SBOM vs Traditional Software Documentation: Key Differences
Post Summary
When it comes to managing software in medical devices, SBOMs (Software Bill of Materials) and traditional software documentation serve very different purposes. SBOMs focus on listing every software component, including third-party libraries and dependencies, to address cybersecurity risks. Traditional documentation, on the other hand, explains how the device is designed, validated, and functions. Here's the key takeaway:
- SBOMs provide a detailed, machine-readable inventory of software components, enabling automated vulnerability tracking and compliance with cybersecurity regulations like FDA's Section 524B.
- Traditional documentation focuses on safety, functionality, and regulatory compliance, but often overlooks software supply chain transparency.
Quick Comparison
| Aspect | SBOM | Traditional Documentation |
|---|---|---|
| Purpose | Software transparency, risk management | Safety, design validation, functionality |
| Content | Software components, versions, dependencies | Architecture, requirements, risk mitigations |
| Format | Machine-readable (JSON, XML) | Human-readable (PDF, Word) |
| Update Frequency | With every software release | At major lifecycle milestones |
| Cybersecurity Use | Automates vulnerability scanning | Assesses clinical risk and context |
SBOMs are now mandatory for connected medical devices under FDA regulations, reflecting their importance in managing cybersecurity risks. Together, SBOMs and traditional documentation provide a complete picture, helping manufacturers and healthcare providers manage both safety and security.
SBOM vs Traditional Software Documentation: Key Differences for Medical Devices
SBOM and Traditional Software Documentation: Core Concepts
What Is an SBOM?
An SBOM is like a software ingredient list. Just as a food label tells you what's inside a product, an SBOM outlines every component within a piece of software - this includes open-source libraries, third-party modules, COTS (Commercial Off-The-Shelf) packages, and their dependencies [1][3].
"The analogy is a food ingredient label: just as food packaging lists every ingredient, an SBOM lists every software component so that regulators, healthcare providers, and manufacturers themselves can identify vulnerabilities." - Ran Chen, Global MedTech Expert [1]
One of the key advantages of an SBOM is its machine-readable format, which allows for instant vulnerability scanning. These are typically provided in standard formats like CycloneDX and SPDX:
- CycloneDX is often preferred for medical devices due to its ability to support VEX (Vulnerability Exploitability eXchange) files. These files clarify whether a known vulnerability is exploitable within a specific device configuration.
- SPDX, now an ISO standard (ISO/IEC 5962:2021), is widely used for license compliance and global interoperability [1][3].
Every SBOM must include seven baseline fields as defined by the NTIA (National Telecommunications and Information Administration): Supplier Name, Component Name, Version String, Unique Identifier (like a purl or CPE), Dependency Relationship, SBOM Author, and Timestamp [1][3]. These fields help manufacturers and healthcare delivery organizations (HDOs) pinpoint vulnerabilities and map their connection to the software architecture.
Unlike traditional documentation, which focuses on design and functionality, SBOMs address modern cybersecurity needs by offering detailed insight into software components.
Traditional Software Documentation in Medical Devices
Traditional software documentation has long been a cornerstone for medical device development, emphasizing design integrity and regulatory compliance. This includes documents such as:
- Software Requirements Specifications (SRS)
- Software Design Specifications (SDS)
- Architecture diagrams
- Source code documentation
- Validation reports
These materials are critical for FDA premarket submissions and compliance with standards like IEC 62304 and ISO 13485 [5][7]. Their primary purpose is to demonstrate that a device is designed safely and works as intended.
However, traditional documentation was developed for a time when proprietary code dominated, and third-party or open-source software was often treated as a "black box." These components were labeled as SOUP (Software of Unknown Provenance) or OTS (Off-The-Shelf) without delving into their specifics. As a result, while traditional documentation might appear complete, it often fails to expose the software supply chain - a significant issue given that supply chain vulnerabilities affect over 76% of medical devices [6].
| Feature | Traditional Documentation | SBOM |
|---|---|---|
| Primary Purpose | Safety, validation, and functional requirements | Cybersecurity, vulnerability management, supply chain transparency |
| Content Scope | Design specs, architecture, validation reports | All libraries, COTS, and transitive dependencies |
| Format | Human-readable (PDF, Word) | Machine-readable (JSON, XML via SPDX, CycloneDX) |
| Vulnerability Tracking | Manual and point-in-time | Automated and continuous |
| Regulatory Driver | IEC 62304, ISO 13485 | FD&C Act Section 524B, EU Cyber Resilience Act |
While traditional documentation ensures that devices meet functional and safety standards, it doesn't address the cybersecurity risks tied to modern software supply chains. This is the gap SBOMs are designed to fill, providing the transparency needed to manage vulnerabilities effectively.
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Key Differences Between SBOM and Traditional Documentation
Focus and Content Scope
Traditional documentation, like a Design History File (DHF) or Device Master Record (DMR), focuses on design controls, quality management, and device behavior. In contrast, a Software Bill of Materials (SBOM) dives deep into the software side, listing all components such as libraries, frameworks, firmware packages, and even transitive dependencies. It also includes metadata like version details and unique identifiers (e.g., PURLs or CPEs) [4].
Given the heavy reliance on external software components, an SBOM’s ability to expose transitive dependencies is crucial. These dependencies can often conceal medical device security risks, something traditional documentation tends to overlook by treating external components as “black boxes.” An SBOM, however, shines a light on every component with full transparency.
"Your SBOM is not a standalone document - it is part of your device's configuration identity." - MedDeviceGuide [1]
By providing this detailed inventory, SBOMs pave the way for automated processes that traditional documentation simply cannot support.
Format and Automation Potential
Traditional documentation is static and designed to be read by humans, while SBOMs are machine-readable (e.g., JSON, XML). This machine-readable format enables automated processes, such as vulnerability checks, to occur in a fraction of the time. For instance, SBOMs can be cross-referenced with databases like the National Vulnerability Database (NVD) or CISA's Known Exploited Vulnerabilities (KEV) catalog. When a new Common Vulnerabilities and Exposures (CVE) entry is published - 28,902 were recorded in 2023 alone - tools can quickly flag affected components across an entire product portfolio. Traditional documentation, with its manual review process, simply can't match this speed.
"An SBOM that is generated once for regulatory submission and then filed away provides compliance but not security." - Amie Harpe, Sakara Digital [3]
For automation to work effectively, SBOMs must stay up-to-date, reflecting real-time software changes.
Lifecycle and Update Frequency
Traditional documentation tends to be updated only at key milestones, like a new product version, regulatory submission, or major design change. This makes it a static artifact, often frozen in time for compliance purposes. SBOMs, on the other hand, are designed to evolve. They are regenerated with every build, patch, or software release, functioning as a living document that always represents the current state of the software.
As J. David Giese, Partner at Innolitics, explains:
"The SBOM should be updated as the software is updated. Thus, you must create a new SBOM for each release of the software." - J. David Giese [8]
This dynamic updating is critical for proactive vulnerability management. Unlike traditional documentation, which offers no insight into vulnerabilities discovered after an FDA submission, an up-to-date SBOM integrated into a CI/CD pipeline ensures ongoing visibility and strengthens security.
How SBOM Strengthens Cybersecurity for Medical Devices
Risk Visibility and Vulnerability Management
One of the toughest cybersecurity hurdles for medical devices is dealing with the unknown. Did you know that over 75% of the software in medical devices is made up of external components? These include open-source libraries, third-party modules, and commercial off-the-shelf (COTS) software [1]. Unfortunately, traditional documentation often fails to account for all these hidden dependencies.
This is where a Software Bill of Materials (SBOM) shines. It maps every single component, including those deeply buried in dependency chains, making it easier to identify which devices are at risk when a vulnerability comes to light. A perfect example is the Log4Shell vulnerability (CVE-2021-44228):
"The Log4Shell vulnerability (CVE-2021-44228) demonstrated drastically that a single vulnerable component buried deep in a dependency chain can compromise thousands of devices across hundreds of manufacturers." - Ran Chen, Global MedTech Expert [1]
With automated tools, this inventory can be cross-referenced against databases like the NVD or CISA's KEV catalog. Pairing an SBOM with a Vulnerability Exploitability eXchange (VEX) file further refines the process, helping teams determine if a known vulnerability is actually exploitable in a specific setup. This approach not only sharpens focus on genuine risks but also supports compliance with regulatory requirements.
Regulatory Alignment and FDA Guidance
SBOMs aren’t just helpful - they’re required for connected medical devices. According to Section 524B of the Federal Food, Drug, and Cosmetic Act, manufacturers of "cyber devices" must include a machine-readable SBOM in their premarket submissions, such as 510(k), PMA, De Novo, and HDE filings [2]. Starting October 1, 2023, the FDA gained the authority to issue a "Refuse to Accept" ruling for submissions missing a compliant SBOM [2].
To streamline vulnerability scanning, the FDA prefers machine-readable formats like CycloneDX or SPDX. They're also moving toward exploitability-based risk scoring, aligned with CVSS v4.0, that ties directly to SBOM components [9]. By February 2026, the FDA's Quality Management System Regulation will treat the SBOM as a core part of configuration management.
"The SBOM is no longer optional for connected devices." - Fabien Pezous, CEO, Apotech
And it’s not just the U.S. making moves. The EU Cyber Resilience Act will require SBOMs for all products with digital elements by December 11, 2027 [1]. These regulatory shifts don’t just meet compliance goals - they also bring practical benefits to healthcare providers.
Benefits for Healthcare Delivery Organizations
The combination of better visibility and regulatory mandates makes SBOMs a powerful tool for healthcare delivery organizations (HDOs). Many HDOs now require an SBOM before purchasing devices to evaluate their security posture [1]. Once a device is in use, SBOM data helps prioritize patches, monitor end-of-life dates for components, and respond quickly to emerging vulnerabilities. With 28,902 CVEs published in 2023 alone [3], manual tracking is simply not feasible. A dynamic, continuously updated SBOM is the only way to stay ahead.
Platforms like Censinet RiskOps™ take this a step further by integrating SBOM data into enterprise risk management workflows. This gives HDOs a unified view of risks across third-party vendors and individual devices. By linking SBOM details to broader risk factors - like patient data exposure, clinical application vulnerabilities, and supply chain risks - security teams can shift from reactive patching to proactive risk management.
"SBOM management is foundational for medical device cybersecurity. Without a comprehensive, accurate, and continuously maintained inventory... it is impossible to systematically identify which devices are affected when a new vulnerability is disclosed." - Sakara Digital [3]
How SBOM and Traditional Documentation Work Together
Combined Use in Risk Assessment
SBOMs and traditional documentation play distinct but complementary roles in managing software risks. Think of an SBOM as an ingredient label - it lists the components that make up the software. On the other hand, traditional documentation acts like the recipe, explaining the design rationale and how everything fits together.
This combination is crucial for ISO 14971 risk management. For instance, if an SBOM identifies a component with a known CVE (Common Vulnerabilities and Exposures), that vulnerability is flagged as a potential hazard. Traditional documentation, such as the Software Architecture Design or the Risk Management File, then steps in to provide the clinical context needed to assess how this issue might impact patients and determine its severity. Together, they offer a comprehensive view of risk.
The FDA's 2025 guidance emphasizes this connection, requiring manufacturers to maintain traceability between the threat model, cybersecurity risk assessment, SBOM, and testing documentation [1][8]. Similarly, ISO 13485 calls for SBOM data to be integrated into key design records, improving traceability. For healthcare delivery organizations (HDOs), combining SBOM data with traditional device manuals helps establish controls and schedule timely patches across their installed devices [1]. The table below highlights how these two forms of documentation complement each other.
SBOM vs Traditional Documentation: Side-by-Side Comparison
Here’s a quick breakdown of how SBOMs and traditional documentation contribute to medical device cybersecurity:
| Aspect | SBOM | Traditional Documentation |
|---|---|---|
| Purpose | Provides transparency into software components and identifies vulnerabilities | Explains design intent and offers clinical context |
| Content | Lists software components, versions, and dependencies | Covers architecture, requirements, and risk mitigations |
| Format | Machine-readable (e.g., CycloneDX, SPDX) | Human-readable (e.g., PDFs, Word documents) |
| Update Frequency | Updated with every build or release | Updated at major lifecycle milestones |
| Cybersecurity Use Cases | Enables automated vulnerability scanning and mapping | Assesses clinical impact and informs risk management |
| Regulatory Link | FD&C Act Section 524B | IEC 62304 / ISO 14971 |
For FDA eSTAR submissions, including a concise, human-readable summary alongside the machine-readable SBOM file can be incredibly helpful. It gives reviewers a clear understanding of how the SBOM is generated, maintained, and monitored, bridging the gap between automated tools and traditional documentation [1].
Webinar: FDA Expectations for SBOMs - A Deep Dive with Blue Goat Cyber
Conclusion
SBOMs (Software Bill of Materials) play a crucial role in strengthening software security by complementing traditional documentation. While traditional documentation outlines the reasoning behind a device's design, an SBOM delivers a detailed, up-to-date inventory of its components, including every nested dependency and third-party library. This level of transparency is vital because even one vulnerable library hidden deep within a dependency chain can pose serious risks to patient safety [1]. Unlike static documentation, SBOMs integrated into CI/CD pipelines and paired with automated vulnerability scans - using resources like the CISA Known Exploited Vulnerabilities catalog - provide ongoing visibility into potential risks.
Regulatory expectations have evolved to reflect the importance of SBOMs. For instance, under Section 524B of the FD&C Act, SBOMs are now legally required for cyber devices. Since October 1, 2023, the FDA has had the authority to issue a "Refuse to Accept" ruling for non-compliant submissions. Similarly, the EU Cyber Resilience Act introduces mandatory vulnerability reporting requirements starting September 11, 2026 [1].
"The FDA's June 2025 guidance expects SBOMs to be living documents, updated as part of your quality system's configuration management process." - Ran Chen, Global MedTech Expert, MedDeviceGuide [1]
This guidance emphasizes the need to treat SBOMs as active, evolving components of a broader cybersecurity strategy. The most effective use of SBOMs involves integrating them into the ISO 14971 risk management file and the Design History File, ensuring they remain updated throughout the device's lifecycle. This approach not only enhances patient safety but also simplifies compliance efforts across the lifecycle of a device. For healthcare delivery organizations (HDOs) managing extensive device inventories, SBOMs enable timely patching and stronger security controls. Platforms like Censinet RiskOps™ are specifically designed to assist HDOs in managing the complexities of medical device cybersecurity, offering structured and ongoing risk management at scale.
FAQs
What should an SBOM include at minimum?
An SBOM should cover seven key NTIA baseline attributes: supplier name, component name, version string, unique identifiers (like Package URL or CPE), dependency relationships, SBOM data author, and a timestamp. Additionally, it must detail the component support status, end-of-support dates, and include a vulnerability assessment that outlines known issues, discovery methods, and mitigation strategies. To ensure usability, this data should be presented in a machine-readable format, such as SPDX or CycloneDX.
How do you keep an SBOM updated across releases?
To maintain an SBOM as an up-to-date resource, think of it as a "living document" that evolves with every software release or patch. Each new version of your software - especially when components are updated - should have its own freshly generated SBOM. Automating this process through your CI/CD pipeline can save time and reduce errors. Be sure to include key metadata like timestamps and detailed component information. Pair this with ongoing vulnerability monitoring to ensure the SBOM stays accurate and helps you spot potential risks as they arise.
When should you add a VEX file with an SBOM?
Starting in March 2026, you'll need to include a VEX file with your SBOM to meet FDA expectations. A VEX file provides clarity on whether the vulnerabilities listed in your SBOM can actually be exploited in your device's specific setup. This addition enhances vulnerability tracking and makes communication with customers and stakeholders more effective.
