OpenNotes continues to monitor the details about the implementation of the Interoperability Rule and may update this web page on occasion.
September 9, 2020
For more information about the ONC Program Rule in its entirety, visit healthit.gov/curesrule
Federal Rules on Interoperability and Information Blocking, and open notes
This web page is not official technical or legal advice. State laws around data release may not superseded by the 21st Century Cures Act. Consult with your organization’s Health Information Management, compliance, legal, finance, and public affairs teams to find out how it applies to you.
The program rule on Interoperability, Information Blocking, and ONC Health IT Certification, which implements the 21st Century Cures Act passed in 2016, requires patients be provided access to all the health information in their electronic medical records without charge by their healthcare provider beginning November 2, 2020.
OpenNotes is invested in the Cures Act because clinical notes are among the information that must not be blocked—and thus be made available to patients.
CMS: Centers for Medicare & Medicaid Services
EHI: electronic health information
EHR: electronic health record
IT: information technology
HHS: U.S. Department of Health & Human Services
ONC: Office of the National Coordinator for Health IT
USCDI: United States Core Data for Interoperability
What notes must be shared?
The eight (8) types of clinical notes that must be shared are outlined in the United States Core Data for Interoperability (USCDI), and include:
- consultation notes
- discharge summary notes
- history & physical
- imaging narratives
- laboratory report narratives
- pathology report narratives
- procedure notes
- progress notes
Clinical notes to which the rules do not apply:
- Psychotherapy notes recorded (in any medium) by a health care provider who is a mental health professional documenting or analyzing the contents of conversation during a private counseling session or a group, joint, or family counseling session and that are separated from the rest of the individual’s medical record. Note: Clinicians and organizations are required to share medication prescription and monitoring, counseling session start and stop times, the modalities and frequencies of treatment furnished, results of clinical tests, and any summary of the following items: Diagnosis, functional status, the treatment plan, symptoms, prognosis, and progress to date.
- Information compiled in reasonable anticipation of, or use in, a civil, criminal or administrative action or proceeding.
What is the timeline for when these new rules go into effect?
Under this new rule, clinical notes must be shared by health systems by November 2, 2020, and shared with a patient’s 3rd party application (e.g., downloaded to a smart phone) by May 2, 2022. (See this rule posted in the Federal Register.)
In light of COVID-19, the ONC announced it will “exercise its discretion in enforcing all new requirements under 45 CFR (Code of Federal Regulations) Part 170 that have compliance dates and timeframes until 3 months after each initial compliance date or timeline identified in the ONC Cures Act Final Rule.” The ‘Discretion’ timeframe is 3 months after the initial compliance date, which would make the Rule enforceable by February 1, 2021.
Are there any exceptions to the Rules?
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.
A group called actors are referred to throughout the rule. Actors include:
- Health care providers
- Health information networks or health information exchanges
- Health IT developers of certified health IT (e.g., electronic health record vendors)
Featured below are the exceptions outlined by the final rule, which fall into two categories (source).
Category 1. Exceptions that involve not fulfilling requests to access, exchange, or use electronic health information (EHI)
- Preventing Harm Exception: It will not be information blocking for an actor to engage in practices that are reasonable and necessary to prevent harm to a patient or another person, provided certain conditions are met.
- Privacy Exception: It will not be information blocking if an actor does not fulfill a request to access, exchange, or use EHI in order to protect an individual’s privacy, provided certain conditions are met.
- Security Exception: It will not be information blocking for an actor to interfere with the access, exchange, or use of EHI in order to protect the security of EHI, provided certain conditions are met.
- Infeasibility Exception: It will not be information blocking if an actor does not fulfill a request to access, exchange, or use EHI due to the infeasibility of the request, provided certain conditions are met.
- Health IT Performance Exception: It will not be information blocking for an actor to take reasonable and necessary measures to make health IT temporarily unavailable or to degrade the health IT's performance for the benefit of the overall performance of the health IT, provided certain conditions are met.
Category 2. Exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI
- Content and Manner Exception: It will not be information blocking for an actor to limit the content of its response to a request to access, exchange, or use EHI or the manner in which it fulfills a request to access, exchange, or use EHI, provided certain conditions are met.
- Fees Exception: It will not be information blocking for an actor to charge fees, including fees that result in a reasonable profit margin, for accessing, exchanging, or using EHI, provided certain conditions are met
- Licensing Exception: It will not be information blocking for an actor to license interoperability elements for EHI to be accessed, exchanged, or used, provided certain conditions are met.
Details regarding conditions that must be met to meet these exceptions can be found on the ONC website.