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ONC EHR safety plan in the works; public comment sought

Just before the U.S. health care system went on skeleton crews for the long holiday, the Office of the National Coordinator for Health IT dropped a little policy package under the tree that might seem like an innocent little 39-page PDF, but it could have much larger ramifications for CIOs and the IT vendors who serve them.

The “Health IT Patient Safety Action & Surveillance Plan for Public Comment” proposes some pretty hefty goals, from spearheading collection of EHR safety adverse event reports – which has been a difficult row to hoe – to potential FDA regulatory frameworks governing EHR safety, scheduled to be debated in 2014. The plan creates no new quality reporting system but instead uses present patient safety mechanisms such as the Agency for Healthcare Research and Quality (AHRQ) and patient safety organizations (PSOs) to improve health IT safety and develop guidance on safer implementations.

Vendors could be held accountable, as the document speaks of their shared responsibility in patient safety through certified EHR development that follows usability guidelines, reporting adverse events to the federal government and contributing to reports that compare user experiences between different vendors’ health IT systems. Vendors will be encouraged to participate in a voluntary code of conduct “that ensures vendors work with safety organizations to aggregate and analyze events and promote adverse event reporting among providers.” ONC-Authorized Certification Bodies (ONC-ACBs) may also incorporate health IT safety in post-market surveillance of EHR technology it certifies for meaningful use.

On the provider side, state CMS surveyors and surveyors from accrediting organizations such as the Joint Commission could be trained to recognize and investigate health IT-related events. The document states that “reports of specific adverse events or patterns of serious events must trigger investigations and, when appropriate, corrective actions.”

Finally, the agency will consider issuing public notices related to serious adverse events or unsafe conditions involving EHR technology, conjuring images of the HHS data breach “wall of shame.” An ONC spokesperson told SearchHealthIT that that particular facet of the safety plan is far enough in the future that it’s not known if it will come to pass and if so, what it will look like.

Many of the actions in the plan come directly from recommendations the Institute of Medicine made in its ONC-commissioned 2011 report, Health IT and Patient Safety: Building Safer Systems for Better Care. Rep. Renee Ellmers (R-NC), sent letters to the ONC on June 12 and Nov. 14 demanding to see the plan.

Interested parties have until February 4, 2013, at 11:59 pm EST to submit comments to ONC.Policy@hhs.gov.

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