HIPAA Compliance

Covered Information

HIPAA regulations apply to Protected Health Information (PHI), which includes:

• Patient identifiers (name, address, dates, phone/fax numbers, email addresses)
• Medical record numbers and health plan beneficiary numbers
• Account and certificate/license numbers
• Device identifiers and serial numbers
• Biometric identifiers (fingerprints, voiceprints)
• Full-face photographs and comparable images
• Any other unique identifying number, characteristic, or code

Key HIPAA Requirements

Business Associate Agreement

Telesoft serves as a Business Associate to Covered Entities using our API. We provide a comprehensive Business Associate Agreement (BAA) for enterprise customers processing PHI:

• Standard BAA available for enterprise accounts
• Custom BAA terms negotiable for larger implementations
• Clear delineation of responsibilities between parties
• Specific provisions for data handling, breach notification, and compliance

Technical Safeguards

Administrative Safeguards

• Security Management: Risk analysis, risk management, sanctions policy
• Security Personnel: Dedicated HIPAA compliance officer and team
• Information Access: Authorization and supervision procedures
• Workforce Training: Regular security and privacy training for all staff
• Evaluation: Periodic technical and non-technical evaluations
• Business Associate Management: Documented agreements with all subcontractors

Physical Safeguards

• Facility Access: Controlled physical access to data centers
• Workstation Security: Policies for secure use of workstations
• Device Controls: Policies for hardware movement and disposal
• Media Handling: Secure procedures for media reuse and disposal

Compliance Certifications

• HITRUST CSF Certification
• SOC 2 Type II Compliance
• Annual HIPAA Security Risk Assessment
• Regular third-party penetration testing

Compliance documentation is available to enterprise customers under NDA.

Authentication and Authorization

• Implement strong authentication (MFA recommended)
• Role-based access control for different user types
• Session management with appropriate timeouts
• API key rotation policies

// Example: Secure API key management
// DO NOT hardcode API keys in client-side code
// Instead, use server-side authentication:

// Server-side code (Node.js example)
app.post('/api/analyze-medical-data', async (req, res) => {
  try {
    // Get the API key from secure environment variable
    const apiKey = process.env.TELESOFT_API_KEY;
    
    // Make authenticated request to Telesoft API
    const telesoftClient = new TelesoftClient(apiKey);
    
    // Process request with PHI
    const result = await telesoftClient.analyze(req.body.medicalData);
    
    // Return result (no PHI stored client-side)
    res.json({ result });
  } catch (error) {
    console.error('Error:', error);
    res.status(500).json({ error: 'An error occurred' });
  }
});

Data Minimization

• Only transmit PHI elements necessary for the specific function
• De-identify data when full PHI is not required
• Implement field-level encryption for sensitive elements
• Clear client-side storage of PHI after use

// Example: Data minimization
// Instead of sending full patient records, send only required fields

// BAD practice - sending unnecessary PHI
const fullPatientRecord = {
  name: "John Doe",
  dob: "1945-05-25",
  ssn: "123-45-6789",
  address: "123 Main St, Anytown, US 12345",
  phoneNumber: "555-123-4567",
  diagnosis: "Hypertension",
  medications: ["Lisinopril", "Hydrochlorothiazide"],
  vitalSigns: { ... }
};

// GOOD practice - sending only needed information
const minimizedData = {
  // Use an opaque identifier instead of direct identifiers
  patientId: "hashed-or-tokenized-id",
  
  // Include only medically necessary information for the API call
  age: 76, // Instead of full DOB
  diagnosis: "Hypertension",
  medications: ["Lisinopril", "Hydrochlorothiazide"]
};

Secure Storage and Transmission

• Encrypt PHI in transit and at rest
• Use secure, encrypted databases for PHI storage
• Implement secure backup and recovery procedures
• Maintain data integrity with checksums and validation

Audit Logging

• Log all PHI access and modifications
• Include user identity, timestamp, and action details in logs
• Protect audit logs from unauthorized access and modification
• Implement log retention policies compliant with HIPAA requirements

// Example: HIPAA-compliant audit logging
function logPHIAccess(user, action, resourceType, resourceId) {
  const auditLog = {
    timestamp: new Date().toISOString(),
    user: {
      id: user.id,
      username: user.username,
      role: user.role
    },
    action: action, // e.g., "view", "update", "delete"
    resource: {
      type: resourceType, // e.g., "patient_record", "diagnostic_result"
      id: resourceId
    },
    sourceIP: request.ip,
    userAgent: request.headers["user-agent"]
  };
  
  // Store audit log securely
  secureAuditLogStorage.store(auditLog);
}

Breach Response Plan

• Develop and document an incident response procedure
• Establish breach notification protocols
• Designate responsible personnel for breach management
• Conduct regular breach response drills

De-identification Options

Our API provides built-in de-identification capabilities:

// Example: Using de-identification options
const analysis = await telesoft.diagnostics.analyze({
  patientData: medicalRecord,
  options: {
    deidentification: {
      method: "safe-harbor", // Options: "safe-harbor", "expert-determination", "none"
      preserveAge: true,      // Keep age but remove exact DOB
      preserveZip3: true,     // Keep first 3 digits of ZIP code
      preserveGender: true,   // Keep gender information
      dateShifting: {         // Consistently shift dates while preserving intervals
        enabled: true,
        maxDaysShift: 30
      }
    }
  }
});

Audit Trail API

Enterprise customers can access comprehensive audit logs for all API operations:

// Example: Querying the Audit Trail API
const auditRecords = await telesoft.admin.auditTrail.query({
  timeRange: {
    startTime: "2023-01-01T00:00:00Z",
    endTime: "2023-01-31T23:59:59Z"
  },
  filters: {
    users: ["user-123", "user-456"],
    actions: ["analyze", "diagnose"],
    resources: ["patient-record"]
  },
  pagination: {
    limit: 100,
    offset: 0
  }
});

// Export audit logs for compliance reporting
const exportUrl = await telesoft.admin.auditTrail.export({
  format: "csv",
  timeRange: {
    startTime: "2023-01-01T00:00:00Z",
    endTime: "2023-01-31T23:59:59Z"
  }
});

Data Retention Controls

Configure custom data retention policies for different data types:

// Example: Setting data retention policies
await telesoft.admin.dataRetention.configure({
  // Set retention period for request data
  requestData: {
    retentionPeriod: "30d", // Options: "immediate", "1d", "7d", "30d", "90d", "1y", "forever"
    retentionType: "anonymized" // Options: "deleted", "anonymized"
  },
  
  // Set retention for analysis results
  analysisResults: {
    retentionPeriod: "90d",
    retentionType: "deleted"
  },
  
  // Set retention for specific data types
  imageData: {
    retentionPeriod: "7d",
    retentionType: "deleted"
  }
});

Access Controls

Enterprise accounts can implement fine-grained access controls:

// Example: Managing API access tokens with permissions
// Create a restricted API key for specific operations
const restrictedApiKey = await telesoft.admin.apiKeys.create({
  name: "Clinical Assistant App - Production",
  description: "API key for the clinical assistant frontend application",
  permissions: [
    "diagnostics:analyze", // Can analyze diagnostic data
    "imaging:analyze",     // Can analyze medical images
    "reference:read"       // Can access reference information
  ],
  restrictions: {
    ipAddresses: ["203.0.113.0/24"], // Restrict to specific IP range
    rateLimits: {
      requestsPerMinute: 100
    },
    expiresAt: "2023-12-31T23:59:59Z" // Set expiration date
  }
});

Telesoft Resources

• HIPAA BAA Template
• HIPAA Implementation Guide
• Security White Paper
• Compliance Documentation (Enterprise)

External Resources

• HHS HIPAA Portal
• HHS Security Risk Assessment Tool
• HIPAA Journal
• NIST Health IT Security