Clinical AI with HIPAA-grade evidence.

Clinical AI decisions have consequences that do not wait for regulators — patients live or die on them. Assurance in healthcare AI is an ethical commitment before it is a compliance one.

Where healthcare AI needs evidence

Healthcare is the most regulated industry AI enters, and the regulatory stack is complex by jurisdiction. FDA oversight for software-as-a-medical-device. HIPAA for privacy and security of protected health information. HHS OCR for non-discrimination obligations under Section 1557 of the Affordable Care Act, which now explicitly covers AI-driven decisions. State medical boards for scope-of-practice implications. In the EU, the Medical Device Regulation and the AI Act both apply. Every one of these authorities asks variants of the same question: what did the AI do, to whom, under what policy, and can you prove it?

The five use cases we focus on

Clinical decision support (CDS)

CDS systems that advise on diagnosis, treatment selection, or risk stratification produce decisions that become part of the clinical record. Veridra signs each CDS decision with the model version, clinical context hashes, confidence, and guideline reference. When a clinician accepts or overrides a recommendation, that acceptance or override is itself signed — so the human-in-the-loop evidence is as durable as the AI evidence.

Triage and prior authorization

AI-driven triage decisions — emergency department, telehealth intake, nurse advice lines — must show consistency across patient populations. AI-driven prior authorization, recently scrutinized by HHS and class-action counsel, must show that algorithmic denials were based on coverage policy, not on outcome optimization. Veridra's signed decision stream produces the evidence for both.

Imaging and diagnostic AI

Imaging AI often falls under FDA Class II SaMD oversight with PCCP (Predetermined Change Control Plan) requirements for model updates. Veridra's Verify module (Q1 2027) directly supports model lineage across version updates, and the Attest pipeline signs each diagnostic decision with the exact model version in use. FDA re-submission evidence is continuously available.

Claims adjudication (payer)

Payer AI faces specific scrutiny for adverse determinations — denials, prior authorization rejections, network adequacy rulings. The 2023-2025 wave of class actions against Medicare Advantage plans using AI for authorization decisions raised the bar significantly. Veridra signs each payer decision with policy version, clinical input hashes, and adjudication rationale. The evidence supports regulatory defense and internal audit equally.

Documentation and coding AI

Ambient documentation and AI-assisted coding tools are now standard in provider workflows. They also create new compliance exposure — miscoded claims, documentation that does not match the clinical encounter, and HIPAA minimum-necessary concerns for training data. Veridra signs documentation-AI outputs with the source recording hash and the model version, producing a defensible chain of custody for audit.

FDA and international alignment

• FDA 21 CFR Part 11 — electronic records and electronic signatures. Veridra's Ed25519 signatures satisfy the Part 11 signature requirements for regulated records.
• FDA PCCP for AI/ML-based SaMD — model version changes require controlled release. Verify module preserves the full version lineage for regulatory submission.
• HHS OCR Section 1557 — AI non-discrimination in healthcare. Watch module's drift detection surfaces disparate impact across protected groups before regulators do.
• EU MDR + AI Act — for providers and devices serving EU patients, the overlapping obligations map to Veridra evidence cleanly.
• Joint Commission standards — accreditation increasingly references AI governance; Veridra outputs are survey-ready.