Would it be information blocking if an actor does not fulfill a request to access, exchange, or use EHI in order to comply with federal privacy laws that require certain conditions to have been met prior to disclosure?**
Would it be information blocking if an actor does not fulfill a request to access, exchange, or use EHI in order to comply with federal privacy laws that require certain conditions to have been met prior to disclosure?**
No, it would not be information blocking if the actor’s practice of not fulfilling a request in such circumstances meets the Privacy Exception (45 CFR 171.202). All actors remain responsible for disclosing EHI only when the disclosure is allowed under all applicable federal laws. For example, actors who are HIPAA covered entities or business associates must comply with the HIPAA Privacy Rule and any other applicable federal laws that limit access, exchange, or use of EHI in particular circumstances. Adherence to such federal laws is not information blocking, if the other conditions of the Privacy Exception are also met.*
In particular, where federal law such as the HIPAA Privacy Rule does not permit EHI to be used or disclosed unless certain requirements (“preconditions”) are met, then an actor’s practice of not fulfilling a request to access, exchange, or use EHI when these preconditions are not met is not information blocking.*** The Precondition Not Satisfied (45 CFR 171.202(b)) sub-exception of the Privacy Exception outlines a framework for actors to follow so that the actors’ practices of not fulfilling requests to access, exchange, or use EHI would not constitute information blocking when a precondition of applicable law has not been satisfied.
One example that highlights the alignment between the HIPAA Privacy Rule and the information blocking regulations is when a law enforcement official requests records of abortions performed from a clinic. As explained in the “HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care” guidance issued by the Office for Civil Rights, there are certain preconditions that must be met before this disclosure can be made: “If the request is not accompanied by a court order or other mandate enforceable in a court of law, the Privacy Rule would not permit the clinic to disclose PHI in response to the request. Therefore, such a disclosure would be impermissible and constitute a breach of unsecured PHI requiring notification to HHS and the individual affected.” In this example, federal law does not permit the disclosure of EHI unless certain requirements are met, and therefore, the actor’s practice not to disclose EHI would not be information blocking. We note that this is just one example of how the HIPAA Privacy Rule gives individuals confidence that their protected health information, including information relating to abortion and other sexual and reproductive health care, will be kept private. Please see the guidance from the Office for Civil Rights for additional information and examples.
A second example of the alignment between the HIPAA Privacy Rule and the information blocking regulations is in circumstances where the HIPAA Privacy Rule permits a covered entity to use or disclose EHI only following receipt of a valid HIPAA authorization from the individual (patient) or the individual’s personal representative. If an actor does not have a valid HIPAA authorization from the individual or their personal representative that permits the use or disclosure of EHI for the requested purpose, then a precondition for disclosure is not satisfied. Accordingly, the actor’s practice of not disclosing EHI would not be considered information blocking if it is consistent with the requirements of the Precondition Not Satisfied sub-exception.
To emphasize, wherever any federal law requires the authorization of the individual to disclose the EHI, an individual may always choose not to give such authorization, and an actor who does not disclose the EHI would not be information blocking if the actor meets all applicable requirements of the Privacy Exception.
* For more information on how practices would be evaluated to determine whether the unique facts and circumstances constitute information blocking, please see the following FAQ: How would any claim or report of information blocking be evaluated? (IB.FAQ46.1.2022FEB)
** It is important to remember that the information blocking exceptions defined in 45 CFR part 171 subparts B and C are voluntary, offering actors certainty that any practice meeting the conditions of one or more exceptions would not be considered information blocking. An actor’s practice that does not meet the conditions of an exception would not automatically constitute information blocking. Rather, such practices will be evaluated on a case-by-case basis to determine whether information blocking has occurred. (See, e.g., IB.FAQ29.1.2020NOV).
*** “EHI” as defined in 45 CFR 171.102 is a subset of protected health information (PHI). See 45 CFR 160.103 (definition of “protected health information”). For more information on the HIPAA Privacy Rule, who must comply with it, and its conditions for disclosures of protected health information (PHI), please see resources of the Office for Civil Rights at HHS.gov/HIPAA.