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Membership Applications Sought for FDA Safety Innovation Act Workgroup

ONC is now accepting applications for potential membership for the new FDASIA Workgroup of the HITPC until March 8, 2013

The Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup is 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 in order 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. FDASIA indicated that if a workgroup was formed, it should be geographically diverse and include representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant experience.

If you are interested in being considered for membership on the workgroup, please register at ONC’s Workgroup Application Database. The three agencies will be reviewing the applications received by March 8, 2013.

Anticipated Focus Areas:

Throughout the report's development, the three agencies expect to seek input from the HITPC through this workgroup on various topics associated with what constitutes a risk-based regulatory framework for health IT that can also promote innovation, protect patient safety and avoid regulatory duplication.

The FDASIA Workgroup is expected to build 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 will seek input on issues relevant to the report, which include:

  • 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.

All FDASIA Workgroup meetings and documents discussed at such meetings will be publicly available and will offer opportunities for public comments.

Background:

Section 618 of the 2012 FDASIA charges the Secretary of Health and Human Services (the Secretary) acting through the Commissioner of the Food and Drug Administration (i.e., FDA), in consultation with the National Coordinator for Health Information Technology (i.e., ONC) and the Chairman of the Federal Communications Commission (i.e., FCC) to publish a report by January 2014 that expresses "a proposed strategy and recommendations 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."

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