Documentation Strategies for Open Notes in Healthcare: The Cures Act

Kathleen Stillwell, MPA/HSA, RN, Senior Patient Safety Risk Manager, and Richard F. Cahill, JD, Vice President and Associate General Counsel, The Doctors Company, Part of TDC Group

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:

• If it is believed that the patient will harm another person or themself as a result of reading a note.
• To protect the security of another person’s electronic health information (e.g., a mother’s health information in a child’s record).
• Mental health notes.

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:

• Document with the knowledge that your patients can and may access their records.
• Invite patients to participate in the note-writing process. During visits, ask patients to read the notes you take to confirm understanding and accuracy. Encourage your patients to access the system later to review the notes.
• Consider formatting your EHR to display your note with the assessment and plan sections as the first items. Your EHR system may allow changes based on your needs; e.g., you document in a typical subjective, objective, assessment, and plan (SOAP) format, but once the note is final, the assessment and plan are displayed front and center.
• Consider composing at least a portion of the note as instructions addressed directly to the patient. Using direct language may help reinforce instructions for patients.
• Emphasize important instructions and information with formatting. If your system allows you to change how text looks, add bolding to important statements or increase the font to a bigger point size.
• Avoid using medical terminology and acronyms or abbreviations. Patients do not expect a layperson’s terminology, but they need to be able to understand the note.
• Make technology work for you. It may be possible to configure your EHR to spell out acronyms and abbreviations automatically. Offer patients a list of common medical or dental abbreviations or provide links to sites that provide an accurate glossary of clinical terms. You may also be able to create templated versions of common explanations that you frequently provide to patients.
• Avoid subjective comments about the patient’s appearance or manner. Instead, use respectful person-first language that maintains the patient’s dignity by seeing the patient as a person first and not labeling an individual with a disease or condition. For example, the patient is affected by obesity instead of the patient is obese.
• Train practice staff to keep any subjective comments out of written communication, task notes, and documentation. Task notes include items like reminders from staff members to practitioners to return a call from the patient and comments exchanged between staff and practitioners.

Get Additional Help

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

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