The federal rule on interoperability and information blocking mandates that healthcare providers offer patients access to all the health information in their medical records “without delay” and without charge.
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The federal rule on interoperability and information blocking mandates that healthcare providers offer patients access to all the health information in their medical records “without delay” and without charge.
November 2023 – ”Disincentive Penalties for Information-Blocking Providers” proposed by the Department of Health and Human Services (HHS). This proposed rule was posted to the Federal Register and is taking comments until 11:59 p.m. ET on January 2, 2024.
The rule will affect physicians who participate in the Medicare program.
As of April 2021, “blocking” patients from their own health records is against the law and may result in fines for hospitals and clinicians. Learn how the Cures Act and information-blocking rule affect patients at WhereIsMyMedicalRecord.org.
The Cures Act final rule and information-blocking guidelines apply to:
For more details about each of these groups, review this document from the Office of the National Coordinator for Health Information Technology (ONC). If you or your job is listed in this document, the Cures rule applies to you.
In June 2023, the Department of Health and Human Services Office of the Inspector General (OIG) posted its final rule implementing information-blocking penalties. The final rule established statutory penalties created by the 21st Century Cures Act.
These penalties apply to electronic health record vendors (EHRs), health information exchanges, and health information networks (HINs).
If OIG determines that individuals or entities have blocked information, they may be subject to a penalty of up to one million dollars per violation.
Only certain entities are subject to an OIG information-blocking penalty:
All notes must be shared with patients. On October 6, 2022, the definition of electronic health information (EHI) in the 21st Century Cures Act expanded. It now encompasses not only the United States Core Data for Interoperability (USCDI) Version 1, but also all electronic protected health information (ePHI).
PHI encompasses any identifiable health information about a patient that is used, maintained, stored, or transmitted by a health care provider who bills an insurance company for services provided to any patient—also known as a covered entity. To be clear, patient access isn’t affected by whether the patient has insurance or not.
With this change to the interoperability and information blocking rule, EHI now extends to the designated record set (as defined by the Health Insurance Portability and Accountability Act), which includes both medical and payment records. This means the rule now applies to any information that could be used to make decisions about individuals, including patients. For entities subject to information-blocking rules, all ePHI within a designated record set will be treated as EHI and subject to the rules.
EHI could include:
More information about EHI and ePHI can be found at HealthIT.gov.
Yes. There are complex situations in which information can be blocked—and these are called exceptions. Unless one of the exceptions applies, clinical notes must not be blocked.
For complete details, refer to the information-blocking FAQ on HealthIT.gov.
Summary of the Exceptions
The rule refers throughout to “actors.” They include:
We list below exceptions outlined by the final rule. These fall into two categories (source).
Category 1. Exceptions that involve not fulfilling requests to access, exchange, or use electronic health information (EHI):
Category 2. Exceptions that involve procedures for fulfilling requests to access, exchange, or use of EHI:
Details regarding conditions that must be met to fulfill these exceptions can be found on the ONC website.
There are a few types of clinical notes to which the rules do not apply. Examples include:
Under the Cures rule, in certain specified situations, you can block (or “hide”) information from patient access on online portals. These are known as exceptions. For instance, you can block information in the following scenarios:
Unless one of the exceptions applies, clinical notes must not be blocked. Details about exceptions are outlined at HealthIT.gov.
So far, studies suggest that some clinicians are changing the way they write notes in response to open notes implementations, while some are not. However, many clinicians experienced in sharing notes have reported positive changes in the way they write their notes, commenting that that the notes have become more valuable overall, especially to patients.
Few report “dumbing down” their language. Instead, they find themselves using fewer abbreviations in their notes and trying to avoid language that could appear judgmental to patients. Some report modulating their approach so that their notes become “teaching notes.”
In general, patients do not expect clinicians to write notes in layperson language, and in one large study, more than 90% report understanding their notes well. Studies suggest that most patients are not bothered by terms they don’t understand; they are happy to research them. They feel reading notes helps them prepare more focused questions for clinicians. Overall, studies show repeatedly that patients are enthusiastic about having a window into more information about their health.
Resources:
The 21st Century Cures Act was signed into law by President Barack Obama in 2016 with overwhelmingly bipartisan support. Information sharing is central to the Cures Act. The Cures Act Final Rule—also known as the “information blocking rule,” which defines what and how information must be shared with patients—was released by the Office of the National Coordinator for Health Information Technology (ONC) in 2022.
Some refer to this as the “information sharing rule.” It mandates that patients have rapid, free, and full access upon request to test results, medication lists, referral information, and clinical notes, all in electronic formats.
Some refer to the Cures Act final rule as the “Open Notes Rule.” This is inaccurate. While ONC strongly supports the concept of open notes and the efforts of the OpenNotes movement based at Beth Israel Deaconess Medical Center, it's important to note that the Cures Act final rule and open notes are not synonymous. The final rule extends well beyond clinical notes.
This web page hosted by OpenNotes is for informational purposes only and does not confer official technical or legal advice.
State laws around data release may not supersede the 21st Century Cures Act. The Cures Act final rule specifically states that information need not be released to patients if such release is prohibited by other laws. For example, the California Health and Safety Code limits the online release of the specified results related to HIV antibodies, hepatitis antigens, “abusing the use of drugs,” and malignant pathology.
When necessary, and when possible, health care providers should consult with their organization’s Health Information Management, compliance, legal, finance, and public affairs experts/teams to find out how the rule applies to them.
July 2022: Information Blocking Rule includes ePHI
October 2020: Open notes compliance date
March 2020: OpenNotes Celebrates New Federal Rule on Transparency for Patients
For more information about the ONC Program Rule in its entirety, visit healthit.gov/curesrule.
OpenNotes monitors details affecting the implementation of the 21st Century Cures Act information-blocking rule and provides updates on this web page periodically.
LAST UPDATED:
December 22, 2023
CMS: Centers for Medicare and Medicaid Services
EHI: electronic health information
EHR: electronic health record
IT: information technology
HHS: U.S. Department of Health and Human Services
ONC: Office of the National Coordinator for Health Information Technology
USCDI: United States Core Data for Interoperability
NEW WEBINAR
Getting It Write: What To Do Now That Patients in England Can Read Their GP Notes
Tuesday, November 1, 2022 | 8am Pacific Standard Time (PST)
11am Eastern Standard Time (EST) / 3pm Greenwich Mean Time (GMT)
While open notes have been the “law of the land” in the United States for more than a year, in England, adult patients accessing care through the National Health Service (NHS) will have access to their primary care record online for the first time starting Nov. 1, 2022.
In this webinar, we’ll be joined by open notes experts and discuss what this change means for patients and general practitioner (GP) staff in England.