The Health Law Ticker

In response to the outbreak of COVID-19, we are closely monitoring guidance issued by local, state and federal authorities, as well as information distributed by the Centers for Disease Control and Prevention and the World Health Organization. We are dedicated to helping clients address business disruptions, anticipate potential challenges and mitigate risk associated with irregular operations. We are available to assist in a number of core areas that may impact public agencies and businesses in this rapidly changing environment. Please visit our COVID-19 Response Team page ...

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify its regulatory stance on digital health tools, the agency released a revised guidance in 2019 entitled, Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (the “Guidance”) ...