Date: Nov. 8, 2011
FOR IMMEDIATE RELEASE
To Improve Patient Safety, Health Information Technology Needs Better Oversight, Accountability
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
Luwam Yeibio, Media Relations Assistant
Office of News and Public Information
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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 http://www.nap.edu. 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)
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
Richard Baron (until March 2011)
Professor and CEO
David W. Bates 1
General Medicine Division
Brigham and Women’s Hospital
Chief Information Officer
Emory Healthcare Inc.
David C. Classen
Associate Professor of Medicine,
Senior Vice President, and Chief Medical Officer
Richard I. Cook
Associate Professor of Anesthesia and Critical Care
Don E. Detmer
Division of Advocacy and Health Policy
Professor Emeritus and Professor of Medical Education
Director of Clinical Systems Analysis
Health IT Transformation and Analytics
Associate Professor of Health Policy and Management
Michael Lesk 2
Arthur A. Levin
Center for Medical Consumers
John R. Lumpkin 1
Senior Vice President and Director
Health Care Group
Robert Wood Johnson Foundation
Vimla L. Patel
Senior Research Scientist
Adjunct Professor of Biomedical Informatics
Clinical Professor and Associate Dean
Christine A. Sinsky
Department of Internal Medicine
Medical Associates Clinic and Health Plans
Paul C. Tang
Vice President and Chief Innovation
and Technology Officer
Consulting Associate Professor of Medicine
Samantha M. Chao