Software Bill of Materials (SBOM) for Healthcare & Medical Devices
The healthcare sector faces unique challenges that make SBOMs particularly critical. Medical devices increasingly rely on software - from pacemakers and insulin pumps to diagnostic imaging systems and electronic health record platforms. A vulnerability in any of these systems could directly impact patient safety, making software transparency a matter of life and death rather than just business risk.
Explanation of SBOM in Healthcare and Medical Devices
Medical Device Security and Patient Safety
Medical devices often have long operational lifespans, sometimes lasting a decade or more. During that time, the software components they contain may introduce new vulnerabilities. Without an SBOM, healthcare providers and device manufacturers struggle to determine which devices are affected when new vulnerabilities emerge. This information gap can leave critical medical equipment vulnerable to attack or require extensive manual investigation to assess risk.
The FDA has recognized this challenge and now expects medical device manufacturers to maintain SBOMs for their products. This regulatory attention reflects the growing understanding that software transparency is a prerequisite for effective medical device security. When a vulnerability is discovered in a widely-used library, hospitals need to know immediately if their MRI machines, ventilators, or patient monitoring systems are affected.
Healthcare IT Infrastructure Complexity
Beyond medical devices themselves, healthcare organizations operate complex IT environments that include electronic health records, billing systems, patient portals, telemedicine platforms, and countless other applications. Each of these systems processes sensitive patient information and must comply with HIPAA privacy requirements. SBOMs help healthcare IT teams maintain security hygiene across this diverse application landscape.
Healthcare organizations face particular challenges with legacy systems. Many hospitals still run critical applications built on outdated platforms because replacing them would be prohibitively expensive or disruptive. SBOMs help security teams understand exactly which components legacy systems contain, enabling risk-based decisions about mitigation controls when upgrades aren't feasible. The transparency provided by SBOMs doesn't eliminate technical debt, but it does make managing that debt more systematic and defensible.
Supply Chain Security in Healthcare
The healthcare supply chain extends beyond traditional medical suppliers to include software vendors, cloud service providers, and medical device manufacturers. Each link in this chain introduces potential security risks. The 2020 SolarWinds attack demonstrated how compromised software updates could impact thousands of organizations, including healthcare providers.
Healthcare organizations are now scrutinizing their software suppliers more carefully, and SBOMs are central to that scrutiny. Before deploying new healthcare IT systems or medical devices, procurement teams can review the SBOM to identify security concerns. This proactive approach prevents vulnerable software from entering the environment in the first place, which is far more efficient than discovering and remediating vulnerabilities after deployment.
Why Are Software Bill of Materials Critical for Medical Device Security?
Software Bill of Materials have become particularly critical in the medical device sector due to the unique combination of safety risks, regulatory requirements, and operational constraints that characterize this industry. Medical devices increasingly rely on software for core functionality, from insulin pumps that calculate and deliver doses to diagnostic imaging systems that help doctors identify diseases. Vulnerabilities in medical device software can directly impact patient safety, making security transparency through SBOMs a matter of life and death rather than merely business risk.
Medical devices typically have very long operational lifespans compared to typical IT equipment. A hospital might use the same MRI machine or patient monitoring system for ten or fifteen years, far longer than most software remains supported. During this extended operational period, components in the device software will inevitably develop newly discovered vulnerabilities. Without a Software Bill of Materials, healthcare providers and device manufacturers struggle to determine which specific devices are affected when new vulnerabilities are disclosed, leaving critical medical equipment potentially vulnerable or requiring extensive manual investigation to assess risk.
The FDA has recognized these challenges and now expects medical device manufacturers to maintain SBOMs for their products throughout the device lifecycle. This regulatory expectation reflects the understanding that software transparency is a prerequisite for effective medical device security management. When a vulnerability is discovered in a widely-used open source library, hospitals need immediate answers about whether their ventilators, anesthesia machines, or electronic health record systems are affected. The Software Bill of Materials provides those answers quickly and reliably.
Medical device manufacturers face particular challenges updating device software due to regulatory requirements around validation and approval. Every software change potentially requires regulatory submissions and clinical validation, making rapid patching impractical. SBOMs help manufacturers and healthcare providers make risk-based decisions about which updates are truly necessary versus which vulnerabilities can be mitigated through compensating controls. This visibility enables more informed decision-making about managing the tradeoffs between security currency and regulatory compliance.