Sen. Chuck Grassley, R-Iowa and ranking member of the Senate Finance Committee, has asked Health and Human Services Secretary Kathleen Sebelius to review the Food and Drug Administration oversight of health information technology safety.
In a letter released Wednesday, February 24, Grassley asked Sebelius to outline health care IT safety monitoring at HHS, the FDA and elsewhere and assess whether regulators require additional authority.
Grassley, who last month asked roughly 30 hospitals for information on health IT and surveyed vendors in October 2009, also released a letter to the Health Information and Management Systems Society. Grassley asked the trade group to respond by March 10 to questions about recommendations put forward in 1997 for voluntary and regulatory oversight of health care information technology.
The recommendations, published in the Journal of the American Medical Informatics Association, called for local oversight “whenever possible”; FDA oversight of the riskiest clinical software and labeling for most health IT; and an industrywide code of good business practices.