FDA and Regulating E-health Records

Lurking behind the movement toward electronic health records has been the idea of which federal agency should regulate the digital files. Or, IF an agency should. At the Wednesday meeting of a Health and Human Services Department advisory panel, a representative from the Food and Drug Administration, which regulates medical devices, explained why the agency hadn't pursued EHRs. From a Government Health IT report on the meeting:

Although the Food and Drug Administration has authority to regulate health IT, the agency has refrained from doing so because EHRs are not stand-alone products and are linked with each other in networks, according to Dr. Jeff Shuren, director of FDA's Center for Devices and Radiological Health.