On Tuesday, Rep. Renee Ellmers (R-N.C.) sent a letter to HHS Secretary Kathleen Sebelius asking whether HHS has taken steps to create a federal agency to oversee safety of health IT systems, as recommended in a 2011 Institute of Medicine report, Modern Healthcare reports (Conn, Modern Healthcare, 6/12).
Currently, no federal agency investigates the safety of health IT systems and no individuals or entities are required to report health IT-related safety issues.
Background on the IOM Report
IOM released the report -- titled, "Health IT and Patient Safety: Building Safer Systems for Better Care" -- in November 2011. It recommended that HHS create a new agency to investigate the safety of health IT systems rather than give such authority to FDA.
The report stated that FDA lacks the funds, investigative capabilities and human resources to oversee the safety of electronic health record systems and other health IT tools.
IOM said that a new, independent watchdog agency created by HHS should investigate health IT safety issues and develop recommendations for health care organizations, health IT vendors and government officials. The agency would not have enforcement power, IOM said
The report also recommended that the federal government require all health IT vendors to report adverse events associated with their products. Health care providers should be able to voluntarily report health IT-related safety issues, the report stated (iHealthBeat, 11/8/11).
Details of the Letter
In the letter, Ellmers -- who is a nurse -- asked Sebelius to provide information about the actions that HHS has taken to carry out IOM's recommendations.
Ellmers requested a copy of any plan that HHS has developed "to minimize patient safety risks and the associated schedule for working with the private sector as recommended." If such a plan and schedule have not been developed, Ellmers called for HHS to disclose that and provide a timeline by which it expects to complete such work.
She also requested an update about the development of a system to allow health IT vendors and users to report health IT-related safety issues.
Ellmers asked for HHS to provide the requested materials within 30 days (Modern Healthcare, 6/12).