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Laboratory tests that are displayed without the date and time of the results could lead to clinical decisions based on outdated information.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 health care 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 health care environment—can affect the usability and safety of the technology.
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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.
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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 health care 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.
Unlike many other high-risk sectors, such as the airline and medical device industries, there is no standard for routinely testing health care software for safety issues and concerns.
To address these two challenges, The Pew Charitable Trusts, MedStar Health’s National Center for Human Factors in Healthcare, and the American Medical Association conducted a literature review and convened a multidisciplinary expert panel composed of physicians, nurses, pharmacists, EHR vendors, patients, and health information technology experts. This information led to the development of:
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Use of the voluntary certification tenets and test cases by health care facilities and technology developers can improve the usability and safety of EHRs. They also allow for the proactive identification of potential harm associated with the implementation and customization of EHRs.
EHR software must meet minimum certification criteria established by the federal government to ensure that it can share data, provide key capabilities to clinicians, and protect patient privacy. The current EHR certification program—implemented by the federal Office of the National Coordinator for Health Information Technology (ONC)—is intended to set the baseline standards that EHRs must meet so that hospitals and health care providers can confidently adopt and use the technology to meet requirements in certain federal programs.
Regardless of which test cases are used, ONC’s usability criteria require the testing of certain EHR functions, such as the ability to order medications electronically and receive medication alerts. The NIST-developed test cases do not explicitly address each of the required functions laid out in ONC’s certification regulations.
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The Health Information Technology for Economic and Clinical Health (HITECH) Act, passed in 2009, established the Medicare and Medicaid EHR Incentive Program—known as Meaningful Use—to provide financial incentives for hospitals and doctors’ offices to purchase and utilize electronic health records. The program has provided more than $37 billion
To obtain those incentive payments, hospitals and doctors had to demonstrate that they used EHRs in certain ways—such as by sending prescriptions to pharmacies electronically instead of on paper.
To provide assurances to hospitals and doctors that the EHRs they use can perform those functions, HITECH also created the EHR certification program administered by ONC. This establishes technological requirements for EHRs, including their functions, how to record information, and security features. ONC has periodically updated the requirements. The initial certification requirements were published in 2010 (2011 Edition), with updates in 2012 (2014 Edition) and 2015 (2015 Edition).
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To obtain certification, EHR developers submit data on their products to accredited testing labs for review. The labs forward their findings to an ONC-authorized certification body, which issues a certification based on the lab’s finding.
In September 2017, ONC modified its testing requirements to require health IT developers to state that they meet 30 certification criteria (approximately half of the total) instead of having them reviewed by an accredited testing lab.
In 2016, ONC issued regulations giving it direct authority to enter health care facilities and review and test EHRs that posed serious risks to patients. If a risk was found, ONC could require the health IT developer to fix the problem or suspend certification of products with unresolved problems.
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In 2017, ONC announced it would no longer require testing labs to perform random surveillance to allow labs to focus on complaint-based investigations.
However, the 21st Century Cures Act requires health IT products to meet new criteria for EHRs used in the care of children, which affords another opportunity to improve safety.
Many EHR developers and health care providers have engaged in additional efforts to improve usability and safety throughout the product life cycle:
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These practices can serve as the foundation for a more comprehensive certification program during product development and after implementation to improve EHR safety.
Several factors throughout the EHR life cycle affect usability and safety. Current certification tests are focused on evaluating the usability of key system requirements. According to published articles and experts consulted, best practices for testing, which are not required, include:
Given the gaps of current regulations and practices implemented by health care facilities and technology developers, the literature review and expert panel discussions identified additional initiatives that could improve EHR safety.
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Several additional best practices, criteria, and factors emerged from the literature review and expert panel discussions that could help EHR developers and health care facilities improve product usability and safety. These criteria could provide a foundation for a voluntary certification program. Given that both EHR developers and health care providers have roles in ensuring the safe use of products, specific criteria were established for each. Additional standards for improving safety are also under development by the American Association of Medical Instrumentation.
Several discrete actions and criteria were also identified that developers and health care providers should undertake. A voluntary certification program that encompasses these components could ask developers and providers to consider each criterion and, where appropriate, to adopt and implement these methods and processes. While the criteria provide a framework for factors that can be included in voluntary certification programs, each institution creating such a program would have to tailor it to its specific goals and mission.
By focusing on the entire EHR life cycle and having specific criteria in place to improve usability and safety, the voluntary certification framework can augment the current certification process. Adherence to these recommendations by EHR developers and health care providers can reduce the likelihood of unintended patient harm from clinician use of this technology.
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To identify and address usability and safety challenges with EHRs before health care facilities use them in patient care, one method developers typically use is to evaluate their products with clinical test cases.
These cases are scenarios that reflect realistic patient conditions as well as the clinician tasks that would occur in caring for an individual. The scenarios allow for the observation of clinicians interacting with the EHR
