Office of National Coordinator for Health Information Technology: (HTI-1) Final Rule Summary

Last Updated: Jul 29, 2024

On January 3^rd, 2024, the Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Final Rule which is commonly referred to as HTI-1 (ONC, 2024b). This rule provides updates to the ONC Certification Program, an update to information blocking, and transparency requirements when using AI. With the direct impact Information Blocking has on private practice, we will review this aspect of the rule.

The HTI-1 proposed rule was released in April 2023 (ONC, 2024b). The final rule attempts to decrease confusion surrounding the actors of information blocking. TEFCA or the Trusted Exchange Framework and Common Agreement went live in December 2023, this is intended to be the nationwide health information exchange. There are rules within the HTI-1 final rule, because of TEFCA, surrounding primarily information blocking.

There were four changes to the exceptions for Information Blocking. Those changes were the addition of two exceptions under the infeasibility exception, a modification to an exception under the infeasibility exception, and exceptions to protect the exchanging of health information through TEFCA (ONC, 2024a). We will review each of these rules and summarize the impact.

Under the infeasibility exception, the Uncontrollable Events was revised to help require the actor to connect the dots as to how the uncontrollable event impacted their inability to share PHI, below is the update to the Uncontrollable event condition:

“The actor cannot fulfill the request for access, exchange, or use of EHI because of a natural or human-made disaster, public health emergency, public safety incident, war, terrorist attack, civil insurrection, strike or other labor unrest, telecommunication or internet service interruption or act of military, civil or regulatory authority that negatively impacts the actor’s ability to fulfill the request” (ONC, 2024a).

The two new conditions added to the Infeasibility Exception are the Third-party seeking modification use condition and the Manner Exception Exhausted Condition. The third-party seeking modification use condition is implemented to reduce the actor burden and uncertainty such as less documentation requirements and no need to determine if another exception applies (ONC, 2024a). This condition is met when the actor is asked to use a third party to modify EHI within the records or systems maintained by the actor and the request is not from a health care provider requesting such use from an actor that is its business associate. Below is the wording from the rule itself:

“The request is to enable use of EHI to modify EHI provided that the request for such use is not from a health care provider requesting such use from an actor that is its business associate” (ONC, 2024a).

The Manner Exception Exhausted Condition may be used when the actor is unable to reach an agreement with a requestor or is technically unable to fulfill a request for EHI in the manner requested (ONC, 2024a). Also under this condition, the actor offered at least two alternative manners, and they do not provide the same access, exchange, or use of the requested EHI to a substantial number of individuals or entities that are in a similar situation as the requester (ONC, 2024a).

This condition provides certainty, reduces inappropriate or unnecessary diversion of actor resources, and ensures actors reasonably allocate resources toward interoperable, standards-based manners (ONC, 2024a).

The final exception that was added to the information-blocking rule was the TEFCA manner exception. This exception allows for an actor to limit the manner it fulfills a request for access, exchange, or use of EHI only by way of TEFCA IF:

1. Actor and requestor are both part of TEFCA
2. Requestor is capable of such access, exchange, or use of requested EHI from the actor by way of TEFCA
3. The request is not by way of the HL7 FHIR standards presented in 45 CFR 170.215(FHIR) including versions of those standards under 45 CFR 170.405(b)(8) which speaks to Standards Version Advancement Process. (SVAP).
4. The actor complies with the Fees and Licensing Exceptions (ONC, 2024a)

This exception aligns with the Cures Act’s goal for interoperability and establishment of TEFCA by acknowledging its value in promoting access, exchange, and use of EHI in a secure and interoperable way (ONC, 2024a).

Given the extensiveness of this rule and the corresponding update to Information Blocking, stay tuned for an update to our Quick Consult, and a possible presentation on this matter.

References:

1. ONC. (2024a, January 29). HTI-1 proposed rule: Information blocking enhancements. ONC HTI-1 Final Rule . https://www.healthit.gov/sites/default/files/2023-05/HTI-1 Proposed Rule 5.18 IB Presentation_508.pdf
2. ONC. (2024b, March 7). Health Data, technology, and interoperability: Certification Program updates, algorithm transparency, and information sharing (HTI-1) final rule. HealthIT.gov. https://www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-certification-program