HHS panel considers EHR risks as reports detail injuries, deaths

While electronic health records are considered key to improving the quality of healthcare they can also be a risk to patient safety, and government and industry officials are calling for better use practices and possible closer oversight of EHRs by regulatory agencies. The Food & Drug Administration has received 260 reports of health IT-related malfunctions with the potential for patient harm in the past two years, including 44 reported injuries and six reported deaths, said Dr. Jeffrey Shuren, director of FDA's Center of Devices and Radiological Health. Vendors, patients, clinicians and facilities voluntarily reported the problems but, because of that, "they may represent only the tip of the iceberg in terms of the HIT-related problems that exist," he said at a Feb. 25 hearing of the Health IT Policy Committee's adoption and certification work group, a Health and Human Services Department advisory panel.