HHS should update the House Small Business Committee on the department’s plans to minimize patient safety risks associated with the use of health information technology, said committee Chairwoman Renee Ellmers, R-N.C., in a June 12 letter to HHS Secretary Kathleen Sebelius. Ellmers cited a November 2011 report from the Institute of Medicine recommending greater public and private oversight of health IT, which called for more research into risks associated with the use of the technology. (See Also see "IOM Wants More Government Oversight For Health Information Technology" - Medtech Insight, 14 November, 2011..) Among other things, Ellmers asks Sebelius for “any internal HHS or FDA reports, analyses, investigations, memoranda or other documents outlining the authority, capability and advisability of FDA or another federal agency to regulate electronic health records and/or other health IT devices.”
Regulatory agencies such as FDA should require medical device manufacturers to identify and mitigate security hazards to their devices, according to Arnab Ray, a research scientist for Fraunhofer USA and...
