Harmonizing Regulatory Compliance and AI-Driven Vulnerability Management in Global Medical Device Ecosystems
Keywords:
Medical Device Cybersecurity, Regulatory Harmonization, AI-Driven Vulnerability Management, IoMTAbstract
The rapid digitalization of healthcare through the Internet of Medical Things (IoMT) has outpaced the evolution of traditional cybersecurity frameworks, creating critical vulnerabilities in patient care environments. This article examines the intersection of divergent regulatory standards—specifically the US FDA guidance, European Union MDR/IVDR, and Indian CDSCO requirements—and the operational realities of vulnerability management in large-scale asset environments. While regulatory bodies mandate rigorous cybersecurity controls, healthcare organizations struggle to implement these across legacy and modern infrastructure simultaneously. This study proposes a harmonized, AI-driven framework for vulnerability management that bridges the gap between compliance mandates and technical execution. By synthesizing current regulatory texts with advanced algorithmic approaches to threat mitigation, we analyze how automated frameworks can manage environments exceeding 100,000 assets. The results indicate that while regulatory harmonization remains fragmented, the integration of deep learning for predictive maintenance and log centralization significantly reduces the Mean Time to Detect (MTTD) and Mean Time to Remediate (MTTR). Furthermore, we discuss the implications of data leakage prevention maturity and the role of organizational factors in security governance. The article concludes that a static compliance checklist is insufficient; a dynamic, AI-enhanced posture is required to protect the confidentiality, integrity, and availability of medical ecosystems.
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Copyright (c) 2025 Dr. Selvina K. Osterman (Author)
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