Clinical studies sponsored by digital health companies participating in the FDA’s Precertification Pilot Program: A cross-sectional analysis

1, 2, 3, 4, 5

1Yale School of Medicine, New Haven, CT, USA

2Section of Cardiology, San Francisco Veterans Affairs Health Care System, Department of Medicine, School of Medicine, University of California, San Francisco, San Francisco, CA, USA

3Division of Health Care Delivery Research, Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA

4Section of General Internal Medicine and National Clinician Scholars Program, Center for Outcomes Research & Evaluation, Department of Health Policy and Management, Yale-New Haven Hospital, Yale School of Public Health, Yale School of Medicine, Yale University, New Haven, CT, USA

5Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA


Corresponding Author:

Joseph S Ross, Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, PO Box 208093, New Haven, CT 06520-8093, USA. Email:

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