On July 10, the Office of the National Coordinator for Health Information (ONC) released Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed regulation. The HTI-2 proposed rule is a continuation of ONC’s efforts to advance interoperability and improve information sharing among patients, providers, payers, and public health. The rule does not include laboratory information system (LIS) certification despite the request for information on LIS certification in the HTI-1 proposed rule.

This proposed regulation is a continuation of the ONC’s HTI-1 rule, which the CAP submitted comments on in June 2023, supporting the overall objectives of the proposed rule.

The current provisions in the HTI-2 proposed regulation that could have implications for laboratory and pathology data include:

• The United States Core Data for Interoperability (USCDI) standard is a baseline set of data that can be commonly exchanged across care settings for a wide range of uses and is a required part of certain certification criteria in the Health IT Program. In the HTI-2 Proposed Rule, ONC proposes to add USCDI v4 and establish an expiration date of January 1, 2028, for USCDI v3 for purposes of the Health IT Program. The CAP advocated in favor of this in its comments, noting that USCDI v4 is more closely aligned with CLIA requirements.
• ONC is proposing several changes to existing certification criteria as well as the creation of new certification criteria related to health IT for public health. Some of these changes impact the way that certified health IT (which does not include LISs) communicate to laboratories and receive pathology data. The CAP is currently assessing these changes.
  
• The proposed rule would update two existing information blocking exceptions and establish two new exceptions.
  • Proposed new Protecting Care Access Exception would, under specified conditions, cover actors’ limiting electronic health information (EHI) sharing in order to reduce a risk of potentially exposing patients, providers, or persons who facilitate care to legal action based on the mere fact that they sought, obtained, provided, or facilitated lawful reproductive health care. The Protecting Care Access Exception would also apply where an actor limits sharing of a patient’s EHI potentially related to reproductive health care in order to protect that patient from potential exposure to legal action.
  • Proposed new Requestor Preferences Exception would provide actors a framework under which they can be confident they will not be committing information blocking if they agree to a requestor’s ask for restrictions on when, under what conditions, and how much EHI is made available to that requestor.
  • Revisions to existing exceptions would:
    • Expand application of the existing Privacy Exception to further support more actors’ practices protecting the privacy of patients’ health information.
    • Update the existing Infeasibility Exception to offer actors more clarity and more flexibility under certain conditions. Other proposals would also enhance clarity around the codified definitions of certain terms for information blocking purposes.

The CAP is currently assessing the effects these provisions will have on pathologists and laboratories and will submit comments that advocate for regulations to protect patients without overburdening pathologists and laboratories.

For more information, the ONC will be hosting an information session on Wednesday, July 17 at 2:00 PM ET. Register for the session here.

Download the HTI-2 Proposed Rule Fact Sheet Here.