01/23/2025 | News release | Distributed by Public on 01/23/2025 16:18
On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. § 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for screening, risk prediction, diagnosis, prognosis, clinical decision-making, treatment planning, health care operations, and allocation of resources.
On January 10, 2025, OCR released a "Dear Colleagues" letter focused on how covered entities can comply with the Final Rule's requirements in their use of patient care decision support tools.
Patient care decision support tools are defined as "any automated or non-automated tool, mechanism, method, technology, or combination thereof used by a covered entity to support clinical decision-making in its health programs or activities." 45 C.F.R. § 92. Included in this definition is any artificial intelligence (AI) algorithm used in diagnosis, treatment, patient monitoring, or any other aspect of health care operations. Covered entities that are subject to the Final Rule are (1): recipients of Federal financial assistance; (2): the U.S. Department of Health and Human Services, and (3): entities established under Title I of the Affordable Care Act.
So, what exactly is it that covered entities utilizing AI in their health care operations must do?
In addition to the general prohibition against discrimination on the basis of race, color, national origin, sex1, age, or disability in covered entities' health programs or activities through the use of patient care decision support tools, the January 10 letter expands upon two specific requirements in the Final Rule.
Identification of risk - First, covered entities under the Final Rule have an "ongoing duty to make reasonable efforts to identify uses of patient care decision support tools in [their] health programs or activities that employ input variables or factors that measure race, color, national origin, sex, age, or disability." 45 C.F.R. § 92.210(b). The Final Rule does not specifically describe how covered entities must make these reasonable efforts, but the January 10 letter provides the following examples:
The January 10 letter also makes clear that any OCR review of whether a covered entity made "reasonable efforts" to identify this risk will be conducted through a case-by-case analysis that may consider a multitude of factors, including:
Mitigation of risk - Second, for each patient care decision support tool for which risk of discrimination is identified, covered entities must "make reasonable efforts to mitigate the risk of discrimination resulting from the tool's use in its health programs or activities." 45 C.F.R. § 92.210(c). Once again, the January 10 letter provides specific examples of how this mitigation might be accomplished:
Whether or not a covered entity took reasonable efforts to mitigate discrimination risks will depend on a variety of factors like entity size, the context in which the AI tool was used, or the policies used to address complaints. Notably, OCR has opined that if an AI tool utilizes an input variable like race, it may trigger greater scrutiny than an input variable like age, which is more likely to have a clinical and evidence-based purpose for its use. Thus, additional mitigation policies and efforts may be needed when a tool uses race as an input variable, as opposed to age.
While the Final Rule's general prohibition on discrimination in the use of patient care decision support tools took effect on July 5, 2024, these requirements to make reasonable efforts to identify and mitigate risks of discrimination in the use of those tools will take effect on May 1, 2025.
We will continue to monitor developments related to Section 1557 and the Final Rule and any actions taken by the new administration.
If you have any questions or concerns regarding this alert, please reach out to Alexandra P. Moylan, Alisa L. Chestler, Samuel Cottle, Michael J. Halaiko, or any member of Baker Donelson's Health Law team.
1 There is a nationwide injunction staying enforcement of portions of the Final Rule which prohibit sex discrimination based on gender identity. See Tennessee v. Becerra, Case No. 1:24cv161-LG-BWR (S.D. Miss. 2024)