The usability of EHR systems, while recognized as a critical factor in the successful adoption, safe and effective use of these systems, has not historically received the same level of attention as software features, functions and technical requirements. In recognition of the importance of this issue, the Agency for Healthcare Research and Quality (AHRQ) initiated a series of research activities focused on assessing and improving the state of usability in Electronic Health Record (EHR) systems.
Based on a research gap identified by a multi-disciplinary expert panel formed to recommend and prioritize research and policy actions in this area, AHRQ funded a follow-on project to gain insight into the processes and practices that certified EHR vendors employ during different phases of the product development to make their products usable.
Specifically, AHRQ contracted with James Bell Associates and the Altarum Institute to conduct a series of structured discussions with selected certified EHR vendors to understand their processes and practices with regard to:
- The existence and use of standards and “best practices” in designing, developing, and deploying products
- Testing and evaluating usability throughout the product life cycle
- Supporting post-deployment monitoring to ensure patient safety and effective use
- Vendors perspectives on the role of certification in evaluating and improving usability
While all vendors interviewed for the report expressed a deep commitment to the development and provision of usable EHR product(s) to the market, vendors described an array of usability engineering processes and the use of end users throughout the product life cycle, practices such as formal usability testing, the use of user-centered design processes, and specific resource personnel with expertise in usability engineering are not common.
Because nearly all vendors view usability as their chief competitive differentiator, collaboration among vendors with regard to usability is almost nonexistent. Specific best practices and standards of design, testing, and monitoring of the usability of EHR products are not readily available. Vendors reported use of general (software) and proprietary industry guidelines and best practices to support usability. Reported perspectives on critical issues such as allowable level of customization by customers varied dramatically.
Surprisingly, many vendors did not initially address potential negative impacts or harms caused by their products as a priority design issue. Vendors reported a variety of formal and informal processes for identifying, tracking, and addressing patient safety issues related to the usability of their products. Most vendors reported that they collect, but do not share, lists of incidents related to usability as a subset of user-reported “bugs” and product-enhancement requests. While all vendors described a process, procedures to classify and report usability issues of EHR products are not standardized across the industry.
No vendors reported placing specific contractual restrictions on disclosures by system users of patient safety incidents that were potentially related to their products.
Disagreement exists among vendors as to the ideal method for ensuring usability standards, and best practices are evaluated and communicated across the industry as well as to customers. Many view the inclusion of usability as part of product certification as part of a larger “game” for staying competitive, but also as potentially too complex or something that will “stifle innovation” in this area. To overcome competitive pressures, many vendors expressed interest in an independent body guiding the development of voluntary usability standards for EHRs. This body could build on existing models of vendor collaboration, which are currently focused predominantly on issues of interoperability.
Key recommendations from the project’s expert panel echo and build on their policy recommendations from the initial AHRQ-funded project in this area
First, the panel recommends establishment of usability / information design of EHRs as an essential part of the certification requirements for EHRs, basing certification on a practical and fair process of usability evaluation, and designing certification programs for EHR usability in a way that focuses on objective and important aspects of system usability.
Findings also reinforced the prior recommendation to require/strongly recommend that vendors establish and document their programs for testing the usability of their systems (people and processes), including evaluating potential impacts on quality and safety by finding ways to encourage vendors to address key shortcomings that exist in current processes and practices related to the usability of their products. Most critical among these are lack of adherence to formal user-design processes, dependence on post-deployment review supporting usability assessments, and a lack of diversity in end users involved in the testing and evaluation process. Potentially under-sampled populations include end users with limited past experience with health information technology and those with disabilities (only one vendor mentioned efforts to make their products accessible for healthcare professionals with disabilities).
The lack of voluntary collaboration among vendors supports the panel’s prior recommendation for a “National EHR Usability Laboratory” or independent body to support public-private efforts to overcome market forces that discourage collaboration, development of best practices, and standards harmonization in this area. Such a body could also support development of best practices around EHR usability / information design customization during system deployment and use.
Finally, the panel recommended the development of tools and processes to support evaluation of the usability and information design of EHR products and their implementations. AHRQ is working closely with the National Institute of Standards and Technology (NIST) and the Office of the National Coordinator (ONC) to address this and other recommendations identified in its research. In June, AHRQ plans to award a follow-on project for the development, testing and dissemination of an easy-to-use, objective and evidence-based toolkit that healthcare organizations can use to evaluate critical aspects of their EHR systems’ usability, accessibility and information design. In addition, NIST is currently seeking applications for development of an EHR usability evaluation framework and ONC, AHRQ NIST and other agencies are collaborating on a joint conference in July to promote collaboration in health IT usability among government, industry, and academia to prioritize, align and coordinate short, medium, and long term strategies and tactics to improve the usability of EHRs.