Evidence Bundle Report

Policy Configuration

{
  "name": "keyhealth",
  "version": "1.0.0",
  "description": "Healthcare compliance cartridge with HIPAA enforcement and FHIR integration",
  "author": "IOA Project",
  "license": "Commercial EULA",
  "dependencies": [
    "ioa-core>=2.5.0",
    "python>=3.10"
  ],
  "compliance": {
    "hipaa": {
      "enabled": true,
      "rules": [
        {
          "id": "hipaa-minimum-necessary",
          "name": "HIPAA Minimum Necessary Principle",
          "enforcement": "strict",
          "description": "Limit PHI disclosure to minimum necessary for purpose"
        },
        {
          "id": "hipaa-phi-redaction",
          "name": "PHI Redaction Required",
          "enforcement": "strict",
          "description": "All PHI must be redacted unless explicitly authorized"
        },
        {
          "id": "hipaa-audit-trail",
          "name": "HIPAA Audit Trail",
          "enforcement": "strict",
          "description": "All PHI access must be logged with immutable audit trail"
        }
      ]
    },
    "gdpr": {
      "enabled": true,
      "rules": [
        {
          "id": "gdpr-health-data-protection",
          "name": "GDPR Special Category Data Protection",
          "enforcement": "strict",
          "description": "Health data requires explicit consent and enhanced protection"
        },
        {
          "id": "gdpr-data-minimization",
          "name": "GDPR Data Minimization",
          "enforcement": "strict",
          "description": "Only necessary health data should be processed"
        }
      ]
    },
    "fda": {
      "enabled": true,
      "rules": [
        {
          "id": "fda-tplc-assurance",
          "name": "FDA Total Product Life Cycle Assurance",
          "enforcement": "advisory",
          "description": "Maintain assurance evidence for AI/ML model lifecycle"
        },
        {
          "id": "fda-pccp-monitoring",
          "name": "FDA Predetermined Change Control Plan",
          "enforcement": "advisory",
          "description": "Document and monitor planned model changes"
        }
      ]
    }
  },
  "phi_detection": {
    "engine": "presidio",
    "entities": [
      "PERSON",
      "EMAIL_ADDRESS",
      "PHONE_NUMBER",
      "SSN",
      "MEDICAL_RECORD_NUMBER",
      "DATE_OF_BIRTH",
      "ADDRESS",
      "IP_ADDRESS"
    ],
    "redaction_method": "mask"
  },
  "fhir": {
    "version": "R4",
    "smart_on_fhir": {
      "enabled": true,
      "required_scopes": [
        "patient/*.read",
        "user/*.read"
      ]
    },
    "resource_types": {
      "allowed": [
        "Patient",
        "Observation",
        "DiagnosticReport",
        "Condition",
        "MedicationRequest"
      ],
      "restricted": [
        "AuditEvent"
      ]
    }
  },
  "audit": {
    "enabled": true,
    "format": "FHIR-AuditEvent",
    "signature": true,
    "retention_days": 2555,
    "fields": [
      "timestamp",
      "actor_id",
      "action_type",
      "resource_type",
      "outcome",
      "phi_accessed"
    ]
  },
  "bias_detection": {
    "enabled": true,
    "engine": "aif360",
    "protected_attributes": [
      "race",
      "gender",
      "age"
    ],
    "fairness_metrics": [
      "disparate_impact",
      "equal_opportunity_difference"
    ],
    "threshold": 0.8
  },
  "laws": {
    "law1_compliance_supremacy": true,
    "law2_governance_precedence": true,
    "law3_auditability": true,
    "law4_immutable_governance": true,
    "law5_fairness": true,
    "law6_human_oversight": true,
    "law7_sustainability": true
  },
  "evidence": {
    "export_format": "json+html",
    "signature": true,
    "includes": [
      "policy_yaml",
      "model_versions",
      "audit_slice",
      "fairness_probes",
      "jurisdiction_tags",
      "compliance_attestations"
    ]
  },
  "scoring": {
    "weight": 0.15,
    "components": [
      {
        "name": "phi_protection",
        "weight": 0.3
      },
      {
        "name": "audit_completeness",
        "weight": 0.25
      },
      {
        "name": "fhir_compliance",
        "weight": 0.2
      },
      {
        "name": "fairness",
        "weight": 0.15
      },
      {
        "name": "human_oversight",
        "weight": 0.1
      }
    ]
  }
}

Model Versions

Audit Slice

Total Events: 3

Date Range: 2025-09-02T12:46:07.182248+00:00 to 2025-10-02T12:46:07.183013+00:00

Fairness Probes

{
  "threshold": 0.8,
  "protected_attributes": [
    "race",
    "gender",
    "age"
  ],
  "last_run": "2025-10-02T12:46:07.185064+00:00",
  "metrics": {
    "disparate_impact": 0.85,
    "equal_opportunity_difference": 0.12
  }
}

Laws Enforced

Bundle Signature

fa8f44c2f98b8dcab4f07f7af0d3869c58783a36be69f7d153ef72b3da763a68