By Bob Anderson, JD, and Stephanie Eckerle, JD
Krieg DeVault LLP
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Webinar: Information Blocking and the Impact on Your Practice
Accredited for 1.0 AMA PRA Category 1 Credits™
Wednesday, April 14
Noon to 1 p.m. EDT
Registration is required. Submit questions for discussion to jdavis@ismanet.org no later than Thursday, April 9.
Register >>
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As health care providers prepare to comply with the information blocking rules that become effective in just over a week on April 5, they should be aware of recent guidance from the Office of National Coordinator (ONC) addressing nuances of these rules.
Previously in ISMA Reports, we discussed that there are three key actions that health care providers should undertake to ensure compliance with the information blocking rules: (1) implement a new information blocking and exceptions policy; (2) train workforce on information blocking; and (3) ensure patient access to electronic health information (EHI). As health care providers work through these steps, they should also review the most recent
FAQs from ONC on the information blocking rule, and they should also consider watching the recent
webinar delivered by ONC. These resources are free and provide important insights into the views of the ONC staff who wrote the rule.
Two key areas that health care providers need to consider when creating and operationalizing an information blocking policy are access to laboratory results and access to clinical notes.
Access to laboratory results
As ONC has noted, the information blocking rule does not require health care providers to proactively make available any EHI, including lab results, to patients or others who have not requested such information. However, once a patient makes such a request, the government may view any delay in the release or availability of EHI as prohibited information blocking. This can be an especially difficult issue, as it relates to lab results.
Most health care providers are used to reviewing lab results before the patient receives them, in order to review them and discuss them with their patients. However, under the new information blocking rules, once a request has been made, patients will likely have access to their lab results prior to or in parallel with the health care provider reviewing them. In fact, the information blocking rule applies to laboratories, many of whom have their own patient portals established. Providers should anticipate patients obtaining their results from an outside lab (and probably Googling about them) before the provider has had a chance to review them.
In its recent FAQ, ONC specifically stated that health care providers should not have “blanket delays that affect a broad array of routine results.” If a health care provider believes that the receipt of test results by the patient prior to the provider having the ability to counsel the patient would cause harm, the health care provider would need to utilize the preventing harm exception, which may only be utilized on an individualized basis in the context of a clinician-patient relationship. Standing orders to delay delivery of laboratory results to patients would likely violate the rule. Neither the information blocking rule nor the ONC have addressed whether a patient could agree in advance to wait for results until the provider has had a chance to review them and go over them with the patient.
Clinical notes
Under the information blocking rules, as well as HIPAA and state laws, health care providers must be aware that their clinical notes are part of the patient’s record. Some providers have mistakenly believed that they can write notes to themselves about a patient that are not for patient consumption and do not have to be provided to the patient upon request (think physical file jackets). While that has never been legally true, it is especially untrue after adoption of the information blocking rule. Patients have a well-established legal right to access their medical records (subject to certain exceptions, such as those governing psychotherapy notes).
In its recent FAQ, ONC specifically stated that the definition of EHI does not specifically include or exclude notes or other clinical observations based on specialty type. Currently, notes that constitute consultation notes, discharge summaries, histories and physicals, imaging reports, lab reports, pathology reports, procedure notes or progress notes are subject to the information blocking rule.
1 Beginning on Oct. 6, 2022, subject to the information blocking rule exceptions, all notes will be subject to patient access.
Providers may believe that draft clinical notes may not be appropriate to provide to a patient or other health care providers until they are finalized. However, ONC specifically stated that if the data is used to make health care decisions about an individual, then that data would fall within the definition of the designated record set and, therefore, within the definition of EHI that may be accessed by the patient. Therefore, providers should be prepared to allow patients access to all clinical notes of the provider when a request for access is made (unless there is an exception that applies, such as psychotherapy notes or the health care provider has relied on one of the information blocking exceptions, such as the preventing harm exception). Even then, if the health care provider denies access to the patient to all or part of the medical record based on these exceptions, the health care provider must follow all procedural requirements under HIPAA, the information blocking rules and state law when denying access to all or part of the records.
Recently, the U.S. Health and Human Services Office for Civil Rights (OCR) emphasized the need to follow the procedural requirements under HIPAA when denying access to psychotherapy notes or any other part of a patient record. OCR entered a settlement agreement with a psychiatric medical group that failed to provide a patient with a written explanation of why a request to access was denied. While the medical group was not required to provide the patient with psychotherapy notes in the record, it was required to provide all other records to the patient and it failed to do so – multiple times. As is its practice, OCR issued a press release naming the medical group and describing the facts of the case and the settlement reached.
1 Technically, for transitional purposes, the information blocking rule currently limits the requirement to provide the patient with electronic health information to information that is contained within the United States Core Data for Interoperability elements. Those elements are a pre-defined set of items or fields in electronic medical records that are frequently a subset of all elements in an electronic medical record. Beginning on Oct. 6, 2022, providers must provide all information in an electronic medical record to patients who request it, subject to the regulatory exceptions in the information blocking rule.