Panel Set to Study Safety of Electronic Patient DataBy MILT FREUDENHEIM
Published: December 13, 2010
Almost two years ago, President Obama pledged $19 billion in stimulus incentives to help convert the nation’s doctors and hospitals to using a paperless system of electronic health records intended to improve the quality of care and reduce costs. But the conversion is still a slow work in progress.
A family clinic in Walsenburg, Colo., is part of the Spanish Peaks Regional Health Center, which planned to adopt an electronic health records system. Administrators predicted the cost would be recovered through federal funds.
Only about one in four doctors, mostly in large group practices, is using the electronic record system. A vast majority of physicians in small offices, the doctors who serve most Americans, still track patients’ illnesses and other problems with pen and paper.
The thousands of sometimes deadly medical errors tallied by an Institute of Medicine study in 1999 are still all too common, according to a recent report on North Carolina hospitals in the New England Journal of Medicine. And the electronic record systems are themselves increasingly attracting concerns that computer errors, design flaws and breakdowns in communication sometimes endanger patients.
For example, parts of a patient’s electronic medical records have disappeared or been saved in the wrong patient’s file, according to the Food and Drug Administration. Incorrect entries have sometimes been posted for drug allergies and blood pressure readings, the agency said.
Taking a fresh look at such concerns, the Institute of Medicine created the Committee on Patient Safety and Health Information Technology to run a yearlong study and issue recommendations. The 16-member panel is meeting for the first time on Tuesday in Washington.
In February, the F.D.A. said it had received 260 reports of malfunctions related to health information technology “with the potential for patient harm,” including 44 reported injuries and six reported deaths in 2008 and 2009. The malfunctions were reported voluntarily to the agency, mainly by hospitals.
“Because these reports are purely voluntary, they may represent only the tip of the iceberg,” said Dr. Jeffrey Shuren, a senior F.D.A. policy and enforcement official.
In an indication of interest from Congress, Senator Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee, wrote to the health information industry and to Kathleen Sebelius, the secretary of Health and Human Services, to ask what was being done to make sure the systems were being reviewed and monitored for patient safety concerns and what role the F.D.A. played in regulating health information technology.
Dr. Shuren suggested that F.D.A. regulators could consider a range of new safety requirements under the agency’s authority to assure the safety, effectiveness and quality of medical devices, including software devices.
“All options for assuring safety are on the table,” said Dr. David Blumenthal, the Obama administration’s national coordinator for health information technology. His office gave the Institute of Medicine $989,000 for the patient safety panel, which is led by Gail L. Warden, the former president and chief executive of the Henry Ford Health System in Detroit.
Dr. Blumenthal said health information experts like Dr. Donald M. Berwick, the Medicare and Medicaid administrator, and Dr. Brent James, of Intermountain Healthcare, based in Salt Lake City, “agree that electronic health records will improve the safety of care.”
“At the same time, any time you change the world you create risks,” Dr. Blumenthal said in a telephone interview last weekend. “We want to make sure that implementation is as safe as it can be and all safety benefits are realized.”
He said that if the Institute of Medicine “concludes that regulation is an important part of this fabric of assuring safety, we will want to balance regulation and innovation as we do in every marketplace.”
Manufacturers of the systems have long opposed government regulation of their products.
“The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future,” said Carl Dvorak, executive vice president of Epic Systems, which has built electronic records systems for Kaiser Permanente and other large health care and hospital groups.
The industry has recently avoided speaking out on a role for the F.D.A. In a statement for this article, the Healthcare Information and Management Systems Society, a Washington-based industry group, said only that it “supports the administration’s decision to ask the Institute of Medicine to study this complex issue and report back over the next 12 months.”
Last month, in protest of one common industry practice, the American Medical Informatics Association said “hold harmless” clauses in many purchasing contracts were unethical. The clauses typically absolve manufacturers of responsibility for any errors or misuse.
“We said we value innovation, but we don’t value it more than safety,” said Kenneth W. Goodman, a University of Miami bioethicist who headed an association advisory group on patient safety.
“We just do not have good data on medical errors, whatever the cause,” said Arthur A. Levin, a member of the new Institute of Medicine commission. Mr. Levin, director of Center for Medical Consumers in New York, also was a member of the institute group that warned in a 1999 report, “To Err Is Human,” that there could be 98,000 preventable deaths each year in hospitals.
An article in the New England Journal of Medicine last month pointed to a potential for malpractice liability risks because more information might be available on electronic records that might have gone unnoticed on a paper chart. Health care providers must weigh the substantial upfront costs and possible risks against the potentially sizable, but uncertain long-run benefits, Dr. Sandeep S. Mangalmurti, an internist at New York University’s Langone Medical Center, and his colleagues wrote.
“We probably catch about 2 percent of the errors,” said Ross Koppel, a University of Pennsylvania sociologist and investigator for RAND Corporation, the research organization based in Santa Monica, Calif. “The errors are the 98 percent that got through
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