Concerned about potential safety risks in health information technology, the U.S. Food and Drug Administration may be moving closer to regulating the systems for the first time.
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.
By Fred Schulte and Emma Schwartz
23 February 2010