Authors: Dilani Jayawardena, Kasun Rathnayake, Nimali Dissanayake, Sahan Abeysekera
Abstract: Biomedical data systems operate under stringent uptime requirements, complex regulatory constraints, and increasingly sophisticated cyber threats. Ensuring the security and reliability of these systems through regular patching presents a significant operational challenge, particularly in environments where downtime is unacceptable. This review examines state-of-the-art patching strategies tailored for always-on biomedical infrastructures, including electronic health records (EHR), PACS, LIMS, and real-time monitoring platforms. Key considerations such as risk-based patch prioritization, live kernel patching, failover strategies, and automation via CI/CD pipelines are discussed in detail. Emphasis is placed on regulatory compliance with HIPAA, FDA 21 CFR Part 11, and ISO 27001, as well as alignment with industry standards such as NIST SP 800-40 and CIS benchmarks. The review also explores governance mechanisms, stakeholder coordination, and validation processes essential for maintaining both uptime and auditability. Through real-world case studies and analysis of common pitfalls, the paper provides actionable insights into achieving secure, reliable, and regulation-ready patch deployment in biomedical environments. Future directions highlight the convergence of artificial intelligence, continuous compliance validation, and threat-informed patch orchestration as the next evolution in patch management for mission-critical healthcare systems.
DOI: https://doi.org/10.5281/zenodo.15847374
