Frequently Asked Questions

Anyone who believes they may have experienced or observed information blocking by any health care provider, health IT developer of certified health IT, or health information network or health information exchange is encouraged to share their concerns with us through the Information Blocking Portal on ONC’s website, HealthIT.gov.

Please see the other questions under this heading for more information about reporting claims of potential information blocking. For more information about applicability dates and enforcement dates for the information blocking regulations, please review the question(s) under the “Enforcement” heading.

Updated:

This FAQ has been updated to reflect that we have passed the applicability date (4/5/2021) for the information blocking regulations, and to simplify the internal reference in the final paragraph.

The Cures Act, passed by Congress in 2016, directs ONC to implement a standardized process for the public to report claims of potential information blocking, and gives the HHS Office of Inspector General (OIG) the responsibility of investigating any claim of potential information blocking. Once received, ONC will confirm receipt with the submitter and the report is automatically assigned a tracking number (e.g. IB-XXX). Depending on the facts and details included in the complaint, ONC may contact the submitter for additional information.

ONC has authority to review claims of potential information blocking against health IT developers of certified health IT that may constitute a non-conformity under the ONC Health IT Certification Program. Separately, OIG has authority to investigate claims of potential information blocking across all types of actors: health care providers, health information networks and health information exchanges, and health IT developers of certified health IT. Therefore, upon receiving a claim of potential information blocking, ONC shares the claim with OIG. ONC makes every effort to share these claims of information blocking within two business days of receipt. To contact OIG about a claim of potential information blocking, please use the OIG Hotline via the web at https://oig.hhs.gov/fraud/report-fraud/index.asp or by phone at 1-800-HHS-TIPS (1-800-447-8477).  Please note that the OIG Hotline will not be able to respond to any inquiries about action taken in response to a complaint.  For more information, please see OIG’s Hotline website: https://oig.hhs.gov/fraud/report-fraud/before-you-submit/.

For more information about applicability dates and enforcement dates for the information blocking regulations, please review the question(s) under the “Enforcement” heading.

Yes. Anyone who chooses to report their concerns through the Information Blocking Portal can choose to do so anonymously.

However, if you do submit an anonymous report, we will not be able to contact you, and you will not be able to revisit your report, to add information or clarify your concern. Therefore, it is important to ensure you include all the information that you want us to have about your concern.

In addition, as specified  in the 21^st Century Cures Act, please note that any information received by ONC in connection with a claim or suggestion of possible information blocking and that could reasonably be expected to facilitate identification of the source of the information would fall under protections in section 3022(d)(2) of the Public Health Service Act. These protections limit the public disclosure of the source of the information.

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.

No, if the actor’s conduct satisfies the requirements of the information blocking regulations, such as the Privacy Exception (45 CFR 171.202). For example, the sub-exception Respecting an Individual’s Request Not to Share Information permits an actor, unless the disclosure is required by law, to honor an individual’s request not to provide access, exchange, or use of the individual’s EHI, which aligns with the individual’s right to request a restriction on disclosures of their protected health information under the HIPAA Privacy Rule (45 CFR 164.522(a)(1)).

Separately, if an actor has privacy or security concerns about disclosing EHI to an app/app developer with which an individual may choose to share their EHI, an actor may educate the individual about such concerns consistent with the following FAQ: Will educating patients about the privacy and security risks posed by third-party apps that the patient chooses be considered interference?

Yes, if the actor satisfies the requirements of the information blocking regulations, such as the Precondition Not Satisfied sub-exception of the Privacy Exception (45 CFR 171.202(b)).** For purposes of the information blocking regulations, health care providers and other information blocking actors operating under multiple state laws, or state and tribal laws, with inconsistent legal requirements for EHI disclosures may choose to adopt uniform policies and procedures so that the actor only makes disclosures of EHI that meet the requirements of the state law providing the most protection to individuals’ privacy (45 CFR 171.202(b)).** Essentially, the Precondition Not Satisfied sub-exception establishes conditions under which an actor may adopt policies to satisfy state laws with more restrictive preconditions and apply those policies in all the jurisdictions in which they operate. 

To illustrate, consider a scenario in which an actor operates in two states, “State A” and “State B.” State A forbids disclosure of certain EHI, such as EHI specific to reproductive health care, to another health care provider, who is also currently treating the individual, without first obtaining written authorization from the individual. This scenario assumes State B’s law does not require authorization from the individual for disclosure of reproductive health care EHI for treatment purposes. In this scenario, an actor subject to the laws of both State A and State B can, consistent with the Privacy Exception (see 45 CFR 171.202(b)(3)), adopt uniform privacy policies and procedures that result in the actor disclosing EHI only when the individual has provided written authorization for a specific disclosure (consistent with the more privacy-protective requirements of State A’s law) of EHI about them for treatment purposes across the actor’s operations in both State A and State B. If the actor’s policies, procedures, and actions are consistent with the requirements of the Precondition Not Satisfied sub-exception (45 CFR 171.202(b)), the actor’s practices would not be considered information blocking – even though the actor’s uniform privacy policies and procedures may deny or delay access, exchange, or use of EHI in State B that (under laws in force in State B) would not require specific written authorization.

In a second, similar scenario, State A’s law sets more privacy protective or more “stringent”  requirements (“preconditions”) than both State B’s law and the HIPAA Privacy Rule for disclosures of EHI^[1] for particular purposes (such as disclosing information related to reproductive health care for law enforcement purposes^[2]). An actor operating in States A and B can meet the requirements of the Precondition Not Satisfied sub-exception (45 CFR 171.202(b)(1) through (3)) in order to have confidence that disclosing EHI only when the disclosure is consistent with the most privacy protective (most restrictive or most “stringent”) preconditions (in this example, State A’s) across all their operations in both State A and State B would not be considered information blocking.

^[1] “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 and its conditions for disclosures of protected health information (PHI), please see resources of the Office for Civil Rights at HHS.gov/HIPAA.

^[2] For example, see “HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care,” which discusses the permissibility of disclosures for law enforcement purposes under the HIPAA Privacy Rule.