Authors: Nadeesha Perera, Tharindu Silva, Ishara Fernando, Chamika Weerasinghe
Abstract: Secure data storage in biomedical environments is a foundational requirement for maintaining regulatory compliance, safeguarding patient privacy, and enabling ethical scientific research. As healthcare and life sciences organizations generate and manage vast amounts of sensitive information ranging from electronic health records to genomic sequences the need for secure, resilient, and policy-driven storage architectures has become increasingly urgent. This review examines the technical, regulatory, and operational considerations involved in designing storage systems that align with frameworks such as HIPAA, GDPR, and FDA 21 CFR Part 11. The paper begins by analyzing the classification of protected health information (PHI) and the importance of data sensitivity in biomedical workflows. It explores regulatory mandates related to auditability, legal retention, and chain-of-custody, followed by a detailed examination of the evolving threat landscape, including ransomware and insider attacks. The review compares traditional SAN/NAS models, object-based architectures, and software-defined storage solutions, highlighting their respective roles in compliance-driven deployments. Further sections address critical security practices such as encryption, key management, access control, and data lifecycle enforcement. The integration of secure storage with biomedical systems like PACS, LIMS, and EHRs is evaluated, with attention to secure APIs and auditability. Emerging technologies including confidential computing, blockchain-based integrity tracking, and AI-driven anomaly detection are also explored for their future impact. Through real-world case studies, the review illustrates successful implementations in hospitals, research institutions, and hybrid infrastructures. It concludes with an analysis of common challenges such as vendor lock-in and the trade-offs between compliance and usability. Looking ahead, the paper advocates for zero trust-aligned architectures and adaptive compliance automation as guiding principles for next-generation biomedical storage design.
DOI: https://doi.org/10.5281/zenodo.15847131
