IOM to Health I.T. Industry: Improve Safety or Be Regulated

If the health information technology industry won't improve the safety of its products, then the Food and Drug Administration should regulate health I.T., the Institute of Medicine recommends in a new report.

The Office of the National Coordinator for Health Information Technology asked IOM to study the issue of I.T. safety. In the resulting report, a committee of the IOM makes a series of recommendations for building safer systems and monitoring safety, including:

* The Department of Health and Human Services should ensure that vendors support users in freely exchanging information about I.T. experiences and issues including safety;

* ONC should work with the private sector to make comparative user experiences publicly available;

* HHS should fund a new Health I.T. Safety Council within an existing standards organization to evaluate criteria for judging the safety of health I.T.;

* HHS should establish a mechanism for vendors and users to report health I.T.-related deaths, serious injuries or unsafe conditions; and

* HHS should recommend that Congress establish an independent federal entity, similar to the National Transportation Safety Board, to perform investigations in a transparent, non-punitive manner.

"These and other recommendations would comprise the first stage for action, greatly advancing current understanding of the threats to patient safety," the IOM committee's report states. "However, because the private sector has not taken substantive action on its own, the committee further recommends that HHS monitor and publicly report on the progress of health I.T. safety annually, beginning in 2012. If progress is not sufficient, HHS should direct the Food and Drug Administration to exercise its authority to regulate health I.T. To be effective, the FDA will need to commit sufficient resources and add capacity and expertise to carry this out."

The report, "Health IT and Patient Safety: Building Safer Systems for Better Care," is available at


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