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Report calls for new agency to monitor safety of health IT

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An influential panel of health experts is calling for more oversight of the use of electronic health records, saying an independent federal body is needed to investigate potential safety issues, including deaths and injuries.

The new entity would monitor and analyze health information technology data and publicly report its findings, according to a report released Tuesday by the Institute of Medicine, part of the National Academy of Sciences. The current state of safety in health information technology “is not acceptable,” the report said, adding that “specific actions are required” to improve it.

Some serious errors involving these technologies have included medication dosing errors, failure to detect fatal illnesses and treatment delays due to poor human-computer interactions or loss of data, the experts found.

“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,” Gail Warden, president emeritus of the Henry Ford Health System and chairman of the IOM committee that wrote the 188-page report, said in a statement.

The report recommended that Health and Human Services Secretary Kathleen Sebelius direct the Food and Drug Administration to take over regulation of electronic health records if she determines that there has been insufficient progress on safety within a year.

Although electronic health records and other health information technology are playing a larger role in patient care, there is little published evidence quantifying risk, experts found. No central repository exists, for example, to collect information related to safety.

In addition, nondisclosure agreements in contracts between vendors and health-care providers and “hold harmless” clauses that shift the liability for unsafe health IT features to providers are also barriers that “pose unacceptable risks to safety,” the report said. The report recommends that Sebelius establish a mechanism for vendors and users to report deaths, injuries or unsafe conditions.

The report also highlighted how differences in implementation of health IT can lead to different results. For example, two pediatric intensive care units put the same electronic health record system into use, but the experience in Pittsburgh led to a significant increase in mortality while the one in Seattle did not. In Pittsburgh, workflow changes that resulted in a breakdown in communication between nurses and doctors were among reasons cited for the increased mortality rate.

The study was commissioned by the Department of Health and Human Services. In a statement, a department spokesman said the report recognized the early safety successes of electronic health records, but “also highlights how some of the complexities associated with EHRs have introduced new risks into the system.”

The agency said it agreed that “more can and should be done” on safety issues unique to electronic health records. Among several safety measures already underway are an HHS-appointed technical expert panel that regularly reports its safety findings and an agency-funded training curriculum for health IT workers.

The Office of the National Coordinator for Health Information Technology, also part of HHS, will work with the FDA and other organizations to develop a comprehensive safety action and surveillance plan for electronic health records “well within the 12-month period” recommended by the Institute of Medicine, the statement said.

The federal government has been encouraging doctors to convert from paper to electronic health records as part of an ambitious $27 billion plan to modernize health care over 10 years.

Under the program, part of the 2009 economic stimulus, health-care professionals who effectively use electronic records can each receive up to $44,000 over five years through Medicare or up to $63,750 over six years through Medicaid. Doctors must meet a host of strict criteria, including regularly using computerized records to log diagnoses and visits, ordering prescriptions and monitoring for drug interactions.

Starting in 2015, those who haven’t adopted digital record keeping risk having their Medicare reimbursements cut. Many practitioners worry that the benefits of more accurate documentation are outweighed by costs, both in dollars and in changes required in the workplace.

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