Working to find actionable solutions to the nation's key challenges.

Through a collaborative six-month effort, the Bipartisan Policy Center conducted research and engaged more than 100 experts and stakeholders representing clinicians, consumers, health plans, hospitals, patient safety organizations, research institutions, and technology companies to develop a set of principles and recommendations for an oversight framework for health IT that protects patient safety, promotes innovation, is flexible enough to meet the needs of a rapidly changing health care system, and has the support of experts and stakeholders across every sector of health care.

The findings and recommendations of this collaborative effort are summarized in the BPC report, An Oversight Framework for Assuring Patient Safety in Health Information Technology.

This effort was in response to the Food and Drug Administration Safety Innovation Act (FDASIA) of 2012, which calls for the Secretary of Health and Human Services (HHS) to work with the Food and Drug Administration (FDA), the Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to post a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.

BPC also drafted formal public comments on a risk-based regulatory framework in response to FDASIA: Request for Comments on the Development of a Risk-Based Regulatory Framework and Strategy for Health IT, published by HHS on May 30, 2013.

Read the report l View the event l Read the press release l Review the support letter

In the News

The Hill: Framework for patient care through robust IT
Op-ed by BPC Health Project Co-Chairs Senators Tom Daschle and Bill Frist

Staff Analysis

Bipartisan Policy Center Calls for Congressional Action on Risk-Based Regulatory Framework for Health Information Technology
By Janet Marchibroda
October 9, 2014

Federal Government’s Proposed Risk-Based Regulatory Framework for Health IT: A Step in the Right Direction
By Janet Marchibroda and John Michael De Carlo
July 7, 2014

FDASIA Workgroup Key Themes: Innovation, Accountability and a Learning Environment, Align with BPC Oversight Framework
By Janet Marchibroda
August 22, 2013

Protecting Patient Safety and Promoting Health Care Innovation: An Oversight Framework for Health IT
By Janet Marchibroda
March 20, 2013

Key Documents

BPC Letter to FDA Assistant Commissioner for Policy Leslie Kux on the Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report
July 7, 2014

Input shared on the SOFTWARE Act in a collaborative letter from Health IT Now, HIMSS, and BPC
April 16, 2014

Bipartisan Policy Center Statement on the SOFTWARE Act of 2013
October 25, 2013

Bipartisan Policy Center Calls for Health IT Oversight Framework That Engages Health Care Stakeholders, Protects Patient Safety, Supports Learning, and Promotes Continuous Innovation
September 4, 2013

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
August 31, 2013