ONC: Staying Focused on EHR Usability
by Helen R. Pfister and Susan R. Ingargiola, Manatt Health Solutions, iHealthBeat, Thursday, February 20, 2014

Most health IT stakeholders agree that lack of "usability" can make efficient use of electronic health records challenging. The Healthcare Information and Management Systems Society even identified usability as possibly the most important factor hindering widespread adoption of EHRs. 
Despite this, policymakers and others involved in the nation's health IT implementation process sometimes prioritize the job of making EHRs easy to use below other health IT-related goals (e.g., making EHRs affordable and overcoming providers' resistance to change). Recognizing the potential for this important issue to fall by the wayside, the Office of the National Coordinator for Health IT recently highlighted EHR usability's priority status on the nation's health IT "To Do" list.
Background: Why EHR Usability Is Important

According to the International Organization for Standardization (ISO) -- the world's largest developer of voluntary international standards across various fields -- usability is "the effectiveness, efficiency and satisfaction with which users can achieve a specific set of tasks in a particular environment." In the context of EHRs, usability is often directly correlated with clinical productivity, error rate, user fatigue and user satisfaction, all of which are critical factors for provider adoption. 
Unfortunately, however, it can be difficult to make EHR systems easy to use. The health care industry has a wide range of complex information needs, which vary from setting to setting and among different administrative, financial and clinician groups. There are numerous clinical specialties, and each has its own unique needs. Other clinicians, such as nurses, pharmacists, physical therapists and others, also have unique needs. Further, each discipline may have several different task-related scenarios in a working day, with each scenario demanding a different user interface design. 
While usability is hard to design, it is extremely important to patient safety. The Institute of Medicine addressed the relationship between usability and patient safety in a 2011 report commissioned by ONC, titled "Health IT and Patient Safety: Building Safer Systems for Better Care." According to the report, "usability is a key driver of safety." Many EHRs and other health IT tools provide poor support for the cognitive tasks and workflows of clinicians. This can lead to clinicians spending time unnecessarily identifying the most relevant data for clinical decision making, potentially selecting the wrong data and missing important information that may increase patient safety risks. And if the design of the software disrupts an efficient workflow or presents a cumbersome user interface, the potential for harm rises. 
Despite the many health care industry-specific challenges that make developing usable EHRs a difficult feat, experts agree it can be done. For example, some, like the HIMSS EHR Usability Task Force have "identified certain principles" of EHR usability for vendors to follow when developing their products. These include simplicity, naturalness, consistency, efficient interactions, effective use of language and effective information presentation, among others. 
The need for action on these and other principles related to improving EHR usability is growing.  According to a March 2013 survey of physicians by the American College of Physicians, satisfaction and usability ratings for certified EHRs have decreased since 2010 among clinicians across a range of indicators. Overall, user satisfaction fell 12% from 2010 to 2012. The percentage of clinicians who would not recommend their EHR to a colleague increased from 24% in 2010 to 39% in 2012. Dissatisfaction with ease of use increased from 23% in 2010 to 37% 2012, while satisfaction with ease of use dropped from 61% to 48%.
ONC's Efforts To Improve Usability

 Working with experts in the field and in other government agencies, ONC has been trying to improve EHR usability by:

• Including usability-related requirements in the 2014 EHR Standards and Certification Criteria for EHRs;
• Supporting research on usability under HITECH's Strategic Healthcare IT Advanced Research Projects (SHARP) program; and
• Partnering with other government agencies, such as the National Institute for Standards and Technology and the Agency for Health Care Research and Quality, to convene experts in the field.

2014 EHR Standards and Certification Criteria
The 2014 EHR Standards and Certification criteria set forth the technical capabilities and related standards and implementation specifications that certified EHR technology must include to support the achievement of meaningful use under the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in 2014.
ONC included two new usability-related requirements in the 2014 Criteria:

• One that focuses on EHR vendor application of user-centered design principles to medication-related certification criteria (i.e., the "Safety-Enhanced Design" requirement set forth at §170.314(g)(3) of the Certification Final Rule); and
• Another that focuses on the quality management system that vendors use during the EHR design process (i.e., the "Quality Management System" requirement set forth at (§170.314(g)(4) of the Certification Final Rule).

These criteria address sentiments expressed by the IOM in its 2011 report, including a recommendation that "[t]he secretary of HHS should specify the quality and risk management process requirements that health IT vendors must adopt, with a particular focus on human factors, safety culture, and usability."
Safety-Enhanced Design (§170.314(g)(3))
User-centered design (UCD) is an approach that puts the user, rather than the system, at the center of the software design process. This philosophy incorporates user concerns and advocacy from the beginning of the design process and dictates that the needs of the user should be foremost in any design decisions. Under the new safety-enhanced design requirement in the 2014 Criteria, EHR vendors must apply UCD principles to the following eight EHR capabilities, which ONC believes pose the greatest risk for patient harm: computerized physician order entry; drug-drug and drug-allergy interaction checks; medication list; medication allergy list; clinical decision support; electronic medication administration record; electronic prescribing; and clinical information reconciliation. Vendors may choose their own UCD approach; ONC did not prescribe use of specific UCD processes to meet the criterion.
Quality Management System (§170.314(g)(4))
A quality management system (QMS) is a collection of business processes that enable an organization to meet internally or externally-imposed quality-related requirements. One example is ISO 9001, which provides guidance and tools for organizations that want to ensure that their products and services consistently meet customer requirements and that quality is consistently improved. Under the new QMS requirement in the 2014 criteria, an EHR vendor must indicate the QMS that it used in the development, testing, implementation and maintenance of each capability for which the vendor is seeking certification (e.g., electronic prescribing). Vendors are free to use any quality management system of their choosing (e.g., they may use an industry-standard QMS such as ISO 9001 or they may utilize a modified or "home-grown" QMS). If no quality management system is used, vendors must indicate as such.
SHARP Program Support
Under the SHARP program, ONC has provided funding to several research organizations to develop solutions to problems that impede health IT adoption. SHARP researchers are focused on the following areas:

• Security;
• Patient-centered cognitive support;
• Health care application and network design; and
• Secondary use of EHR data. 

For example, the SHARP C team from the University of Texas at Houston is performing research designed to integrate and support physician reasoning and decision-making as providers care for patients using health IT tools. As part of this work, the researchers are developing tools for EHR usability evaluation, such as Turf, which is an integrated toolkit for evaluating, testing and measuring the design of EHRs from the perspective of usability. Using the tools built into Turf, evaluators can identify design concerns and capture video and still images related to the concerns they identified. Turf employs heuristic evaluation, which is a usability inspection method for computer software that helps to identify usability problems in the user interface design. In a heuristic evaluation, evaluators examine the interface and judge its compliance with recognized usability principles.
The University of Texas researchers have also developed a host of other helpful materials. This includes guidance for EHR vendors to incorporate usability into their development lifecycle, including examples of how vendors can make complex tasks like medication reconciliation easier and more accurate. It also includes safety-enhanced design briefs, which can be used by anyone who develops or implements health IT applications but which may be particularly useful for EHR vendor teams engaged in safety-enhanced designed. The briefs offer concise, actionable recommendations along with visual examples. 
Finally, in partnership with the University of Missouri and the California HealthCare Foundation (CHCF publishes iHealthBeat), the SHARP team will publish an interactive, illustrated "style guide" to enhance EHR usability by recommending common user interface elements for key features such as medication list, allergy list, medication reconciliation, e-prescribing, computerized provider order entry, drug interaction and allergy alerts, and clinical decision support.
Convening Experts
Over the past three years, ONC has hosted an annual usability conference in collaboration with NIST. At the conferences, ONC and NIST have gathered industry experts, health IT developers, provider and patient advocates and representatives of other federal agencies to discuss strategies for improving EHR usability.
These conferences are part of a larger health IT usability initiative in which ONC is engaging with NIST, AHRQ and FDA. The purpose of the initiative is to create a detailed specification for an objective, repeatable procedure for measuring and evaluating the usability of health IT systems. To do so, the initiative is examining the human factors critical to designing usable EHRs and will guide industry in usability engineering practices.
ONC Requests Stakeholder Feedback To Inform Next Steps

Put simply by IOM, health IT should make "the right thing to do the easy thing to do." ONC has taken a number of steps to ensure that EHRs comply with this important maxim.  However, in the rush to launch the Medicare and Medicaid EHR Incentive Programs, many health care providers are now using EHRs whose usability is less than optimal.
Recognizing that more work needs to be done on this important front, ONC is continuing to look for new ways to encourage EHR developers to improve the usability of their products. If you have ideas, or if you have feedback about the appropriate role of government in making health IT tools more user friendly, ONC is actively soliciting stakeholders' perspectives. 
Source: iHealthBeat, Thursday, February 20, 2014