Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations?utm_medium=email&utm_source=govdelivery This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient. https://www.fda.gov/media/180193/download?attachment=&utm_medium=email&utm_source=govdelivery