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New CMS rule challenges hospitals, but not vendors, to make EHRs safer


In a little-noticed action last month, the Centers for Medicare & Medicaid Services (CMS) published a regulation requiring hospitals to attest that they have completed an annual safety assessment of their electronic health record (EHR) products so as to meet an objective of the Medicare Promoting Interoperability Program, starting next year.


Experts praised the move but said that EHR developers should share the responsibility for ensuring that the use of their products doesn’t harm patients.

A number of safety problems are associated with hospital EHR systems, ranging from insufficient protection against medication errors and inadvertent turnoffs of drug interaction checkers to allowing physicians to use free text instead of coded data for key patient indicators. Although hospitals aren’t required to do anything about safety problems that turn up in their self-audits, practitioners who perform the self-assessment will likely encounter challenges that they were previously unaware of and will fix them, experts say.

Studies over the past decade have shown that improper configuration and use of EHRs, as well as design flaws in the systems, can cause avoidable patient injuries or can fail to prevent them. For example, one large study found that clinical decision support (CDS) features in EHRs prevented adverse drug events (ADEs) in only 61.6% of cases in 2016. That was an improvement over the ADE prevention rate of 54% in 2009. Nevertheless, nearly 40% of ADEs were not averted.

Another study, sponsored by the Leapfrog Group, found that EHRs used in U.S. hospitals failed to detect up to 1 in 3 potentially harmful drug interactions and other medication errors. In this study, about 10% of the detection failures were attributed to design problems in EHRs.

The new CMS measure requires hospitals to evaluate their EHRs using safety guides that were developed in 2014 and were revised in 2016 by the Office of the National Coordinator for Health IT (ONC). Known as the Safety Assurance Factors for Resilience (SAFER) guides, they include a set of recommendations to help health care organizations optimize the safety of EHRs.

Surprises in store for hospitals

Dean Sittig, PhD, a professor at the University of Texas Health Science Center, Houston, told this news organization that a 2018 study he conducted with his colleague Hardeep Singh, MD, MPH, found that eight surveyed health care organizations were following about 75% of the SAFER recommendations.

He said that when hospitals and health care systems start to assess their systems, many will be surprised at what they are not doing or not doing right. Although the new CMS rule doesn’t require them to correct deficiencies, he expects that many will.

For this reason, Dr. Sittig believes the requirement will have a positive effect on patient safety. But the regulation may not go far enough because it doesn’t impose any requirements on EHR vendors, he said.

In a commentary published in JAMA, Dr. Sittig and Dr. Hardeep, a professor at the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, cite a study showing that 40% of “EHR-related products” had “nonconformities” with EHR certification regulations that could potentially harm patients. “Many nonconformities could have been identified by the developer prior to product release,” they say.


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