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[This story was edited July 8 to clarify that the National Institute of Standards and Technology does not certify technologies; it develops technical standards and test methods].
Federal policymakers and the health IT community are converging rapidly around the need to agree on standard practices for clearly communicating information contained in electronic health records and making it much easier for clinicians to navigate their way around tasks in an EHR.
Healthcare researchers, technology experts and EHR user advocates, bolstered by a new government commitment, are championing the idea that the "usability" of EHR systems is critical to efforts to get the nation's clinicians to effectively use the software in daily healthcare practice.
The conclusion that uneven or poor usability is a barrier to IT adoption and must be overcome is being advanced strongly by Dr. David Blumenthal, who heads up the Office of National Coordinator for Health Information Technology (ONC). The ONC boss has put his special assistant, Dr. Sachin Jain, in charge of an internal usability work group to light a fire under the issue.
"This is a top priority for David Blumenthal," says Jain, a recent graduate of Harvard Medical School, who has his own war stories to tell about the confusion of mastering multiple EHRs during his medical training. With the objectives of the Health Information Technology for Economic and Clinical Health (HITECH) incentive program at stake, the ONC has realized that billions of dollars alone will not suffice in winning clinicians over to meaningful use of EHRs.
"The success of the HITECH Act is really going to hinge upon whether physicians actually make the leap to adopt electronic health records and whether they use the systems," says Jain. "There's a lot of attention paid to meaningful use, but then there's the whole issue of whether physicians are going to integrate the electronic health record into their life and be satisfied doing it. And usability is a key piece of that."
Beyond emphasizing that usability matters, though, the ONC's game plan has not jelled.
"There's been a lot of parallel activity around usability for some time now. What ONC is trying to do is coordinate those activities into some kind of cohesive strategy," says Jain. "We're not quite sure just yet what the timeline is or exactly how to do this, but we'd like to see some objective standard of usability established, that can then inform purchasing behavior."
That objective requires first making the case to health IT vendors and purchasers alike that there is a science, a set of tangible principles, surrounding the design of how data and interactive elements are displayed, selected and manipulated on a screen"essentially, right ways and wrong ways.
But the first challenge is to torpedo the notion of usability as synonymous with satisfaction and basic ease of use, says Janey Barnes, a consultant on the human factors that go into designing technical products, such as computers and medical equipment.
The force gathering behind the importance of EHR information design is an opportunity to "educate [health IT] firms that usability is not just user satisfaction, that it actually can be measured with objective and repeatable measures, and those measurements can then in turn be directed back to improve the products."
In addition to innately good design, EHR development has to consider the often swirling environment in which clinicians do their work, says Dr. Jeffery Belden, chair of the Healthcare Information and Management Systems Society's Usability Task Force and a co-author of a 2009 HIMSS report on usability.
"Healthcare workers get interrupted all the time," says Belden, who has practiced as a family physician for 30 years in Columbia, Mo. "So if we don't evaluate usability in the context of interruption, we're going to miss the point."
But how to make the points? A series of three reports issued during the past year by the Agency for Healthcare Research and Quality (AHRQ) on the state of usability affairs in health IT concluded that usability has not been accorded the same software development priority as features, functions and technical standards.
Among other findings, vendors generally demoed products in development to end users, but more sophisticated engineering practices such as user-centered design processes, formal usability testing and use of personnel with specific expertise in usability is not common.
In vendors' defense, the reports also granted that there is very little systematic evidence and direction for vendors to follow on EHR usability design. What's more, there are neither guides to good practices in usability nor frameworks to evaluate and rate how well EHRs do.
Moreover, a survey of seven commercial EHR vendors and the Department of Veterans Affairs, released in late May by AHRQ, revealed that all are taking their own approach to making systems usable, says Matthew Quinn, project officer for the AHRQ usability push.
"Every vendor we talked to thought that their secret sauce was the usability of their product," Quinn says, but added, "none of them talk, and none of them use the same principles, and they have completely divergent views on whether the system should be standard or configurable."
An objective third-party source of guidance on best practices could circulate principles that all should incorporate into EHR development, overcoming vendors' stated reluctance to share what they currently see as competitive differentiators.
Quinn says AHRQ was poised to award a contract in the third quarter of federal fiscal 2010 ended June 30, through its National Resource Center for Health IT, for an "EHR usability evaluation toolkit" of objective and evidence-based measures, metrics and benchmarks for evaluating usability.
The formal evaluation piece is in the hands of the National Institute of Standards and Technology, which has "expansive, unique experience" in technical standards and testing methods for other technologies that it's bringing to bear on health IT with the help of AHRQ's industry-specific expertise, says Svetlana Lowry, NIST's project lead and a veteran of 25 years' experience in human factors design.
Usability and certification
NIST is developing testing and certification specifications for EHRs on the market to demonstrate they can help providers deliver the meaningful-use results that will make them eligible for incentive payments under HITECH's Stage 1 criteria.
According to the ONC's Jain, "no one's made a firm decision as to the eventual certainty" of incorporating usability criteria into certification, but he adds, "It's something we're actively considering."
Meanwhile NIST has announced plans for development of a "usability framework" that will seek objective and measurable standards for EHR usability" no small task, but achievable given NIST's success in developing technical standards and test methods for these standards. Outside of NIST, Lowry notes that human factors techniques have also been used to certify systems and equipment for high-risk, rapid-decision environments such as nuclear power plants and military aircraft.
"Certification never has a shade of gray"it is black or white, pass or fail," she says. "So the biggest challenge in certification is to draw that line. It sounds simple but it's complicated, and it takes vast experience to understand that process. That's what makes NIST unique in this sense."
Lowry adds that in gauging the healthcare environment's likely requirements, "my primary model is the Nuclear Regulatory Commission, because they are actually the ones who pioneered very structured human factor standards and processes to ens