The Institute of Medicine (IOM) released a report Tuesday stating that an independent agency – aside from the FDA — is needed to investigate deaths and injuries that may be caused by health IT, in particular electronic health records. The report recommended that the new agency should be modeled after the Transportation Safety Board.
According to an article in The New York Times, the Department of Health and Human Services ordered the study after it received a request from physicians and public health experts who were concerned that the rush to implement digital records might bring with it a new wave of technologic medical errors.
Interestingly, the report recommended the removal of “hold harmless” clauses from EHR sales contracts. These clauses are put in place to prohibit physicians and/or hospitals from publically raising questions about software errors or defects.
According to an article published in iWatchNews, the study descries 10 recommendations to help ensure safety when using health IT.
The article also states that the report authors’ recommend a new government entity to monitor health IT because the FDA “would likely restrict market innovation in health IT, which could also jeopardize patient safety,” and that “the agency does not have the investigative capabilities, funding or manpower to regulate devices such as electronic health records, personal health records or health information exchanges.”
The official IOM press release listed the following next steps:
“The secretary of the U.S. Department of Health and Human Services should publish a plan within 12 months to minimize patient safety risks associated with health IT and report annually on the progress being made, the report says. The plan should include a schedule for working with the private sector to assess the impact of health IT on patient safety. However, if the secretary determines that progress toward improving safety is insufficient within a year, the U.S. Food and Drug Administration should exercise its authority to regulate these technologies.”
The full report is scheduled to be released today, yet there is already much discussion on the topic, including this recommended Google+ post from Brian Ahier, who reassures health IT professionals – and all patients – that using technology to improve healthcare is a necessity, and that, “Trying to pull back from adoption by saying that health IT has safety problems would be like saying that because there are automobile accidents we should ban cars. Health IT can improve patient safety and the quality of care we provide.”
Stay tuned on this issue – there is much more, undoubtedly, to be written. Click Here to download the Nov. 11 #HITsm TweetChat discussion on this topic.
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