By name: post-quantum-secure-pharmacovigilance description: "NIST-standard PQC migration (ML-KEM + ML-DSA) for pharmacovigilance and healthcare data systems. Use when designing post-quantum security for adverse event reporting, clinical observation systems, or any healthcare pipeline handling sensitive patient data that needs quantum-resistant cryptography." metadata: arxiv_id: "2606.09412" published: "2026-06-09" authors: "Saee Desai, Tom Shimoni, Eddie Cameron, David Akamine, Aniketh Chunduri" tags: [post-quantum-cryptography, pharmacovigilance, ML-KEM, ML-DSA, healthcare-security]
Post-Quantum Secure Pharmacovigilance
Core Framework
This paper presents the first practical PQC migration framework for pharmacovigilance systems — critical infrastructure handling adverse drug reaction reports, clinical trial data, and patient safety information.
Key Components
- ML-KEM (CRYSTALS-Kyber): Post-quantum key encapsulation for encrypting pharmacovigilance data in transit. Replaces RSA/ECDH in the E2E pipeline.
- ML-DSA (CRYSTALS-Dilithium): Post-quantum digital signatures for authenticating adverse event reports and ensuring non-repudiation of submissions.
- Hybrid TLS Migration: Gradual migration strategy combining classical + PQC algorithms during transition period, ensuring backward compatibility with legacy healthcare systems.
Security Properties
- Confidentiality: ML-KEM-768 provides NIST Level 3 security (equivalent to AES-256)
- Integrity: ML-DSA-65 provides authenticated report submission
- Harvest-now-decrypt-later protection: Even if adversaries harvest encrypted pharmacovigilance data today, they cannot decrypt it with future quantum computers
Activation
- 药品安全, pharmacovigilance security, post-quantum healthcare
- ML-KEM, ML-DSA, CRYSTALS migration
- 抗量子药物监测, quantum-resistant adverse event system
- healthcare data encryption, PQC migration
Implementation Patterns
Pattern 1: Secure Adverse Event Submission Pipeline
Reporter → ML-DSA signature verification → ML-KEM encrypted channel → Central PV Database
Pattern 2: Hybrid TLS for Healthcare Interoperability
During migration, support both:
- Classical TLS 1.3 (ECDHE + AES-256-GCM)
- Hybrid TLS 1.3 (X25519 + ML-KEM-768, AES-256-GCM)
Pitfalls
- Regulatory compliance: FDA/EMA pharmacovigilance systems have strict validation requirements — PQC migration must not alter data integrity guarantees
- Performance overhead: ML-KEM key exchange adds ~2-3ms latency; ML-DSA signature verification adds ~1ms — acceptable for most PV workflows but test with high-volume systems
- Key size: ML-KEM-768 ciphertexts are 1088 bytes (vs 32 bytes for X25519) — may impact bandwidth-constrained IoMT devices
References
- arXiv: 2606.09412 - "Towards Post-Quantum Secure Pharmacovigilance with ML-KEM and ML-DSA"
- NIST FIPS 203 (ML-KEM) and FIPS 204 (ML-DSA)