Usability improvements that could enhance patient safety are occurring in electronic health record systems, but not at an acceptable pace and not necessarily for the expected reasons or even the right ones, some industry gurus and researchers report.

On the upside, market consolidation among EHR vendors and the intensifying regulatory environment -- notably the Office of the National Coordinator for Health IT's recently issued EHR user-centered design (UCD) reporting requirements -- are producing the net effect of weeding out vendors whose systems have usability issues or that have decided not to invest in improvements, according to Joshua Lee, CIO at USC Health in Los Angeles.  

"The market consolidation is working in favor of potentially improving EHR safety because the world is splitting into health systems using a smaller number of systems," said Lee, who has commandeered EHR implementations at major U.S. health systems, including Dartmouth-Hitchcock in New Hampshire.

"We've seen usability advances in EHRs, but progress has been slow. We appear to be stuck in perpetual midpoint," he said. "We've gotten so far, but we've got so much farther to go before we start seeing real EHR improvements." At the same time, Lee expressed optimism because "there's more dialogue occurring with end users" about usability.

Jiajie Zhang, dean of the University of Texas' School of Biomedical Informatics, concurs with Lee on some points. He thinks that usability is "better than it was a year ago" but observes that the gains are not occurring because of specific product improvements. "We haven't seen much change in the usability of the products. But what we are seeing is that usability is now being practiced as a competitive advantage" because of the ONC's UCD reporting requirements, he said. Zhang -- who is the principal investigator charged with leading establishment of the National Center for Cognitive Informatics and Decision Making in Healthcare -- added, "The large vendors, such as Epic and Cerner, now have professionals who are focused on UCD and usability. Three to five years ago, most EHR companies didn't even have dedicated professionals."

Analysis Uncovers Significant EHR UCD Challenges

A recent study -- led by Raj Ratwani of the National Center for Human Factors in Healthcare and published in the June issue of the Journal of the American Medical Informatics Association -- illustrates the "stuck scenario" to which Lee alludes. Researchers, with funding from the ONC's SHARPC (Strategic Health IT Advanced Research Projects) program, analyzed UCD processes at 11 EHR vendors of varying sizes to identify challenges to integrating improved UCD in product development. The results were telling. While four of the 11 studied (on condition of anonymity) have a well-developed UCD participant infrastructure, perform remote usability testing and leverage a mechanism for integrating UCD with the product development timeline, these companies also have significant challenges. These include insufficient information about actual EHR safety hazards and inadequate resources for researching physician sub-specialty workflow.

Among the remaining vendors studied, even large and mid-sized companies -- one with revenue of more than $100 million and several with revenues in the $20 million-plus range -- had either limited or nonexistent effective UCD infrastructure, and they cited several challenges to improving that situation. These ranged from scant knowledge of EHR user training, to insufficient use cases, to inefficient participant recruiting. Three vendors struggled with insufficient leadership support for UCD, and inadequate UCD resources and staff.

Further, researchers found that three of the vendor companies have misconceptions about UCD and do not solicit user recommendations until after product deployment.

Certification Counts, but It Doesn't Ensure UCD

ONC's move to require EHR vendors to report their UCD principles and incorporate the NIST Customized Common Industry Format for EHR Usability Testing, in concert with the SHARPC initiatives, is moving the industry, if slowly, toward improved product usability and incrementally better safety, leading health IT researchers acknowledge.

"That's because people are finally talking about [EHR] usability at a science level, like other industries have done for a long time. It's long been said that EHR usability is more art than science, but I don't think that's true," said Dean Sittig, a professor at the UTHealth School of Biomedical Informatics and a longtime EHR usability and safety researcher. "To make EHR systems safer, we have to incorporate [usability] science and we need more industry oversight. Most of these systems were designed 10 to 15 years ago, and vendors have been slow to change them."

The ONC requirements are a step in the right direction, Sittig said, but there's one inherent issue with the approach: The UCD reporting doesn't require vendors to make modifications to improve UCD. "What that means is that vendors can meet the letter of the law without really improving usability," he said.

Zhang agrees. "We have looked at these vendor [UCD] reports, and they are not complete. Some are actually very minimal," he said, "And just conducting use cases isn't enough. That's the bare minimum, and talking to users doesn't change anything."

On the plus side, the reporting is increasing awareness, Zhang said. "That's one positive thing that's happening, but what we really need is more people trained in EHR usability and more tools to make system changes that improve safety." He cited the recently released Task, User, Function, Representation -- or TURF -- software developed at the nascent National Center for Cognitive Informatics & Decision Making in Healthcare as a start in that direction. Zhang is leading the center's development. The tool enables organizations to define, measure and evaluate EHR usability.

Transparency: Still Seriously Lacking

Andrew Gettinger, ONC's recently hired CMIO, acknowledged that the ONC requirements aren't enough to move the industry to incorporating UCD advances to improve safety. What's required, he pointed out, is the thing critics of the EHR industry have cited for many years: More transparency in reporting system-associated safety issues and errors, open sharing of usability flaws and more head-to-head comparisons of systems' UCD to arrive at best practices and design standards that are applied across the board.

"Clearly, we've signaled to the [EHR] developer community that we want vendors to focus more on UCD," Gettinger said. "But there hasn't been a safe forum for the developer and user communities to come together to talk about what works and what doesn't in usability." The hope is that the planned creation of the national Health IT Safety Center will eventually house such a forum, Gettinger said.

"That lack of transparency is one of the huge debates now," Sittig said. "Right now, vendors are still saying that their screen technology is proprietary, so people can't openly talk about it. We've seen a lot of graphs in EHRs that don't even have a label, for example. That's dangerous, and these are the things people need to talk about." 

Zhang added, "That lack of transparency and disclosure gag is the biggest challenge to improving EHR safety," he said. Vendors, including major ones, have contracts with hospitals that prevent hospitals from taking screen shots of usability problem areas and safety issues and sharing those in the public domain, he noted. "Until that changes, we won't see big improvements," he said.