Health Law Highlights

HTI-1 Final Rule in Effect

From The HIPAA Journal, by Steve Adler:

The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule, issued by the HHS’ Office of the National Coordinator for Health Information Technology (ONC), took effect on February 8, 2024. It implements provisions of the 21st Century Cures Act and updates the ONC Health IT Certification Program with new standards for AI systems.

The Final Rule is designed to advance ONC-certified health IT interoperability, algorithm transparency, and data standardization. It aims to improve patient outcomes and reduce healthcare costs by promoting the safe, secure, and trustworthy development of AI.

The Final Rule introduces new transparency requirements for AI and other predictive algorithms within ONC-certified health IT. It allows clinical users to access a consistent set of information about the algorithms and assess them for fairness, validity, effectiveness, and safety.

It adopts the United States Core Data for Interoperability (USCDI) Version 3 (v3) as the new baseline standard within the ONC Health IT Certification Program. Developers of certified health IT have until January 1, 2026, to transition to USCDI v3.

The Final Rule introduces new information blocking requirements and definitions, adds a new exception to support information sharing, and introduces new interoperability-focused reporting metrics. It is crucial that IT systems, information sharing policies, data collection, and reporting practices are assessed to ensure compliance with these new requirements.