More Health IT Oversight Proposed

The Institute of Medicine recommends creating a new federal organization to investigate health IT safety failures and suggest safety improvements, similar to the way the National Transportation Safety Board investigates airline and rail disasters.

Blaming the health IT industry for not taking "substantive action on its own," the institute also calls for the Department of Health and Human Services to monitor and publicly report on efforts to improve health IT safety, beginning next year. If patient safety doesn't improve sufficiently within another year, the institute says HHS should direct the Food and Drug Administration to regulate health IT. The independent institute, the health-care arm of the federally chartered National Academy of Sciences, says emerging risks to patient safety spurred the call to action.

"Proactive steps must be taken to ensure that health IT is developed and implemented with safety as a primary focus," according to the report brief released today. The full report, "Health IT and Patient Safety: Building Safer Systems for Better Care," is due to be released Thursday.

HHS, through its Office of the National Coordinator for Health IT (ONC), asked the Institute of Medicine to review safety concerns and identify ways that government and industry can rectify problems, according to the brief.

A study group appointed by the institute cited case reports blaming "poorly designed health IT" for creating "new hazards in the already complex delivery of care." The Problems, which include medication-dosing errors and treatment delays, have led to several deaths and serious injuries.

But quantifying the scope of errors is difficult, in part because many technology vendors' contracts discourage health-care providers from reporting safety-related failures, according to the brief. Some contracts shift liability for errors from the vendor to users.

The report recommends that ONC work with industry to publicly share "comparative user experiences" on health IT-related deaths, injuries or unsafe conditions. ONC and vendors should also consider creating a consumer guide for health IT safety, the report says.

Creating the NTSB-like organization would be the next step in building a framework for understanding and improving patient safety "in a transparent, nonpunitive manner." Under the proposal, the organization would investigate problems and make nonbinding recommendations to the HHS secretary for making health IT safer.

Federal regulation of the industry, under the FDA or another entity, would be the last step if other safety-monitoring and -improvement efforts fail.

"Just as the potential benefits of health IT are great, so are the possible harms to patient safety if these technologies are not being properly designed and used," Gail L. Warden, president emeritus of Henry Ford Health System and chair of the committee that wrote the report, said in a news release. "To protect patients, industry and government have a shared responsibility to ensure greater transparency, accountability, and reporting of health IT-related medical errors."