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BPC's Formal Response to the Food and Drug Administration Safety and Innovation Act: Request for Comments on the Development of a Risk-Based Regulatory Framework and Strategy for Health Information Technology

This document includes the Bipartisan Policy Center’s (BPC’s) response to the FDASIA: Request for Comments on the Development of a Risk-Based Regulatory Framework and Strategy for Health Information Technology. BPC’s response is based on a report it developed and released on February 13, 2012, An Oversight Framework for Assuring Patient Safety in Health Information Technology.

Through a collaborative five-month effort, BPC conducted research and engaged more than 100 experts and stakeholders representing clinicians, consumers, health plans, hospitals and other providers, mobile technology companies, patient safety organizations, research institutions, and technology companies, holding more than 40 meetings, to develop a set of principles and recommendations for the key elements of an oversight framework for health information technology (IT), that are contained in the BPC report. A list of the organizations that contributed their time and expertise to this effort are summarized in the “Acknowledgements” section on page 34.

The principles and recommendations included in the report—and summarized below—call for a framework that protects patient safety, is risk-based, promotes innovation, is flexible, leverages existing quality and patient safety-related systems and processes, avoids regulatory duplication, and has the support of experts and stakeholders across every sector of health care.

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