FDA issues policy recommendations on telehealth to combat coronavirus

The US Food and Drug Administration (FDA) issued policy recommendations to expand the availability and capability of non-invasive remote patient monitoring devices and softwares, which is only effective during the public health emergency of the coronavirus outbreak declared by the Department of Health and Human Services (HHS). Highlighting that network-connected non-invasive patient monitoring technology will help reduce unnecessary patient contact and ease the burden on healthcare systems, the FDA allows manufacturers to make modifications to the indications, claims, functionality, or hardware or software of FDA approved patient monitoring devices without prior submission of a pre-market notification. The FDA intends to foster the enhanced availability of safe and effective medical devices while strengthening flexibility regarding modifications made to remote monitoring systems to respond to the coronavirus public health crisis.