Federal Regulators Increase Focus on Patient Risks From Electronic Health Records

Insights from clinicians will help reduce potential for medical errors tied to software usability flaws

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Federal Regulators Increase Focus on Patient Risks From Electronic Health Records

As part of a federal program to routinely publish data on the capabilities of electronic health record (EHR) systems, the government recently finalized a component that will help collect information from doctors, nurses, and other clinicians about the effects of these technologies on patient safety.

The Office of the National Coordinator for Health Information Technology (ONC) will collect clinicians’ feedback through a survey developed by the Urban Institute under a contract with the agency. ONC will release aggregated results as part its EHR reporting program. Congress required the program’s creation in the 21st Century Cures Act, the wide-ranging federal health legislation enacted in 2016. The act directs ONC to determine which data to gather from health information technology vendors. That information can then be used to illuminate the strengths and weaknesses of EHR products, as well as industry trends.

The Pew Charitable Trusts, major medical organizations and hospital groups, and health information technology experts have urged that the reporting program examine usability-related patient risks. Confusing, cumbersome, and poorly customized EHR systems can cause health care providers to order the wrong drug or miss test results and other information critical to safe, effective treatment. Usability challenges also can increase providers’ frustration and, in turn, their likelihood of making mistakes.

The data collected from clinicians will shed light on these problems, encourage developers to improve the safety of their products, and help hospitals and doctor’s offices make better-informed decisions about the purchase, implementation, and use of these tools. Research shows that aggregated data about EHRs can generate product-specific insights about safety deficiencies, even when health care facilities implement the same system in distinct ways.

Importantly, the survey plan unveiled in October created opportunities for health care providers to share EHR input, and specifically any usability-related safety concerns. In August, Pew and MedStar Health, the operator of 10 hospitals in the mid-Atlantic region, had recommended the change in comments on the agency’s initial proposal. For example, the final survey includes open-ended questions about clinicians’ perceptions of patient risks in the EHRs they use. In addition, the section on high-risk software functions, such as automated alerts about drug interactions, was augmented to solicit views on their safety, not simply their ease of use.

However, ONC can still do more to ensure that the EHR reporting program spurs advances in the safe design and use of digital health record systems. The Cures Act requires the agency to gather data from EHR vendors about their products and publicly release assessments of these tools with measures that include usability. ONC also should require that vendors report on their methods to identify and reduce patient risks related to a product’s usability.

To inform the agency’s work in this area, Pew and MedStar published a brief in March 2020 that proposed 15 evidence-based reporting criteria for EHR vendors. The criteria cover overall product design and testing processes as well as system functions with significant implications for patient care, such as interfaces for medication orders and alerts that warn clinicians of potential safety issues.

Such information from vendors—together with clinicians’ survey responses—would help EHR developers, health care facilities, researchers, and regulators detect and remedy risks arising from a product’s original design or how it has been customized and used in individual hospitals and medical practices. These complementary components should lead to EHRs that are both easier to use and less likely to lead to medical errors.

Ben Moscovitch directs The Pew Charitable Trusts’ health information technology initiative.