Electronic health record “gag clauses” and the prevalence of screenshots in peer-reviewed literature

Abstract

Objective

To determine whether the Office of the National Coordinator’s policy change restricting the use of “gag clauses” in contracts between electronic health record (EHR) vendors and healthcare facilities increased the prevalence of screenshots in peer-reviewed literature.

Materials and Methods

We reviewed EHR usability and safety-related peer-reviewed journal articles from 2015 to 2023 and quantified the number of articles containing screenshots. For those that did not contain screenshots, we identified whether they would have benefited from screenshots.

Results

When gag clauses were permitted 6 of 79 (7.6%) of articles contained screenshots and 8 (10.1%) would have benefited from screenshots. When gag clauses were restricted 3 of 40 (7.5%) contained screenshots and 8 (20%) would have benefited from screenshots.

Discussion

The policy change does not appear to have an impact on the prevalence of screenshots in peer-reviewed literature.

Conclusions

Additional steps are necessary to promote the use of screenshots in peer-reviewed literature.

INTRODUCTION

The association between electronic health record (EHR) usability, which is the extent to which the technology can be used efficiently, effectively, and satisfactorily, and patient safety has been well documented.^1–3 Several studies have identified specific EHR usability design flaws that have contributed to patient harm such as medication dose and/or timing information prepopulating to default values in the ordering screen without the ordering provider’s knowledge, cluttered EHR displays that make it difficult to find relevant information, and confusing data entry fields that may result in height/weight documentation errors.^4–6 These usability and safety issues have been identified in EHRs used to provide care to both adult and pediatric populations.^2,7

To improve EHR usability and safety, there has been a call to share screenshots and other media that demonstrate the specific EHR issues that are contributing to patient harm.^8–10 However, historically, contracts between EHR vendors and healthcare facilities have contained non-disclosure clauses, commonly referred to as “gag” clauses.^8,11 These clauses restricted healthcare facility employees from sharing any visual representation of the EHR without special permission from the vendor. The sharing of this information would allow for replicability of studies analyzing design flaws in EHR systems, play an important role in training EHR users on specific safety issues, and serve to more adequately communicate challenges with usability, as compared text-based descriptions alone, to bring greater awareness of EHR usability and safety challenges that could harm patients.

With the growing concerns regarding EHR usability and safety challenges, there has been a push to remove these gag clauses. As a response to this demand, the Office of the National Coordinator for Health Information Technology (ONC) restricted the use of gag clauses in all existing and new vendor contracts as of June 30, 2020, as part of the 21st Century Cures Act.¹² This policy change enables researchers and other stakeholders to openly share EHR screenshots without facing legal repercussions, yet the impact of this policy has not been assessed.

OBJECTIVE

We sought to assess the impact of the gag clause policy change by analyzing the prevalence of EHR screenshots in peer-reviewed literature when gag clauses were in effect compared to when they were restricted. The results of this analysis could provide useful insights into whether the removal of gag clauses has indeed led to better sharing of EHR design flaws associated with patient harm in the peer-reviewed research.

MATERIALS AND METHODS

To assess the impact of the policy change that restricted the use of gag clauses in EHR vendor contracts, we conducted a review of studies published between January 1, 2015 and April 30, 2023. Specifically, we retrieved studies related to EHR usability and safety to determine whether they contained an EHR screenshot, both before and after the policy change.

To identify the relevant studies, we conducted a search using the keywords “Medical Records Systems, Computerized” and “usability,” “patient safety,” or “user-computer interface” in Medline (Ovid), a database of biomedical literature. The search was limited to studies published in the United States and included various types of articles such as case reports, clinical trials, evaluation studies, introductory journal articles, legal cases, observational studies, randomized controlled trials, and reviews.

After retrieving the articles, each article was independently reviewed by the first and last author to determine if it was related to EHR usability and patient safety, contained an EHR screenshot depicting a design or technical issue, and if there was detailed text-based description of an EHR issue that would have benefited from a screenshot if one was not present.

The study was deemed exempt from institutional review by the MedStar Health Research Institute Institutional Review Board as all reports and data used were publicly available.

RESULTS

Between 2015 and 2019, when gag clauses were permitted, 151 articles were retrieved, 79 were relevant to EHR usability and safety, 6 (7.6% of 79) included an EHR screenshot, and 8 (10.1% of 79) would have benefited from a screenshot but did not include one. For the years 2020–2023, after gag clause restrictions, 70 articles were retrieved, 40 articles were relevant to EHR usability and safety, 3 (7.5% of 40) included an EHR screenshot, and 8 (20% of 40) would have benefited from a screenshot but did not include one.

DISCUSSION

Despite the ONC restricting gag clauses in EHR contracts since June 2020, our results demonstrate little impact of the policy change on the use of screenshots in the EHR usability and safety-related peer-reviewed literature. Further, the percentage of articles that would have benefited from screenshot use nearly doubled from when gag clauses were permitted to when they were restricted. There are limitations to this study. When gag clauses were permitted there may have been numerous authors that never considered including screenshots because of the potential implications of doing so. Thus, the count of articles that included screenshots or may have benefited from screenshots may be underrepresented. Also, there is the possibility that articles may have been submitted to journals when gag clauses were in effect but were published by the journal after gag clauses were restricted which would bias our results.

The limited use of EHR screenshots continues to pose several patient safety challenges. Specifically, it limits the ability to communicate key research findings that may serve to increase awareness of specific EHR usability hazards that pose patient safety risks. Further, the lack of screenshots limits the ability to replicate studies since text-based descriptions alone may not provide the full context necessary to design studies appropriately.

Reasons for limited screenshot use may include author and/or publisher confusion over the ONC’s regulatory language restricting gag clauses and the potential for EHR vendor retaliation if product screenshots are published. Healthcare facilities are often reliant on their EHR vendor for product fixes and upgrades and may not want to disrupt the relationship with their vendor. The ONC can take action to ensure stakeholders are aware of the gag clause policy changes and by making it clear that there are implications for EHR vendors if screenshot use is explicitly or implicitly blocked. There may also be a role of journal editorial boards to identify where screenshots may be beneficial to communicating key messages in articles and explicitly asking authors to include screenshots. Promoting the use of screenshots will take deliberate effort and is important for improving EHR usability and safety.

CONCLUSION

Restricting gag clauses has not resulted in an increase in EHR screenshot prevalence in the peer-reviewed literature. Researchers may be unaware of their rights to share screenshots and/or may still feel some pressure to omit screenshots. The lack of screenshots hinders effective communication of EHR usability and safety issues.

FUNDING

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

AUTHOR CONTRIBUTIONS

All authors contributed to the conceptualization of the research question. MB led the analysis with support from KM and RMR. All authors drafted and reviewed the manuscript.

ACKNOWLEDGMENTS

Thank you to the Frank S. Pellegrini, MD Medical Student Research Scholarship Endowment for supporting this work.

CONFLICT OF INTEREST STATEMENT

The authors have no competing interests to declare.

DATA AVAILABILITY

The data underlying this article will be shared on reasonable request to the corresponding author.

REFERENCES