The FDASIA Health IT Report


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.

The 32-page Report is open to public comment until July 7, 2014 via a public docket (FDA-2014-N-0339). Comments may be submitted through The agencies seek public comments on whether the Report addresses the appropriate focus areas, and whether the proposed next steps are appropriate. The Report itself also poses questions for the public throughout, seeking input on specific recommendations. Additionally, on May 13-15 FDA will hold a public workshop to discuss the following topics raised in the Report: use of quality management principles, standards and best practices, conformity assessment tools, creating an environment of learning and continual improvement, and clinical decision support (CDS) software.

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