HHS Finalizes Rule for AI Transparency and Data Interoperability

HHS Finalizes Rule for AI Transparency and Data Interoperability
HHS Finalizes Rule for AI Transparency and Data Interoperability


What You Should Know:

– The U.S. Department of Health and Human Services (HHS) took a major step forward in healthcare data sharing and artificial intelligence (AI) transparency with the finalization of the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule.

– This rule was finalized after months of public feedback, promises to revolutionize how healthcare data is used and accessed in the United States.

Key Highlights of the HTI-1 Rule

This final rule builds upon the proposed rule released in April 2023 and addresses four key areas:

1. Algorithm Transparency

The HTI-1 rule establishes the first-ever nationwide requirements for transparency around artificial intelligence (AI) and other algorithms used in certified health IT. This affects the vast majority of healthcare providers, with ONC-certified health IT supporting over 96% of hospitals and 78% of office-based physicians.

This groundbreaking move aims to promote responsible AI by empowering clinicians with a consistent set of information about the algorithms they use to inform their decisions. This includes details about the algorithms’ fairness, appropriateness, validity, effectiveness, and safety.

2. USCDI Version 3

The rule adopts USCDI Version 3 (v3) as the new baseline standard for data exchange within the ONC Health IT Certification Program. This updated standard focuses on capturing more accurate and complete patient characteristics data, potentially reducing disparities and supporting public health data interoperability. Developers will have the option to move to USCDI v3 earlier than the January 1, 2026, mandatory adoption date.

3. Enhanced Information Blocking

The HTI-1 rule revises certain information blocking definitions and exceptions to facilitate data sharing between healthcare providers and patients. It also introduces a new exception to encourage secure and efficient data exchange under the Trusted Exchange Framework and Common Agreement (TEFCA).

4. New Interoperability Metrics

The rule implements the 21st Century Cures Act’s requirement for certified health IT developers to report specific metrics about how their products are used in healthcare delivery. This will provide valuable insights into the real-world impact of health IT and inform future improvements.

“The HTI-1 final rule is a major win for patients, providers, and the future of healthcare,” said Micky Tripathi, Ph.D., national coordinator for Health Information Technology. He emphasized the importance of continued efforts to build a stronger digital foundation for healthcare and ensure that technology serves to improve patient access, care quality, and well-being for all Americans.

The HTI-1 final rule is posted at HealthIT.gov/HTI-1 and will be submitted to the Office of the Federal Register (OFR) in the coming days



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