Articles and Blogs

A pair of final rules were published May 1, 2020, by HHS. The first rule issued by the Office of the National Coordinator for Health IT (“ONC”) relates to the 21st Century Cures Act information blocking provisions and the ONC Health IT certification program (“Info Blocking Regulations”). The second rule issued by CMS relates... READ MORE

On September 6, 2017, the U.S. Food and Drug Administration (“FDA”) published final guidance (“Guidance”) summarizing its recommendations for medical devices that are connected to each other and to other technology (“interoperable medical devices”). The Guidance finalizes preliminary guidance from January 2016 and is intended to encourage rapid innovation in the marketplace by allowing... READ MORE