Over the last 9 years the US health care system has undergone an unprecedented transition from paper-based clinical record keeping to electronic health records (EHRs). This transition, incentivized by the Health Information Technology for Economic and Clinical Health Act passed in 2009, has many potential benefits for clinicians and patients, including improved efficiency, quality, and safety for many clinical processes.1
Yet as with any major technology transition, there have also been challenges. One of the biggest challenges has been that many clinicians report that EHRs are difficult to use, require too much time to perform certain tasks, and create frustration in performing other tasks, especially those performed infrequently.2 EHR usability, which is the extent to which this technology can be used efficiently, effectively, and safely by clinicians to deliver care, has emerged as one of the most pressing issues in health care.3
But even more important than clinician frustration is the association between EHR usability and potential harm to patients.4 Although these data are limited, and patient harm certainly occurred with paper records, examples of potential harm associated with EHRs include the incorrect medication or the correct medication and an incorrect dose being ordered for a patient because of a cluttered visual display or a setting with an incorrect default.4,5 A key piece of data, such as a markedly elevated blood pressure value, can be missed because that information is not prominently highlighted. These issues can result in errors and can cause harm and, possibly, death.4Improving EHR usability and safety has been stressed as a top priority by federal government agencies, the Institute of Medicine, and the Joint Commission.6,7
A major impediment to addressing usability and safety issues has been the inability of clinicians, researchers, and developers to communicate openly and share specific usability and safety challenges associated with EHR technology. Although medical device companies are required to share usability and safety issues, some EHR vendors have resisted sharing this information—even information related to events that have resulted in substantial harm. Many contracts signed between EHR vendors and health care organizations include clauses that prevent health care organizations from sharing specific information about the EHR product. Such “gag clauses” require authorization from the vendor to share screenshots, videos, and any other information about the purchased EHR product.8 For example, some vendors specify that a clinician who identifies a critical usability and safety issue cannot share a visual example illustrating the issue, which could potentially prevent other clinicians from committing a similar error. A researcher studying usability and safety issues cannot publish a screenshot that may advance EHR design. A vendor may permit release after review of the content, but this process is often lengthy and permission may not be granted.
Even though it is important to recognize the need to protect intellectual property—the issue vendors generally raise when discussing gag clauses—the inability to share critical usability and safety information can affect product improvement and patient safety initiatives. Specific usability challenges associated with a product that may need immediate attention cannot be effectively disseminated with clear illustrations of the issue, preventing important product enhancements that would likely happen without these contract clauses. More generally, without transparency and independent assessments of product usability, purchasers cannot make informed decisions, and EHR vendors have less incentive to compete on usability.
Section 4002 of the 21st Century Cures Act—passed in 2016 with bipartisan congressional support—states that a condition of certification is that EHR vendors cannot prohibit or restrict the communication of information related to the usability of EHRs. Although this is a major step forward, the specific details of what constitutes prohibition and restriction of usability information has not been defined, and it is unclear what actions by an EHR vendor may be included under this provision. As the Office of the National Coordinator of Health Information Technology defines the blocking of usability and safety information under the 21st Century Cures Act, 3 main criteria should be considered.
Identifying usability and safety challenges to optimize EHRs requires the ability to study the usability and safety of this technology systematically using methods such as simulated clinical scenarios and test cases. Some EHR vendors make it difficult to conduct such studies. For example, researchers may not be given reasonable access to the EHR to enter clinical scenarios that are important for studying clinician interaction with the EHR in a controlled manner. EHR testing or research environments, separate from the EHR production system used for clinical care, may not be well developed, preventing the ability to have multiple clinicians interacting with the same patient record to identify variances in their interaction patterns. Without EHR environments that support testing, effective studies of usability and safety threats with appropriate experimental designs are not possible. Policies should require basic EHR functionality for usability and safety testing, such as the ability to enter test cases into the EHR system, and require reasonable access to EHR testing environments.
Health care organizations are often completely reliant on their EHR for delivering clinical care and on their EHR vendor for technical support, upgrades, and numerous other aspects of the technology. This asymmetrical relationship may prevent health care organizations from participating in usability and safety studies and prevent clinicians in those organizations from sharing specific usability and safety challenges, given the need to maintain a positive relationship with their vendor. Policies should prohibit adverse actions that may be taken by EHR vendors to dissuade health care organizations and clinicians from participating in usability and safety research or acting in good faith to report usability and safety issues.
Currently, any visual representation of the EHR product, including screenshots, videos, and mock-ups that closely resemble the EHR product, are prohibited from release under many contracts in the United States. Therefore, this content is not included in journal articles, safety presentations, informational reports that compare EHR products, and even in safety alerts such as those issued by The Joint Commission. However, visuals are critically important for communicating specific usability and safety challenges, particularly because these challenges may be nuanced and difficult to explain with text alone. Policies should require EHR vendors to permit the release of information in a timely manner when it informs the usability and safety of the EHR product and enables comparison of specific challenges across products.
Policies should promote a culture of safety that encourages identification and dissemination of usability and safety issues by EHR vendors and provider organizations. Overall, the inability to address the issues of usability represents a market failure. Government has a critical role in this area, and important policy steps are required to enable research on usability and safety, comparisons of usability among vendor products, and sharing of specific safety incidents. Both clinician satisfaction and patient safety depend on this—and in the end, everyone will benefit, because patient care and EHR technology will improve.
Published Online: November 29, 2018. doi:10.1001/jama.2018.14079
Conflict of Interest Disclosures: Dr Ratwani reported receiving a grant from the Agency for Healthcare Research and Quality. Dr Bates reported receiving a grant from EarlySense and holding equity in ValeraHealth, CLEW, and MDClone. No other disclosures were reported.