EHRs Lack Standards, Best PracticesEHRs Lack Standards, Best Practices

A report raises growing concerns that electronic health record products are being developed without specific best practices and design standards related to EHR product use in a healthcare setting. To overcome this difficulty, many vendors support an independent body guiding development of voluntary usability standards for EHRs, the study found.

The Electronic Health Record Usability Vendor Practices and Perspectives report was published this month by the Agency for Healthcare Research and Quality. The study, which was conducted by James Bell Associates and the Altarum Institute on behalf of AHRQ, interviewed vendors of ambulatory EHR products that came on the market during the mid-1990s to 2007.

The study's objective was to examine vendors' 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; and supporting post-deployment monitoring to ensure patient safety and effective use.

The adoption of EHRs is a cornerstone of President Obama's healthcare reform strategy, with billions of dollars earmarked in the American Recovery and Reinvestment Act to fund a new healthcare IT infrastructure. The adoption of EHR technology is pivotal to that strategy, with the government declaring that its goal is to provide every citizen with an electronic health record by 2014.

Given the importance of EHR implementation to the success of healthcare reform, along with the strategy to demonstrate meaningful use of technology to improve patient outcomes, vendors should follow specific best practices and standards relating to health IT and incorporate them in their workflow during different phases of product development. According to the report, however, this is not happening.

The report noted that because comprehensive standards for EHR specific functionalities are lacking, vendors rely on general software design best practices to inform design, development, and usability. The result, vendors say, is that while these software design principles guide their process, they must be adjusted to fit specific customer needs in a healthcare environment.

"In addition to following existing general design guidelines such as Microsoft Common User Access, Windows User Interface, Nielsen Norman Group, human factors best practices, and releases from user interface and usability professional organizations, many vendors consult with Web sites, blogs, and professional organizations related to health IT to keep up-to-date with specific industry trends," the document said. The majority of vendors also said that usability assessments and evaluations are not a common activity during the design and development process. "There was a common perception among the vendors that usability assessments are expensive and time consuming to implement during the design and development phase," the report said.

The document went on to say: "Although vendors described an array of usability engineering processes and the use of end users throughout the product lifecycle, 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."

Additionally, end-user involvement during product development is often limited to workgroups, advisory panels, or clinicians who have a strong interest in technology and are part of an academic medical center. Vendors say they turn to these groups to provide feedback when developing initial product requirements, evaluating wireframes and prototypes, and participating in initial beta testing.

Based on its findings the AHRQ made the following eight recommendations.