Regulators are paying closer attention to how clinical AI treats different patient groups. Two frameworks come up often in our conversations: Section 1557 of the Affordable Care Act in the United States, and the EU AI Act.
What the frameworks ask
Under the Section 1557 rule (45 CFR 92.210), covered health programs are expected to make reasonable efforts to identify patient care decision support tools that could discriminate, and to mitigate that risk. The EU AI Act sets obligations for high-risk AI systems, including monitoring after they reach the market. The duties fall on the hospitals and providers who are covered. Please speak with qualified counsel about how they apply to you.
Where documented evidence can help
A governance committee needs documentation it can read and question. A retrospective assessment can produce structured subgroup performance reports on a model's existing outputs. That is evidence for your process. It is not a compliance determination, and Synod IntelliCare does not certify compliance with any statute or regulation.
What we do today
The Data Diversity and Fairness Auditor (DDFA) is a team-operated retrospective workflow that analyzes de-identified structured data and existing model outputs supplied under appropriate institutional approvals. It does not currently connect to live EHRs, ingest images or unstructured records, certify legal compliance, or provide point-of-care alerts.
Editor's note: this article was first published in August 2026. Our positioning was updated in October 2026 to reflect what Synod IntelliCare does today. We would rather tell you plainly what we can do now than promise what we have not yet built.