ONC Final Rule on Information Blocking
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Beginning in April 2021, patients will have the right to directly access their electronic health information under a new federal requirement. On May 1, 2020 the DHS Office of the National Coordinator for Health Information Technology (ONC) issued a Final Rule on Interoperability, Information Blocking, and the ONC Health IT Certification Program (part of the 21st Century Cures Act). The law is also known informally as the “Open Charts law.”
The Final Rule prohibits the practice of “information blocking,” which is defined as any practice which is likely to interfere with access, exchange, or use of electronic health information (EHI) by patients or other health care providers.
The Final Rule does not affect patients’ existing right of access to their own health information, as required under HIPAA and state laws; rather, it outlines how this information needs to be made available to patients and other providers.
The Final Rule applies to all “health care providers” as defined by the Public Health Service Act (42 U.S.C. 300jj). Physicians, physician assistants, nurse practitioners, clinical nurse specialists, CRNAs, CNMs, clinical social workers, clinical psychologists, and registered dieticians/nutritionists are included in this definition. Additionally, the Final Rule applies to all “actors” including hospitals and other medical facilities, developers of certified health IT, Health Information Exchanges and Health Information Networks (HIEs/HINs).
Importantly, the deadline for provider compliance was recently delayed from November 2, 2020 to April 5, 2021 in light of the ongoing COVID-19 pandemic. However, with the approaching November deadline, many health care systems, hospitals, and other healthcare facilities have already changed their EMR systems to comply with the new requirements.
Now that the deadline has been extended, individual medical practices now have more time to prepare for compliance with the requirements of the Final Rule. In essence, providers are required do two things:
- Provide patients with access to electronic health information in a form convenient for the patient, such as through the adoption of standards and certification criteria.
- Implement information blocking policies that support patient electronic access to their EHI at no cost.
What Types of Information are Included?
There are 8 types of clinical notes that must be made available according to the U.S. Core Data for Interoperability (USCDI):
- Consultation notes
- Discharge summary notes
- History & physical
- Imaging narratives
- Laboratory report narratives
- Pathology report narratives
- Procedure notes
- Progress notes
Importantly, the following types of notes are not included:
- Psychotherapy notes: As defined in 45 CFR 164.501, notes recorded (in any medium) by a mental health professional documenting or analyzing the contents of a conversation during a private counseling session or a group, joint, or family counseling session. Psychotherapy notes must be separated from the rest of the medical record.
Providers must still share other mental health records, including:- medication information
- counseling session start/stop times
- treatment modalities and frequency
- results of clinical tests
- summaries of symptoms, diagnosis, functional status, treatment plan, progress to date, and prognosis
- Information compiled in reasonable anticipation of, or use in, a civil, criminal or administrative action or proceeding.
Are there any exceptions?
The ONC lists 8 different exceptions to the information blocking provision, each with its own set of conditions and requirements. These exceptions are as follows:
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.
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.
Physician Concerns:
Out of the many inquiries MIEC has received about the ONC Final Rule, most were concerned with how specially protected records, such as behavioral health and chemical dependency records, or sensitive records involving minors, can be appropriately protected under one of the allowable exceptions while still being made generally available under the Final Rule. The exceptions cannot be applied generally, but rather must be applied on a case-by-case basis if the requirements are met.
Since access to EHI no longer will depend on formal written requests, appropriate management of specially protected or sensitive information will depend on the prior location and labeling of EHI in the electronic health record. Many EMR systems allow for the separate labeling or filing of psychotherapy notes or records relating to a legal matter; additionally, clinicians can mark notes in various ways (example: EPIC users can include “dot phrases,” such as “/.blockshare” at the end of notes to mark them as not accessible).
For mental health providers, the American Psychiatric Association has information on its website about the ONC Final Rule, and the unique nature of mental health records and psychotherapy notes in the setting of enhanced access.
Additionally, in June 2020 the APA sent a letter to the National Coordinator for Health Information Technology requesting clarification on compliance by psychiatrists. Among the issues raised were the “Preventing Harm” and “Promoting the Privacy of Electronic Health Information” exceptions and the potential for misinterpretation of the scope of those exceptions. For example, the letter pointed out that physicians from many areas of practice incorrectly believe that HIPAA prevents them from sharing any mental health or substance abuse information with other providers. It was also pointed out that some providers could interpret these two exceptions as allowing them to withhold any part of the mental health record. For these reasons, the APA requested that the ONC develop training for providers on how to apply the exceptions in practice.
It is important to note that enhanced patient access to EHI does not change the doctor patient relationship, and it should not affect what is documented in the medical record; all medical care should be completely and accurately documented regardless of access. Rather, providers should rely on proper information management and application of the above exceptions to protect patients and their privacy when appropriate.
However, enhanced patient access to chart notes should cause physicians and other health care providers to reconsider and perhaps adjust how they document. For instance, certain clinical terminology may be negatively misinterpreted by patients (for example, “incompetent cervix”), and this could have an effect on the physician-patient relationship if the information is taken out of context. At a minimum, physicians should read their own notes and consider the perspective of the patients who will be reading them. Additionally, enhanced patient access should encourage physicians to have more discussions with patients about what is recorded in their chart, in an attempt to put information into the right context.
If you have any questions about the ONC Final Rule, please contact MIEC’s Patient Safety & Risk Management team at patientsafetyriskmgmt@miec.com.