As connected medical devices become essential to clinical workflows, the traditional boundaries between safety and security risk management are rapidly dissolving. Yet, many organizations still treat these disciplines as parallel efforts rather than interconnected components of a comprehensive patient-protection strategy. This presentation explores why security must now be viewed as an intrinsic part of safety risk management, and how the distinctions between them are just as important as their integration.

Safety risk management has historically focused on foreseeable device failures and user errors. Security risk management, however, introduces new dimensions: adversarial behavior, exploitation of vulnerabilities, and dynamic threats that evolve well beyond the product development lifecycle. Incorporating activities such as threat modeling, vulnerability scanning, and continuous monitoring is essential to identifying security-based hazards that can cascade into safety risks. These proactive practices reflect the unique nature of cybersecurity, where risk is measured by by exploitability, exposure, system context, and real-world threat intelligence.

A key differentiator lies in scoring. Traditional safety risk scoring methods fall short when applied to security events, where the likelihood of exploitation cannot be predicted through historical data alone. The inclusion of factors such as attack complexity, vulnerability maturity, known exploitations, and attack proximity leads to more accurate and actionable security risk characterization.

The session will demonstrate how outputs from robust security risk management directly feed into safety assessments, enabling manufacturers and healthcare organizations to uncover security-driven safety risks that might otherwise remain invisible. Additionally, attendees will learn how cyber incidents can create unexpected consequences by disrupting hospital operations, clinical workflows, and availability of critical care.