On April 5, 2021, a requirement of the 21st Century Cures Act went into effect: Patients must be able to access information in their EHRs "without delay." (This requirement does not apply to paper records.) The Cures Act prohibition against information blocking, often referred to as an "open notes" provision, provides patients with transparency in the outcomes of their healthcare via convenient access to information in their EHR, which can positively or negatively impact the patient-doctor relationship.

Patient access to records is not new, and neither is the Cures Act, which dates to 2016. What is new is the requirement that patients have electronic records access that is fast and easy. This requirement is expected to result in more patients—still a small proportion overall, but more patients—accessing additional EHR information, including providers' notes.

The requirement to provide patients with EHR access raises questions for healthcare practices. Some questions are logistical, and some are relational. Concerns include the potential for increased time for patient education, or patient requests for changes to their records that the clinician cannot support.

Healthcare providers should understand the good, bad, and ugly implications of the Cures Act open notes provisions so they can meet the requirements and reap their benefits, while avoiding the potential for fines or sanctions based on noncompliance, or other negative impacts.

Good News About Open Notes

Many patients feel better about their provider after reading a note. Positive effects on the patient-provider relationship may be most significant among vulnerable patients, such as those with fewer years of formal education.

Further, open notes have positive impacts on patient engagement and understanding. Patients report that reading notes is a way to better understand and feel more in control of their healthcare. They also say it builds trust with their provider. The nonprofit organization OpenNotes (not a part of the Cures Act) cites helping laypeople maintain trust in scientific medicine as one benefit of the transparency created by the Cures Act open notes provisions.

Bad News About Open Notes

Concerns about open notes mainly revolve around the potential for conflicts with patients and potential time conflicts. Concerns include:

• Timing: The originally planned implementation date for the open notes provisions in the Cures Act was November 2020. Because of the COVID-19 pandemic, this was pushed back to April 2021. However, many providers and practices are still feeling the pandemic's effects, leading to the question: "Will new demands never end?"
• Uncertainty about the documentation process: Most patients will not understand clinical shorthand, and providers may need added time for explanation. Providers are wondering: "How can I make my notes comprehensible to patients while still writing them quickly?"
• Technology: Some EHR vendors are still racing to provide services that allow practices to remain in compliance with the Cures Act. It may be necessary for a provider to call their EHR vendor and say, "What are you doing to ensure my interoperability compliance?" Meanwhile, secure drop box options for records requests provide a workaround.

Ugly News About Open Notes

Some patient requests for record amendment are legitimate and easily handled. Some patients, however, will request removal of material they find embarrassing, even though it is accurate.

More frequent requests for records changes from patients could increase already weighty administrative burdens on providers. Worse, some of these requests will be for changes providers cannot support, and making time for careful conversations with patients and providing written responses for requests that are rejected will be a challenge. Inevitably, some of these conversations will not go well, whether through the patient feeling the provider did not adequately respond to their concerns, or through the patient insisting on unreasonable demands. These negative relationship outcomes will add emotional stress on both the patient and the provider, as well as a reputational threat to providers from angry patients posting negative reviews online.

More tangibly, noncompliance with the open notes requirement carries the potential for fines, penalties, and/or sanctions from medical boards. The specifics of potential penalties are not yet known—there are more changes coming with the Cures Act.

Making Changes in Open Notes

Patients will ask providers to amend their medical records. Be familiar with what the patient has the right to ask, what the provider can grant and/or refuse, and how to amend notes. Here are some highlights:

• Patients have the right to request amendments to their medical records: The Health Insurance Portability and Accountability Act (HIPAA) requires a signed, dated request from the patient regarding what they want changed and why.
• Providers have the right to determine whether the requested amendment will be made: The provider must respond, in writing, within 60 days of receipt of the patient's request.
• Common reasons to deny a patient's request include that the provider who received the request did not create the record entry, or that the medical record is accurate as is.
• The patient's request and the provider's response both become part of the patient's medical record.

Strategies for Success

When composing notes, certain simple strategies will raise the odds that notes will be well understood and well received. Beyond being clear and succinct, strategies for success include composing at least a portion of the note as instructions directly addressed to the patient—"Start taking lisinopril and check your blood pressure twice a week," vs. "Initiated lisinopril and instructed her to check her blood pressure twice a week"—and providing a list of commonly used medical terms and abbreviations.

For an in-depth review of strategies for success when composing notes, see 12 Strategies for Success With Open Notes in Healthcare: The Cures Act.

Exceptions

Unless an exception applies, clinical notes must not be blocked, but the Cures Act allows for a fairly long list of specific, well-delineated exceptions. For instance, a record can be blocked if a provider believes that viewing a note presents a substantial risk of harm to the physical safety of the patient or someone else. The Cures Act also recognizes exemptions that apply to certain caregiving situations, such as when parents attempt to access confidential parts of an adolescent child's records.

For information regarding exceptions to open notes, please see What Open Notes Exceptions Does the Cures Act Allow?

Seeing Open Notes as Part of High-Touch, High-Value Care While many physicians and other providers have anticipated open notes with dread, most outcomes so far have been positive. Patients have reacted well to clarity. They have used open notes as a tool to improve their own understanding of and adherence to care instructions. When patients have noted valid issues or miscommunications, they have appreciated being able to quickly clear them up. More than an administrative burden, open notes present an opportunity to improve documentation, patient-provider relationships, and patient safety. By improving patient adherence to treatment plans, open notes have the potential to improve provider satisfaction, as well.