Unsolicited Patient Complaints Following the 21st Century Cures Act Information-Blocking Rule

The 21st Century Cures Act includes an information-blocking rule (IBR) that requires health systems to provide patients with immediate access to their health information in the electronic medical record upon request. Patients accessing their health information before they receive an explanation from their health care team may experience confusion and may be more likely to share unsolicited patient complaints (UPCs) with their health care organization.

To evaluate the quantity of UPCs about physicians before and after IBR implementation and to identify themes in UPCs that may identify patient confusion, fear, or anger related to the release of information.

This retrospective cohort study was conducted with an interrupted time-series analysis of UPCs spanning January 1, 2020, to June 30, 2022. The data were obtained from a single academic medical center, Vanderbilt University Medical Center, at which the IBR was implemented on January 20, 2021. Data analysis was performed from January 11 to July 15, 2023.

Implementation of the IBR on January 20, 2021.

The primary outcome was the monthly rate of UPCs before and after IBR implementation. A qualitative analysis was performed for UPCs received after IBR implementation. The Wilcoxon rank-sum test was used to compare monthly complaints between the pre- and post-IBR groups. The Pearson χ2 test was used to compare proportions of complaints by UPC category between time periods.

The medical center received 8495 UPCs during the study period: 3022 over 12 months before and 5473 over 18 months after institutional IBR implementation. There was no difference in the monthly proportions of UPCs per 1000 patient encounters before (median, 0.81 [IQR, 0.75-0.88]) and after (median, 0.83 [IQR, 0.77-0.89]) IBR implementation (difference in medians, -0.02 [95% CI, -0.12 to 0.07]; P =.86). Segmented regression analysis revealed no difference in monthly UPCs (β [SE], 0.03 [0.09]; P =.72).

In this cohort study, implementation of the Cures Act IBR was not associated with an increase in monthly rates of UPCs. These findings suggest that review of UPCs identified as IBR-specific complaints may allow clinicians and organizations to prepare patients that their test and procedure results may be available before clinicians are able to review them and respond.