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Cynthia Suarez is an associate in the Corporate Practice Group in the firm's New York office and a member of the Healthcare Team.

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On December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from participants in clinical investigations. DHTs (such as wearables and sensors) are playing a growing role in clinical research, accelerated by the need for decentralized clinical trials and remote patient monitoring during the COVID-19 pandemic. Though largely directed to study sponsors using DHTs, the guidance raises issues that developers and manufacturers of these technologies will want to be mindful of given the ways in which their products might be used in a broader clinical use case than originally anticipated. Comments on the draft guidance are due March 23, 2022. The full text of the guidance can be accessed here.
Continue Reading FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations

About

Cynthia Suarez is an associate in the Corporate Practice Group in the firm's New York office and a member of the Healthcare Team.

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