Documentation Strategies for Open Notes in Healthcare: The Cures Act

On April 5, 2021, the 21st Century Cures Act prohibition on information blocking (also known as the open notes requirement) went into effect. The Cures Act Final Rule requires that patients must be able to access information in their EHRs “without delay” and provides transparency by allowing patients convenient access to their electronic health information.

Effective October 6, 2022, the Act extended unblocking of clinical information to allow patients access to electronic health information included in the designated record set as defined by HIPAA—which includes “medical records, billing records, payment and claims records, health plan enrollment records, case management records, as well as other records used, in whole or in part, by or for a covered entity to make decisions about individuals” (45 CFR 164.501). Patients are now able to view electronic record notes exchanged between staff and practitioners if the information was used to make decisions about the individual.

Exceptions apply in certain situations, however, when information may be blocked or “hidden” from patient access on online portals. Examples of exceptions include the following:

Access to Test Results

While emphasis has been placed on giving patients immediate access to the practitioner’s notes, the 21st Century Cures Act also includes a requirement for immediate patient access to test results. Many states, however, have laws requiring that certain test results, such as a diagnosis of a malignancy, be conveyed by a licensed practitioner. If either an exception or a state law exists, the practitioner would not be considered to be information blocking by delaying the release of certain test results to the patient.

An example of this exception is California Health and Safety Code 123148(f). The law requires that a healthcare professional disclose certain test results “in person, by telephone, or by other means of oral communication.” This includes an initial diagnosis of HIV, hepatitis infection, abusing the use of drugs, or a new or recurring malignancy.

The Office of the National Coordinator for Health Information Technology (ONC) has stated that enforcement of this regulation will be determined through a “fact-based, case-by-case assessment of the circumstances.” It has also been stated, however, that if a facility imposes a delay on all test results in order to provide the practitioner with time to review the results prior to their release, that situation would be considered an interference under the information blocking regulation.

Strategies for Success

Consider the following strategies to help ensure that your notes will be well received by patients:

Get Additional Help

For additional assistance, contact the Department of Patient Safety and Risk Management at (800) 421-2368 or patientsafety@thedoctors.com.

Frequently Asked Questions: Filter questions by topic or category

Information Blocking and Blocking Exceptions: Find definitions and links to blogs, journal articles, data briefs, and a PDF handout of the exceptions.

ONC’s Cures Act Final Rule: View the Final Rule and find information about laws, regulation, and policy.

United States Core Data for Interoperability (USCDI): Find information about EHR interoperability under the Cures Act.

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

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