Information Blocking

Exceptions – General

If an actor does not fulfill a request for access, exchange, and use of EHI in “any manner requested” that they have the technical capability to support, is the actor automatically an information blocker unless they satisfy at least one of the information blocking exceptions?

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.

ID:IB.FAQ29.2.2024APR

How is an actor expected to fulfill a request for the USCDI under the Manner Exception if they do not yet have certified health IT in place that supports the Cures Act Final Rule updates necessary to include the USCDI in certified technology?

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.

ID:IB.FAQ30.2.2024APR