tives. For example, during a recent Food & Drug Administration (“FDA”) podcast, the Director of the Office of Medical Policy within the FDA’s Center for Drug Evaluation and Research noted that, “AI [is] being used to assist in recruitment, and is being really developed and used … to more effectively connect individuals as part of the trials. This can … involve mining vast amounts of data from diverse sources … including social media, medical literature, registries, and structured and unstructured data in electronic health records.” However, as numerous studies have shown, bias in AI—including underrepresentation of certain populations in the data sets used to train the AI—can further exacerbate inequities.In a development that could arguably help ameliorate problems of bias in clinical research, on May 6, 2024, the United States Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a final rule, “Nondiscrimination in Health Programs and Activities,” 89 Fed. Reg. 37522 (“Final Rule”). The Final Rule, codified at 45 C.F.R. § 92.210 and effective May 1, 2025, prohibits specified covered entities from discriminating on the basis of race, color, national origin, sex, age, or disability in certain “health programs or activities” through the use of “patient care decision support tools,” and expressly addresses certain clinical research activities.Pursuant to the Final Rule, covered entities include (1) recipients of Federal financial assistance, including any grant, loan, credit, subsidy, contract (other than a procurement contract but including a contract of insurance), or any other arrangement by which the federal government, directly or indirectly, provides assistance or otherwise makes assistance available; (2) HHS; and (3) any health benefit exchange created under Title I of the Affordable Care Act (“ACA”). As described in more detail, below, a “health program or activity” is defined to span clinical care, health insurance coverage and health educati

aw, Thomson Reuters, w-025-7755, 2024.[ix] White House Office of Science and Technology Policy, Blueprint for An AI Bill of Rights, October 2022.[x] Executive Order on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, October 30, 2023; 88 Fed. Reg. 75191, November 1, 2023.[xi] White House Briefing: Delivering on the Promise of AI to Improve Health Outcomes, December 14, 2023 (Payor and provider commitments include: Allina Health, Bassett Healthcare Network, Boston Children’s Hospital, Curai Health, CVS Health, Devoted Health, Duke Health, Emory Healthcare, Endeavor Health, Fairview Health Systems, Geisinger, Hackensack Meridian, HealthFirst (Florida), Houston Methodist, John Muir Health, Keck Medicine, Main Line Health, Mass General Brigham, Medical University of South Carolina Health, Oscar, OSF HealthCare, Premera Blue Cross, Rush University System for Health, Sanford Health, Tufts Medicine, UC San Diego Health, UC Davis Health, and WellSpan Health).[xii] 89 Fed. Reg. 37522 (May 6, 2024), https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08711.pdf.[xiii] Federal Trade Commission, Department of Labor, Department of Justice, Consumer Financial Protection Bureau, Department of Education, Department of Homeland Security, Department of Health and Human Services, and Equal Employment Opportunity Commission, JOINT STATEMENT ON ENFORCEMENT OF CIVIL RIGHTS, FAIR COMPETITION, CONSUMER PROTECTION, AND EQUAL OPPORTUNITY LAWS IN AUTOMATED SYSTEMS, April 4, 2024; Federal Trade Commission, Privacy and Data Security Update, 2023.[xiv] 21 U.S.C. § 360j(o)(1)(E).[xv] U.S. Food and Drug Administration, Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together, March 15, 2024; Clinical Decision Support Software, September 28, 2022.[xvi] U.S. Food and Drug Administration, Clinical Decision Support Software, September 28, 2022, pp. 4-6.[xvii] Office of the National Coordinator for Health Information Technology, Health Data, Technology, and In

On April 26, 2024, the Department of Health and Human Services (HHS) issued a final rule under Section 1557 of the Affordable Care Act (ACA), which broadly protects against discrimination in health programs or activities that receive Federal financial assistance.The final rule, 89 Fed. Reg. 37522 (May 6, 2024) (Final Rule or Rule), retains most of the rule proposed in 2022, 87 Fed. Reg. 47824 (Aug. 4, 2022) (Proposed Rule), including: (1) protections against discrimination on the basis of sexual orientation or gender identity; and (2) the express carveout for employment practices, including the provision of health benefits.The Final Rule is generally effective on July 5, 2024, with delayed compliance deadlines for some requirements.BackgroundThe Final Rule is the latest administrative step in what has been a long, ever-changing, and often confusing period for those subject to Section 1557. Much of the controversy and confusion related to Section 1557 has revolved around the regulatory interpretation of the statute’s protections for discrimination on the basis of “sex.”The first regulation issued under Section 1557, 81 Fed. Reg. 31376 (May 18, 2016) (2016 Rule), by the Obama Administration, construed sex discrimination to include that based on gender identity and termination of pregnancy. Sh

cement mechanisms in the underlying Civil Rights laws shall apply for purposes of Section 1557, and OCR clarifies that it is the agency within HHS that investigates and enforces 1557 complaints. The preamble to the Final Rule also notes that courts have recognized that Section 1557 authorizes a private right of action under any of the bases for discrimination.As with prior Section 1557 rulemakings, the Final Rule already has drawn a legal challenge from the State of Florida and the Catholic Medical Association filed on May 6, 2024 in the U.S. District Court for the Middle District of Florida. The focus of the legal challenge is whether the Final Rule’s interpretationof discrimination on the basis of sex is contrary to Title IX, violates the First Amendment and RFRA, and suffers from other administrative and constitutional law deficiencies. If past Section 1557 rulemakings are any guide, there likely will be additional litigation challenging this and other aspects of the Final Rule.[1] 89 Fed. Reg. 37522; see also Section 1557 Final Rule: Frequently Asked Questions, U.S. Department of Health and Human Services (Apr. 30, 2024), https://www.hhs.gov/civil-rights/for-individuals/section-1557/1557faqs/index.html.[2] The 2020 Rule prohibited discriminatory benefit design in health insurance coverage and other health-related coverage that receives Federal Financial Assistance. As a result, compliance with the Final Rule’s provisions at 45 C.F.R. §§ 92.207(b)(1)-(5) does not include a delayed applicability date for some covered entities—such as Medicare Advantage plans, Part D plans, Medicaid managed care plans, and QHPs—because they already had to comply with the same criteria.[3]Bostock v. Clayton County, Georgia, 590 U.S. 644 (2020).[4]Translated Resources for Covered Entities, U.S. Department of Health and Human Services (May 3, 2024), https://www.hhs.gov/civil-rights/for-individuals/section-1557/translated-resources/index.html.[5] Note that predictive decision support interventions are s

the Civil Rights Act of 1964.31The Age Discrimination Act of 1975.32Section 504 of the Rehabilitation Act of 1973, including the new 504 regulations that were published on May 9, 2024.33If and to the extent another law is less protective or creates exceptions not permitted in the § 1557 rules, HHS takes the position that the § 1557 rules preempt the other law.34ADDITIONAL RESOURCES.HHS and the OCR maintain a website for § 1557 compliance. In addition to general guidance, the website contains Fact Sheet and FAQs. These may be accessed at https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html. As mentioned above, HHS has indicated that it has or will post sample policies and procedures on its website. In addition, Holland & Hart will present a webinar and intends to publish more specific guidance concerning various aspects of § 1557 rules. To access those additional resources, visit our website at https://www.hhhealthlawblog.com/.1 42 U.S.C. § 18116; 45 C.F.R. part 92; 89 F.R. 37522 (5/6/24).2 45 C.F.R. § 92.2(a).3 The regulations do recognize federal protections for religious freedom and conscience and establish a process for obtaining exemptions based on religion or conscience. 45 C.F.R. § 92.302.4 45 C.F.R. § 92.201(a).5 45 C.F.R. § 92.201(b).6 45 C.F.R. § 92.201(c), (f), and (g).7 45 C.F.R. § 92.201(e).8 45 C.F.R. § 92.202(a).9 45 C.F.R. § 92.202(b).10 45 C.F.R. § 92.204(a).11 45 C.F.R. § 92.204(b).12 45 C.F.R. § 92.205.13 45 C.F.R. § 92.206(a).14 45 C.F.R. § 92.211.15 45 C.F.R. § 92.10(a)(2).16 45 C.F.R. § 92.210(b), (c).17 45 C.F.R. § 92.9(b)(1).18 45 C.F.R. § 92.8(b).19 45 C.F.R. § 92.8(c).20Seehttps://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html.21 45 C.F.R. § 92.11(a), (b).22 45 C.F.R. § 92.11(c)(5).23 45 C.F.R. § 92.8(h).24 45 C.F.R. § 92.9(b).25 45 C.F.R. § 92.10(a)(2).26 45 C.F.R. § 92.11(c).27 45 C.F.R. § 92.11(d).28 45 C.F.R. § 92.3(c) and 92.302.29 45 C.F.R. § 92.9(c).30 45 C.F.R. § 92.8(c)(2).31 42 U.S.C. § 2000d et seq.32 42 U