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SBOM Guidance for Medical Device Security Provides Clearer Framework
Imagine learning that a critical vulnerability has been discovered in software used by hospitals nationwide. The problem isn’t with the medical device itself, it’s buried in a small software component hidden deep inside the device. Without knowing that component is there, healthcare organizations may have no easy way to determine whether they’re at risk. That should no longer be the case.
The Cybersecurity and Infrastructure Security Agency (CISA) has updated its guidance for Software Bills of Materials (SBOMs), giving healthcare organizations and medical device manufacturers a clearer framework for identifying software components that could introduce cybersecurity vulnerabilities.
The update was announced jointly on July 29 by CISA, the National Security Agency (NSA), the Federal Bureau of Investigation (FBI), and international cybersecurity partners.
What Exactly is an SBOM?
An SBOM is an inventory of every software component, library, and dependency that makes up a software product. Like an ingredient list on food packaging, it provides visibility into what’s running behind the scenes, helping organizations identify affected devices when new vulnerabilities are disclosed.
The updated recommendations replace the minimum SBOM elements first published by the National Telecommunications and Information Administration (NTIA) in 2021. The guidance also recognizes that newer technologies, including artificial intelligence (AI) applications and cloud-based software-as-a-service (SaaS), may require additional SBOM elements beyond the baseline recommendations.
Why the Updated SBOM Guidance Matters for Medical Devices
For medical device manufacturers, the guidance reinforces existing FDA cybersecurity requirements under Section 524B of the Federal Food, Drug, and Cosmetic Act, which requires an SBOM for new medical device applications submitted to the FDA after October 1, 2023. These updated recommendations are directly significant to the medical device industry because of those FDA requirements.
How SBOMs Strengthen Healthcare Cybersecurity
An SBOM provides greater visibility into the software running inside connected medical devices and applications. Instead of waiting for a device to be identified as vulnerable, organizations can determine whether an underlying software component is affected by a newly disclosed security flaw.
“Take a look at the many software components that run a medical imaging device as an example,” said Scott Gee, American Hospital Association deputy national advisor for cybersecurity and risk. “The device itself may not be listed as compromised, but one deeply embedded software component could contain an unpatched technical vulnerability that may lead to compromise of the device and, therefore, the hospital network it’s attached to.”
How Healthcare Organizations Can Use SBOMs
Although the SBOM requirement applies directly to medical device manufacturers, healthcare organizations can also use SBOMs to strengthen cybersecurity and vendor risk management. An SBOM can help organizations:
- Identify medical devices affected by newly disclosed software vulnerabilities.
- Prioritize software updates and remediation efforts.
- Improve software supply chain risk management.
- Strengthen medical device inventory and lifecycle management.
- Support faster incident response when vulnerabilities are identified.
As healthcare organizations increasingly rely on connected medical devices, cloud services, AI-powered technologies, and third-party vendors, understanding the software components within these systems is becoming essential to cybersecurity and HIPAA compliance.
A comprehensive Vendor Risk Assessment complements SBOMs by identifying risks posed by business associates that create, receive, maintain, or transmit protected health information (PHI), helping organizations reduce risk and strengthen compliance. PrivaPlan Associates specializes in evaluating third-party vendors across various industries. Contact us to discuss how our Vendor Risk Assessment solutions can elevate your data protection efforts.
Discover the vital importance of medical device security in our recent article: Medical Device Cybersecurity: Managing Risks and Protecting PHI
Medical Device Cybersecurity FAQ
How does HIPAA define a "medical device"?
HIPAA defines a medical device as any tool that stores, accesses, creates, or receives electronic protected health information (ePHI). If the medical device touches patient data, it should become part of your HIPAA Security strategy.
Why are medical devices considered a security risk?
Newer devices are network-connected and data-rich, creating more entry points for attackers. Common weak spots include default credentials, unpatched firmware, and unsegmented networks that let one compromised device expose your whole system.
Do medical devices need to be part of our annual Security Risk Analysis (SRA)?
Yes. Every connected medical device should be evaluated for what data it holds, who can access it, whether it has authentication controls, and whether its firmware is current. Folding devices into your SRA turns a routine compliance task into a genuine business safeguard.
What are the best defensive practices for reducing medical device risk?
A strong HIPAA Security program layers several safeguards: phishing-resistant multi-factor authentication, a risk-based vulnerability management program, a defined schedule for tracking and retiring end-of-life hardware and software, and third-party risk management for the vendors and manufacturers behind your medical devices.
Know Your Risk With a PrivaPlan SRA
A Security Risk Assessment is only as valuable as the expertise behind it. PrivaPlan’s team of HIPAA compliance specialists brings more than two decades of healthcare privacy and security experience to every SRA we conduct. We help organizations identify real risks, meet regulatory requirements, and strengthen their compliance efforts. Reach out to learn how we can help.
