🛡️ Compliance & Regulatory Dashboard

📊 DPDP Compliance Report

🔒 SHA-256 Hash Chain Verification

Verifies that no audit log entries have been tampered with (21 CFR Part 11 §11.10(e))

🔍 Run Integrity Check

🔗 HL7 FHIR R4 REST API

Content-Type: application/fhir+json · Reference: hl7.org/fhir/R4

📋 Terminology Bindings

Domain	System	Standard	Coverage
Vaccines	CVX (CDC)	HL7 FHIR	20 codes
Vaccines	SNOMED CT	IHTSDO	20 codes
Vaccines	ATC (WHO)	WHO	20 codes
Observations	LOINC	Regenstrief	14 codes
Diagnoses	ICD-11	WHO	10 codes
Diagnoses	ICD-10-CM	CMS	10 codes
Diagnoses	SNOMED CT	IHTSDO	10 codes
Consent	HL7 v3 ActReason	HL7	6 codes

📊 Regulatory Compliance Status

• ✅ DPDP Act 2023 (India) — Consent management, processing records, withdrawal support
• ✅ GDPR (EU) — Purpose-based consent, right of access, data processing records
• ✅ HIPAA (US) — PHI audit trail, access logging, immutable records
• ✅ 21 CFR Part 11 (FDA) — SHA-256 hash-chain audit integrity, electronic records
• ✅ HL7 FHIR R4 — Patient, Immunization, Consent, Observation, AuditEvent resources
• ✅ SNOMED CT — 30+ clinical concept codes mapped
• ✅ LOINC — 14 observation codes (vitals, growth, lab)
• ✅ CVX (CDC) — 20 vaccine codes mapped
• ✅ ICD-11 / ICD-10-CM — 10 neonatal diagnosis codes
• ⏳ IEC 62304 — SDLC documentation template ready
• ⏳ ISO 14971 — Risk management file template ready
• ⏳ SOC 2 Type II — Audit infrastructure in place, formal audit pending
• ⚠️ Database — SQLite (dev) → PostgreSQL required for production
• ⚠️ Encryption at rest — Not yet implemented (required for HIPAA/GDPR production)

🏥 Data Protection Officer (DPO)

🌏 Per-Country Compliance

🔀 Health Information Exchange (HIE) Status

🏥 Certification Readiness

📋 8-Chapter Assessment

⚠️ Priority Gaps