The regulatory analysis is already done. You don't have to build the argument from scratch.
IntelliNurse™ is clinical AI built for nursing reasoning — scoped from the start as non-device clinical decision support under the FDA's January 2026 revised guidance. Compliance and legal leaders at Medicare Advantage plans, Medicaid managed care organizations, FQHC networks, primary care groups, ACOs, and IDNs are the ones who decide whether a vendor's scoping analysis holds up to the scrutiny of state regulators, federal auditors, and the plaintiff's bar. The scoping addresses Medicaid managed care and Medicare Advantage regulatory exposure, FDA non-device CDS scoping, and state AI practice law alignment (California SB 1120 and AB 3030, Texas SB 1188 and HB 149) — with the documentation to back it.
FDA scoping.
IntelliNurse™ is designed to remain on the non-device side of the FDA's January 2026 revised clinical decision support guidance. Every recommendation is reviewable by a licensed clinician, traceable to a named protocol, and presented with the underlying medical guideline evidence and the corresponding outcome targets. The full scoping analysis — including the specific criteria addressed and the design choices made to remain non-device — is available under NDA as part of the compliance pre-read.
What IntelliNurse™ is not used for. IntelliNurse™ is not used for utilization-management decisions, prior-authorization decisions, or coverage-denial decisions. The product surfaces clinical recommendations to a licensed nurse for clinical care planning and care delivery; coverage and utilization determinations remain with the program's clinical and medical leadership, under the applicable supervision and payer rules. This boundary is structural — the product is not configured to make, recommend, or score utilization or coverage outcomes. The scoping analysis documents the design choices that hold the boundary in place.
State AI law alignment.
California SB 1120 (physician oversight of AI-driven utilization decisions) and AB 3030 (patient disclosure of generative AI use in clinical communications) are addressed at the product-configuration level, not at the policy-document level. Texas SB 1188 (data residency for electronic health records) and HB 149 (AI governance framework for state entities) are supported by deployment-level controls. The product is architected to accommodate state-by-state variation without requiring code changes. The compliance brief documents the alignment approach in the detail your counsel will need.
Framework alignment.
Alignment with the American Academy of Nursing's February 2026 position statement on AI is designed into the product, not retrofitted as documentation. The Joint Commission and Coalition for Health AI Responsible Use framework is addressed through audit log structure, decision traceability, and the standing Nursing Council that advises the platform — reviewing the clinical framework, the governance discipline, and the protocol architecture that workflows are built and validated against. The ANA Code of Ethics framework for AI in nursing is anchored through the deferral mechanism — when evidence is insufficient, the system says so and hands the decision back to the nurse, on the record.
What the governance brief covers.
The full FDA non-device scoping analysis, the state AI law mapping, the framework alignment documentation, the data-handling scope and residency options, the incident-response structure, the audit log schema, and the known regulatory and legal risks the product is designed to manage. Built to be reviewed by your counsel and your Chief Compliance Officer in a single sitting.