“On February 25, Jeffrey Shuren, the director the FDA’s Center for Devices and Radiological Health, announced that his agency had received reports of 6 deaths and several dozen injuries associated with electronic health records (EHRs) in the previous 2 years.
Shuren subsequently proposed that the FDA should regulate the safety of EHRs. The FDA could implement a post-market surveillance program, or even classify EHRs as medical devices, he suggested.”
Article
Glenn Laffel, EHR Bloggers, 17 March 2010
