ASTP completed only part of the HTI-2, much to the disappointment of health IT developers

This first installment of Health Database, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability, Second Edition finalizes the updates to the Trusted Exchange Framework and Common Agreement and makes certain administrative corrections effective January 15, 2025.

But it leaves questions about certifying AI improvements unanswered for now.

Why does it matter?

The US Department of Health and Human Services said on Monday Publishing New Health Data, Technology, and Interoperability: TEFCA rules that although it received 270 comments on the range of proposals in the proposed draft HTI-2, it has only reviewed and responded to comments on a narrower set of proposals at this time.

The Assistant Secretary for Technology Policy/Office (ASTP) of the National Coordinator for Health IT summarized and responded to comments related to the TEFCA information blocking exceptions and made some administrative updates to the health IT certification program on Monday.

For example, HTI-TEFCA updates specific requirements related to the expiring condition that allows health IT to expose security flags to standardized clinical document architecture documents at the document level.

The new final rule focuses on revised information blocking regulations that include definitions related to the TEFCA method exception and provisions implemented to support the framework, according to Lee Burchill of Altera Digital Health, a current vice president and incoming chair of the Electronic Health Registries Association’s Executive Committee.

This first part, which finalizes parts of HTI-2, allows ASTP to “cement the pillars” of TEFCA that the outgoing leadership “wants to leave as a legacy,” Burchill said in a statement from the HIMSS EHR Association sent to Healthcare IT News Thursday.

The updates complement corrections to the ONC HTI-1 Final Rule, which adds privacy and security certification requirements for algorithm-based clinical decision support tools.

While HTI-1 created a certification standard for DSI, replacing the term “clinical decision support,” the agency said it erred in not proposing or finalizing the corresponding privacy and security requirements needed to certify DSI modules.

“This omission was an oversight,” the agency said.

However, the agency said comments regarding the insights measures — key to HHS certification of health IT units — “remain under review and consideration, and may be the subject of subsequent final rules related to such proposals in the future.”

The biggest 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, became effective 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 the delivery of care.

Developers have long been concerned about the scope of work required to comply with AI Transparency and the tight timelines for compliance, which the agency did not specify in HTI-1.

“We have not finalized proposed requirements that health IT units explicitly indicate when third-party source features are not available,” the agency said last year.

“As currently formulated, the insights measures are likely to produce data of questionable value — something we have been stressing to ASTP since the HTI-1 proposed rule was published in 2023,” Burchill said.

“As we approach the start date of January 1, 2026, uncertainty about final measurements creates challenges. We hope that future rules finalizing HTI-2 proposals will include useful and necessary clarifications.”

The health IT industry is not the only group involved in finalizing HTI-2. In October, the American Hospital Association expressed concern about “burdensome” encryption requirements and timelines in the proposed rule for healthcare IT interoperability.

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“We expect that the remaining components of the HTI-2 proposed rule will be split into several other final rules,” Burchell said in a statement. “In doing so, the Electronic Health Records Association hopes that ASTP/ONC will prioritize additional necessary technical corrections specific to health IT vendors, the most urgent of which relate to insights metrics.”

Andrea Fox is a senior editor at Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS media publication.