United States - ONC HTI-1 Final Rule on Decision Support Intervention Transparency

Published on 9 January 2024 by the HHS Office of the National Coordinator (now the Assistant Secretary for Technology Policy), the HTI-1 final rule replaced the prior clinical decision support certification criterion with Decision Support Interventions, including evidence-based and Predictive DSIs. It applies to developers of health IT certified under the ONC Health IT Certification Program, and is a leading example of federal AI transparency requirements in the health sector.

Certified developers must disclose source attributes, described as nutrition-label-style information, for the DSIs supplied through their certified health IT, and must implement Intervention Risk Management practices covering the validity, fairness, reliability, robustness, safety and security of predictive interventions. They must make information about their risk-management practices available and maintain the transparency information over time. Compliance with the DSI certification criterion was required by 31 December 2024. Non-compliance can lead to suspension or loss of ONC certification, with ties to information-blocking and CMS program conditions.