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## U.S. Department of Health and Human Services Finalizes Health Data, Technology, and Interoperability: Certification Program Updates

The U.S. Department of Health and Human Services has recently finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule. This rule, which builds upon the earlier HTI-1 proposed rule released in April, is a significant step forward for patient access, interoperability, and standards in healthcare.

## Advancing Algorithm Transparency in Health IT

One key focus area of the finalized rule is algorithm transparency, with the HHS establishing pioneering transparency requirements for artificial intelligence and predictive algorithms within certified health IT. These transparency requirements are aimed at promoting responsible AI and providing clinical users with essential information about the algorithms they utilize to support their decision-making. The goal is to enable users to assess these algorithms for fairness, appropriateness, validity, effectiveness, and safety.

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## Adoption of United States Core Data for Interoperability Version 3

Additionally, the HTI-1 final rule adopts the United States Core Data for Interoperability (USCDI) Version 3 as the new baseline standard within the ONC Health IT Certification Program, effective from January 1, 2026. This version includes updates that focus on enhancing the accuracy and completeness of patient characteristics data, with the aim of promoting equity, reducing disparities, and supporting public health data interoperability.

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## Revisions to Information Blocking Definitions and Exceptions

Furthermore, the finalized rule revises certain information blocking definitions and exceptions to support information sharing, while adding a new exception to encourage secure, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement (TEFCA).

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## Implementing Insights Condition for Certified Health IT Developers

As part of the rule, the 21st Century Cures Act’s requirement to adopt a Condition of Certification, namely the “Insights Condition,” for developers of certified health IT to report specific metrics has been implemented. These metrics will provide valuable insights into how certified health IT is utilized in supporting care delivery.

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## Aiding in the Advancement of Interoperable Exchange

The HTI-1 rule reflects the ongoing progress in improving interoperability among healthcare providers and technology developers. With increased electronic exchange and integration of patient health information into electronic health records (EHRs), the healthcare industry is moving closer to achieving seamless data exchange and integration.

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In conclusion, the HTI-1 final rule represents a pivotal development in advancing healthcare data, technology, and interoperability standards. The AI legalese decoder offers a valuable resource for healthcare organizations, legal professionals, and technology developers by providing AI-powered support in understanding, interpreting, and complying with the complex legal and regulatory requirements outlined in the HTI-1 rule.