Did the 21st Century Cures Act Patient Data Access Rules Hurt Experience?

The information blocking rule under the 21st Century Cures Act, which eased patient data access, may have had the unintended consequence of disrupting the patient experience, with a new study in JAMA Health Forum showing an increase in patient complaints after the rule’s rollout.

In particular, the information blocking rule may have made it more likely that a patient would get abnormal and potentially upsetting test results via the patient portal before they could meet with a doctor. This may have prompted anxiety and, in turn, the complaints, the researchers said.

This was an inherent risk with the rollout of the information blocking rule, some experts predicted. While patient data access is a fundamental right, many expressed concern about a patient viewing abnormal test results digitally—something the Cures Act facilitates—without the consult of a doctor or other medical professional. These test results could be upsetting, clouding the patient experience.

This latest data, which looks at one academic medical center, corroborates those concerns.

The researchers measured patient experience of the information blocking rule using unsolicited patient complaints (UPCs) because UPCs are reliably coded based on the nature of the complaint.

The team compared the number of UPCs related to communication, documentation, treatment, and diagnosis (CDTD) a year before information blocking rule implementation (January 2020 until January 20, 2021) and for more than a year after (January 21, 2021 until June 30, 2022) at Vanderbilt University Medical Center.

Overall, there were more UPCs after the rule’s implementation (5,473 complaints) than before (3,022 complaints). There was no difference in the monthly rate of UPCs per 1,000 patient encounters before and after rule implementation, but there were specific complaints filed that directly referenced changes made under the information blocking rule.

“In our qualitative analysis of post-[information blocking rule] UPCs, themes were identified regarding diagnostic results from radiology and pathology reports, documentation in the medical record, anxiety related to unexplained medical findings, medical team communication, and unexpected findings in the medical record,” the researchers explained.

In other words, many patient complaints were related to seeing a test or lab result that confused them, they felt went unexplained, or that caused them anxiety.

This study was limited in that it took place in only one academic medical center, plus it did not parse out UPCs that only pertained to the information blocking rule. Still, it adds food for thought as providers continue to navigate the bevy of patient engagement tools that facilitate patient data access.

Moreover, this study counters what some data has found with patient data access and open notes. In particular, a March 2021 study found that patients are okay with getting their lab results via the patient portal, even before they can get counsel from their healthcare providers.

This latest study challenges that notion and provides caveats for clinicians to ensure they can adhere to 21st Century Cures Act provisions while still ensuring a good patient experience. According to the VUMC researchers, ensuring a good experience starts with setting expectations with the patient.

“For example, a practice called precounseling involves communicating to the patient that they should expect results to populate in their online portal and to consider waiting to view them until their follow-up appointment or phone conversation,” the VUMC researchers advised. “Also, having a mechanism within a practice to follow up with patients on potentially worrisome results could help to reassure patients that communication will occur if there is a concern.”

The team also recommended an avenue in which patients could opt in or opt out of viewing protected health information (PHI) via the patient portal or else only opt into seeing abnormal test results. Of course, such programs would require clarifications within the 21st Century Cures Act, the team acknowledged.