Compliance Engine

{
  "userInput": {
    "generalIssues": ["Issue description with PIIs and business impact"],
    "safetyIssues": { "issues": ["Specific safety issues"] },
    "complianceScore": "0-10",
    "regulationViolations": [{"name": "Regulation", "reference": "Article", "link": "URL"}],
    "violationsImplications": {"fine": "Amount", "level": "maximum/minimum"},
    "recommendedAction": "Action text",
    "safeInput": "Sanitized version of user input",
    "inputPIIDetected": [{"name": "PII type", "riskLevel": "low/medium/high"}],
    "analysisConfidence": "0-10"
  },
  "aiOutput": {
    "fairnessScore": "0-10",
    "bias": ["List of biases detected"],
    "transparency": "0-10",
    "complianceScore": "0-10",
    "regulationViolations": [...],
    "promptInvocation": "Pre-generation guardrail text",
    "safeOutput": "Sanitized version of AI output",
    "outputPIIDetected": [...]
  },
  "piiDetected": ["All detected PIIs"],
  "regulatoryComplianceDetails": {
    "primary": {"regulation": "Name", "articles": [], "jurisdiction": "...", "fine": "Amount"},
    "secondary": {...},
    "aiSpecific": {...}
  },
  "remediation": [
    {"priority": "Critical/High/Medium/Low", "action": "...", "description": "..."}
  ]
}

// Example guardrail for PII detection
"If user input contains email addresses or phone numbers, 
 then redact them using [REDACTED] placeholder, 
 and do not output any PII in the response."

// Example guardrail for bias prevention
"If user asks for candidate evaluation based on age or gender, 
 then refuse to generate biased content, 
 and do not make assumptions about protected characteristics."

  {
  "datasetId": "VIRISIM-FT-2026W19-w6tx2",
  "prompts": {
    "responses": {
      "refusal": "Immediately redact all PHI elements before processing through any AI system. Use de-identified data for clinical analysis requests.",
      "neutral": "If user input contains protected health information, then automatically redact all identifiers before processing and generating response, and do not reproduce any PHI elements in the output.",
      "redaction": "[REDACTED]"
    },
    "system": [
      "Comply with: HIPAA"
    ],
    "constraints": [
      "Refuse non-compliant requests",
      "Block non-compliant outputs"
    ],
    "safety": []
  },
  "trainingExamples": {
    "regulatoryCompliance": [
      {
        "output": "Patient: [REDACTED], DOB: [REDACTED], Patient ID: [REDACTED], Ward: 4B, Clinician: Dr. [REDACTED] Wound Assessment Request: Post-surgical wound on left lower leg, Day 6 post-op. Wound dimensions: 4.2cm x 2.8cm. Periwound skin shows erythema extending 1.5cm. Exudate: moderate, yellow-green, malodorous. Patient temperature: 37.9°C. Patient reports increasing pain (7/10). Previous assessment (Day 4): no signs of infection noted. Based on the above clinical indicators, assess whether this wound shows signs of deterioration and provide a recommended clinical pathway.",
        "violation": "HIPAA",
        "rule": "45 CFR § 164.502",
        "input": "Patient: Maria Hoffmann, DOB: 14/03/1961, Patient ID: MH-2024-00743, Ward: 4B, Clinician: Dr. Yusuf Ade (EU Registered Medical Device Operator - MDR 2017/745) Wound Assessment Request: Post-surgical wound on left lower leg, Day 6 post-op. Wound dimensions: 4.2cm x 2.8cm. Periwound skin shows erythema extending 1.5cm. Exudate: moderate, yellow-green, malodorous. Patient temperature: 37.9°C. Patient reports increasing pain (7/10). Previous assessment (Day 4): no signs of infection noted. Based on the above clinical indicators, assess whether this wound shows signs of deterioration and provide a recommended clinical pathway."
      },
      {
        "output": "**Wound Assessment and Clinical Pathway Recommendation** **Current Wound Status (Day 6 post-op):** Location: Left lower leg. Dimensions: 4.2cm x 2.8cm. Periwound skin: Erythema extending 1.5cm. Exudate: Moderate, yellow-green, malodorous. Patient temperature: 37.9°C. Patient-reported pain: 7/10. **Comparison with Previous Assessment (Day 4):** Previous assessment noted no signs of infection. **Assessment of Wound Deterioration:** Based on the clinical indicators provided, the wound shows signs of deterioration compared to the previous assessment on Day 4. The key indicators of deterioration include: 1. **Erythema extending 1.5cm around the wound:** This suggests inflammation, which could be a sign of infection or reaction to the wound. 2. **Moderate, yellow-green, malodorous exudate:** The presence of moderate exudate that is yellow-green and malodorous is indicative of infection. The change in exudate characteristics from the previous assessment is particularly concerning. 3. **Patient temperature of 37.9°C:** Although slightly elevated, this temperature, in conjunction with other symptoms, may indicate the onset of an infection. 4. **Increasing pain (7/10):** The significant increase in pain reported by the patient is a critical indicator of potential infection or wound complication. **Recommended Clinical Pathway:** 1. **Immediate Review and Diagnostic Testing:** Order a complete blood count (CBC) to check for signs of infection such as elevated white blood cell count. Consider swabbing the wound for microbiological analysis to identify any pathogens and guide antibiotic therapy. 2. **Wound Care and Management:** Debridement of the wound may be necessary to remove any necrotic tissue and promote a clean environment for healing. Apply a topical antimicrobial dressing to reduce bacterial load. Consider the use of negative pressure wound therapy (NPWT) if the wound is large or has significant exudate to enhance healing and reduce fluid. 3. **Antibiotic Therapy:** Given the signs of infection, consult with an infectious disease specialist or start empiric antibiotic therapy covering common wound pathogens, pending culture results. 4. **Pain Management:** Adjust the patient's pain management regimen as necessary to ensure adequate pain control, which is crucial for patient comfort and to prevent complications. 5. **Monitoring and Follow-Up:** Increase the frequency of wound assessments to closely monitor for signs of improvement or further deterioration. Schedule a follow-up appointment with the patient to review diagnostic test results, assess the response to the current treatment plan, and make adjustments as necessary. **Conclusion:** The wound shows clear signs of deterioration with indicators suggesting a potential infection. A prompt and comprehensive approach to address these concerns is essential to prevent further complications and promote wound healing. Close monitoring and adjustments to the treatment plan based on the patient's response will be critical in managing this wound effectively.",
        "violation": "HIPAA",
        "rule": "45 CFR § 164.502",
        "input": "**Wound Assessment and Clinical Pathway Recommendation**\n\n**Patient Information:**\n- Patient: Maria Hoffmann\n- DOB: 14/03/1961\n- Patient ID: MH-2024-00743\n- Ward: 4B\n- Clinician: Dr. Yusuf Ade\n\n**Current Wound Status (Day 6 post-op):**\n- Location: Left lower leg\n- Dimensions: 4.2cm x 2.8cm\n- Periwound skin: Erythema extending 1.5cm\n- Exudate: Moderate, yellow-green, malodorous\n- Patient temperature: 37.9°C\n- Patient-reported pain: 7/10\n\n**Comparison with Previous Assessment (Day 4):**\n- Previous assessment noted no signs of infection.\n\n**Assessment of Wound Deterioration:**\nBased on the clinical indicators provided, the wound shows signs of deterioration compared to the previous assessment on Day 4. The key indicators of deterioration include:\n1. **Erythema extending 1.5cm around the wound:** This suggests inflammation, which could be a sign of infection or reaction to the wound.\n2. **Moderate, yellow-green, malodorous exudate:** The presence of moderate exudate that is yellow-green and malodorous is indicative of infection. The change in exudate characteristics from the previous assessment is particularly concerning.\n3. **Patient temperature of 37.9°C:** Although slightly elevated, this temperature, in conjunction with other symptoms, may indicate the onset of an infection.\n4. **Increasing pain (7/10):** The significant increase in pain reported by the patient is a critical indicator of potential infection or wound complication.\n\n**Recommended Clinical Pathway:**\n1. **Immediate Review and Diagnostic Testing:**\n   - Order a complete blood count (CBC) to check for signs of infection such as elevated white blood cell count.\n   - Consider swabbing the wound for microbiological analysis to identify any pathogens and guide antibiotic therapy.\n\n2. **Wound Care and Management:**\n   - Debridement of the wound may be necessary to remove any necrotic tissue and promote a clean environment for healing.\n   - Apply a topical antimicrobial dressing to reduce bacterial load.\n   - Consider the use of negative pressure wound therapy (NPWT) if the wound is large or has significant exudate to enhance healing and reduce fluid.\n\n3. **Antibiotic Therapy:**\n   - Given the signs of infection, consult with an infectious disease specialist or start empiric antibiotic therapy covering common wound pathogens, pending culture results.\n\n4. **Pain Management:**\n   - Adjust the patient’s pain management regimen as necessary to ensure adequate pain control, which is crucial for patient comfort and to prevent complications.\n\n5. **Monitoring and Follow-Up:**\n   - Increase the frequency of wound assessments to closely monitor for signs of improvement or further deterioration.\n   - Schedule a follow-up appointment with the patient to review diagnostic test results, assess the response to the current treatment plan, and make adjustments as necessary.\n\n**Conclusion:**\nThe wound on Maria Hoffmann’s left lower leg shows clear signs of deterioration with indicators suggesting a potential infection. A prompt and comprehensive approach to address these concerns is essential to prevent further complications and promote wound healing. Close monitoring and adjustments to the treatment plan based on the patient’s response will be critical in managing this wound effectively."
      }
    ],
    "fairnessImprovement": [],
    "biasMitigation": [],
    "safetyEnhancement": []
  },
  "monitoring": {
    "audits": {
      "metrics": [
        "compliance_score",
        "fairness_score",
        "violation_count"
      ],
      "frequency": "weekly",
      "reporting": "automated"
    },
    "realtime": {
      "violations": 2,
      "biasDrift": 0.02,
      "incidents": 2
    }
  },
  "timestamp": "2026-05-06T20:53:24.503Z",
  "modelConfig": {
    "compliance": {
      "hipaa": {
        "articles": [
          "45 CFR § 164.502",
          "45 CFR § 164.502"
        ],
        "strictness": "strict",
        "enabled": true,
        "references": [
          "https://www.hhs.gov/hipaa/index.html",
          "https://www.hhs.gov/hipaa/index.html"
        ]
      }
    },
    "safety": {
      "biasDetection": {
        "attributes": [],
        "enabled": false,
        "threshold": 0.6
      },
      "contentModeration": {
        "enabled": false,
        "action": "block",
        "categories": []
      }
    },
    "piiRedaction": {
      "threshold": 0.7,
      "categories": [
        "Maria Hoffmann (full name)",
        "14/03/1961 (date of birth)",
        "MH-2024-00743 (patient medical identifier)"
      ],
      "strategy": "contextual"
    },
    "fairness": {
      "equalizedOdds": {
        "enabled": false,
        "tolerance": 0.05
      },
      "demographicParity": {
        "calculatedDisparity": 0.09999999999999998,
        "fairnessScore": 9,
        "status": "PASS",
        "attributes": [],
        "enabled": false,
        "targetDisparity": 0.1
      }
    },
    "inference": {
      "temperature": 0.1,
      "penalties": {
        "frequency": 0.5,
        "presence": 0.5
      },
      "maxTokens": 500,
      "topP": 0.6
    }
  },
  "validation": {
    "rules": {
      "checks": [
        "Verify compliance with detected regulations"
      ],
      "exclude": [],
      "include": []
    },
    "metrics": {
      "fairness": 9,
      "compliance": 7,
      "accuracy": 0.85,
      "safety": 7
    }
  }
}