Frequently Asked Questions
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 to reflect the effective date of 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.
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 21st 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 to reflect the effective date of the HTI-1 Final Rule.
Under section 4004 of the 21st Century Cures Act (Cures Act), the HHS OIG has authority to investigate any claim that health care providers, health information networks (HINs) and health information exchanges (HIEs), and health IT developers of certified health IT (collectively defined as “actors” in 45 CFR 171.102) have engaged in information blocking.
For actors HHS OIG determines have committed information blocking, enforcement consequences depend upon the actor involved.
- For health IT developers of certified health IT and HINs/HIEs (as defined in 45 CFR 171.102), the Cures Act subjects these entities to civil monetary penalties if HHS OIG determines they committed information blocking. Under the Cures Act, these penalties could be up to $1 million per violation. The HHS OIG has issued a final rule on this enforcement authority.
- For health care providers (as defined in 45 CFR 171.102) the Cures Act authorizes the Secretary of Health and Human Services to establish appropriate disincentives through notice and comment rulemaking. HHS has posted its proposed rule to establish appropriate disincentives as directed by the 21st Century Cures Act. For additional information, see the Disincentives Proposed Rule Overview fact sheet and the Disincentives Common Questions fact sheet. Until the appropriate disincentives are established, HHS OIG will not prioritize investigation of information blocking conduct by health care providers.
Updated:
This FAQ has been updated to reflect the effective date of the HTI-1 Final Rule.