Cybersecurity Risk Management For Healthcare Devices: Testing For Vulnerabilities And Navigating Compliance With UL 2900

This whitepaper explores the rising cybersecurity risks associated with connected healthcare devices. As these devices become more integral to patient care and clinical operations, manufacturers must prioritize security throughout the device lifecycle. The paper highlights risk assessment frameworks such as STRIDE and DREAD, which help identify, categorize, and prioritize vulnerabilities. It emphasizes the importance of secure development practices, including threat modeling, vulnerability testing, and compliance with the UL 2900 standards.

In addition to technical guidance, the document provides a practical roadmap for manufacturers to follow, including risk prioritization, security enhancements (like AES-256 encryption and multi-factor authentication), and third-party product certification. By aligning with UL 2900, manufacturers can meet global regulatory expectations while ensuring device safety and data integrity. The whitepaper also includes a case study of a remote patient monitoring device, demonstrating the step-by-step application of these cybersecurity practices in a real-world scenario.

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