On May 6th, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) finalized a rule implementing Section 1557 of the Affordable Care Act (“Section 1557”). This landmark rule prohibits discrimination based on race, color, national origin, age, disability, or sex—including pregnancy, sexual orientation, gender identity, and sex characteristics—in health programs or activities receiving federal funding. This article focuses on how this Final Rule applies nondiscrimination principles to the increasing use of Automated Client Care Tools in healthcare. This rule directly responds to the President’s Executive Order on Artificial Intelligence and public comments on the proposed rule for Section 1557. For details on other crucial aspects of the Final Rule, including restored protections for LGBTQI+ individuals and pregnant people, please refer to our companion alert.
Understanding the Foundation
The Final Rule reinforces the Biden-Harris administration’s commitment to health equity. It strengthens safeguards against discrimination in both healthcare delivery and the rapidly evolving field of health technology. Crucially, it clarifies the broad scope of these protections, particularly concerning the use of automated client care tools. These tools, encompassing artificial intelligence (AI), clinical algorithms, and even non-AI based decision-making systems, are now subject to specific standards under the Final Rule when utilized by covered entities.
Core Provisions of the Final Rule
The Final Rule’s reach is extensive. It applies to any health program or activity receiving federal financial assistance—even partial funding—programs administered by executive agencies, and entities established under Title I of the ACA. Notably, the Final Rule explicitly states that Medicare Part B qualifies as federal financial assistance under Section 1557. Health insurance plans are also clearly defined as covered entities. All covered entities are now mandated to meet specific standards, including proactively informing individuals about the availability of no-cost accessibility services. Furthermore, the OCR extends accessibility standards to telehealth services and protects LGBTQI+ patients from sex-based discrimination. A comprehensive overview of these key provisions is available in our companion alert.
The Spotlight on Automated Client Care Tools
The Final Rule addresses the growing integration of AI and other automated client care tools within health programs and activities. Recognizing the potential for these technologies to inadvertently introduce or perpetuate discrimination, the OCR applies Section 1557’s nondiscrimination principles to their use in clinical settings. Consequently, covered entities—such as hospitals, healthcare providers, and health insurers—are now obligated to proactively identify and mitigate potential discrimination arising from their use of AI and other decision support tools in patient care.
Section 92.210 of the Final Rule explicitly prohibits discrimination based on race, color, national origin, sex, age, or disability through the use of “automated client care tools” within health programs or activities. The rule mandates covered entities to:
- Implement ongoing and reasonable efforts to identify where automated client care tools utilize input variables or factors that could reflect race, color, national origin, sex, age, or disability.
- For each automated client care tool in use, undertake reasonable efforts to minimize the risk of discrimination within their health programs or activities.
The Final Rule introduces the term “automated client care tool,” defined broadly 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.” The OCR clarifies that Section 92.210 is specifically designed to apply to tools impacting clinical decision-making directly related to patient care. This definition encompasses a wide range of tools, from sophisticated AI software to non-automated systems like triage flowcharts, directly addressing feedback received on the proposed rule for Section 1557. These tools can influence various aspects of patient care, including health status assessments, care eligibility determinations, medical necessity analyses, and recommendations for care and disease management.
It’s important to note that Section 92.210 is deliberately limited to tools involved in clinical decision-making affecting patient care within covered entities’ health programs. It excludes tools used for administrative or billing functions, patient scheduling, or facilities management. The OCR emphasizes that the goal of Section 92.210 is not to ban automated client care tools, but to ensure they are utilized in a non-discriminatory manner.
Specific Responsibilities for Utilizing Automated Client Care Tools
In response to the proposed rule, stakeholders sought clarification on the specific steps covered entities should take to ensure compliance with Section 92.210. Recognizing that covered entities often rely on tools developed by third parties and may not have insight into their underlying datasets, the OCR acknowledges that covered entities are not required to obtain these datasets as part of their compliance obligations. However, the OCR stipulates that if a covered entity has reason to believe that an automated client care tool uses variables related to race, color, national origin, sex, age, or disability, or if they otherwise know or should know that the tool could lead to discrimination, they are expected to consult publicly available resources or the tool developer. This requirement aligns with the Office of the National Coordinator for Health Information Technology’s recent final rule mandating certain developers to disclose information about decision support interventions. The OCR has opted not to prescribe specific risk mitigation measures under Section 92.210(c), maintaining that the “reasonable efforts” standard strikes an appropriate balance between protecting against discrimination and minimizing burden on covered entities, while still allowing them to implement more robust safeguards if desired.
Enforcement of Section 92.210 will be handled by the OCR on a case-by-case basis. Factors considered will include the covered entity’s size and resources, whether tools are used as intended by developers and approved by regulators, the availability of product information regarding potentially discriminatory variables, and whether the entity has established processes for evaluating automated client care tools. The OCR is currently soliciting feedback on potentially expanding the scope of Section 92.210 to include tools that may not directly impact clinical decision-making but could still result in discrimination or violations of Section 1557.
Key Takeaways for Healthcare Providers
Section 92.210 mandates that covered entities take proactive steps to identify automated client care tools, encompassing both AI-driven and non-AI systems affecting patient care, that could potentially lead to discrimination based on protected characteristics. Upon identifying such tools, covered entities are obligated to make reasonable efforts to mitigate discriminatory risks.
To ensure compliance with these new requirements under Section 92.210, covered entities must establish and implement policies and procedures for assessing their use of automated client care tools and their potential discriminatory impact on patient care within 300 days of the Final Rule’s effective date (July 5, 2024). Given the pervasive and increasing use of automated client care tools in modern healthcare, this Final Rule establishes significant responsibilities for both covered entities and health technology companies involved in developing these tools.
Our team at Crowell & Moring is prepared to assist you in understanding your obligations under this Final Rule and in implementing effective safeguards against discrimination arising from the use of automated client care tools. For further information, please reach out to the professionals listed below or your regular Crowell contact.
