ONC's New Guidance Helps Further Clarify Application of the Information Blocking Rules

Alerts / January 28, 2021

On Jan. 15, 2021, the Office of the National Coordinator (ONC) posted additional Frequently Asked Questions (FAQs) on information blocking. The FAQs help resolve some of the lingering questions in the industry about complying with the regulatory requirements under the ONC’s Cures Act Final Rule regarding information blocking that are slated to become effective on April 5, 2021. We have summarized some of the key FAQs below.

Push vs. Pull (Proactive vs. Reactive Releases of EHI)

One of the primary issues that the industry has wrangled with is whether the information blocking rules require electronic health information (EHI) to be proactively “pushed” to patient portals, application programming interfaces (APIs) or other health information technology. The ONC confirmed that “there is no requirement under the information blocking regulations to proactively make available any EHI to patients or others who have not requested the EHI.” However, any delays in the release or availability of EHI in response to a request for legally permissible access, exchange or use of such information may be deemed information blocking unless the conditions of an exception under the information blocking regulations are satisfied.

Thus, entities required to comply with the information blocking regulations (referred to as “actors”) must respond to the request (e.g., a patient request for lab results) in a timely manner once a request to access, exchange or use EHI is made to the actor. The ONC expressly states that “this could mean a patient would be able to access EHI such as test results in parallel to the availability of the test results to the ordering clinician.”

Whether this new guidance will ease an actor’s operational burden will generally depend on the functional capabilities of the actor’s health information technology. To the extent that an actor’s electronic health record system, portal or other health information technology is currently configured to allow for the release of EHI requested by patients in real time without delay, the actor may have already satisfied information blocking information requirements with respect to such requests. However, if an actor’s health information technology lacks this functionality, proactively making EHI available to all patients may be the actor’s only option if its systems and infrastructure are unable to promptly release the information upon request. Finally, actors need to review their mechanisms for responding to non-patient requests as well since the information blocking rules apply to all requests for the legally permissible access, exchange or use of EHI and not just requests from patients.

Blanket Delays of Test Results and the Preventing Harm Exception

The FAQs make clear that blanket delays on the release of lab or other test results requested by patients so that the ordering physician can review each result for potential risk of harm to the patient as a result of the release do not qualify for the “Preventing Harm” exception under the information blocking rules. Instead, the FAQs provide that the Preventing Harm exception is designed to cover only that narrow set of practices necessary to reduce a risk of harm to the individual patient or another person.

Regarding test results specifically, the ONC reiterated its position from the regulatory commentary that the ordering clinician should formulate an individualized determination for each patient as to whether in his or her professional judgment: (a) withholding certain test results would substantially reduce a risk to the patient’s or another person’s life or physical safety, or (b) withholding the results of the particular test(s) from a representative of the patient would substantially reduce a risk of substantial harm to the patient or another person. To explain this rationale, the ONC noted that, generally, the clinician ordering a particular test does so in the context of the treatment relationship and as such would know the range of results that could be returned, making this clinician best positioned to make the harm determination described above.

However, the ONC clarified that the Preventing Harm exception does not include a requirement that the harm be expected to occur within a particular time period or that the likelihood of the harm be high enough to be considered “imminent.”

Clinical Notes

The ONC confirmed that clinical notes are included within the definition of EHI for purposes of information blocking. However, the ONC clarified that until Oct. 6, 2022, only those notes that map to any of the eight types specified in the “Clinical Notes” data class within the United States Core Data for Interoperability would be required to be included in a response to a request for legally permissible access, exchange or use of EHI. The ONC also clarified in the FAQs that nonfinal clinical notes (i.e., draft/unsigned notes) would likely not be appropriate to disclose unless the information is used to make health care decisions about an individual, in which case such notes would be part of the “designated record set” and be deemed EHI as such. However, if the draft/unsigned notes are not being used to make health care decisions, the FAQs provide that they would not need to be released until the notes are final.

Authorship Credit: Vimala Devassy and Kyle Gregory

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