Contrary to misperceptions among industry stakeholders who might not have read the National Institute of Standards and Technology's EHR Usability Protocol guidelines (NIST 7804), the government isn't mandating EHR interface design.
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In fact, according to co-authors Svetlana Lowry of NIST and User Centric managing director Robert Schumacher, the guidelines -- referred to as "the EUP" -- don't prescribe any design elements. Instead, they provide a "thermometer" to measure usability and help vendors mitigate risks of caregivers committing critical errors in the course of patient care. Moreover, the EUP recommends reporting EHR usability test results in the common industry format for which NIST has developed a template.
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NIST is moving forward developing further EHR usability guidelines with a $1.2 million federal contract to develop a usability framework from empirical data it will collect. But there isn't any health care-related empirical data at present, so the EUP catalogs existing protocols and best practices for measuring software usability in industries where safety is critical, all in a presentation customized for EHR software vendors.
The EUP aims to address problems such as mixing up medication, providing care to the wrong patient and administering unintended care to a patient "due to actions taken to test software, train users, or demonstrate software to potential customers."
"Usability is a broad term, it includes objective acceptance, objective performance and many other things," said Lowry, an interface expert who also has worked on aircraft control software as well as applications used at nuclear power plants. "It covers critical issues of usability that may impact safety. Why? Because we couldn't cover everything in a short period of time, so we started with something we considered the most critical -- human error that may impact the safety of the patient."
Intermingling user evaluation, expert reviews to improve EHR usability
Schumacher and Lowry underscored that the document does not mandate interface design, but, instead, sets up formal processes for determining an EHR application's usability. Doing so includes observing impartial users and experts -- parties far removed from the software development process in the target audience of the software (i.e. nurses and physicians) -- as they take the application for a spin.
"We are part of the Department of Commerce. Our ultimate goal is supporting industry and not to stifle innovation," Lowry said, adding that is why the EUP bases EHR usability evaluations on user performance instead of design factors. "Designers -- not only in the EHR industry but in many other industries we're working with at NIST – worry that innovation will be stifled, that we would say, 'That button has to be round, the color has to be black, and this color has to be green.'"
Instead, she said, NIST makes recommendations such as level of contrast between a button and its background, for the benefit of middle-aged users to better read text critical to performing work. She and Schumacher -- two of nine co-authors on the EUP, which included experts from academia, industry and government -- underscored that the guidelines do not prescribe any design details. Furthermore, they are voluntary.
Farzad Mostashari, M.D., said that his Office of the National Coordinator for Health IT (ONC) is promoting in its currently proposed EHR certification criteria the use of NIST EHR usability guidelines, as well as EHR usability recommendations issued in 2011 by the ONC's own Health IT Policy Committee and the Institute of Medicine's 2011 report "Health IT and Patient Safety: Building Safer Systems for Better Care." At a conference in Boston, Mostashari told attendees "not a day goes by" that he doesn't get a complaint from a doctor that they hate meaningful use policy because it's "making them do stupid stuff." Usability, in many of these cases, is the culprit.
The market has got to demand usability, and we've got to give the market tools by which to do that.
Farzad Mostashari, M.D., National Coordinator for Health IT
"It turns out it's not the policy. It turns out it's their vendor, who has slammed in something as a way to get certified without considering the usability aspects of it," Mostashari said, adding that he observed much poor health IT software usability while walking the exhibit hall at HIMSS 2012. "If there's one big threat to this great trend that we're seeing [in U.S. health IT adoption], it's the usability issue. Diagnosing the problem's easy; prescribing the solution's hard."
So far, he said, ONC has followed the advice of its advisory committees and has not recommended EHR systems be regulated as medical devices. It has, however, hardwired some usability mandates, which intend to prevent medication errors, into vendor EHR certification standards.
He said he hopes the NIST guidelines will shed light on EHR usability, adding that docs can demand to see how prospective applications measure up. That way they don't have to rely just on sales demonstrations when making their purchasing decisions.
"The market has got to demand usability," Mostashari said, "and we've got to give the market tools by which to do that."
Vendors -- and hospitals -- can integrate NIST EHR usability guidelines
Because the NIST usability evaluation guidelines are voluntary, they can be applied at the software developer's discretion. Hospitals that author or commission small applications for their own networks can get in on usability testing too, Schumacher said. Getting just one user in on testing is better than none.
"We would hope that any development shop, large or small, would understand that the human interactiveness of the system is as important -- if not more important -- than testing the data connections between two underlying systems," Schumacher said.
At the HxD Conference in Boston just days after the final NIST guidelines were released, Allscripts Healthcare Solutions Inc. user experience research manager Jill Reed said she was looking forward to reading the 112-page document and seeing its approach to improving EHR usability.
"In theory, I'm really, really glad that they're taking an interest," Reed said. "I think that it's going to help, if we can all get on the same page as vendors."