The facts and circumstances of each situation or allegation would need to be evaluated. Whether a practice constitutes information blocking depends on the unique facts and circumstances of the practice. More specifically, information blocking occurs when: an individual or entity engaging in a practice is an actor as defined in 45 CFR 171.102; the practice involves EHI as defined in 45 CFR 171.102; the actor meets the requisite knowledge standard applicable to the type of actor; the practice is likely to prevent, materially discourage, or otherwise inhibit the access, exchange, or use of EHI; the practice is not one that is required by law; and the practice is not covered by an exception under 45 CFR Part 171.

Yes, but only to the extent that the fees for the EHI export comply with the “Fees Exception” (45 CFR 171.302). For example, if the fees to export or convert data from the technology were not agreed to in writing at the time the technology was acquired, then the “Fees Exception” would not be available and such fees could implicate the information blocking definition unless another exception applies (45 CFR 171.302(b)(4)).

Note that if the EHI export would be performed using health IT certified under the ONC Health IT Certification Program (45 CFR Part 170) to the “EHI Export” certification criterion (45 CFR 170.315(b)(10)), a fee that is charged to perform such export for purposes of switching health IT or to provide patients their electronic health information (45 CFR 171.302(b)(3)) would not qualify for the “Fees Exception”.

Yes. On and after April 5, 2021, any actor’s agreements, arrangements, or contracts are subject to and may implicate the information blocking regulations in 45 CFR part 171.

No. The information blocking regulations do not require actors to have or use health IT certified under the ONC Health IT Certification Program. Actors subject to the information blocking regulations are not required to immediately upgrade their certified health IT (as of the applicability date (i.e., April 5, 2021)) if they also happen to participate in a separate regulatory program that requires the use of certified health IT, such as CMS’ Promoting Interoperability Programs.

Please review the questions under the "Electronic Health Information" heading for more information.

The applicability date for the information blocking regulations in 45 CFR part 171 was established in the ONC Cures Act Final Rule, and was subsequently adjusted in the ONC Interim Final Rule. The Interim Final Rule moved the applicability date from November 2, 2020 to April 5, 2021.

The Interim Final Rule also revised the information blocking definition in 45 CFR 171.103 to adjust the timeframe for the “USCDI limitation.” Before October 6, 2022, electronic health information (EHI) for the purposes of the information blocking definition is limited to the EHI identified by the data elements represented in the United States Core Data for Interoperability (USCDI) standard.

Enforcement of the information blocking regulations depends upon the individual or entity that is subject of an enforcement action or "actor." For health IT developers and health information networks/HIEs, the HHS Office of the Inspector General posted its final rule implementing information blocking penalties. For health care providers, HHS has posted its proposed rule to establish appropriate disincentives as directed by the 21^st Century Cures Act. For additional information, see the Disincentives Proposed Rule Overview fact sheet and the Disincentives Common Questions fact sheet.

Updated:

This FAQ has been updated pursuant to the HTI-1 Final Rule.

Yes, an individual’s request for a copy of their EHI in some form of physical media, such as where the EHI is printed to paper or copied onto a CD or USB drive, could implicate the information blocking regulations. The definition of information blocking includes any practice (act or omission by an actor, as defined at 45 CFR 171.102) that is not required by law or covered by an exception and that is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI) (as defined at 45 CFR 171.102). Importantly, however, any fee charged for providing this type of access to EHI that does not meet the Fees Exception (45 CFR 171.302) potentially could be considered information blocking.

We have consistently interpreted the broad definition of information blocking in section 3022(a) of the Public Health Service Act to encompass potentially any fee that is likely to interfere with, prevent, or materially discourage the access, exchange, or use of EHI (84 FR 7521, 85 FR 25880). This would include any fees charged to individuals for copies of their EHI furnished on paper or on electronic media (such as CDs or USB drives). To be covered by the Fees Exception, any fee(s) charged for copies of EHI on electronic media or printed to paper must meet all of its conditions, including that fees(s) are not among the list of excluded fees at 45 CFR 171.302(b).  Of note, one of the exception’s conditions ensures alignment with HIPAA in that any fee prohibited by the HIPAA Privacy Rule for an individual’s right of access (45 CFR 164.524(c)(4)) is not covered by the Fees Exception. (84 FR 7540, 85 FR 25886).

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.

Yes, any individual or entity that meets the definition of at least one category of actor—“health care provider,” “health IT developer of certified health IT,” or “health information network or health information exchange” —as defined in 45 CFR 171.102  is subject to the information blocking regulations in 45 CFR part 171. The information blocking regulations in 45 CFR part 171 apply to a health care provider, as defined in the Public Health Service Act and incorporated in 45 CFR 171.102, regardless of whether any of the health IT the provider uses is certified under the ONC Health IT Certification Program.

Yes, any individual or entity that meets the definition of at least one category of actor —“health care provider,” “health IT developer of certified health IT,” or “health information network or health information exchange” — as defined in 45 CFR 171.102 is subject to the information blocking regulation in 45 CFR part 171. The information blocking regulations in 45 CFR part 171 apply to an entity that meets the HIN or HIE definition regardless of whether any of the health IT the HIN or HIE uses is certified under the ONC Health IT Certification Program.

The definition of “health information network (HIN) or health information exchange (HIE)” in 45 CFR 171.102 is a single, functional definition. We did not specifically exclude any particular entities from the definition, nor did we specifically identify particular entities in the definition. In order to determine whether your organization is a HIN/HIE for information blocking purposes, you should assess whether your organization’s functional activity meets the HIN/HIE definition in 45 CFR 171.102. The Information Blocking Actors fact sheet on HealthIT.gov presents the actor definitions in an easy-to-use format.

The answer depends on whether your company or organization meets the definition of “health IT developer of certified health IT” in 45 CFR 171.102. Under the definition, an individual or entity that develops or offers health IT is a “health IT developer of certified health IT” so long as that individual or entity develops or offers at least one Health IT Module certified under the ONC Health IT Certification Program. However, the definition explicitly excludes a health care provider that self-develops Health IT that is not offered to others. The Information Blocking Actors fact sheet on HealthIT.gov presents the actor definitions in an easy-to-use format.

Updated:

This FAQ has been updated pursuant to the HTI-1 Final Rule.

Yes. For purposes of the information blocking regulation, a “health IT developer of certified health IT” is defined in 45 CFR 171.102. With the sole exception of a health care provider that self-develops certified health IT that is not offered to others, this definition is met by any individual or entity that develops or offers health IT certified under the ONC Health IT Certification Program. If an individual or entity offers certified health IT for any period of time on or after the applicability date of 45 CFR part 171, then they would be considered to be a “health IT developer of certified health IT” for purposes of their conduct during that time. The information blocking provision would not apply to conduct the individual or entity engaged in after they no longer have or no longer offer any certified health IT. However, claims of information blocking with respect to conduct occurring while the individual or entity had certified health IT could be acted upon by HHS after the individual or entity no longer had or offered certified health IT. (See also ONC Cures Act Final Rule page 85 FR 25797).

Updated:

This FAQ has been updated pursuant to the HTI-1 Final Rule.

For purposes of the information blocking regulation in 45 CFR part 171, the term "actor" includes health care providers, health IT developers of certified health IT, and health information networks (HIN) or health information exchanges (HIE), as defined in 45 CFR 171.102. Although health plans and other payers are not specifically identified within any of these definitions, they also are not specifically excluded. To the extent an individual or entity that is a payer also meets the 45 CFR 171.102 definition of "health care provider," "health IT developer of certified health IT" or "health information network or health information exchange," that individual or entity would be considered an "actor" for purposes of information blocking. In addition, the HIN/HIE definition is a functional definition and should be reviewed for potential applicability to a health plan’s activities. The Information Blocking Actors fact sheet on HealthIT.gov presents these definitions in an easy-to-use format. (See also Cures Act Final Rule page 85 FR 25803)

In some instances, a business associate will be an actor under the information blocking regulation in 45 CFR part 171 and in other situations, it may not be an actor. The information blocking regulations in 45 CFR part 171 apply to health care providers, health IT developers of certified health IT, and health information networks (HIN) and health information exchanges (HIE), as each is defined in 45 CFR 171.102. Any individual or entity that meets one of these definitions is an “actor” and subject to the information blocking regulation in 45 CFR part 171, regardless of whether they are also a HIPAA covered entity (CE) or business associate (BA).

It depends. The Manner Exception, in particular the last provision of the “alternative manner” (45 CFR 171.301(b)(1)(iii)), does not specify the particular file extensions or outputs that must be supported. Instead, as a last alternative to make electronic health information (EHI) accessible, exchangeable, or useable, this specific provision within the exception requires actors to produce EHI in a “machine-readable format, including the means to interpret the electronic health information, agreed upon with the requestor.” If it is necessary to produce a PDF for the purpose of meeting this provision, the PDF should be an interpretable, machine-readable output. While this may be possible for some PDFs, other PDFs, such as those that include EHI as images, generally might not be an interpretable, machine-readable output.  

One way a PDF could be a machine-readable format would be if it was structured so that the data it conveyed could be consumed by another software program using consistent processing logic, consistent with the National Institute of Standards and Technology’s definition of “machine-readable.” If a data output format is structured so that the EHI it conveys is machine readable, then that output format is a machine-readable format, regardless of the file extension.

Updated:

This FAQ has been updated pursuant to the HTI-1 Final Rule.