Commissioner Scott Gottlieb of the U.S. Food and Drug Administration (“FDA”) stole the spotlight this past month when he delivered a speech discussing big promises from the agency regarding artificial intelligence (“AI”) in healthcare. “One of the most promising digital health tools is artificial intelligence, particularly efforts that use machine learning,” said Gottlieb when explaining

The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) recently issued its Medical Device Safety Action Plan:  Protecting Patients, Promoting Public Health (Action Plan), an aspirational set of goals concerning the agency’s approach to medical device safety.  This Action Plan can be considered the FDA’s attempt to reorganize its toolbox

On February 28, Ethan Davis, the U.S. Department of Justice’s (DOJ) deputy assistant attorney general responsible for consumer protection, gave a speech discussing the Department’s plans for enforcement of laws governing the marketing of medical products. Mr. Davis highlighted recent DOJ enforcement actions and previewed how the Department intends to approach the issue in the