The latest update to the Health Data, Technology, and Interoperability rule, version two, has been finalized with some key changes taking effect on Jan. 15, 2025. While the rule addresses updates to the Trusted Exchange Framework and Common Agreement, it also raises questions about certifying artificial intelligence enhancements that remain unanswered for now.
The U.S. Health and Human Services received 270 comment submissions on the proposed HTI-2 draft but only reviewed and responded to comments on a narrower set of proposals in this final rule. The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology summarized and responded to comments related to TEFCA information blocking exceptions and made some administrative updates to the Health IT Certification Program.
One of the main focuses of the final rule is on amended information blocking regulations, including definitions related to the TEFCA Manner Exception and provisions to support the framework. The updates also include corrections to the ONC HTI-1 Final Rule, adding privacy and security certification requirements for algorithmic-based clinical decision support tools.
While the HTI-1 final rule had established certification requirements for HIT developers, concerns remain about the scope of work required for AI transparency compliance and tight timelines for compliance. The industry is hoping for future rules to provide clarifications on AI transparency requirements and insights measures that are essential for gaining HHS certification.
As the healthcare IT industry awaits further clarification on the remaining components of the HTI-2 proposed rule, stakeholders are concerned about burdensome encryption requirements and timelines for healthcare IT interoperability. The EHR Association is urging ASTP/ONC to prioritize technical corrections specific to health IT vendors, especially related to Insights Measures.
Overall, the finalization of the Health Data, Technology, and Interoperability rule version two brings some clarity on information blocking regulations and certification requirements, but there are still unanswered questions surrounding AI enhancements. As the industry continues to evolve, stakeholders are hopeful for future rules that provide necessary clarifications and support for healthcare IT vendors.
