A Regulation To Promote Responsible AI In Health Care

Health Affairs February 28, 2024
Jordan Everson, Jeffery Smith, Kathryn Marchesini, Micky Tripathi

The Department of Health and Human Services through the Office of the National Coordinator for Health Information Technology (ONC) recently published the “Health Data, Technology, and Interoperability,” (HTI-1) final rule, which includes first-of-its-kind federal requirements for artificial intelligence (AI) and machine learning (ML)-based predictive software in health care.

This rule impacts a wide range of technologies—referred to as predictive decision support interventions (predictive DSIs)—and directly applies to health information technology, including electronic health records (EHRs), which ONC certifies as having specific technical capabilities. Certified EHRs, which more than 96 percent of hospitals and 78 percent of office-based clinicians use nationwide, are the foundation of digital health care in the US.

The ONC’s vision is for better health enabled by data,...

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