This first installment of the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing and Public Health Interoperability rule, version two, completes the updates to the Trusted Exchange Framework and the Common Agreement and implements some administrative corrections effective January 15, 2025 enter.
But questions about certifying improvements in artificial intelligence remain unanswered for now.
WHY IT’S IMPORTANT
The US Health and Human Services said this on Monday publication of the New Health Data, Technology and Interoperability: TEFCA determines that while it has received 270 comments on the set of proposals in the proposed HTI-2 draft, it has only reviewed and responded to comments on a more limited number of proposals at this time.
The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology summarized and responded to comments regarding TEFCA information blocking exceptions and made some administrative updates to the Health IT Certification Program on Monday.
For example, HTI-TEFCA is updating specific requirements related to the expired provision that will allow healthcare IT to demonstrate security tagging of Consolidated-Clinical Document Architecture documents at the document level.
The new final rule addresses amended information blocking regulations, which include definitions related to the TEFCA Manner Exception, and has implemented provisions to support the framework, said Leigh Burchell of Altera Digital Health, the current vice chair and new chairman of the Electronic Health Organization. Executive Committee of the Health Records Association.
This first part, which concludes portions of HTI-2, will allow ASTP to “strengthen the pillars” of TEFCA that “the outgoing leadership wants to leave as a legacy,” Burchell said in a statement sent by the HIMSS EHR Association Unpleasant Healthcare IT news Thursday.
The updates conclude with corrections to the ONC HTI-1 Final Rule, which add privacy and security certification requirements for algorithmic-based clinical decision-making tools.
Although HTI-1 has established a certification criterion for DSI, replacing the term clinical decision support, the agency said it erred by not proposing or including the corresponding privacy and security requirements needed to certify DSI modules to complete.
“This omission was a mistake,” the agency said.
However, comments regarding the Insights Measures – a key to obtaining HHS certification of healthcare IT modules – “are still being reviewed and considered, and may be the subject of subsequent final rulemaking regarding such proposals,” the agency said.
THE BIG TREND
The HTI-1 final rule, which implements the EHR reporting program provision of the 21st Century Cures Act by establishing certification requirements for HIT developers, became effective in March.
HTI-1 included requirements for certified healthcare IT developers to report on metrics that provide insight into how certified healthcare IT is used to support healthcare delivery.
Developers have long been concerned about the scope of work required for AI transparency compliance and the tight timelines for compliance, which the agency did not specify in HTI-1:
“We have not yet finalized the proposed requirements so that Health IT modules clearly indicate when third-party source attributes are not available,” the agency said last year.
“As currently constructed, the Insights Measures are likely to produce data of questionable value – something we at ASTP have emphasized since the publication of the proposed HTI-1 rule in 2023,” Burchell said.
“As we move closer to the January 1, 2026 start date, the uncertainty of final measurements poses challenges. We hope that future rules finalizing HTI-2 proposals will provide useful and necessary clarifications.”
The healthcare IT sector isn’t the only group concerned about the completion of HTI-2. In October, the American Hospital Association raised concerns about the “burdensome” encryption requirements and timelines in the proposed healthcare IT interoperability rule.
ON THE RECORD
“We expect that the remaining components of the proposed HTI-2 rule will 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 corrections specific to healthcare IT vendors, the most urgent of which relate to Insights Measures.”
Andrea Fox is editor-in-chief of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.