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

Members

  • David W. Bates
    Brigham and Women's Hospital
  • Patricia F. Brennan
    University of Wisconsin-Madison
  • Geoff Clapp
    Better
  • Todd Cooper
    Center for Medical Interoperability
  • Meghan Dierks
    Harvard Medical Faculty, Division of Clinical Informatics
  • Esther Dyson
    EDventure Holdings
  • Richard Eaton
    Medical Imaging & Technology Alliance
  • Anura Fernando
    Underwriters Laboratories
  • Lauren Fifield
    Practice Fusion, Inc.
  • Michael Flis
    Roche Diagnostics
  • Elisabeth George
    Philips Healthcare
  • Julian Goldman
    Massachusetts General Hospital/ Partners Healthcare
  • T. Drew Hickerson
    Happtique, Inc.
  • Jeffrey Jacques
    Aetna
  • Robert Jarrin
    Qualcomm Incorporated
  • Keith Larsen
    Intermountain Health
  • Mary Anne Leach
    Children’s Hospital Colorado
  • Meg Marshall
    Cerner Corporation
  • Mary Mastenbrook
    Consumer
  • Jackie McCarthy
    CTIA - The Wireless Association
  • Anna McCollister-Slipp
    Galileo Analytics
  • Jonathan Potter
    Application Developers Alliance
  • Jared Quoyeser
    Intel Corporation
  • Martin Sepulveda
    IBM
  • Joseph Smith
    West Health
  • Michael Swiernik
    MobileHealthRx, Inc.
  • Paul Tang
    IBM Watson Health
  • Bradley Thompson
    Epstein Becker Green, P.C
  • Bakul Patel
    Food and Drug Administration
  • Matthew Quinn
    FCC
  • Content last reviewed on June 17, 2015
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