The Office of the National Coordinator for Health Information Technology (ONC) has issued the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency and Information Sharing Final Rule. In addition to implementing the provisions of the 21st Century Cures Act, the rule adopts updated Decision Support Interventions (DSI) certification criterion, including the establishment of a definition for Predictive DSI, which follows:

Predictive DSI is technology that supports decision-making based on algorithms or models that derive relationships from training data and then produce an output that results in prediction, classification, recommendation, evaluation, or analysis.

Recognition of artificial intelligence (AI) associated with DSI aligns with President Biden’s October 30, 2023 Executive Order (EO) entitled the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence. The updated DSI criterion includes new technical capabilities and transparency requirements for Health Information Technology (Health IT) modules that improve trustworthiness and support consistency around the use of predictive algorithms or models in health care. The DSI regulations apply to hospitals and physician offices, which use Department of Health and Human Services (HHS) certified decision support software.

Go Deeper

The President’s EO recognizes the value that AI brings to many aspects of American life, including health care; however, it also acknowledged potential risks including exacerbating harms due to fraud, discrimination, bias and disinformation. The EO then established eight guiding principles and priorities, including one that specifically directed the federal government to lead the way in pioneering systems and safeguards needed to deploy AI-related technology responsibly. This includes developing frameworks within which the federal government can manage AI’s risks, through safety and security principles and actions.

In addition to the Predictive DSI definition, the DSI criterion serves as an update and replacement for “clinical decision support (CDS)” certification criterion. The DSI Criterion require Health IT module transparency related to how software is developed and how modules support data elements important to health equity and enable transparent use of predictive models and algorithms to aid in health care decision making. The final rule also implements provisions of the 21st Century Cures Act, which include updates to the standards and certification criteria of the ONC Health IT Certification Program supporting interoperability, transparency and improved exchange of electronic health information. Below are key provisions:

• Algorithm transparency: Establishes first of its kind transparency requirements for the AI and other predictive algorithms that are part of certified health IT. According to the rule, this provision will promote responsible AI and make it possible for clinical users to access a consistent, baseline set of information about the algorithms they use to support their decision making and to assess such algorithms for fairness, appropriateness, validity, effectiveness and safety.

• USCDI version 3: Adopts the United States Core Data for Interoperability (USCDI) Version 3 (v3) as the new baseline standard within the ONC Health IT Certification Program (Certification Program) as of January 1, 2026. Version 3 is focused on advancing more accurate and complete patient characteristics data that could help promote equity, reduce disparities and support public health data interoperability.

• Enhanced information blocking requirements: Revises certain information blocking definitions and exceptions to support information sharing, and adds a new exception to encourage secure, efficient, standards-based exchange of electronic health information.

• New interoperability-focused reporting metrics for certified health IT: Implements adoption of Condition of Certification for developers of certified health IT to report certain metrics that provide more insight into how certified health IT is used in support of care delivery.

For more information review the ONC News Release and Final Rule Fact Sheet.