Overview
As of May 1, 2025, hospitals and health plans must comply with the revised Section 1557 of the Affordable Care Act, which now explicitly prohibits discrimination through the use of clinical decision support tools—including AI algorithms. This is a transformative shift. Health systems must now audit and mitigate potential bias in any clinical tool that uses protected characteristics like race, sex, age, disability, sexual orientation, or gender identity. Yet while the law is active, federal guidance remains limited, leaving healthcare leaders navigating a compliance minefield without a map.
🧠What Section 1557 Now Requires:
Leading law firms—including Hogan Lovells, Epstein Becker Green, Manatt, and King & Spalding—all underscore the same message: health systems bear the burden of proof. You cannot rely on your vendors or assume that regulatory approval means a model is free of bias. As Hogan Lovells put it: “You must assess not just what a tool was designed to do—but how it’s used in your environment.”Meanwhile, Epstein Becker Green notes that AI regulation in the U.S. remains in flux, and that Section 1557 is just one piece of an evolving, fragmented compliance landscape. With definitions, risk thresholds, and enforcement mechanisms still emerging, proactive strategies are essential.
đź“Ť Real-World Examples Show the Way Forward:
These examples demonstrate that compliance is not theoretical. It starts with internal audits, cross-functional coordination, and a willingness to interrogate the assumptions embedded in your decision-making tools.
🔄 Relevance to GMLP, PCCP, and FDA Lifecycle Guidance
The Section 1557 rule reinforces the importance of lifecycle oversight frameworks such as the FDA’s Good Machine Learning Practice (GMLP) principles, the Predetermined Change Control Plan (PCCP), and the AI/ML Lifecycle Guidance Document. These initiatives emphasize continuous model monitoring, explainability, and risk mitigation—principles that directly align with the 1557 mandate to identify and address bias throughout a model’s deployment, not just at the time of approval. For AI teams and compliance officers, this means building auditability, documentation, and fairness assessments into every phase of AI development and use.
🧑‍⚕️ Who Is This Rule Applicable To?
Section 1557 applies to a broad range of AI users in healthcare—including hospitals, health systems, academic medical centers, health insurers, and digital health technology companies. If your organization receives federal funding and uses AI, predictive analytics, or clinical decision support tools in care delivery, you are responsible for ensuring those tools do not discriminate. Whether you’re building algorithms internally or licensing them from vendors, the accountability remains with you.
🧩 How Gesund.ai Supports Strategic AI Compliance
At Gesund.ai, we help healthcare organizations transform regulatory uncertainty into a roadmap for trustworthy AI. Our validation and monitoring platform is designed to support Section 1557 requirements through: We combine data science with regulatory-grade validation to ensure your tools are not just technically excellent—but equitable, compliant, and defensible.
🔎 Don't wait for perfect guidance—build trust, reduce risk, and lead with integrity. → Learn how Gesund.ai can support your compliance strategy: www.gesund.ai/get-in-touch-gesund
#AICompliance , #Section1557 , #AICompliance , #AlgorithmicBias , #HealthEquity , #DigitalHealth , #AIGovernance , #ClinicalAI , #GesundAI , #AIValidation , #GMLP , #PCCP , #AIlifecycle
đź“š Sources
1. Hogan Lovells. HHS Finalizes Changes to Section 1557 Regulations.
2. STAT News. HHS stays quiet about nondiscrimination rules for AI, algorithms.
3. Epstein Becker Green. Embrace the Chaos: AI Regulation in the US Remains in Flux.
4. Manatt. HHS Finalizes Antidiscrimination Rules on Patient Care Decision Support Tools.
5. King & Spalding. Health Headlines – May 6, 2024.
https://www.kslaw.com/news-and-insights/health-headlines-may-6-2024
6. RSNA. FAQ for Section 1557 ACA.
https://www.rsna.org/-/media/files/rsna/practice-tools/faq-for-section-1557-aca.pdf
7. Digital Medicine Society. Removing Harmful Race-Based Clinical Algorithms Toolkit.
https://dimesociety.org/removing-harmful-race-based-clinical-algorithms-a-toolkit/
About the Author
Gesund.ai
Gesund is the world’s first compliant AI factory on a mission to help bring clinical-grade AI solutions to market. Backed by marquee investors including Merck, McKesson, Northpond and 500, Gesund orchestrates the entire AI/ML lifecycle for all stakeholders by bringing models, data and experts together in a no-code environment.