Annex I

Legal & Regulatory Alignment


ANNEX I LEGAL & REGULATORY ALIGNMENT (v 1.0‑β)

This cross‑walk is informative, not legal advice.

0. Purpose & Scope

Annex I bridges CIRIS duties with binding law so that one set of controls suffices for both ethical and legal compliance.
Coverage areas:
1. Global data‑protection regimes (GDPR, CCPA/CPRA, LGPD, PIPEDA).
2. Sector statutes (HIPAA, GLBA, FINRA, FDA‑SaMD, NERC‑CIP).
3. Product‑safety & AI‑specific laws (EU‑AI‑Act, ISO/IEC 42001).
4. Liability allocation & evidence duties.


1. Data‑Protection Cross‑Walk (“DP‑Map”)

DP TopicGDPR Art.CCPA §CIRIS ClauseImplementation Hook
Lawful Basis / Purpose Limitation5 & 61798.100(b)Section II Step 1 (Contextualisation)processing_basis field in PDMA context
Data Minimisation5(1)(c)1798.140(e)Annex G §2 TX‑6Prompt‑sanitiser strips surplus PII
Transparency Notice12‑141798.100(a)Section II Step 6, KPI F‑T‑3/privacy/notice.md auto‑generated from PDMA metadata
Right of Access151798.110Annex J API → /results/{run_id}Auth‑gated user portal
Rectification / Deletion16‑171798.105Section IV Ch 3 DutyErasure service with hash tombstone
Portability201798.130(a)(2)(B)(ii)Section II Step 6export.json compliant with ISO CSV‑A
Automated Decision Safeguards221798.185(a)(16)Annex F Autonomy TiersConditional override & explanation panel

LGPD, PIPEDA mirror mappings are available in /legal/dp-map.yaml.


2. Data‑Subject Rights (DSR) Hooks

  • Endpoint: POST /dsr with {right, identifier, scope}.
  • SLA: ≤ 30 d response (GDPR) ; ≤ 45 d (CCPA) ; track KPI F‑T‑4.
  • Processor vs. Controller: Use Structural Influence (SI) (Annex E) to derive which party carries controller duties.

3. Sector‑Specific Overlays

SectorStatute / RuleExtra ControlsCIRIS Add‑ons
HealthHIPAA (45 CFR §164)ePHI encryption at rest & transit; BAA contractidentity_id:"hipaa_cls_a" guardrail; audit tag PHI=true
FinanceGLBA, FINRA 2210Audit trail retention 6 y; suitability checksPDMA Step 1 require KYC context
Children / EdTechCOPPA, FERPAParental consent; data age gatingGuardrail gr_child_content; COPPA flag in prompt schema
Critical InfrastructureNERC‑CIP, TSA SDs15‑min cyber‑incident report; physical access logsAutonomy capped at A2 unless CRE passes

Products entering a new sector MUST attach “Overlay Sheet” (overlay.yaml) in release PR.


4. Product‑Safety & AI‑Act Alignment

EU‑AI‑Act ArticleRisk‑LevelCIRIS Mapping
Art 9 Risk MgmtHigh‑riskSection II PDMA + Annex D CRE
Art 13 TransparencyUniversalKPI F‑T‑3, explainability panel
Art 16 Human OversightHigh‑riskAnnex F Autonomy Tiers
Art 15 RobustnessHigh‑riskAnnex G RS ≥ 0.97
Conformity AssessmentHigh‑riskF‑Audit (Annex H) doubles as EU‑AI‑Act MDR

5. Liability Matrix

Failure VectorPrimary Liable PartyReference LawCIRIS Role Reference
Design flaw (algorithm)Creator / DeveloperProd‑Liab Dir (EU); Restatement §402A (US)Book VI Creator Ledger
Operational negligenceDeploying OrgTort Law; OSHASection IV Ch 2
Oversight failureWise Authority (if gross)Fiduciary / NegligenceAnnex B §9
Data breachControllerGDPR Art 82; CCPA private actionAnnex G TX‑6
Unlawful automated profilingControllerGDPR Art 22Annex F Autonomy

Joint & several liability may apply; SI score (Annex E) informs apportionment.


6. Reg‑Change Tracker

  • Source Feeds: EUR‑Lex, Federal Register API, ISO ballot tracker.
  • Bot: lexwatcher.py runs daily; creates GitHub issue with tag reg‑update.
  • Compliance Impact Label: minor, material, breaking. “Material” triggers S‑Dive audit; “Breaking” opens WA docket & possible spec patch.

7. Compliance Evidence Pack (CEP)

Every F‑Audit (Annex H) must export a CEP zip containing:

  1. dp-map.yaml - live cross‑walk.
  2. PDMA logs (redacted) proving lawful basis.
  3. DSR ledger CSV.
  4. Signature bundle (.sigstore) of all model artefacts (Annex G).
  5. Overlay Sheets by sector.
  6. Liability matrix acknowledgement signed by legal.

CEP hashed and uploaded to /compliance/cep/{version}.zip; root hash anchored in transparency log.


8. Inter‑Annex Hooks

  • Annex F: Autonomy Tiers ensure human‑in‑the‑loop requirements of GDPR Art 22 & EU‑AI‑Act Art 16.
  • Annex G: TX‑6 privacy defenses satisfy GDPR pseudonymisation recommendations (Recital 28).
  • Annex H: F‑Audit timing supplies evidence for periodic re‑assessment duties in EU‑AI‑Act Art 61.
  • Annex J: Benchmark explanations furnish “meaningful information” for automated‑decision queries (GDPR Art 15(1)(h)).

9. References

  • GDPR (2016/679), CCPA/CPRA (Cal. Civ. §1798), LGPD (Lei 13.709/2018)
  • HIPAA Privacy Rule (45 CFR §164), GLBA Safeguards (16 CFR 314)
  • EU‑AI‑Act (2024 text), ISO/IEC 42001:2023
  • Restatement (Third) of Torts, Product Liability

End of Annex I