The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more
The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health...more
The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more
On April 7, 2014, the Food and Drug Administration (FDA) released a report entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (the “Report”). The Report was mandated by...more
As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information...more