ARCA.VISION
// USE CASE

High-Compliance Healthcare

Kernel-level audit logs as evidence for HIPAA and FDA SaMD reviews — the proof health-AI vendors hand to their hospital customers.

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// HEALTH-AI VENDORS · SaMD · ILLUSTRATIVE SCENARIO

High-Compliance Healthcare

Kernel-level audit logs as evidence for HIPAA and FDA SaMD reviews — the proof health-AI vendors hand to their hospital customers.

HIPAAFDA · SaMDHITRUSTSOC 2 · TYPE II
Imagine a health-AI vendor shipping a GPU-backed diagnostic imaging model to hospital customers. Every customer's security review wants evidence that PHI never left the host. Arca Sentry attaches at libcuda.so and the ioctl tracepoint, records every GPU launch and ioctl as a structured event, exposes counts via Prometheus, and seals the kernel-side event stream into a tamper-evident Ledger the vendor hands to every customer's auditor — the same artifact for HIPAA and FDA SaMD review, captured below the application.
// AT FLEET SCALE · ARCA NEXUS

Across every customer deployment, Arca Nexus rolls each Sentry's verdicts into one signed compliance trail the vendor can produce on demand — the fleet view, not a stack of per-host logs.

Audit posture
kernel-side · below the app
Evidence
Prometheus + tamper-evident ledger
Numbers above
design target · not measured