Telemedicine: Understanding the FDA’s role in recent regulatory and enforcement actionsAugust 28, 2019 Download PDF
Interest in and use of telemedicine services appears to be dramatically increasing.
According to researchers, telehealth visits by members of one private US health plan rose
by 52% annually from 2005 to 2014, and soared by 261% from 2015 to 2017. As more
people seek to use telemedicine services, there has been an increased focus on what
constitutes the appropriate use of these services. In addition, increased utilization has also
increased the potential risk for fraud and abuse. In 2017, the Department of Health and
Human Services Office of Inspector General (OIG) added Medicaid telehealth payment
audits to its Work Plan.
Many discussions of the risks related to telemedicine focus on state-regulated practice of
medicine issues and healthcare fraud and abuse concerns that typically fall under the
purview of the Centers for Medicare & Medicaid Services (CMS); however, recent regulatory
and enforcement actions have also been undertaken by the U.S. Food and Drug
Administration (FDA or the Agency). This article will provide an overview of the FDA’s
enforcement authority and discuss two examples of how the Agency has recently exercised
that authority over telemedicine-related activities. This article will not discuss the FDA’s
authority to regulate products used to provide digital health services (e.g., clinical decision
support software, mobile medical apps).