This first part of the Health Data, Technology and Interoperability Policy: Patient Engagement, Information Sharing and Public Health Interoperability version two finalizes updates to the Trusted Exchange framework and the Joint Agreement and makes certain administrative corrections effective on January 15, 2025.
But for now, it leaves unanswered questions about certifying AI improvements.
WHY IT’S IMPORTANT
This was announced by the US Department of Health and Human Services on Monday publication fresh health, technology and interoperability data: TEFCA determined that while it received 270 comments on the scope of the proposals included in the proposed HTI-2 draft, at that time it had only reviewed and responded to comments on a narrower set of proposals.
The Assistant Secretary for Policy/Technology Office (ASTP) of the National Coordinator for Health Information Technology summarized and responded to comments related to TEFCA information blocking exceptions and made several administrative updates to the Health IT Certification Program on Monday.
For example, HTI-TEFCA updates specific requirements related to an expired provision allowing healthcare IT to demonstrate Consolidated Clinical Document Architecture document security markings at the document level.
According to Leigh Burchell of Altera Digital Health, who is the current vice chair and incoming chair of Electronic Health, the fresh final rule focuses on revised information blocking provisions that include definitions related to the TEFCA method exception and the provisions implemented to support this framework. Records Association Executive Committee.
This first part, finalizing parts of HTI-2, allows ASTP to “strengthen the pillars” of TEFCA that “outgoing leadership wants to leave as a legacy,” Burchell said in a statement provided by the HIMSS EHR Association.
Rounding out the updates are amendments to the ONC HTI-1 final rule that add privacy and security certification requirements for algorithm-based clinical decision support tools.
While HTI-1 established a certification criterion for DSI by replacing the term “clinical decision support,” the agency said it did not err in proposing or finalizing the appropriate privacy and security requirements necessary to certify DSI modules.
“This omission was an oversight,” the agency said.
However, comments on Insights Measures – the key to HHS certification for health IT modules – “are still under review and consideration and may be the subject of subsequent final rules related to such proposals in the future,” the agency said.
A BIGGER TREND
The HTI-1 final rule, which implements the EHR Reporting Program provisions of the 21st Century Cures Act by establishing certification requirements for HIT developers, went into effect in March.
HTI-1 includes requirements for certified health IT developers to report metrics that provide insight into how certified health IT is used to support care delivery.
Developers have long been concerned about the scope of work required to comply with AI transparency and the tight compliance timelines that the agency did not specify in HTI-1.
“We have not finalized proposed requirements that health IT modules clearly indicate when source attributes from other parties are unavailable,” the agency said last year.
“As currently designed, Insights Measures is likely to produce data of questionable value – something that has been brought to ASTP’s attention since the publication of the HTI-1 proposed rule in 2023.” Burchell said.
“As we approach the January 1, 2026 start date, uncertainty in final measurements creates challenges. We hope that future rules finalizing the HTI-2 proposals will provide helpful and necessary clarifications.”
The healthcare IT industry is not the only group concerned about the finalization of HTI-2. In October, the American Hospital Association expressed concern about “burdensome” encryption requirements and deadlines in proposed health IT interoperability rules.
ON RECORDING
“We expect the remaining elements of the HTI-2 proposed rule to be split into multiple other final rules,” Burchell said in a statement. “In doing so, the EHR Association hopes that ASTP/ONC will prioritize necessary additional technical fixes specific to healthcare IT vendors, the most pressing of which relate to insight measures.”