Health IT policy group calls for patient safety oversight program

Modern Healthcare: The federal Health Information Technology Policy Committee is calling for the development of a national program that would monitor patient safety problems in health care IT systems. "The first among the work group's recommendations was a proposal to create 'a national transparent oversight process and information system,' similar to a patient-safety organization, that could receive reports from various sources about patient-safety issues linked to the use of healthcare IT systems."

"'There is a need for this national database and for this national oversight process,' [Paul Egerman, a member of the HIT Policy Committee] said, but the work group stopped short of defining how such a program should be implemented or saying who would run it."

The Food and Drug Administration, which currently has regulatory authority over medical IT, says it will work with the recommendations from the group. "'The agency is very willing to be flexible and part of a broader approach' to health IT safety," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health (Conn, 4/22).

Information Week: The committee that made the recommendation "was created as part of the HITECH Act, a component of the massive American Reinvestment and Recovery Act of 2009." Among the recommendations for the oversight program included "having a feedback button built into the user interface of HIT applications, so people wouldn't have to search for the agency to contact with their concerns. Also the workgroup recommended the creation of an environment that encourages the reporting of 'near misses'--where an error could have caused major harm, but didn't."

A problem that was raised is the amount of time changes like these will take to implement, and the group is calling for expediency in getting the program started. "One way or the other, [Marc Probst, co-chair the committee's certification and adoption workgroup] said the industry needs ample time to implement HIT-related technologies, lest patient safety be compromised by the very program created to improve it" (Guerra, 4/22).

Government Health IT: Now that the recommendations have been made, the committee will deliver them "to the Office of the National Coordinator (ONC) to decide whether to adopt them and to define how the patient safety proposals would be put into practice." ONC will work with FDA to implement some of the changes including collaborating on "certification criteria that improve patient safety and selected health IT areas, such as design quality, that are creating safety risks for EHR [electronic health record] implementations." The partnership though, makes some wary about FDA's involvement because with it comes a lot of regulations that "could inhibit innovation, like iPhone mobile health applications, and increase costs" (Mosquera, 4/22).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.