• FDA Finalizes the FDASIA Health IT Report
  • April 28, 2014 | Author: Igor Gorlach
  • Law Firms: Foley Hoag LLP - Washington Office ; Foley Hoag LLP - Boston Office
  • 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 section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which required the FDA consult with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC). These three agencies were tasked to work together to prepare a report containing “a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT [information technology], including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.” The Report emerged in substantial part from meetings of the FDASIA workgroup.