We have focused the EHI definition on terms that are used in the HIPAA Rules and that are widely understood in the health care industry as well as on a set of health information that is currently collected, maintained, and made available for access, exchange, and use by actors. On and after October 6, 2022, the definition of information blocking will apply to the full scope of EHI (as defined in 45 CFR 171.102):  

“Electronic health information (EHI) means electronic protected health information as defined in 45 CFR 160.103 to the extent that it would be included in a designated record set as defined in 45 CFR 164.501, regardless of whether the group of records are used or maintained by or for a covered entity as defined in 45 CFR 160.103, but EHI shall not include:

     (1) Psychotherapy notes as defined in 45 CFR 164.501; or

     (2) Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding.” (emphasis added)

EHI as defined for the purposes of information blocking is information that is consistent with the definitions of electronic protected health information (ePHI) and the designated record set (DRS) regardless of whether they are maintained by or for an entity covered by the Health Insurance Portability and Accountability Act (HIPAA) Rules. Just like ePHI, the data that constitutes EHI is not tied to a specific system in which the EHI is maintained. We also noted in our final rule that health information that is de-identified consistent with the requirements of 45 CFR 164.514(b) is not included in the definition of EHI for the purposes of information blocking (85 FR 25804). Thus, any individually identifiable health information that is transmitted by or maintained in electronic media is EHI to the extent that the information would be included in the designated record set.

As defined in the HIPAA Rules, the designated record set comprises:

• medical records and billing records about individuals;
• enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan;
• other records that are used, in whole or in part, to make decisions about individuals.

The term “record” means any item, collection, or grouping of information that includes protected health information. (45 CFR 164.501)

As stated in the United States Core Data for Interoperability Version 1 (July 2020 Errata) (“USCDI v1”), a progress note “represents a patient’s interval status during a hospitalization, outpatient visit, treatment with a LTPAC provider, or other healthcare encounter.” Any note that meets the above definition is considered a progress note for the purposes of the information blocking regulations codified in 45 CFR part 171.

From April 5, 2021 through October 5, 2022, the definition of information blocking is limited to the subset of EHI that is represented by data elements in the USCDI v1. The initial limitation of information blocking to the subset of EHI that is described in USCDI v1 was established to create a transparent, predictable starting point for sharing EHI while actors prepare for the sharing of all EHI (85 FR 25794).        

In our final rule, we noted that clinical note types identified in the USCDI are content exchange standard agnostic, and thus they should not necessarily be only interpreted or associated with the specific C-CDA Document Templates that may share the same name (85 FR 25674-5).

For more information on EHI including clinical notes, please review the other FAQs under the Electronic Health Information heading.

This FAQ is specific to the information blocking regulations codified in 45 CFR part 171. For more information about certification of health IT under the ONC Health IT Certification Program, including certification to criteria that include the USCDI as a standard, please see the About The ONC Health IT Certification Program and 2015 Edition Cures Update Test Method pages of ONC’s website, HealthIT.gov.

Yes. Electronic health information (EHI), as defined in 45 CFR 171.102, does not specifically include or exclude notes or other clinical observations based on the type or specialty of the professional who authors them.

Until October 6, 2022, EHI’s scope for purposes of the information blocking definition (45 CFR 171.103) is limited to that information represented by data classes and elements within the United States Core Data for Interoperability (USCDI). Therefore, until October 6, 2022, only those notes that map to any of the eight types specified in the “Clinical Notes” data class within the USCDI would be required to be included in a response to a request for legally permissible access, exchange, or use of EHI. However, actors (health care providers, health IT developers of certified health IT, and health information networks or health information exchanges) should bear in mind that none of the eight types of clinical notes currently represented within the USCDI are limited based on the type or specialty of the professional who authors them.

Please review the other questions under this heading for more information.

It depends. To the extent the content of any particular note meets the definition of “psychotherapy notes” in the HIPAA Rules (see 45 CFR 164.501), that note would be considered a psychotherapy note for purposes of information blocking. The information blocking regulations do not specify types of health care providers to be mental health professionals for purposes of applying the “psychotherapy notes” definition under the information blocking regulations. Thus, all notes that are “psychotherapy notes” for purposes of the HIPAA Rules are also “psychotherapy notes” for purposes of the information blocking regulations in 45 CFR part 171, and are therefore excluded from the definition of EHI for purposes of the information blocking regulations.  

It depends. Draft clinical notes and laboratory results pending confirmation are, as we discussed in the ONC 21st Century Cures Act Final Rule, examples of data points that may not be appropriate to disclose or exchange until they are finalized. However, if such data are used to make health care decisions about an individual then that data would fall within the definition of “designated record set” (see 45 CFR § 164.501), and therefore within the definition of EHI. To the extent a data point falls within the definition of EHI, practices likely to interfere with legally permissible access, exchange or use of that EHI could implicate the information blocking definition.

From April 5, 2021 through October 5, 2022, EHI’s scope for purposes of the information blocking definition is limited to the EHI that is represented by data classes and elements within the United States Core Data for Interoperability (USCDI). Therefore, during this period, interference with a request for legally permissible access, exchange, or use of non-final data points would potentially implicate the information blocking regulations only to the extent noted in the above paragraph and only to the extent that the data are within both the definition of EHI and the data classes and elements represented within the USCDI.

No. The definition of electronic health information in 45 CFR 171.102 is not limited by whether the data is recorded or could be exchanged using any particular technical functionality or standard. The information blocking definition (45 CFR 171.103) provides that before October 6, 2022, electronic health information (EHI) is limited to the subset of EHI represented by the data elements identified by the USCDI standard. This limitation of EHI for purposes of the information blocking definition is not contingent on whether those data elements are recorded or represented using the specific content and vocabulary standards in the USCDI standard at 45 CFR 171.213. On and after October 6, 2022, the information blocking regulations in 45 CFR part 171 pertain to all EHI as defined in 45 CFR 171.102.

An actor is not automatically required to fulfill a request using the specific content and vocabulary standards identified in the United States Core Data for Interoperability (USCDI) standard for the representation of data classes and data elements, nor are they required to use certified technology or any specific functionality. The information blocking definition (45 CFR 171.103) provides that before October 6, 2022, electronic health information (EHI) is limited to the subset of EHI represented by the data elements identified by the USCDI standard. This limitation of EHI for purposes of the information blocking definition is not contingent on whether those data elements are recorded or represented using specific content and vocabulary standards in the USCDI standard in 45 CFR 171.213. On and after October 6, 2022, the information blocking regulations in 45 CFR part 171 pertain to all EHI as defined in 45 CFR 171.102.

Again, the information blocking regulations do not require the use of any specific standard or functionality. Instead, the “Manner” exception (45 CFR 171.301) outlines a process by which an actor may prioritize the use of standards in fulfilling a request for EHI in a manner that supports and prioritizes the interoperability of the data. This means that, for the purposes of information blocking, before October 6, 2022, an actor may have fulfilled a request with the EHI identified by the data elements represented in the USCDI standard, first in the manner requested and, if not, in an alternate manner agreed upon with the requestor, following the order of priority specified in the exception.

Updated:

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

No, the definition of electronic health information (EHI) is not limited by when the information was generated. Before October 6, 2022, an actor must respond to a request to access, exchange, or use EHI with, at a minimum, the requested EHI that they have and that can be identified by the data elements represented in the United States Core Data for Interoperability (USCDI), regardless of when the information was generated. On and after October 6, 2022, an actor must respond to a request to access, exchange, or use EHI with EHI as defined in 45 CFR 171.102, regardless of when the information was generated. For example, an actor who has the necessary technical capability to do so is required to fulfill a request to access, exchange or use EHI that they have and could appropriately disclose in response to that request even if the EHI was generated before the ONC Cures Act Final Rule was published and even if the EHI was generated before the Cures Act was enacted by Congress.

The fulfillment of a request for access, exchange or use of EHI, including what EHI is shared, should be based on the request. However, any activity by the actor that seeks to artificially restrict or otherwise influence the scope of EHI that may be requested may constitute interference and could be subject to the information blocking regulation in 45 CFR part 171.

In terms of fulfilling requests for EHI, it is important to remember that the requirement to fulfill requests for access, exchange, and use of EHI is in any case limited to what the actor may, under applicable law, permissibly disclose in response to a particular request. Under the information blocking regulations in 45 CFR part 171, the actor is only required to fulfill a request with the requested EHI that they have and that can be permissibly disclosed to the requestor under applicable law. However, for protected health information they have, but do not maintain electronically, all HIPAA requirements would still be applicable, including the right of access.

Not necessarily. The information blocking exceptions defined in 45 CFR part 171 are voluntary and offer actors certainty that any practice meeting the conditions of one or more exceptions will not be considered information blocking. However, an actor’s practice that does not meet the conditions of an exception will not automatically constitute information blocking. Instead, such practices will be evaluated on a case-by-case basis to determine whether information blocking has occurred.

Whether information blocking occurred in a particular case would be based on whether:

• the individual or entity engaging in the practice is an "actor" as defined in 45 CFR 171.102;
• the claim involves "EHI" as defined in 45 CFR 171.102;
• the practice was required by law;
• the actor's practice met the conditions of an exception under 45 CFR 171;
• the practice rose to the level of an interference under 45 CFR 171; and,
• the actor met the requisite knowledge standard.

Please note, the knowledge standard varies based on the type of actor.  For health care providers, the standard is that the actor “knows that such practice is unreasonable and is likely to interfere with access, exchange, or use of electronic health information.” For health IT developers of certified health IT and health information networks (HINs) or health information exchanges (HIEs), the standard is that the actor “knows, or should know, that such practice is likely to interfere with access, exchange, or use of electronic health information.” In addition, we recommend review of the examples included in the Final Rule of what is and is not considered interference at 85 FR 25811.

Updated:

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

The “Manner” exception does not require the use of any specific standard or functionality. Instead, the “Manner” exception (45 CFR 171.301) outlines a process by which an actor may prioritize the use of standards in fulfilling a request for EHI in a manner that supports and prioritizes the interoperability of the data. This means that, for the purposes of information blocking, before October 6, 2022, an actor could have fulfilled a request with the EHI identified by the data elements represented in the USCDI standard, first in the manner requested and, if not, in an alternate manner agreed upon with the requestor, following the order of priority specified in the exception.

Updated:

This FAQ has been updated to reflect the effective date of the HTI-1 Final Rule.

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.