FDA May Set Patient Safety Regulations For Health IT

The Huffington Post Investigative Fund: "In the past two years, the agency has received reports of six patient deaths and several dozen injuries linked to malfunctions in the systems, Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in testimony prepared for a government hearing on Thursday. ... The FDA has been studying the issue for several years. Its latest concerns are surfacing as the government ramps up an ambitious plan to spend as much as $27 billion in stimulus money helping doctors and hospitals across the country purchase electronic medical records systems that rely on digital software rather than paper medical charts."

The problems that have been reported to the FDA's "voluntary notification system" include systems that "have mixed up patients, put test results in the wrong person's file and lost vital medical information." Possible steps the agency could take to tighten scrutiny include requiring "makers of the devices to register them with the government and to submit reports on safety issues and correct problems that surface." The agency also could "could require manufacturers to report safety concerns and set minimum guidelines to assure the quality of products on the market. In a third approach, the systems could be subject to the broader regulatory actions that new medical products must face before they ever reach the market" (Schulte and Schwartz, 2/23).

Federal Computer Week: "The White House will form an interagency task force to coordinate federal health information technology programs" The panel "will be led by the Health and Human Services Department's National Coordinator for Health IT, Dr. David Blumenthal." Also included will be officials from the Agriculture, Commerce, Defense and Veterans Affairs departments, the Social Security Administration and the Office of Personnel Management. "The group is needed to facilitate President Obama's health reform agenda and distributing $20 billion in economic stimulus law funding for health IT. Currently, lack of coordination among many councils and advisory groups is holding back progress, the memo said" (Lipowicz, 2/23).

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