Date:  Nov. 8, 2011




To Improve Patient Safety, Health Information Technology Needs Better Oversight, Accountability


WASHINGTON — To protect Americans from potential medical errors associated with the use of information technology in patient care, a new report by the Institute of Medicine calls for greater oversight by the public and private sectors.  The report examines a broad range of health information technologies, including electronic health records, secure patient portals, and health information exchanges, but not software for medical devices. 


The secretary of the U.S. Department of Health and Human Services should publish a plan within 12 months to minimize patient safety risks associated with health IT and report annually on the progress being made, the report says.  The plan should include a schedule for working with the private sector to assess the impact of health IT on patient safety.  However, if the secretary determines that progress toward improving safety is insufficient within a year, the U.S. Food and Drug Administration should exercise its authority to regulate these technologies.  Concurrently, FDA should begin planning the framework needed for potential regulation so that the agency is ready to act if necessary.


"Just as the potential benefits of health IT are great, so are the possible harms to patient safety if these technologies are not being properly designed and used," said Gail L. Warden, president emeritus of Henry Ford Health System and chair of the committee that wrote the report.  "To protect patients, industry and government have a shared responsibility to ensure greater transparency, accountability, and reporting of health IT-related medical errors."   


The federal government is investing billions of dollars to encourage hospitals and health care providers to adopt health IT so that all Americans can benefit from the use of electronic health records by 2014, but demonstrated improvements in care and safety are not yet established, the report says.  Some of these technologies have significantly improved the quality of health care and reduced medical errors.  However, concerns about potential harm are emerging as health care providers increasingly rely on health IT to deliver care. 


Little published evidence exists that quantifies the magnitude of the risk associated with health IT problems, partly because many technology vendors discourage the free exchange of safety-related information in their contracts with health care providers.  But serious errors involving these technologies -- including medication dosing errors, failure to detect fatal illnesses, and treatment delays due to poor human-computer interactions or loss of data -- have led to several reported patient deaths and injuries.



HHS should establish a mechanism for both technology vendors and users to report health IT-related deaths, injuries, or unsafe conditions, the report says.  Reporting events related to patient safety should be mandatory for vendors and voluntary, confidential, and nonpunitive for care providers.  In addition, Congress should establish an independent federal entity to investigate patient deaths, injuries, or potential unsafe conditions associated with health IT.  Based on those investigations, the entity could make nonbinding recommendations, allowing flexibility for HHS, health care organizations, vendors, and other experts to determine the best course forward. 


A new Health IT Safety Council should be funded by HHS to evaluate criteria and develop methods for assessing and monitoring safety and measuring impacts of health IT on safety, the report says.  The agency should also ensure that health IT vendors support the free exchange of information and not discourage health care providers from sharing patient safety concerns, including screen shots.  Nondisclosure agreements in contracts between vendors and health care providers and "hold harmless" clauses that shift the liability of unsafe health IT features to care providers greatly discourage information sharing.  


HHS should establish quality management principles and risk management processes in designing and implementing health IT products, which can be complex and difficult for doctors and nurses to use.  Alerts in technology systems should be designed to have lower false-alarm rates and computer interfaces need to be more intuitive for users.


The study was sponsored by the U.S. Department of Health and Human Services.  Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.  The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies.  For more information, visit  A committee roster follows.




Molly Galvin, Senior Media Relations Officer

Luwam Yeibio, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail


Additional resources:

Project Website


Pre-publication copies of Health IT and Patient Safety: Building Safer Systems for Better Care are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at  Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

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Board on Health Care Services


Committee on Patient Safety and Health Information Technology

Gail L. Warden 1 (chair)

President Emeritus

Henry Ford Health System



James P. Bagian 2


Center for Health Engineering and Patient Safety, and

Chief Patient Safety and Systems Innovation Officer

Department of Industrial and Operations Engineering

University of Michigan

Ann Arbor


Richard Baron (until March 2011)

Professor and CEO

Greenhouse Internists



David W. Bates 1


General Medicine Division

Brigham and Women’s Hospital



Dedra Cantrell

Chief Information Officer

Emory Healthcare Inc.



David C. Classen

Associate Professor of Medicine,

Senior Vice President, and Chief Medical Officer

School of Medicine

University of Utah

Salt Lake City


Richard I. Cook

Associate Professor of Anesthesia and Critical Care

University of Chicago



Don E. Detmer

Medical Director

Division of Advocacy and Health Policy

American College of Surgeons, and

Professor Emeritus and Professor of Medical Education

University of Virginia School of Medicine



Meghan Dierks

Assistant Professor

Harvard Medical School, and

Director of Clinical Systems Analysis

Beth Israel Deaconess Medical Center

Brookline, Mass.


Terhilda Garrido

Vice President

Health IT Transformation and Analytics

Kaiser Permanente

Oakland, Calif.


Ashish Jha

Associate Professor of Health Policy and Management

School of Public Health

Harvard University



Michael Lesk 2


Rutgers University

New Brunswick, N.J.


Arthur A. Levin


Center for Medical Consumers

New York City


John R. Lumpkin 1

Senior Vice President and Director

Health Care Group

Robert Wood Johnson Foundation

Princeton, N.J.


Vimla L. Patel

Senior Research Scientist

New York Academy of Medicine, and

Adjunct Professor of Biomedical Informatics

Columbia University

New York City


Philip Schneider

Clinical Professor and Associate Dean

College of Pharmacy

University of Arizona



Christine A. Sinsky


Department of Internal Medicine

Medical Associates Clinic and Health Plans

Dubuque, Iowa


Paul C. Tang

Vice President and Chief Innovation

and Technology Officer

Palo Alto Medical Foundation, and

Consulting Associate Professor of Medicine

Stanford University

Stanford, Calif.




Samantha M. Chao

Study Director


1          Member, Institute of Medicine

2          Member, National Academy of Engineering