Over 70,000 U.S. clinicians may have used electronic health record solutions that posed risks to patient safety, on account of six vendors who allegedly misrepresented their functionality to obtain certification.

The six paid settlements of more than $379.8 million to the U.S. Department of Health and Human Services Office of Inspector General and the U.S. Department of Justice for alleged kickbacks and misrepresented product capabilities, according to researchers at MedStar Health, Brigham and Women's Hospital, and the University of Utah.

This led to more than 76,831 individual clinicians using suboptimal EHR systems between 2011 and 2016. Under the 2009 Health Information Technology for Economic and Clinical Health Act, EHR solutions must meet capability, functionality and security requirements adopted by HHS to be certified. Violations can result in complaints and in turn, settlements with the DOJ, but oversight is limited.

In their study, the authors reviewed each publicly available settlement related to EHR certification violations and data from the Centers for Medicare & Medicaid. Four of the six vendors were confirmed to have made settlements related to misrepresenting product functionality.

"These data show that even a handful of examples of bad behavior by EHR vendors can have far-reaching impact on patient safety and how providers use these platforms,” said senior author Raj Ratwani, vice president of scientific affairs for MedStar Health Research Institute, director for the MedStar Health National Center for Human Factors in Healthcare, in a statement.

The vendors included in the research were eClinicalWorks, Greenway Health, Practice Fusion, Viztek, athenahealth, and CareCloud Health.

In a 2018 study, MedStar Health found that EHR usability may pose possible patient harm, but is hard to prove when based solely on patient safety reports, which only capture a small fraction of the number of safety incidents and have limited information.

MedStar Health investigators recommend developing resources to proactively monitor and identify opportunities for optimizing EHR functionality, including an assessment tool to evaluate alerts, data entry, automation processes, and visual displays.

They also recommend more rigorous safety standards for certifying EHR systems, such as an HHS national database on usability and safety reporting, and adopting accreditation requirements by the Joint Commission that incentivize hospitals to implement EHR safety best practices.

"While we have made incremental progress, success is dependent on greater transparency across the industry, as well as a shared commitment from governing bodies, health system customers, and vendors to work together to prioritize safety,” said Ratwani.

The findings were published in JAMA Health Forum.