FDASIA

The Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup was charged with providing expert input on issues and concepts identified by the Food and Drug Administration (FDA), Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to inform the development of a report on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication.

The FDASIA Workgroup built on prior work such as the Institute of Medicine (IOM) report, Health IT and Patient Safety: Building Safer Systems for Better Care and ONC's Health IT Patient Safety Action and Surveillance Plan; FDA's mobile medical applications guidance and Medical Device Data Systems Rule; FCC's National Broadband plan and other relevant work. Specifically the three agencies sought input on issues relevant to the report, which included:

  • Types of risk that may be posed by health IT that impact patient safety, the likelihood that these risks will be realized, and the impact of these considerations on a risk-based approach;
  • Factors or approaches that could be included in a risk-based regulatory approach for health IT to promote innovation and protect patient safety; and
  • Approaches to avoid duplicative or overlapping regulatory requirements.

Member List

Content last reviewed on June 17, 2015
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