Advancing digital health: FDA innovation during COVID-19

Abstract

Digital health products have played an important role in the COVID-19 response, from supporting the remote monitoring of patients to enabling continuity in data collection for clinical trials. The U.S. Food and Drug Administration (FDA) has issued a number of temporary policies to support digital health innovation during the pandemic, such as guidance documents to expand the use of digital therapeutics for psychiatric disorders and medical devices for remote patient monitoring. In this article, we contextualize these policies to the agency’s existing regulatory framework for digital health, outline key considerations for patients and health care providers, and identify implications for the future of digital health innovation.