United States of America: Consultation opened on draft FDA guidance on digital health technologies in clinical investigations

On 22 December 2021, the US Food and Drug Administration (FDA) published and opened a consultation on a draft guidance on the use of digital health technologies (DHTs), which are used to remotely acquire data about participants, in clinical trials. In providing guidance on how to select suitable DHTs for trials, the draft also sets out considerations related to cybersecurity, potential data sharing, and the requirement to provide subjects with an informed consent process about the collection and use of data for the study. The consultation will close on 23 March 2022.