable the collection of data from a broader population, such as from those typically unable to report on their own experiences (e.g., infants and persons with cognitive impairments) or unable to travel to a study location. At the same time, DHTs also present unique challenges. For example, how do sponsors validate and verify data...
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