Open Notes as Mandated by the 21st Century Cures Act:
A Clinician's Condensed Guide

21 century cures act condensed guide

In 2016, the 21st Century Cures Act came into effect under President Obama; as of April 5th, 2021, the program rule on Interoperability, Information Blocking, and ONC Health IT Certification, which implements the Act, has set forth new standards for clinicians in sharing patient information.

Information sharing is a central tenet of the Act; in fact, many refer to it as the 'information sharing rule'. Issued by the Office of the National Coordinator for Health IT (ONC), the Act requires clinicians to give patients access to their healthcare records.

The Act also mandates that this information be provided in a secure, automated format at low-to-no cost to the patient. The goals of the Act are to empower patients through easy access to their electronic healthcare information (EHI) and to prevent information blocking in the healthcare industry.

The Cures Act Final Rule is also referred to by some as the 'Open Notes Rule'. Yet while ONC supports open notes, the Final Rule covers more than just clinical notes. It should also be noted that the origin of the open notes concept is OpenNotes, a movement that started at Beth Israel Deaconess Medical Center in Boston.

What Qualifies as an Open Note?

Almost all clinicians record notes after a healthcare visit. These notes include relevant information on the patient; they then become part of the patient's medical records. Once shared with patients, they become an 'open note'.

There are eight types of notes that the Cures Act Final Rule says clinicians must share, including:

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    Consultation notes.

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    Medical history & physical.

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    Discharge summaries notes.

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    Imaging narratives.

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    Lab report narratives.

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    Pathology report narratives.

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    Procedure notes.

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    Progress notes.

There are some exceptions to the rule; for example, psychotherapy notes are protected under HIPAA. Notes relating to civil, criminal, or administrative proceedings may also be an exception.

The Power of Open Notes to Enhance Patient Care

There are several reasons that giving patients access to their health records may enhance patient care.

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    Patients can use open notes for clarification and answers to questions between visits.

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    Notes help caregivers and families to collaborate with patients on health issues.

Studies have also found that over 90% of patients are able to understand their notes, which clears the way for a feeling of empowerment and control.

Open Notes and HIPAA

The HIPAA Right of Access requirement already gives patients the right to access their own health information. This information is contained in 'designated record sets' and maintained by clinicians and health plans.

Designated record sets may include:

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    Billing & claims records.

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    Case management notes.

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    Enrollment in health plans.

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    Medical records.

They may also contain information used by an entity to make decisions about a person, such as:

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    Clinical notes.

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    Disease management information.

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    Insurance information.

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    Lab test results.

The HIPAA Right of Access requirement is in keeping with the new information-sharing mandates. The Interoperability and Information Blocking Rules around Open Notes work well with HIPAA.

Clinicians will find that adherence to the new ruling will fit well with compliance while enhancing patient trust and relationships. In fact, studies have shown that 85% of patients report that they would choose a doctor based on the availability of open notes, which makes the new transparency the future of patient care.