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Health Data, Technology, and Interoperability: Algorithm Transparency (HTI-1)

United States (Federal) | 89 FR 1192 (ONC HTI-1 Final Rule)

Year Enacted
2024
Date Signed
Jan 9, 2024
Effective Date
Mar 11, 2024
Predictive DSI criterion became part of Base EHR as of January 1, 2025
Status
Enacted
Final rule published January 9, 2024; effective March 11, 2024

Categories

Provider Clinical Use Provider Disclosure & Consent

Key Requirements

First federal regulation setting specific reporting requirements for AI tool developers in healthcare. Defines 'Predictive DSI' as technology that produces predictions, classifications, or recommendations from training data. Requires health IT developers to conduct risk management, expose inputs and logic to clinicians, and provide structured source attributes and transparency.

Regulated Parties

Developers of ONC-certified health IT; EHR vendors; health IT developers whose modules contain decision support interventions

Enforcement

ONC through the Health IT Certification Program; covers 96% of hospitals and 78% of office-based physicians

Sources

Official https://www.federalregister.gov/documents/2024/01/09/2023-28857/health-data-technology-and-interoperability-certification-program-updates-algorithm-transparency-and

Notes

First federal rule specifically requiring AI transparency in healthcare. Implements provisions of the 21st Century Cures Act.

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