Electronic health records have transformed modern medicine, giving doctors and nurses better data to guide care, supporting enhanced patient safety through new automated tools, and creating more efficient processes by connecting different health systems.
However, the design, customization, and use of electronic health records (EHRs) by doctors, nurses, and other clinicians can also lead to inefficiencies or workflow challenges and can fail to prevent—or even contribute to—patient harm. For example, an unclear medication list could result in a clinician ordering the wrong drug for a patient. Laboratory tests that are displayed without the date and time of the results could lead to clinical decisions based on outdated information. And failures of systems to issue alerts about harmful medication interactions—situations that can stem from changes made by facilities, how clinicians enter data, or EHR design—could lead to medical errors.
These safety hazards can be associated with EHR usability, which refers to the design and use of the technology and how individuals interact with it. Usability challenges can frustrate clinicians because they make simple tasks take longer, lead to workarounds, or even contribute to patient safety concerns. These challenges can stem not only from the layout of EHRs, but also from how the technology is implemented and operated in healthcare facilities; how clinicians are trained to use it; and how the EHR is maintained, updated, and customized. Each stage of EHR development and use—the software life cycle from development through implementation and use in a healthcare environment—can affect the usability and safety of the technology.
While usability and patient safety are related, not every usability challenge will represent a risk to patients, and not every risk to patients stems from an EHR usability problem. In fact, some changes to EHRs might improve safety but result in less-efficient workflows—for example, if clinicians were prompted to enter “lbs.” or “kg.” every time they entered a patient’s weight. But when a system is challenging to use or patient information is difficult for a clinician to find, safety risks could occur.
As part of federal criteria that provide the certification standards for EHRs, technology developers must state that they engage end users and conduct usability testing during design and development. However, the certification requirements can fall short in two ways when it comes to assessing whether the use of products contributes to patient harm.
First, current federal testing criteria do not address circumstances in which customized changes are made to an EHR as part of the implementation process or after the system goes live. Instead, current rules focus only on the design and development stage of the EHR. While federal regulations mandate the testing of certain safety-related features—such as medication-allergy checks—the requirements do not focus on whether those functions operate in a safe way.
The second key challenge is the absence of requirements and guidance on how to test clinician interaction with the EHR for safety issues. Clinical test cases, which are scenarios that reflect realistic patient conditions and how healthcare providers treat individuals, can help detect hazards. However, there are no clear criteria for what constitutes a rigorous test scenario. Similarly, some of the scenarios for certification, while testing that certain functions work, may not effectively evaluate the EHR for usability or safety. Current certification test cases can be too specific, lack relevant details, or may not test aspects of the EHR that are recognized as posing safety risks.
