The Department of Health and Human Services’ Office for Civil Rights (OCR) has recently issued a final rule regarding the application of section 1557 of the Affordable Care Act. This rule ensures that any health programs funded by federal dollars cannot discriminate based on race, color, nationality, sex, age, or disability.
The rule aligns with the Bostock v. Clayton County Supreme Court decision in 2020, which determined that discrimination “based on sex” includes sexual orientation and gender identity. It also clarifies that even when artificial intelligence (AI) powered technology utilizes machine learning, the providers must still adhere to the standards set forth in Section 1557. This means they are required to assess and address any potential risks of discrimination.
In order to evaluate the risks of bias in AI, the rule defines a “patient care decision support tool” as any technology or method used by a covered entity to assist in clinical decision-making. These tools can include predictive algorithms that assess patient risk and severity of future health events, as well as analysis engines used to approve or deny medical claims based on treatment necessity.
OCR emphasizes that the use of such tools and the reliance on AI-based decision-making must be reevaluated for each patient. Studies have shown that certain algorithms have led to racial and ethnic disparities, highlighting the importance of considering individual characteristics and ensuring equal care for people with disabilities. This definition also encompasses both automated vehicles and non-automated aids like flowcharts.
To prevent bias, covered entities must consider their ability to take on additional consumer responsibility and their financial means. Developers should educate entities about the risk of discrimination, regardless of the data layout, and clarify whether the covered entity has already developed a process for evaluating the tools used.
This rule differs from the previous rule in that Medicare Part B funding is now classified as federal assistance for providers and suppliers. This slightly reduces the number of individuals receiving Part B funds but ensures that they comply with Section 1557 and other civil rights regulations enforced by the OCR office.
