HIPAA Security & Privacy Rules
45 CFR Part 160, 164 (Subparts A, C, E). Signed Evidence Packs™ per record-access give HHS-OCR the contemporaneous trail the Audit Protocol requires. Minimum Necessary attestation + BAA-ready evidence pack shape.
United States
When HHS-OCR audits a HIPAA Privacy or Security incident, when FDA wants the SaMD post-market evidence, when NYDFS Part 500 requires the cyber-controls trail, when OCC Heightened Standards demands model-risk-management proof — KYE Protocol™ answers from a record sealed at the moment of action. Replayable from the publishing tenant's JWKS alone. No vendor dependency in the audit path.
You learn: What happens at each step. You can: Step through it.
Step 1 of 5
KYE Protocol™
Data residency
deploy to US-region edge runtime resources; FedRAMP-ready architecture for federal procurements; per-tenant configurable.
Step 2 of 5
KYE Protocol™
Customer KMS / HSM
signing keys live in the customer's HSM or AWS GovCloud KMS; KYE™ never has access to the private key material.
Step 3 of 5
KYE Protocol™
Open verifier
HHS-OCR, FDA, OCC, NYDFS, SEC, FINRA, FTC and CISA can each replay an Evidence Pack™ using only the publisher's JWKS — no vendor dependency in the audit path.
Step 4 of 5
KYE Protocol™
BAA-compatible
evidence-pack shape designed for HIPAA Business Associate Agreement evidence handling.
Step 5 of 5
KYE Protocol™
Apache 2.0 schemas + vocabulary
the proof formats are open. Patent-track runtime construction is paid; the contracts the customer relies on are not.
US frameworks mapped to KYE™ ™
45 CFR Part 160, 164 (Subparts A, C, E). Signed Evidence Packs™ per record-access give HHS-OCR the contemporaneous trail the Audit Protocol requires. Minimum Necessary attestation + BAA-ready evidence pack shape.
HITECH Breach Notification Rule + HITRUST Common Security Framework. Audit-chain immutability + per-decision evidence ready for HITRUST controls 01.b, 09.aa, 10.ab and the HITECH 60-day breach window.
Software as a Medical Device + electronic-records integrity + Predetermined Change Control Plan (FDA-CDRH 2024). KYE™ binds the runtime decision to the PCCP declaration; signed Evidence Pack™ per inference is the post-market record FDA reviewers expect.
OCC Heightened Standards (model-risk-management) + NYDFS Part 500 (cyber + AI 2024 amendments) + SEC Regulation Systems Compliance & Integrity. Banking-grade audit chain maps directly; signed Replay Proofs™ verify offline from public keys alone.
Govern · Map · Measure · Manage + Zero-Trust Architecture. The Measure + Manage functions map directly to KYE™ runtime-evidence + revocation primitives.
FedRAMP (federal-cloud authorisations) · CISA Secure-by-Design AI guidance · state AI laws (Colorado SB 205, Illinois Generative AI Act). KYE™ records keep the federal-and-state audit trail contemporaneous and replayable across jurisdictional boundaries.
US-sovereign deployment
US pilots · 6 weeks each
US SaMD vendors and US healthcare providers procure differently. Two pilot SKUs reflect that.
Independent — no government affiliation. KYE Protocol™ is an independent protocol and is not affiliated with, endorsed by, or part of any government, regulator, or official “Sovereign AI” programme. References to regulators and frameworks describe the requirements KYE™ helps you evidence — not any official relationship.
Canonical KYE™ surfaces referenced on this page: Evidence Pack™ · KYE Protocol™.