The Importance of SBOM and CVE in Medical
This article explores the critical landscape of medical device cybersecurity, focusing on the IMDRF’s “Principles and Practices for Medical Device Cybersecurity.” It advocates for a holistic approach throughout the product life cycle, with particular emphasis on the vital role of the Software Bill of Materials (SBOM). The article addresses the FDA’s stringent postmarket vulnerability reporting requirements, highlighting challenges posed by the escalating Common Vulnerabilities and Exposures (CVEs) since 2017. Recognizing the impracticality of manual CVE handling, it recommends outsourcing to avoid R&D disruptions. Wind River’s automated managed services offer a solution by streamlining SBOM processes and expertly addressing vulnerabilities. This concise guide is essential for manufacturers navigating the intricate landscape of medical device cybersecurity, promoting a proactive and holistic approach for the safety and integrity of healthcare technologies.