The Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule on July 10 for public comment.
According to the College of American Pathologists, the proposed rule does not include laboratory information system (LIS) certification, despite requests for information on LIS certification in the HTI-1 proposed rule.
The proposed rule features two sets of certification criteria focused on standards-based application programming interfaces to enable health IT for both public health and payers to be certified under the ONC Health IT Certification Program.
HTI-2 proposes to require adoption of the United States Core Data for Interoperability (USCDI) version 4 by Jan. 1, 2028. USCDI v4 builds on the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, published in January 2024.
HTI-2 continues to clarify information blocking regulations to expand the application of the existing Privacy Exception and update the existing Infeasibility Exception. Additionally, HTI-2 proposes two new information blocking exceptions: the “Protecting Care Access Exception,” which would cover limiting electronic health information sharing to reduce the risk of potentially exposing patients or providers to legal action if they are involved in facilitating, seeking, or obtaining lawful reproductive health care; and the “Requestor Preferences Exception,” which would provide a framework under which information blocking would not be occurring if a requestor’s ask for restrictions is granted. Technology and standards updates, such as the ability to exchange clinical images and implementing multifactor authentication support, have also been included.
A fact sheet explaining provisions of the proposed rule can be found here. The period for public comment will be open for 60 days.
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