|
""" |
|
FHIR R4/R5 Dual-Version Validator for FhirFlame |
|
Healthcare-grade FHIR validation with HIPAA compliance support |
|
Enhanced with Pydantic models for clean data validation |
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Supports both FHIR R4 and R5 specifications |
|
""" |
|
|
|
import json |
|
from typing import Dict, Any, List, Optional, Literal, Union |
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from pydantic import BaseModel, ValidationError, Field, field_validator |
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|
|
|
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class ExtractedMedicalData(BaseModel): |
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"""Pydantic model for extracted medical data validation""" |
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patient: str = Field(description="Patient information extracted from text") |
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conditions: List[str] = Field(default_factory=list, description="Medical conditions found") |
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medications: List[str] = Field(default_factory=list, description="Medications found") |
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confidence_score: float = Field(ge=0.0, le=1.0, description="Confidence score for extraction") |
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|
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@field_validator('confidence_score') |
|
@classmethod |
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def validate_confidence(cls, v): |
|
return min(max(v, 0.0), 1.0) |
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|
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class ProcessingMetadata(BaseModel): |
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"""Pydantic model for processing metadata validation""" |
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processing_time_ms: float = Field(ge=0.0, description="Processing time in milliseconds") |
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model_version: str = Field(description="AI model version used") |
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confidence_score: float = Field(ge=0.0, le=1.0, description="Overall confidence score") |
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gpu_utilization: float = Field(ge=0.0, le=100.0, description="GPU utilization percentage") |
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memory_usage_mb: float = Field(ge=0.0, description="Memory usage in MB") |
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|
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class FHIRCoding(BaseModel): |
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system: str = Field(description="Coding system URI") |
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code: str = Field(description="Code value") |
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display: str = Field(description="Display text") |
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version: Optional[str] = Field(None, description="Version of coding system (R5)") |
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|
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class FHIRCodeableConcept(BaseModel): |
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coding: List[FHIRCoding] = Field(description="List of codings") |
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text: Optional[str] = Field(None, description="Plain text representation") |
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|
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class FHIRReference(BaseModel): |
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reference: str = Field(description="Reference to another resource") |
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type: Optional[str] = Field(None, description="Type of resource (R5)") |
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identifier: Optional[Dict[str, Any]] = Field(None, description="Logical reference when no URL (R5)") |
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|
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class FHIRHumanName(BaseModel): |
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family: Optional[str] = Field(None, description="Family name") |
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given: Optional[List[str]] = Field(None, description="Given names") |
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use: Optional[str] = Field(None, description="Use of name (usual, official, temp, etc.)") |
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period: Optional[Dict[str, str]] = Field(None, description="Time period when name was/is in use (R5)") |
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|
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class FHIRIdentifier(BaseModel): |
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value: str = Field(description="Identifier value") |
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system: Optional[str] = Field(None, description="Identifier system") |
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use: Optional[str] = Field(None, description="Use of identifier") |
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type: Optional[FHIRCodeableConcept] = Field(None, description="Type of identifier (R5)") |
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|
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class FHIRMeta(BaseModel): |
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"""FHIR Meta element for resource metadata (R4/R5)""" |
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versionId: Optional[str] = Field(None, description="Version ID") |
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lastUpdated: Optional[str] = Field(None, description="Last update time") |
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profile: Optional[List[str]] = Field(None, description="Profiles this resource claims to conform to") |
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source: Optional[str] = Field(None, description="Source of resource (R5)") |
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|
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class FHIRAddress(BaseModel): |
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"""FHIR Address element (R4/R5)""" |
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use: Optional[str] = Field(None, description="Use of address") |
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line: Optional[List[str]] = Field(None, description="Street address lines") |
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city: Optional[str] = Field(None, description="City") |
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state: Optional[str] = Field(None, description="State/Province") |
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postalCode: Optional[str] = Field(None, description="Postal code") |
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country: Optional[str] = Field(None, description="Country") |
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period: Optional[Dict[str, str]] = Field(None, description="Time period when address was/is in use (R5)") |
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|
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class FHIRResource(BaseModel): |
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resourceType: str = Field(description="FHIR resource type") |
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id: Optional[str] = Field(None, description="Resource ID") |
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meta: Optional[FHIRMeta] = Field(None, description="Resource metadata") |
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|
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class FHIRPatientResource(FHIRResource): |
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resourceType: Literal["Patient"] = "Patient" |
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name: Optional[List[FHIRHumanName]] = Field(None, description="Patient names") |
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identifier: Optional[List[FHIRIdentifier]] = Field(None, description="Patient identifiers") |
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birthDate: Optional[str] = Field(None, description="Birth date") |
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gender: Optional[str] = Field(None, description="Gender") |
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address: Optional[List[FHIRAddress]] = Field(None, description="Patient addresses (R5)") |
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telecom: Optional[List[Dict[str, Any]]] = Field(None, description="Contact details") |
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|
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class FHIRConditionResource(FHIRResource): |
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resourceType: Literal["Condition"] = "Condition" |
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subject: FHIRReference = Field(description="Patient reference") |
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code: FHIRCodeableConcept = Field(description="Condition code") |
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clinicalStatus: Optional[FHIRCodeableConcept] = Field(None, description="Clinical status") |
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verificationStatus: Optional[FHIRCodeableConcept] = Field(None, description="Verification status") |
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|
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class FHIRObservationResource(FHIRResource): |
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resourceType: Literal["Observation"] = "Observation" |
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status: str = Field(description="Observation status") |
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code: FHIRCodeableConcept = Field(description="Observation code") |
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subject: FHIRReference = Field(description="Patient reference") |
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valueQuantity: Optional[Dict[str, Any]] = Field(None, description="Observation value") |
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component: Optional[List[Dict[str, Any]]] = Field(None, description="Component observations (R5)") |
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|
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class FHIRBundleEntry(BaseModel): |
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resource: Union[FHIRPatientResource, FHIRConditionResource, FHIRObservationResource, Dict[str, Any]] = Field(description="FHIR resource") |
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fullUrl: Optional[str] = Field(None, description="Full URL for resource (R5)") |
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|
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class FHIRBundle(BaseModel): |
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resourceType: Literal["Bundle"] = "Bundle" |
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id: Optional[str] = Field(None, description="Bundle ID") |
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meta: Optional[FHIRMeta] = Field(None, description="Bundle metadata") |
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type: Optional[str] = Field(None, description="Bundle type") |
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entry: Optional[List[FHIRBundleEntry]] = Field(None, description="Bundle entries") |
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timestamp: Optional[str] = Field(None, description="Bundle timestamp") |
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total: Optional[int] = Field(None, description="Total number of matching resources (R5)") |
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|
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@field_validator('entry', mode='before') |
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@classmethod |
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def validate_entries(cls, v): |
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if v is None: |
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return [] |
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|
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if isinstance(v, list): |
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processed_entries = [] |
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for entry in v: |
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if isinstance(entry, dict) and 'resource' in entry: |
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processed_entries.append(entry) |
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else: |
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processed_entries.append({'resource': entry}) |
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return processed_entries |
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return v |
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|
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class FHIRValidator: |
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"""Dual FHIR R4/R5 validator with healthcare-grade compliance using Pydantic""" |
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|
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def __init__(self, validation_level: str = "healthcare_grade", fhir_version: str = "auto"): |
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self.validation_level = validation_level |
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self.fhir_version = fhir_version |
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self.supported_versions = ["R4", "R5"] |
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|
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def detect_fhir_version(self, fhir_data: Dict[str, Any]) -> str: |
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"""Auto-detect FHIR version from data""" |
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|
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meta = fhir_data.get("meta", {}) |
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profiles = meta.get("profile", []) |
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|
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for profile in profiles: |
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if isinstance(profile, str): |
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if "/R5/" in profile or "fhir-5" in profile: |
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return "R5" |
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elif "/R4/" in profile or "fhir-4" in profile: |
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return "R4" |
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|
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if self._has_r5_features(fhir_data): |
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return "R5" |
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|
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if hasattr(self, 'current_file') and self.current_file: |
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if "r5" in self.current_file.lower(): |
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return "R5" |
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elif "r4" in self.current_file.lower(): |
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return "R4" |
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return "R4" |
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|
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def _has_r5_features(self, fhir_data: Dict[str, Any]) -> bool: |
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"""Check for R5-specific features in FHIR data""" |
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r5_indicators = [ |
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"meta.source", |
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"meta.profile", |
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"address.period", |
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"name.period", |
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"component", |
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"fullUrl", |
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"total", |
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"timestamp", |
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"jurisdiction", |
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"copyright", |
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"experimental", |
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"type.version", |
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"reference.type", |
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"reference.identifier" |
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] |
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|
|
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def check_nested(obj, path_parts): |
|
if not path_parts or not isinstance(obj, dict): |
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return False |
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|
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current_key = path_parts[0] |
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if current_key in obj: |
|
if len(path_parts) == 1: |
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return True |
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else: |
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return check_nested(obj[current_key], path_parts[1:]) |
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return False |
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|
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for indicator in r5_indicators: |
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path_parts = indicator.split('.') |
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if check_nested(fhir_data, path_parts): |
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return True |
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|
|
|
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entries = fhir_data.get("entry", []) |
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for entry in entries: |
|
if "fullUrl" in entry: |
|
return True |
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resource = entry.get("resource", {}) |
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if self._resource_has_r5_features(resource): |
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return True |
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return False |
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|
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def _resource_has_r5_features(self, resource: Dict[str, Any]) -> bool: |
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"""Check if individual resource has R5 features""" |
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|
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r5_resource_features = { |
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"Patient": ["address.period", "name.period"], |
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"Observation": ["component"], |
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"Bundle": ["total"], |
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"*": ["meta.source"] |
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} |
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resource_type = resource.get("resourceType", "") |
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features_to_check = r5_resource_features.get(resource_type, []) + r5_resource_features.get("*", []) |
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|
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for feature in features_to_check: |
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path_parts = feature.split('.') |
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current = resource |
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found = True |
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|
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for part in path_parts: |
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if isinstance(current, dict) and part in current: |
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current = current[part] |
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else: |
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found = False |
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break |
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|
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if found: |
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return True |
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return False |
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|
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def get_version_specific_resource_types(self, version: str) -> set: |
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"""Get valid resource types for specific FHIR version""" |
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|
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common_types = { |
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"Patient", "Practitioner", "Organization", "Location", "HealthcareService", |
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"Encounter", "EpisodeOfCare", "Flag", "List", "Procedure", "DiagnosticReport", |
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"Observation", "ImagingStudy", "Specimen", "Condition", "AllergyIntolerance", |
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"Goal", "RiskAssessment", "CarePlan", "CareTeam", "ServiceRequest", |
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"NutritionOrder", "VisionPrescription", "MedicationRequest", "MedicationDispense", |
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"MedicationAdministration", "MedicationStatement", "Immunization", |
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"ImmunizationEvaluation", "ImmunizationRecommendation", "Device", "DeviceRequest", |
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"DeviceUseStatement", "DeviceMetric", "Substance", "Medication", "Binary", |
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"DocumentReference", "DocumentManifest", "Composition", "ClinicalImpression", |
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"DetectedIssue", "Group", "RelatedPerson", "Basic", "BodyStructure", |
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"Media", "FamilyMemberHistory", "Linkage", "Communication", |
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"CommunicationRequest", "Appointment", "AppointmentResponse", "Schedule", |
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"Slot", "VerificationResult", "Consent", "Provenance", "AuditEvent", |
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"Task", "Questionnaire", "QuestionnaireResponse", "Bundle", "MessageHeader", |
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"OperationOutcome", "Parameters", "Subscription", "CapabilityStatement", |
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"StructureDefinition", "ImplementationGuide", "SearchParameter", |
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"CompartmentDefinition", "OperationDefinition", "ValueSet", "CodeSystem", |
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"ConceptMap", "NamingSystem", "TerminologyCapabilities" |
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} |
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|
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if version == "R5": |
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|
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r5_additions = { |
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"ActorDefinition", "Requirements", "TestPlan", "TestReport", |
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"InventoryReport", "InventoryItem", "BiologicallyDerivedProduct", |
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"BiologicallyDerivedProductDispense", "ManufacturedItemDefinition", |
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"PackagedProductDefinition", "AdministrableProductDefinition", |
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"RegulatedAuthorization", "SubstanceDefinition", "SubstanceNucleicAcid", |
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"SubstancePolymer", "SubstanceProtein", "SubstanceReferenceInformation", |
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"SubstanceSourceMaterial", "MedicinalProductDefinition", |
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"ClinicalUseDefinition", "Citation", "Evidence", "EvidenceReport", |
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"EvidenceVariable", "ResearchStudy", "ResearchSubject" |
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} |
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return common_types | r5_additions |
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|
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return common_types |
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|
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def validate_r5_compliance(self, fhir_data: Dict[str, Any]) -> Dict[str, Any]: |
|
"""Comprehensive FHIR R5 compliance validation""" |
|
compliance_result = { |
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"is_r5_compliant": False, |
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"r5_features_found": [], |
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"r5_features_missing": [], |
|
"compliance_score": 0.0, |
|
"recommendations": [] |
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} |
|
|
|
|
|
r5_features_to_check = { |
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"enhanced_meta": ["meta.source", "meta.profile"], |
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"enhanced_references": ["reference.type", "reference.identifier"], |
|
"enhanced_datatypes": ["address.period", "name.period"], |
|
"new_resources": ["ActorDefinition", "Requirements", "TestPlan"], |
|
"enhanced_bundles": ["total", "timestamp", "jurisdiction"], |
|
"versioning_support": ["type.version", "experimental"], |
|
"enhanced_observations": ["component", "copyright"] |
|
} |
|
|
|
found_features = [] |
|
for category, features in r5_features_to_check.items(): |
|
for feature in features: |
|
if self._check_feature_in_data(fhir_data, feature): |
|
found_features.append(f"{category}: {feature}") |
|
|
|
compliance_result["r5_features_found"] = found_features |
|
compliance_result["compliance_score"] = len(found_features) / sum(len(features) for features in r5_features_to_check.values()) |
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compliance_result["is_r5_compliant"] = compliance_result["compliance_score"] > 0.3 |
|
|
|
|
|
if compliance_result["compliance_score"] < 0.5: |
|
compliance_result["recommendations"] = [ |
|
"Consider adding meta.source for data provenance", |
|
"Use enhanced reference typing with reference.type", |
|
"Add timestamp to bundles for better tracking", |
|
"Include jurisdiction for regulatory compliance" |
|
] |
|
|
|
return compliance_result |
|
|
|
def _check_feature_in_data(self, data: Dict[str, Any], feature_path: str) -> bool: |
|
"""Check if a specific R5 feature exists in the data""" |
|
path_parts = feature_path.split('.') |
|
current = data |
|
|
|
for part in path_parts: |
|
if isinstance(current, dict) and part in current: |
|
current = current[part] |
|
elif isinstance(current, list): |
|
|
|
for item in current: |
|
if isinstance(item, dict) and part in item: |
|
current = item[part] |
|
break |
|
else: |
|
return False |
|
else: |
|
return False |
|
|
|
return True |
|
|
|
def validate_fhir_bundle(self, fhir_data: Dict[str, Any], filename: str = None) -> Dict[str, Any]: |
|
"""Validate FHIR R4/R5 data (bundle or individual resource) using Pydantic validation""" |
|
from .monitoring import monitor |
|
import time |
|
|
|
start_time = time.time() |
|
|
|
|
|
if filename: |
|
self.current_file = filename |
|
|
|
|
|
detected_version = self.detect_fhir_version(fhir_data) if self.fhir_version == "auto" else self.fhir_version |
|
|
|
|
|
resource_type = fhir_data.get("resourceType", "Unknown") |
|
is_bundle = resource_type == "Bundle" |
|
|
|
|
|
entry_count = len(fhir_data.get("entry", [])) if is_bundle else 1 |
|
with monitor.trace_fhir_validation(self.validation_level, entry_count) as trace: |
|
try: |
|
resource_types = [] |
|
coding_systems = set() |
|
|
|
if is_bundle: |
|
|
|
validated_bundle = FHIRBundle(**fhir_data) |
|
bundle_data = validated_bundle.model_dump() |
|
|
|
if bundle_data.get("entry"): |
|
for entry in bundle_data["entry"]: |
|
resource = entry.get("resource", {}) |
|
resource_type = resource.get("resourceType", "Unknown") |
|
resource_types.append(resource_type) |
|
|
|
|
|
coding_systems.update(self._extract_coding_systems(resource)) |
|
else: |
|
|
|
resource_types = [resource_type] |
|
coding_systems.update(self._extract_coding_systems(fhir_data)) |
|
|
|
|
|
if not self._validate_individual_resource(fhir_data, detected_version): |
|
raise ValueError(f"Invalid {resource_type} resource structure for {detected_version}") |
|
|
|
validation_time = time.time() - start_time |
|
|
|
|
|
monitor.log_fhir_structure_validation( |
|
structure_valid=True, |
|
resource_types=list(set(resource_types)), |
|
validation_time=validation_time |
|
) |
|
|
|
|
|
compliance_score = self._calculate_compliance_score( |
|
fhir_data, resource_types, coding_systems, is_bundle, detected_version |
|
) |
|
is_valid = compliance_score >= 0.80 |
|
|
|
|
|
r5_compliance = self.validate_r5_compliance(fhir_data) if detected_version == "R5" else None |
|
r4_compliant = detected_version == "R4" and is_valid |
|
r5_compliant = detected_version == "R5" and is_valid and (r5_compliance["is_r5_compliant"] if r5_compliance else True) |
|
|
|
|
|
has_loinc = "http://loinc.org" in coding_systems |
|
has_snomed = "http://snomed.info/sct" in coding_systems |
|
has_medical_codes = has_loinc or has_snomed |
|
medical_coding_validated = ( |
|
self.validation_level == "healthcare_grade" and |
|
has_medical_codes and |
|
is_valid |
|
) |
|
|
|
|
|
monitor.log_fhir_terminology_validation( |
|
terminology_valid=True, |
|
codes_validated=len(coding_systems), |
|
loinc_found=has_loinc, |
|
snomed_found=has_snomed, |
|
validation_time=validation_time |
|
) |
|
|
|
|
|
monitor.log_hipaa_compliance_check( |
|
is_compliant=is_valid and self.validation_level in ["healthcare_grade", "standard"], |
|
phi_protected=True, |
|
security_met=self.validation_level == "healthcare_grade", |
|
validation_time=validation_time |
|
) |
|
|
|
|
|
monitor.log_fhir_validation( |
|
is_valid=is_valid, |
|
compliance_score=compliance_score, |
|
validation_level=self.validation_level, |
|
fhir_version=detected_version, |
|
resource_types=list(set(resource_types)) |
|
) |
|
|
|
return { |
|
"is_valid": is_valid, |
|
"fhir_version": detected_version, |
|
"detected_version": detected_version, |
|
"validation_level": self.validation_level, |
|
"errors": [], |
|
"warnings": [], |
|
"compliance_score": compliance_score, |
|
"strict_mode": self.validation_level == "healthcare_grade", |
|
"fhir_r4_compliant": r4_compliant, |
|
"fhir_r5_compliant": r5_compliant, |
|
"r5_compliance": r5_compliance if detected_version == "R5" else None, |
|
"version_compatibility": { |
|
"r4": r4_compliant or (detected_version == "R4" and compliance_score >= 0.7), |
|
"r5": r5_compliant or (detected_version == "R5" and compliance_score >= 0.7) |
|
}, |
|
"hipaa_compliant": is_valid and self.validation_level in ["healthcare_grade", "standard"], |
|
"medical_coding_validated": medical_coding_validated, |
|
"interoperability_score": compliance_score * 0.95, |
|
"detected_resources": list(set(resource_types)), |
|
"coding_systems": list(coding_systems) |
|
} |
|
|
|
except ValidationError as e: |
|
validation_time = time.time() - start_time |
|
error_msg = f"Bundle validation failed for {detected_version}: {str(e)}" |
|
|
|
|
|
monitor.log_fhir_structure_validation( |
|
structure_valid=False, |
|
resource_types=[], |
|
validation_time=validation_time, |
|
errors=[error_msg] |
|
) |
|
|
|
return self._create_error_response([error_msg], detected_version) |
|
except Exception as e: |
|
validation_time = time.time() - start_time |
|
error_msg = f"Validation exception for {detected_version}: {str(e)}" |
|
|
|
|
|
monitor.log_fhir_structure_validation( |
|
structure_valid=False, |
|
resource_types=[], |
|
validation_time=validation_time, |
|
errors=[error_msg] |
|
) |
|
|
|
return self._create_error_response([error_msg], detected_version) |
|
|
|
def _calculate_compliance_score(self, fhir_data: Dict[str, Any], resource_types: List[str], |
|
coding_systems: set, is_bundle: bool, version: str) -> float: |
|
"""Calculate proper FHIR R4/R5 compliance score based on actual bundle assessment""" |
|
score = 0.0 |
|
max_score = 100.0 |
|
|
|
|
|
score += 40.0 |
|
|
|
|
|
if version == "R5": |
|
score += 5.0 |
|
|
|
|
|
if is_bundle: |
|
entries = fhir_data.get("entry", []) |
|
if entries: |
|
score += 20.0 |
|
|
|
|
|
medical_types = {"Patient", "Condition", "Medication", "MedicationRequest", "Observation", "Procedure", "DiagnosticReport"} |
|
found_types = set(resource_types) |
|
medical_coverage = len(found_types & medical_types) / max(1, len(medical_types)) |
|
score += 10.0 * min(1.0, medical_coverage * 2) |
|
else: |
|
|
|
score += 30.0 |
|
|
|
|
|
patient_resources = [entry.get("resource", {}) for entry in fhir_data.get("entry", []) |
|
if entry.get("resource", {}).get("resourceType") == "Patient"] |
|
|
|
if patient_resources: |
|
patient = patient_resources[0] |
|
|
|
if patient.get("name"): |
|
score += 8.0 |
|
if patient.get("birthDate"): |
|
score += 6.0 |
|
if patient.get("gender"): |
|
score += 3.0 |
|
if patient.get("identifier"): |
|
score += 3.0 |
|
elif resource_types: |
|
|
|
score += 10.0 |
|
|
|
|
|
has_loinc = "http://loinc.org" in coding_systems |
|
has_snomed = "http://snomed.info/sct" in coding_systems |
|
has_icd10 = "http://hl7.org/fhir/sid/icd-10" in coding_systems |
|
|
|
|
|
if has_snomed: |
|
score += 5.0 |
|
elif has_loinc: |
|
score += 4.0 |
|
elif has_icd10: |
|
score += 3.0 |
|
elif coding_systems: |
|
score += 2.0 |
|
|
|
|
|
if version == "R5" and self._has_r5_features(fhir_data): |
|
score += 5.0 |
|
|
|
|
|
if is_bundle and len(fhir_data.get("entry", [])) == 0: |
|
score -= 30.0 |
|
|
|
|
|
if self._has_dummy_data(fhir_data): |
|
score -= 5.0 |
|
|
|
|
|
compliance_score = max(0.0, min(1.0, score / max_score)) |
|
|
|
return round(compliance_score, 3) |
|
|
|
def _has_dummy_data(self, fhir_data: Dict[str, Any]) -> bool: |
|
"""Check for obvious dummy/placeholder data""" |
|
patient_names = [] |
|
for entry in fhir_data.get("entry", []): |
|
resource = entry.get("resource", {}) |
|
if resource.get("resourceType") == "Patient": |
|
names = resource.get("name", []) |
|
for name in names: |
|
if isinstance(name, dict): |
|
family = name.get("family", "") |
|
given = name.get("given", []) |
|
full_name = f"{family} {' '.join(given) if given else ''}".strip() |
|
patient_names.append(full_name.lower()) |
|
|
|
dummy_names = {"john doe", "jane doe", "test patient", "unknown patient", "patient", "doe"} |
|
for name in patient_names: |
|
if any(dummy in name for dummy in dummy_names): |
|
return True |
|
|
|
return False |
|
|
|
def _extract_coding_systems(self, resource: Dict[str, Any]) -> set: |
|
"""Extract coding systems from a FHIR resource""" |
|
coding_systems = set() |
|
|
|
|
|
for field_name in ["code", "category", "valueCodeableConcept", "reasonCode"]: |
|
if field_name in resource: |
|
field_value = resource[field_name] |
|
if isinstance(field_value, dict) and "coding" in field_value: |
|
coding_list = field_value["coding"] |
|
if isinstance(coding_list, list): |
|
for coding_item in coding_list: |
|
if isinstance(coding_item, dict) and "system" in coding_item: |
|
coding_systems.add(coding_item["system"]) |
|
elif isinstance(field_value, list): |
|
for item in field_value: |
|
if isinstance(item, dict) and "coding" in item: |
|
coding_list = item["coding"] |
|
if isinstance(coding_list, list): |
|
for coding_item in coding_list: |
|
if isinstance(coding_item, dict) and "system" in coding_item: |
|
coding_systems.add(coding_item["system"]) |
|
|
|
return coding_systems |
|
|
|
def _validate_individual_resource(self, resource: Dict[str, Any], version: str) -> bool: |
|
"""Validate individual FHIR resource structure for specific version""" |
|
|
|
resource_type = resource.get("resourceType") |
|
|
|
if not resource_type: |
|
return False |
|
|
|
|
|
valid_resource_types = self.get_version_specific_resource_types(version) |
|
|
|
if resource_type not in valid_resource_types: |
|
return False |
|
|
|
|
|
if not isinstance(resource, dict) or len(resource) < 2: |
|
return False |
|
|
|
return True |
|
|
|
def _create_error_response(self, errors: List[str], version: str = "R4") -> Dict[str, Any]: |
|
"""Create standardized error response""" |
|
return { |
|
"is_valid": False, |
|
"fhir_version": version, |
|
"detected_version": version, |
|
"validation_level": self.validation_level, |
|
"errors": errors, |
|
"warnings": [], |
|
"compliance_score": 0.0, |
|
"strict_mode": self.validation_level == "healthcare_grade", |
|
"fhir_r4_compliant": False, |
|
"fhir_r5_compliant": False, |
|
"version_compatibility": {"r4": False, "r5": False}, |
|
"hipaa_compliant": False, |
|
"medical_coding_validated": False, |
|
"interoperability_score": 0.0 |
|
} |
|
|
|
def validate_bundle(self, fhir_bundle: Dict[str, Any], validation_level: str = None) -> Dict[str, Any]: |
|
"""Validate FHIR bundle - sync version for tests""" |
|
if validation_level: |
|
old_level = self.validation_level |
|
self.validation_level = validation_level |
|
result = self.validate_fhir_bundle(fhir_bundle) |
|
self.validation_level = old_level |
|
return result |
|
return self.validate_fhir_bundle(fhir_bundle) |
|
|
|
async def validate_bundle_async(self, fhir_bundle: Dict[str, Any], validation_level: str = None) -> Dict[str, Any]: |
|
"""Async validate FHIR bundle - used by MCP server""" |
|
result = self.validate_bundle(fhir_bundle, validation_level) |
|
|
|
return { |
|
"validation_results": { |
|
"is_valid": result["is_valid"], |
|
"compliance_score": result["compliance_score"], |
|
"validation_level": result["validation_level"], |
|
"fhir_version": result["fhir_version"], |
|
"detected_version": result.get("detected_version", result["fhir_version"]) |
|
}, |
|
"compliance_summary": { |
|
"fhir_r4_compliant": result["fhir_r4_compliant"], |
|
"fhir_r5_compliant": result["fhir_r5_compliant"], |
|
"version_compatibility": result.get("version_compatibility", {"r4": False, "r5": False}), |
|
"hipaa_ready": result["hipaa_compliant"], |
|
"terminology_validated": result["medical_coding_validated"], |
|
"structure_validated": result["is_valid"] |
|
}, |
|
"compliance_score": result["compliance_score"], |
|
"validation_errors": result["errors"], |
|
"warnings": result["warnings"] |
|
} |
|
|
|
def validate_structure(self, fhir_data: Dict[str, Any]) -> Dict[str, Any]: |
|
"""Validate FHIR data structure using Pydantic validation""" |
|
try: |
|
detected_version = self.detect_fhir_version(fhir_data) |
|
|
|
if fhir_data.get("resourceType") == "Bundle": |
|
FHIRBundle(**fhir_data) |
|
detected_resources = ["Bundle"] |
|
|
|
if "entry" in fhir_data: |
|
for entry in fhir_data["entry"]: |
|
resource = entry.get("resource", {}) |
|
resource_type = resource.get("resourceType") |
|
if resource_type: |
|
detected_resources.append(resource_type) |
|
else: |
|
detected_resources = [fhir_data.get("resourceType", "Unknown")] |
|
|
|
return { |
|
"structure_valid": True, |
|
"required_fields_present": True, |
|
"data_types_correct": True, |
|
"detected_resources": list(set(detected_resources)), |
|
"detected_version": detected_version, |
|
"validation_details": f"FHIR {detected_version} structure validation completed", |
|
"errors": [] |
|
} |
|
except ValidationError as e: |
|
return { |
|
"structure_valid": False, |
|
"required_fields_present": False, |
|
"data_types_correct": False, |
|
"detected_resources": [], |
|
"detected_version": "Unknown", |
|
"validation_details": "FHIR structure validation failed", |
|
"errors": [str(error) for error in e.errors()] |
|
} |
|
|
|
def validate_terminology(self, fhir_data: Dict[str, Any]) -> Dict[str, Any]: |
|
"""Validate medical terminology in FHIR data using Pydantic extraction""" |
|
validated_codes = [] |
|
errors = [] |
|
|
|
try: |
|
if fhir_data.get("resourceType") != "Bundle": |
|
return { |
|
"terminology_valid": True, |
|
"coding_systems_valid": True, |
|
"medical_codes_recognized": False, |
|
"loinc_codes_valid": False, |
|
"snomed_codes_valid": False, |
|
"validated_codes": [], |
|
"errors": [] |
|
} |
|
|
|
bundle = FHIRBundle(**fhir_data) |
|
bundle_data = bundle.model_dump() |
|
|
|
entries = bundle_data.get("entry", []) |
|
for entry in entries: |
|
resource = entry.get("resource", {}) |
|
code_data = resource.get("code", {}) |
|
coding_list = code_data.get("coding", []) |
|
|
|
for coding_item in coding_list: |
|
system = coding_item.get("system", "") |
|
code = coding_item.get("code", "") |
|
display = coding_item.get("display", "") |
|
|
|
if system and code and display: |
|
validated_codes.append({ |
|
"system": system, |
|
"code": code, |
|
"display": display |
|
}) |
|
except Exception as e: |
|
errors.append(f"Terminology validation error: {str(e)}") |
|
|
|
has_loinc = any(code["system"] == "http://loinc.org" for code in validated_codes) |
|
has_snomed = any(code["system"] == "http://snomed.info/sct" for code in validated_codes) |
|
|
|
return { |
|
"terminology_valid": len(errors) == 0, |
|
"coding_systems_valid": len(errors) == 0, |
|
"medical_codes_recognized": len(validated_codes) > 0, |
|
"loinc_codes_valid": has_loinc, |
|
"snomed_codes_valid": has_snomed, |
|
"validated_codes": validated_codes, |
|
"validation_details": f"Medical terminology validation completed. Found {len(validated_codes)} valid codes.", |
|
"errors": errors |
|
} |
|
|
|
def validate_hipaa_compliance(self, fhir_data: Dict[str, Any]) -> Dict[str, Any]: |
|
"""Validate HIPAA compliance using Pydantic validation""" |
|
is_compliant = isinstance(fhir_data, dict) |
|
errors = [] |
|
|
|
try: |
|
|
|
if fhir_data.get("resourceType") == "Bundle": |
|
bundle = FHIRBundle(**fhir_data) |
|
|
|
if bundle.entry: |
|
for entry in bundle.entry: |
|
resource = entry.resource |
|
if isinstance(resource, dict) and resource.get("resourceType") == "Patient": |
|
if not ("name" in resource or "identifier" in resource): |
|
errors.append("Patient must have name or identifier") |
|
is_compliant = False |
|
except Exception as e: |
|
errors.append(f"HIPAA validation error: {str(e)}") |
|
is_compliant = False |
|
|
|
return { |
|
"hipaa_compliant": is_compliant, |
|
"phi_properly_handled": is_compliant, |
|
"phi_protection": is_compliant, |
|
"security_requirements_met": is_compliant, |
|
"security_tags_present": False, |
|
"encryption_enabled": self.validation_level == "healthcare_grade", |
|
"compliance_details": f"HIPAA compliance validation completed. Status: {'COMPLIANT' if is_compliant else 'NON-COMPLIANT'}", |
|
"errors": errors |
|
} |
|
|
|
def generate_fhir_bundle(self, extracted_data: Dict[str, Any], version: str = "R4") -> Dict[str, Any]: |
|
"""Generate a comprehensive FHIR bundle from extracted medical data with R4/R5 compliance""" |
|
try: |
|
|
|
patient_name = extracted_data.get('patient', extracted_data.get('patient_name', 'Unknown Patient')) |
|
conditions = extracted_data.get('conditions', []) |
|
medications = extracted_data.get('medications', []) |
|
vitals = extracted_data.get('vitals', []) |
|
procedures = extracted_data.get('procedures', []) |
|
confidence_score = extracted_data.get('confidence_score', 0.0) |
|
|
|
|
|
bundle_meta = { |
|
"lastUpdated": "2025-06-06T15:44:51Z", |
|
"profile": [f"http://hl7.org/fhir/{version}/StructureDefinition/Bundle"] |
|
} |
|
if version == "R5": |
|
bundle_meta["source"] = "FHIRFlame Medical AI Platform" |
|
|
|
|
|
patient_name_parts = patient_name.split() if patient_name != 'Unknown Patient' else ['Unknown', 'Patient'] |
|
patient_resource = { |
|
"resourceType": "Patient", |
|
"id": "patient-1", |
|
"meta": { |
|
"profile": [f"http://hl7.org/fhir/{version}/StructureDefinition/Patient"] |
|
}, |
|
"identifier": [ |
|
{ |
|
"use": "usual", |
|
"system": "http://fhirflame.example.org/patient-id", |
|
"value": "FHIR-PAT-001" |
|
} |
|
], |
|
"name": [ |
|
{ |
|
"use": "official", |
|
"family": patient_name_parts[-1], |
|
"given": patient_name_parts[:-1] if len(patient_name_parts) > 1 else ["Unknown"] |
|
} |
|
], |
|
"gender": "unknown", |
|
"active": True |
|
} |
|
|
|
|
|
entries = [{"resource": patient_resource}] |
|
|
|
|
|
condition_codes = { |
|
"acute myocardial infarction": "22298006", |
|
"diabetes mellitus type 2": "44054006", |
|
"hypertension": "38341003", |
|
"diabetes": "73211009", |
|
"myocardial infarction": "22298006" |
|
} |
|
|
|
for i, condition in enumerate(conditions, 1): |
|
condition_lower = condition.lower() |
|
|
|
snomed_code = "unknown" |
|
for key, code in condition_codes.items(): |
|
if key in condition_lower: |
|
snomed_code = code |
|
break |
|
|
|
condition_resource = { |
|
"resourceType": "Condition", |
|
"id": f"condition-{i}", |
|
"meta": { |
|
"profile": [f"http://hl7.org/fhir/{version}/StructureDefinition/Condition"] |
|
}, |
|
"clinicalStatus": { |
|
"coding": [ |
|
{ |
|
"system": "http://terminology.hl7.org/CodeSystem/condition-clinical", |
|
"code": "active", |
|
"display": "Active" |
|
} |
|
] |
|
}, |
|
"verificationStatus": { |
|
"coding": [ |
|
{ |
|
"system": "http://terminology.hl7.org/CodeSystem/condition-ver-status", |
|
"code": "confirmed", |
|
"display": "Confirmed" |
|
} |
|
] |
|
}, |
|
"code": { |
|
"coding": [ |
|
{ |
|
"system": "http://snomed.info/sct", |
|
"code": snomed_code, |
|
"display": condition |
|
} |
|
], |
|
"text": condition |
|
}, |
|
"subject": { |
|
"reference": "Patient/patient-1", |
|
"display": patient_name |
|
} |
|
} |
|
entries.append({"resource": condition_resource}) |
|
|
|
|
|
medication_codes = { |
|
"metoprolol": "6918", |
|
"atorvastatin": "83367", |
|
"metformin": "6809", |
|
"lisinopril": "29046" |
|
} |
|
|
|
for i, medication in enumerate(medications, 1): |
|
med_lower = medication.lower() |
|
|
|
rxnorm_code = "unknown" |
|
for key, code in medication_codes.items(): |
|
if key in med_lower: |
|
rxnorm_code = code |
|
break |
|
|
|
medication_resource = { |
|
"resourceType": "MedicationRequest", |
|
"id": f"medication-{i}", |
|
"meta": { |
|
"profile": [f"http://hl7.org/fhir/{version}/StructureDefinition/MedicationRequest"] |
|
}, |
|
"status": "active", |
|
"intent": "order", |
|
"medicationCodeableConcept": { |
|
"coding": [ |
|
{ |
|
"system": "http://www.nlm.nih.gov/research/umls/rxnorm", |
|
"code": rxnorm_code, |
|
"display": medication |
|
} |
|
], |
|
"text": medication |
|
}, |
|
"subject": { |
|
"reference": "Patient/patient-1", |
|
"display": patient_name |
|
} |
|
} |
|
entries.append({"resource": medication_resource}) |
|
|
|
|
|
if vitals: |
|
for i, vital in enumerate(vitals, 1): |
|
vital_resource = { |
|
"resourceType": "Observation", |
|
"id": f"vital-{i}", |
|
"meta": { |
|
"profile": [f"http://hl7.org/fhir/{version}/StructureDefinition/Observation"] |
|
}, |
|
"status": "final", |
|
"category": [ |
|
{ |
|
"coding": [ |
|
{ |
|
"system": "http://terminology.hl7.org/CodeSystem/observation-category", |
|
"code": "vital-signs", |
|
"display": "Vital Signs" |
|
} |
|
] |
|
} |
|
], |
|
"code": { |
|
"coding": [ |
|
{ |
|
"system": "http://loinc.org", |
|
"code": "8310-5", |
|
"display": "Body temperature" |
|
} |
|
], |
|
"text": vital |
|
}, |
|
"subject": { |
|
"reference": "Patient/patient-1", |
|
"display": patient_name |
|
} |
|
} |
|
entries.append({"resource": vital_resource}) |
|
|
|
|
|
bundle_data = { |
|
"resourceType": "Bundle", |
|
"id": "fhirflame-medical-bundle", |
|
"meta": bundle_meta, |
|
"type": "document", |
|
"timestamp": "2025-06-06T15:44:51Z", |
|
"entry": entries |
|
} |
|
|
|
|
|
if version == "R5": |
|
bundle_data["total"] = len(entries) |
|
for entry in bundle_data["entry"]: |
|
entry["fullUrl"] = f"urn:uuid:{entry['resource']['resourceType'].lower()}-{entry['resource']['id']}" |
|
|
|
|
|
bundle_data["_fhirflame_metadata"] = { |
|
"version": version, |
|
"compliance_verified": True, |
|
"r4_compliant": version == "R4", |
|
"r5_compliant": version == "R5", |
|
"extraction_confidence": confidence_score, |
|
"medical_coding_systems": ["SNOMED-CT", "RxNorm", "LOINC"], |
|
"total_resources": len(entries), |
|
"resource_types": list(set(entry["resource"]["resourceType"] for entry in entries)), |
|
"generated_by": "FHIRFlame Medical AI Platform" |
|
} |
|
|
|
return bundle_data |
|
|
|
except Exception as e: |
|
|
|
return { |
|
"resourceType": "Bundle", |
|
"id": "fhirflame-error-bundle", |
|
"type": "document", |
|
"meta": { |
|
"profile": [f"http://hl7.org/fhir/{version}/StructureDefinition/Bundle"] |
|
}, |
|
"entry": [ |
|
{ |
|
"resource": { |
|
"resourceType": "Patient", |
|
"id": "patient-1", |
|
"name": [{"family": "Unknown", "given": ["Patient"]}] |
|
} |
|
} |
|
], |
|
"_fhirflame_metadata": { |
|
"version": version, |
|
"compliance_verified": False, |
|
"error": str(e), |
|
"fallback_used": True |
|
} |
|
} |
|
|
|
|
|
FhirValidator = FHIRValidator |
|
|
|
|
|
__all__ = ["FHIRValidator", "FhirValidator", "ExtractedMedicalData", "ProcessingMetadata"] |