技能 编程开发 OpenEvidence临床数据处理规范

OpenEvidence临床数据处理规范

v20260423
openevidence-data-handling
本指南详细介绍了OpenEvidence平台的安全数据生命周期管理流程。它涵盖了各类临床信息的分类、严格的国际合规要求(如HIPAA、GDPR和FDA指南),并详细说明了处理受保护健康信息(PHI)的技术要求。核心流程包括PHI去识别化、数据校验、安全API集成和合规数据导出,旨在确保系统在提供临床智能支持的同时,最高级别地维护患者隐私和监管合规。
获取技能
69 次下载
概览

OpenEvidence Data Handling

Overview

OpenEvidence provides AI-powered clinical evidence synthesis for healthcare professionals. Data types include clinical queries (potentially containing PHI), evidence citations from medical literature, patient-contextualized responses, research paper references, and usage analytics. All data handling must comply with HIPAA (PHI safeguards, minimum necessary standard, BAA requirements), GDPR for EU clinicians, and FDA guidance on clinical decision support. Query data may contain patient identifiers, diagnoses, or treatment details that require de-identification before storage or analytics.

Data Classification

Data Type Sensitivity Retention Encryption
Clinical queries (may contain PHI) Critical De-identify within 24h, purge raw in 7 days AES-256 + TLS, field-level for PHI
Evidence citations Low Indefinite (public literature) TLS in transit
Patient-contextualized responses High (derived PHI) 30 days max, then de-identify AES-256 at rest
Research paper metadata Low Indefinite TLS in transit
Clinician usage analytics Medium 1 year (de-identified) AES-256 at rest

Data Import

interface ClinicalQuery {
  queryId: string; clinicianId: string; queryText: string;
  patientContext?: { age?: number; sex?: string; conditions?: string[] };
  timestamp: string;
}

async function submitClinicalQuery(query: ClinicalQuery): Promise<string> {
  const sanitized = { ...query, queryText: deidentifyPHI(query.queryText) };
  const res = await fetch('https://api.openevidence.com/v1/query', {
    method: 'POST',
    headers: { Authorization: `Bearer ${process.env.OPENEVIDENCE_API_KEY}`, 'Content-Type': 'application/json' },
    body: JSON.stringify(sanitized),
  });
  return (await res.json()).evidenceId;
}

function deidentifyPHI(text: string): string {
  return text
    .replace(/\b(MRN|mrn)[:\s]?\d{6,}\b/g, '[MRN_REDACTED]')
    .replace(/\b\d{3}-\d{2}-\d{4}\b/g, '[SSN_REDACTED]')
    .replace(/\b(DOB|dob)[:\s]?\d{1,2}\/\d{1,2}\/\d{2,4}\b/g, '[DOB_REDACTED]')
    .replace(/\b[A-Z][a-z]+ [A-Z][a-z]+, (MD|DO|NP|PA)\b/g, '[PROVIDER_REDACTED]');
}

Data Export

async function exportEvidenceSummary(queryIds: string[]) {
  const summaries = [];
  for (const id of queryIds) {
    const res = await fetch(`https://api.openevidence.com/v1/evidence/${id}`, {
      headers: { Authorization: `Bearer ${process.env.OPENEVIDENCE_API_KEY}` },
    });
    const data = await res.json();
    summaries.push({ queryId: id, citations: data.citations,
      summary: deidentifyPHI(data.summary), confidence: data.confidenceScore });
  }
  return summaries;
}

Data Validation

function validateClinicalQuery(q: ClinicalQuery): string[] {
  const errors: string[] = [];
  if (!q.queryId) errors.push('Missing query ID');
  if (!q.clinicianId) errors.push('Missing clinician identifier');
  if (!q.queryText || q.queryText.length < 10) errors.push('Query too short for meaningful evidence retrieval');
  if (q.queryText.length > 5000) errors.push('Query exceeds 5000 char limit');
  if (/\b\d{3}-\d{2}-\d{4}\b/.test(q.queryText)) errors.push('CRITICAL: SSN detected in query text');
  if (/\b(MRN|mrn)[:\s]?\d{6,}\b/.test(q.queryText)) errors.push('CRITICAL: MRN detected in query text');
  if (q.timestamp && isNaN(Date.parse(q.timestamp))) errors.push('Invalid timestamp');
  return errors;
}

Compliance

  • HIPAA: BAA executed with OpenEvidence before any PHI transmission
  • HIPAA: PHI de-identified using Safe Harbor method before storage/analytics
  • HIPAA: Minimum necessary standard enforced — only transmit required clinical context
  • HIPAA: Audit trail for all PHI access with clinician ID, timestamp, and query purpose
  • HIPAA: Breach notification procedure documented (72-hour window)
  • GDPR: EU clinician data subject rights (access, erasure, portability)
  • FDA: Clinical decision support disclaimer included in all evidence responses
  • Data retention: raw queries purged at 7 days, de-identified analytics retained 1 year

Error Handling

Issue Cause Fix
PHI detected in stored query De-identification regex missed a pattern Add pattern to deidentifyPHI, re-scan stored queries
API 403 on query submission BAA not on file or expired API credentials Verify BAA status, rotate API key
Evidence response contains patient name Upstream model hallucinated PHI Post-process all responses through de-identification before display
Audit log gap Logging service outage during query window Replay from API request logs, flag gap in compliance report
Export exceeds size limit Too many citations in bulk export Paginate export, limit to 50 evidence summaries per request

Resources

Next Steps

See openevidence-security-basics.

信息
Category 编程开发
Name openevidence-data-handling
版本 v20260423
大小 3.78KB
更新时间 2026-04-28
语言