As physicians and hospitals gear up to implement electronic health records and other health information technology products, the federal government should increase its scrutiny of these products to ensure that they don’t actually contribute to medical errors.
That was the conclusion of an Institute of Medicine panel, which called on the Health and Human Services Department to assess potential safety risks associated with health IT and come up with a plan to minimize those risks. The plan should be published in 2012, with new reports each year, according to the panel’s recommendations.
But if the HHS secretary determines that the industry is falling short of the safety goals, the Food and Drug Administration should be tasked with regulating electronic health records, personal health records, and health information exchanges, the IOM committee recommended. The IOM study was sponsored by HHS.
The report comes as physicians and hospitals strive to qualify for federal incentive payments for the use of health IT products to meet certain quality benchmarks. The program includes bonus payments in the early years, followed later by penalties if they fail to adopt health IT.
"Based on the literature, HIT certainly has clear and demonstrated potential to improve the safety and the quality of patient care, but it also can cause harm. We’ve heard about that," said Dr. Paul C. Tang, a member of the IOM committee and vice president and chief innovation and technology officer at Palo Alto (Calif.) Medical Foundation.
Although evidence demonstrates that health IT systems have helped to improve medication safety in some places, the literature is inconclusive about IT’s safety benefits in other areas, Dr. Tang said. And there are reports of harm associated with the use of these systems, from dosing errors to delays in treatment, according to the report.
But right now it’s difficult to quantify the safety issues because unlike drugs or devices, health IT software is installed and used differently from institution to institution, said Dr. Tang, who also serves as the vice chair on the HIT Policy Committee, which advises the federal government on the development of a nationwide health information infrastructure.
In addition, there is a wide array of different types of health IT products on the market. There are also contractual issues, such as confidentiality clauses, that may make it difficult for users to share safety concerns about the products, according to the IOM report.
The IOM panel made a series of recommendations aimed at improving the information available on the safety risks and benefits associated with health IT use.
For instance, the panel called on HHS to develop a way for health IT users and vendors to report adverse events related to health IT. And the panel members urged Congress to establish an independent federal entity charged with investigating those adverse events. The body could be modeled on the National Transportation Safety Board, Dr. Tang said.