{
  "profile_name": "healthcare",
  "version": "1.0.0",
  "description": "Healthcare / Medical Technology Domain Profile (Spec Section 2.3B)",
  "extends": "standard",
  "industries": ["healthcare", "medtech", "pharma", "medical_devices", "telehealth"],
  "additional_namespaces": {
    "compliance": {
      "tags": [
        {
          "name": "hipaa_privacy",
          "description": "HIPAA Privacy Rule - PHI Protection",
          "examples": ["Patient data must be de-identified.", "Access controls for PHI."]
        },
        {
          "name": "hipaa_security",
          "description": "HIPAA Security Rule - Technical Safeguards",
          "examples": ["Encryption of PHI at rest and in transit.", "Audit logging for PHI access."]
        },
        {
          "name": "iso13485",
          "description": "Quality Management System for Medical Devices",
          "examples": ["Design controls required.", "Risk management per ISO 14971."]
        },
        {
          "name": "fda_510k",
          "description": "FDA 510(k) Premarket Notification",
          "examples": ["Device substantially equivalent to predicate.", "Clinical validation required."]
        },
        {
          "name": "gdpr_health",
          "description": "GDPR special category data (health)",
          "examples": ["Explicit consent for health data processing.", "Data portability for patient records."]
        }
      ]
    },
    "class": {
      "description": "Medical device classification",
      "tags": [
        {
          "name": "samd",
          "description": "Software as a Medical Device",
          "examples": ["Diagnostic algorithm.", "Treatment decision support."]
        },
        {
          "name": "class_i",
          "description": "Class I Medical Device (Low Risk)",
          "examples": ["Tongue depressor.", "Elastic bandages."]
        },
        {
          "name": "class_ii",
          "description": "Class II Medical Device (Moderate Risk)",
          "examples": ["Infusion pumps.", "Surgical drapes."]
        },
        {
          "name": "class_iii",
          "description": "Class III Medical Device (High Risk)",
          "examples": ["Heart valves.", "Pacemakers."]
        }
      ]
    },
    "risk": {
      "tags": [
        {
          "name": "patient_safety_class_a",
          "description": "No injury risk",
          "examples": ["Cosmetic issue.", "Minor inconvenience."]
        },
        {
          "name": "patient_safety_class_b",
          "description": "Minor injury risk",
          "examples": ["Temporary discomfort.", "Non-serious adverse event."]
        },
        {
          "name": "patient_safety_class_c",
          "description": "Serious injury or death risk",
          "examples": ["Incorrect diagnosis.", "Device malfunction leading to harm."]
        }
      ]
    },
    "data": {
      "tags": [
        {
          "name": "phi",
          "description": "Protected Health Information",
          "examples": ["Patient name, DOB, SSN.", "Medical record number.", "Diagnosis codes."]
        },
        {
          "name": "clinical_data",
          "description": "Clinical trial or patient data",
          "examples": ["Lab results.", "Imaging studies.", "Treatment outcomes."]
        }
      ]
    },
    "req": {
      "tags": [
        {
          "name": "clinical_validation",
          "description": "Clinical evidence requirements",
          "examples": ["Algorithm validated on 1000+ patient dataset.", "Sensitivity > 95%."]
        },
        {
          "name": "interoperability",
          "description": "Healthcare data exchange standards",
          "examples": ["HL7 FHIR compliance.", "DICOM image format support."]
        }
      ]
    }
  },
  "suggested_dynamic_tags": {
    "topic": ["ehr", "emr", "telehealth", "medical_imaging", "clinical_decision_support", "patient_portal"],
    "entity": ["epic", "cerner", "meditech", "fda", "cms"],
    "domain": ["radiology", "cardiology", "oncology", "pathology", "pharmacy"]
  }
}