VELARU MANDATE EXHIBIT PACK — RADIOLOGY AI (SAMD)
Jurisdiction: Germany (de)
Modality: Text / Chat
Program: Velaru Radiology AI (SaMD) · Germany (galactic_radiology_ai_de)
Product ID: radiology_ai:de:bundle:text
Vertical: radiology_ai
Generated: 2026-08-23T19:05:40.198249Z
Authority: Germany BaFin AI Pack — Radiology AI (SaMD) External Validation Pack
Deadline: FDA SaMD + EU MDR
Velaru verify: https://velaru-erra.onrender.com/verify

EXHIBIT A — AI INVENTORY
[]

EXHIBIT B — GOVERNANCE FRAMEWORK
{
  "framework": "Velaru Mandate Registry \u2014 Radiology AI (SaMD)",
  "exhibit_authority": "Germany BaFin AI Pack \u2014 Radiology AI (SaMD) External Validation Pack",
  "regulatory_frameworks": [
    "HIPAA",
    "FDA SaMD guidance",
    "EU AI Act Annex III",
    "EU AI Act",
    "BaFin AI guidance",
    "GDPR",
    "German AI Strategy"
  ],
  "standards_alignment": [
    "POSS-2",
    "DRP-1",
    "TCB",
    "FRE 707 pre-compliance",
    "ISO 42001"
  ],
  "human_oversight": "execute Radiology AI (SaMD) AI decision",
  "third_party_verification": "https://velaru-erra.onrender.com/verify (operator-independent)",
  "data_lineage": "Hash-chained Ed25519 receipts; optional RFC3161 + external anchor",
  "mirror_trap": "Hospital owns read \u2014 AI vendor owns cleared device label only \u00b7 BaFin expects bank AI documentation in German exam language \u2014 receipt metadata supports localization.",
  "chain_integrity": {
    "depth": 6,
    "invariant_holds": true
  }
}

EXHIBIT D — DATA INPUTS & VALIDATION
{
  "data_validation_method": "Cryptographic receipt per AI decision; public verify without trusting deployer, vendor, or Velaru operator",
  "bias_testing_proxy": "Asymmetry score from live chain signals",
  "model_change_control": "Policy lock registry \u2014 criteria hash frozen pre-dispute",
  "logging_retention": "90-day pre-dispute window minimum; permanent verify permalinks",
  "external_validator": "Nisaba LLC / Velaru",
  "validator_independence": "Client-side Ed25519 verify; BYOK tri-receipt optional",
  "headline_stat": "Radiology AI 510(k) \u2014 per-read decision receipt for malpractice",
  "global_leaders_addressed": [
    "Aidoc",
    "Google Health",
    "FDA",
    "BaFin",
    "Volkswagen",
    "SAP",
    "Siemens"
  ]
}

MIRROR TRAP (regulatory insight)
Hospital owns read — AI vendor owns cleared device label only · BaFin expects bank AI documentation in German exam language — receipt metadata supports localization.

NERVE CARDS — WHY GLOBAL LEADERS CARE
[
  {
    "title": "Missed finding",
    "body": "AI flagged then dismissed \u2014 who owns miss? Receipt settles.",
    "source": "vertical"
  },
  {
    "title": "FDA PCCP",
    "body": "Model update without receipt = off-label use inference",
    "source": "vertical"
  },
  {
    "title": "[Germany] Automotive",
    "body": "German OEM AV and industrial AI \u2014 strict liability culture demands proof.",
    "source": "jurisdiction"
  },
  {
    "title": "[Germany] Works council",
    "body": "Betriebsrat co-determination on workplace AI \u2014 receipt proves consultation occurred.",
    "source": "jurisdiction"
  },
  {
    "title": "[Text / Chat] Modality hook",
    "body": "Baseline \u2014 all frameworks apply to text decisions.",
    "source": "modality"
  }
]

BOOK SUMMARY: {
  "total_insureds": 0,
  "compliant": 0,
  "grace_period": 0,
  "non_compliant": 0,
  "expired": 0,
  "not_enrolled": 0,
  "compliant_pct": 0.0
}

TAM / EXPOSURE: $2B AI radiology
INSURANCE LINES: E&O, Cyber, Sector liability

DISCLAIMER: External validation evidence pack — not legal advice, not filed rate approval.