The U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) in 2024 updated the Affordable Care Act (ACA) Section 1557 nondiscrimination requirements to, in part, prohibit discrimination on the basis of race, color, national origin, sex, age or disability in its health programs or activities through the use of patient care decision support tools. The American College of Radiology® (ACR®) reported previously about the updated rules.
While covered entities must comply by May 1, changing policy priorities, the removal of several online compliance resources and a significant department reorganization have made HHS’ future enforcement intentions less clear.
Per the 2024 final rule, covered entities must make reasonable efforts to identify uses of patient care decision support tools in their health programs and activities that employ input variables or factors that measure race, color, national origin, sex, age or disability. These tools can be any automated or non-automated tool, mechanism, method, technology or combination thereof used to support clinical decision-making, including AI software devices, flowcharts, formulas, calculators, risk assessment/screening eligibility tools and more.
Covered entities must also make reasonable efforts to mitigate the risk of discrimination during medical use. Documentation of compliance is required or advised, including developing policies for tool assessment, discrimination identification, medical use and staff training.
Alleged violations will be reviewed by HHS on a case-by-case basis. During analyses, HHS will consider the size/resources of the entities, intended uses of the tools, information about tools provided by developers to entities, any efforts to review related medical literature and other processes used by entities to evaluate the tools (including reviewing resources such as ACR’s AI Central). It is generally advisable for covered entities to work closely with their qualified legal/compliance teams to better understand and comply with these and other ACA Sec. 1557 requirements.
ACR will continue to monitor the situation at HHS OCR for further developments. For more information about the College’s AI-related initiatives, visit the ACR DSI website. For questions about AI oversight and digital health policy, contact Michael Peters, ACR Senior Director, Government Affairs.
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