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HIPAA Compliance Matrix

This document maps each TransTrack function and component to the applicable HIPAA regulatory requirements, documenting the current implementation status.

Regulatory Reference

  • HIPAA Security Rule: 45 CFR Part 164, Subpart C
  • HIPAA Privacy Rule: 45 CFR Part 164, Subpart E
  • FDA 21 CFR Part 11: Electronic Records and Signatures

No AATB conformance is claimed; see COMPLIANCE.md for why that claim was withdrawn.

Function-Level Compliance

Function HIPAA Rule Requirement Implementation Status
calculatePriority.ts 164.312(b) Audit Controls HIPAA audit log with WHO/WHAT/WHEN/WHY, SHA-256 hash for immutability ✅
calculatePriority.ts 164.312(a)(1) Access Control User authentication required, UUID validation ✅
calculatePriority.ts 164.312(c)(1) Integrity Controls Input validation for MELD/LAS/PRA scores against medical ranges ✅
calculatePriority.ts 164.312(d) Person Authentication api.auth.me() validates user identity ✅
matchDonor.ts 164.312(b) Audit Controls HIPAA audit log with access justification tracking ✅
matchDonor.ts 164.308(a)(1)(i) Security Management Input validation, HLA format checking, blood type verification ✅
matchDonor.ts 164.312(e)(1) Transmission Security Patient names sanitized in notifications, no PHI in error messages ✅
matchDonor.ts 164.312(c)(1) Integrity Controls Race condition mitigation via patient freshness check ✅
exportToFHIR.ts 164.312(b) Audit Controls Structured logging with request ID tracking ✅
exportToFHIR.ts 164.312(e)(1) Transmission Security Diagnosis text sanitized against XSS/injection ✅
exportToFHIR.ts 164.530(c) Notice of Breach Error logging without PHI exposure ✅
importFHIRData.ts 164.312(b) Audit Controls Import records with structured logging ✅
importFHIRData.ts 164.312(c)(1) Integrity Controls FHIR validation before import ✅
pushToEHR.ts 164.312(e)(1) Transmission Security Auth headers for EHR communication ✅
pushToEHR.ts 164.312(b) Audit Controls Sync logs with detailed tracking ✅
checkNotificationRules.ts 164.312(e)(1) Transmission Security Patient names sanitized in notification messages ✅
exportWaitlist.ts 164.312(b) Audit Controls Export action logged with user context ✅
validateFHIRData.ts 164.312(c)(1) Integrity Controls Configurable validation rules ✅
fhirWebhook.ts 164.312(d) Person Authentication Bearer token authentication ✅

Application-Level Compliance

Component HIPAA Rule Requirement Implementation Status
electron/main.cjs 164.312(a)(1) Access Control License validation with fail-closed behavior ✅
electron/main.cjs 164.312(e)(1) Transmission Security CSP headers, X-Frame-Options, X-Content-Type-Options ✅
electron/main.cjs 164.312(a)(2)(iv) Encryption SQLCipher encrypted database ✅
electron/preload.cjs 164.312(a)(1) Access Control Context isolation, restricted IPC bridge ✅
src/App.jsx 164.312(d) Person Authentication Auth state validation, license enforcement ✅
src/App.jsx 164.312(a)(1) Access Control Fail-closed license checking (no bypass on error) ✅

Error Handling Compliance

Requirement Before After Status
No PHI in error responses ❌ error.message exposed ✅ Generic message + request ID ✅
Structured internal logging ❌ Unstructured console.error ✅ JSON-structured with redaction ✅
Error tracking ❌ No correlation ✅ Request ID in response + logs ✅

Audit Trail Requirements (HIPAA 164.312(b))

Requirement Implementation Status
WHO accessed the data user_email, user_role fields ✅
WHAT was accessed/modified entity_type, entity_id, hipaa_action ✅
WHEN was it accessed timestamp (ISO 8601) ✅
WHY was it accessed access_justification field ✅
Outcome of access outcome (SUCCESS/FAILURE) ✅
Data changes data_modified (before/after values) ✅
Immutability verification record_hash (SHA-256) ✅
Access type classification access_type (DIRECT/INCIDENTAL/EMERGENCY/SYSTEM) ✅

Input Validation (164.312(c)(1) Integrity Controls)

Data Type Validation Status
MELD Score Range 6-40, finite number ✅
LAS Score Range 0-100, finite number ✅
PRA Percentage Range 0-100, finite number ✅
cPRA Percentage Range 0-100, finite number ✅
Blood Type Enum validation (8 valid types) ✅
Medical Urgency Enum validation (critical/high/medium/low) ✅
Organ Type Enum validation (6 valid types) ✅
HLA Typing Format regex, length limit, antigen count limit ✅
Patient ID UUID format validation ✅
Diagnosis Text HTML sanitization, length limit ✅
Patient Names HTML sanitization in all notifications ✅

Last updated: 2026-03-21 Document owner: TransTrack Engineering