Protecting Patient Safety and Promoting Health Care Innovation: An Oversight Framework for Health IT

This week, the House Energy and Commerce Subcommittees on Communications and Technology, Health, and Oversight and Investigations are holding a series of hearings focused on health information technology (IT), how innovation can benefit patients, and how regulation affects innovation.

Because the use of health IT has been shown to improve health and health care and has always had strong bipartisan support, members of Congress and leaders across two administrations have actively promoted its adoption. Building upon numerous bipartisan legislative proposals over the last decade, the Health Information Technology and Economic and Clinical Health (HITECH) Act of 2009 brought about new authorities, standards, and significant investments in health IT. As a result of federal, state, and private-sector action, the number of clinicians, hospitals, and other providers across the United States adopting health IT has significantly increased.

Clearly, health IT is an important and timely matter. Policy discussions are now underway to determine the types of oversight that should be applied to assure safety in its development and use. In addition to the hearings being held this week, the Department of Health and Human Services (HHS) is now developing policies to use health IT to make health care safer as well as continuously improve the safety of health IT. The Food and Drug Administration (FDA) Safety and Innovation Act of 2012, signed into law in July 2012 calls for the HHS Secretary to develop—within 18 months—a proposed strategy and recommendations for a risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication. On December 21, 2012, HHS released the Health IT Patient Safety Action and Surveillance Plan for Public Comment, which summarizes HHS’ proposed approach for addressing safety in health IT.

An oversight framework for patient safety and health IT requires national focus and public and private sector collaboration and leadership.

The Bipartisan Policy Center (BPC) has recently undertaken a five-month collaborative effort drawing upon the expertise and experiences of more than 100 leaders representing clinicians, consumers, health plans, hospitals, patient safety organizations, academic and research institutions, and software and technology companies, as well as experts in patient safety and health IT. As a result, we have developed a set of principles and recommendations for assuring patient safety in health IT, which we released through our report, An Oversight Framework for Assuring Patient Safety in Health Information Technology, on February 13, 2013.

Our report outlines a set of principles to guide the federal government’s development of an oversight framework for patient safety and health IT:

1. Any oversight framework for safety should recognize and support the important role that health IT plays in improving the quality, safety, and cost-effectiveness of care, as well as the patient’s experience of care.
2. Assuring patient safety, along with enabling positive patient outcomes, is a shared responsibility that must involve the entire health care system.
3. Any framework for patient safety in health IT should be risk-based, flexible, and not stifle innovation.
4. Existing safety and quality-related processes, systems, and standards should be leveraged for patient safety in health IT.
5. Reporting of patient safety events related to health IT is essential; a non-punitive environment should be established to encourage reporting, learning, and improvement.

The report also recognizes that clinical software should be subject to a new oversight framework–rather than traditional regulatory approaches applied to medical devices. Such an oversight framework should contain the following key components:

1. Agreement on recognized standards and guidelines for assuring patient safety in the development, implementation, and use of health IT.
2. Support for the implementation of standards and guidelines as well as development and dissemination of best practices through education, training, and technical assistance.
3. Developer, implementer, and user participation in patient safety activities, leveraging patient safety organizations, including reporting, analysis, and response.
4. Creation of a learning environment through the aggregation and analysis of data to identify and monitor trends, mitigate future risk, and facilitate learning and improvement.

Finally, the report lays out a series of recommendations to support the implementation of such an oversight framework.

Witnesses and Energy and Commerce Members on both sides of the aisle mentioned and made positive comments about the BPC Oversight Framework during today’s hearing.

As Congress and the Administration move forward in developing a risk-based, regulatory framework for health IT, they should take advantage of the knowledge compiled by this collaborative effort.

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Resources

BPC Report, An Oversight Framework for Assuring Patient Safety in Health Information Technology

Press Release: Bipartisan Policy Center Releases Bold Principles and Recommendations Promoting an Oversight Framework for Patient Safety and Health IT

Op-Ed Authored by Former Senate Majority Leaders and BPC Health Project Co-Leaders Tom Daschle and Bill Frist on Patient Safety and Health IT

March 20th House Energy and Commerce Subcommittee on Health Hearing: Health Information Technologies: How Innovation Benefits Patients