Towards Post-Quantum Secure Pharmacovigilance with ML-KEM and ML-DSA

Abstract

Pharmacovigilance systems handle sensitive healthcare and drug-safety data, including adverse event reports and clinical observations. As quantum computing advances, classical public-key cryptographic systems such as RSA and elliptic-curve cryptography may become vulnerable, creating long-term risks for healthcare data that must remain confidential for many years. This paper presents an educational prototype of a post-quantum secure pharmacovigilance data pipeline. The system uses ML-KEM-768 for post-quantum key establishment, HKDF-SHA-256 for deriving an AES key, AES-256-GCM for efficient file encryption, and ML-DSA-65 for digital signatures and tamper detection. The pipeline supports multiple file formats, including TXT, CSV, JSON, and PDF, by treating files as raw bytes and preserving metadata for reconstruction at the receiver. The prototype includes separate hospital, gateway, pharma receiver, attacker, benchmarking, and dashboard components. We evaluate the system using synthetic pharmacovigilance datasets of different sizes and formats. Our results show that ML-KEM adds a small constant overhead, while AES encryption and ML-DSA signing dominate runtime as file size increases. This work is not a production-ready healthcare system, but rather an educational systems-level exploration of how post-quantum cryptographic primitives can be integrated into healthcare-style data pipelines.