Numerous studies, including a 2011 report from the Institute of Medicine, show that EHRs and other health IT systems may jeopardize patient safety, most commonly due to EHR system interfaces, wrong input into EHRs, system configuration problems, wrong records retrieved and software functionality issues.
That report, along with the ONC's Health IT Patient Safety Action and Surveillance Plan (PDF), released in July of this year, draw attention to the need for more reporting of health IT errors and safety events. And the ONC's latest guide also encourages feedback from healthcare organizations and assistance from EHR developers and outside experts.
But that's not always easy when some contracts with EHRs have gag orders written in that prevent users from discussing their experiences with the system. HHS and the Food and Drug Administration, are exploring whether health IT should be regulated the way the government regulates medical devices, which is causing some anxiety in the industry.
In a letter to HHS Secretary Kathleen Sebelius, the Chicago-based Healthcare Information and Management Systems Society wrote that “most electronic health records and clinical decision support systems, according to current capabilities, neither fit the definition of, nor would be appropriately regulated as medical devices.”
HIMSS' Electronic Health Record Association was also critical of a proposal that would require EHR vendors to list with the FDA all products containing “at least some risk” and one that would create a national health IT patient-safety incident reporting system.
HHS and the FDA are supposed deliver a “proposed strategy and recommendations on a risk-based regulatory framework” for health IT, including mobile applications, by January 2014.
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