“The FDA asserts its authority to regulate medical software as a “device” following some bad patient care outcomes in the radiation therapy, radiology, and other arenas. Observers question whether it is well-equipped to do so, and other agencies regulating and promoting electronic health records (EHRs) are concerned that the FDA could slow down development of products the government is otherwise trying to rush to market.”
Article
GLGroup, 28 April 2010
