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Here at Medcrypt, we know you take your cybersecurity seriously, and so do we. When you create your account, you’ll automatically be enrolled in multi-factor authentication (MFA), also known as two-factor authentication (2FA). This means that you’ll need to provide a code from an authentication app. If you don’t already have an authentication application installed on your smartphone, you’ll need to choose one. We use Google Authenticator ourselves.
You’ll receive a welcome email, inviting you to sign in to your Helm account.
After signing in, you’ll be prompted to enable your MFA for security. At that time, you’ll be provided with recovery codes in case your phone is lost or stolen. Make sure to copy and paste these recovery codes into a safe place.
When you first sign in and until you’ve uploaded your first SBOM, you’ll see a get started modal, prompting you to choose a path. If you already are familiar with SBOMs and have a CycloneDX .json file, you should choose the top left path to upload your SBOM and get started. If you’re not, choose the path that best matches your current state.
If you accidentally closed that get started modal, don’t worry. You can always access it from the sidebar > Help section.
Ready to leverage the power of Helm to streamline your vulnerability management? Let's get you up and running!
Upload your Software Bill of Materials (SBOM) file:
Got an SBOM ready? Upload your SBOM file to Helm. We support CycloneDX and SPDX SBOMs.
Don’t have an SBOM yet? No worries! You can generate a CycloneDX SBOM or SPDX SBOM using our open-source tool suggestions or any other tool you prefer. You can also manually create your SBOM if that works better for you. If you’re unsure how to get started, we’re here to help—contact us so we can assist you.
Automatic matching to the NVD: Once you’ve uploaded your SBOM, our system will automatically attempt to match your components to the NVD (National Vulnerability Database).
Matched status with NVD badge: For each Matched status with an NVD badge, we have identified an exact match for your component in the NVD, allowing you to see vulnerabilities associated with that component.
Matched status with package manager badge: For each Matched status with a package manager badge, this indicates the component was matched to a specific package manager. If you don’t see an NVD badge, it means we couldn’t locate an exact match in the NVD, but your software does exist in the respective package manager. Refer to Match statuses for more details.
Resolve Select match status: For each Select match status, this indicates that we found multiple potential matches in the NVD. Click Resolve to review the match suggestions. Once you find the correct software, you can link it immediately. You must resolve this status by identifying an exact match in the NVD to see vulnerabilities for the component.
Resolve Not found status For each Not found status, this indicates we didn’t find a match in the NVD, meaning that there are no known vulnerabilities listed for that component using the name in your SBOM. You’ll need to resolve this status by identifying an exact match in the NVD to view the vulnerabilities. Remember that software can sometimes have a different name in the NVD.
Save time with reusable aliases: If you’re an Administrator, you can create an alias for a dependency to known software that you identify. This alias will save time and effort by ensuring consistent matching for future SBOM uploads.
Resolve Fix version status: For each Fix version status, this indicates that the version you provided does not match the expected version format. You'll need to resolve this status before you can view vulnerabilities for that component.
Contact Us status: If you see a Contact us status, this means we were unable to process the version. We are aware of the issue and will notify you once support has been added. At that point, we will automatically reprocess the affected component to attempt to find a match in the NVD.
Am I impacted by that vulnerability? Where? You can quickly check whether a particular vulnerability impacts your products, and if so, which products you'll need to focus on. Just enter the vulnerability ID in the global search bar at the top of any page.
Am I impacted by that vulnerable component? Where? You can quickly check whether your products contain a particular component, and if so, which products you'll need to assess. Just enter the component name in the global search bar at the top of any page.
Manage vulnerabilities: You can start managing vulnerabilities for any components that have a Matched status with an NVD badge.
Monitor your progress: You can track your progress on your Dashboard, accessible via the Home icon on the sidebar.
By having an SBOM that represents the current state of your product, you now have a catalog of all of your “ingredient lists”, creating visibility and transparency across your software security supply chain and ensuring that your software is updated and patched on a regular basis. You can then quickly identify any potential exploitable vulnerabilities you need to assess and mitigate.
SBOMs are a critical component for operationalizing software supply chain security; they are key building blocks in your software supply chain cybersecurity programs. SBOMs act like a list of ingredients for the software that makes up applications. You may call these individual software “components” or “dependencies”. Helm enables you to provide transparency to your own company, your auditors, and even your customers, depending on your company policies, on your software supply chain, ensuring that stakeholders are aware of otherwise invisible dependencies on proprietary, open source and licensed, Commercial Off-the-Shelf (COTS) libraries.
Common elements of an SBOM include:
Open-source libraries.
Plug-ins, extensions, and add-ons
Custom source code created in-house
Information about versions, licensing status, and patch status of dependency components
SaaS: Third-party services and API information required to run the SaaS application.
SBOMs are critical to realizing a better and more secure future for your company, your customers, and their patients. It is the latest step in the path to ensure that through making your software dependencies visible, you can then manage vulnerabilities of this software, ensuring that you are focusing on the highest-risk and most critical vulnerabilities first. Per the FDA, it’s no longer sufficient to rely on “security through obscurity”, as medical device manufacturers, you need to take responsibility and realize your pre-market and post-market liability for insecure software being used in your devices and systems, which are then passed down to customers and patients.
According to Gartner, by 2026, at least 60% of companies with mission-critical software solutions will mandate SBOM disclosures in their license and support agreements.
Over the past few years, there have been a number of high-profile software supply chain attacks. Today’s connected devices rely on many software libraries, including home-grown, third-party, and open source projects. As a result of the pandemic, there have been a number of business-critical supply chain shortages, which have forced device and product manufacturers to expand outside their network of trusted suppliers, adding another layer of risk to the software supply chain. Here are a few of the more recent and most impactful attacks, although there are many more:
In 2020, the SolarWinds attack on the software supply chain has a deep and lasting impact on the US governmental infrastructure and many companies across the US, Europe, Asia, and the Middle East, as IT networks were hacked by intruders over a months-long operation against SolarWinds, which supplied the hacked companies with a network monitoring and management platform. It cast a sobering spotlight on the extent to which medical device manufacturers know about the software that is used in their devices.
In 2021, a critical remote-code execution vulnerability was discovered in the ubiquitous Apache Log4j open-source Java logging library. Its widespread usage combined with its ease of exploitation for even inexperienced hackers makes it especially dangerous, putting any Java applications with a user interface at risk of a Log4Shell attack. It made the risk inherent in using open source components in devices painfully clear. Systems and services that use the Log4j library include Twitter, Tesla, Apple, Minecraft, and many others.
In 2017, the WannaCry (also known as WannaCrypt) ransomware attack targeted computers running the Microsoft Windows operating system by using the EternalBlue exploit to encrypt data and the DoublePulsar tool to install and execute copied of itself, then demanding cryptocurrency payments to unencrypt the data. While Microsoft had released patches to close the exploit, many organizations had not applied these patches or were using older Windows operating systems that were past their end-of-life. According to Europol, WannaCry infected over 200K computers across 150 countries, impacting the National Health Service and a myriad of other companies.
Is my company impacted by Log4j or WannaCry?
You can easily check that once you’ve generated and uploaded your SBOM into Helm!
For Log4j, you can search for “log4j” in our global search to return all dependency components that are potentially impacted, or you can search on the vulnerability ID CVE-2021-44228. If you think you are impacted, refer to CISA's Log4j Vulnerability Guidance for more information.
For WannaCry, you can search for older Windows operating systems (e.g., Windows XP and upwards) to make sure that they have been patched. You can also search for associated vulnerability IDs: CVE-2017-0143, CVE-2017-0144, CVE-2017-0145, CVE-2017-0146, CVE-2017-0147, and CVE-2017-0148. If you think that you could be impacted, refer to CISA's WannaCry fact sheet for more information.
According to Gartner, by 2026, at least 60% of companies with mission-critical software solutions will mandate SBOM disclosures in their license and support agreements.
By having an SBOM that represents the current state of your product, you now have a catalog of all of your “ingredient lists”, creating visibility and transparency across your software security supply chain and ensuring that your software is updated and patched on a regular basis. You can then quickly identify any potential exploitable vulnerabilities you need to assess and mitigate.
SBOMs are critical to realizing a better and more secure future for your company, your customers, and their patients. It is the latest step in the path to ensure that through making your software dependencies visible, you can then manage vulnerabilities of this software, ensuring that you are focusing on the highest-risk and most critical vulnerabilities first. Per the FDA, it’s no longer sufficient to rely on “security through obscurity”, as medical device manufacturers, you need to take responsibility and realize your pre-market and post-market liability for insecure software being used in your devices and systems, which are then passed down to customers and patients.
The US government published Executive Order 14028 for Improving the Nation’s Cybersecurity in 2021, after which federal agencies were subsequently required to adopt NIST guidelines, including using SBOMs to conform with NIST secure software development practices.
Hospitals, the consumer of medical devices, are increasingly requesting a detailed SBOM as part of their Business Associate Agreements (ex. Mayo Clinic), with expectations including the device or application name, the vendor and product name based on the NIST CPE dictionary and the version, as well as who is responsible for providing and applying any software updates, how often the software will be updated, how often security patches are applied (particularly when there is a known vulnerability), whether the software is critical for the device to function, how the MDM will notify the Mayo Clinic in case of updates, and expected end-of-life date for the device or application. Due to their need to reduce operating expenses while maintaining the highest quality of healthcare, health systems like the Mayo Clinic will continue to reject supplier price increases, pass-thru taxes (e.g., the Medical Device Tax), or other loss of value. They have asked that MDMs continue to streamline processes and increase efficiencies.
Over the past few years, there have been a number of high-profile software supply chain attacks. Today’s connected devices rely on many software libraries, including home-grown, third-party, and open source projects. As a result of the pandemic, there have been a number of business-critical supply chain shortages, which have forced device and product manufacturers to expand outside their network of trusted suppliers, adding another layer of risk to the software supply chain. Here are a few of the more recent and most impactful attacks, although there are many more:
In 2020, the SolarWinds attack on the software supply chain has a deep and lasting impact on the US governmental infrastructure and many companies across the US, Europe, Asia, and the Middle East, as IT networks were hacked by intruders over a months-long operation against SolarWinds, which supplied the hacked companies with a network monitoring and management platform. It cast a sobering spotlight on the extent to which medical device manufacturers know about the software that is used in their devices.
In 2021, a critical remote-code execution vulnerability was discovered in the ubiquitous Apache Log4j open-source Java logging library. Its widespread usage combined with its ease of exploitation for even inexperienced hackers makes it especially dangerous, putting any Java applications with a user interface at risk of a Log4Shell attack. It made the risk inherent in using open source components in devices painfully clear. Systems and services that use the Log4j library include Twitter, Tesla, Apple, Minecraft, and many others.
To further support this, the US government published Executive Order 14028 for Improving the Nation’s Cybersecurity in 2021, after which federal agencies were subsequently required to adopt NIST guidelines, including using SBOMs to conform with NIST secure software development practices.
Hospitals, the consumer of medical devices, are increasingly requesting a detailed SBOM as part of their Business Associate Agreements (ex. Mayo Clinic), with expectations including the device or application name, the vendor and product name based on the NIST CPE dictionary and the version, as well as who is responsible for providing and applying any software updates, how often the software will be updated, how often security patches are applied (particularly when there is a known vulnerability), whether the software is critical for the device to function, how the MDM will notify the Mayo Clinic in case of updates, and expected end-of-life date for the device or application. Due to their need to reduce operating expenses while maintaining the highest quality of healthcare, health systems like the Mayo Clinic will continue to reject supplier price increases, pass-thru taxes (e.g., the Medical Device Tax), or other loss of value. They have asked that MDMs continue to streamline processes and increase efficiencies.
You can use SBOMS to proactively understand and prevent or reduce risks, as well as to respond to incidents when they do occur.
By having an SBOM that represents the current state of your product, you can create a catalog of all of your “ingredient lists” to create visibility and transparency across your software security supply chain, as well as identifying any potential exploitable vulnerabilities you need to assess and mitigate.
Meet Mayo Clinic requirements
If you’re doing business with the Mayo Clinic, they often request a detailed SBOM as part of their Business Associate Agreements, including the device or application name, the vendor and product name based on the NIST CPE dictionary and the version, as well as who is responsible for providing and applying any software updates, how often the software will be updated, how often security patches are applied (particularly when there is a known vulnerability), whether the software is critical for the device to function, how the MDM will notify the Mayo Clinic in case of updates, and expected end-of-life date for the device or application. Due to their need to reduce operating expenses while maintaining the highest quality of healthcare, the Mayo Clinic will continue to reject for supplier price increases, pass-thru taxes (e.g., the Medical Device Tax), or other loss of value. They have asked that MDMs continue to streamline processes and increase efficiencies.
Per the FDA guidance in Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, manufacturers should be addressing cybersecurity during the design and development of their medical device, which often results in more robust and efficient mitigation of patient and operator risks. Medical device manufacturers also need to establish design inputs for their device related to cybersecurity, as well as establishing a cybersecurity vulnerability and management approach as part of the software validation and risk analysis required by 21 CFR 820.30(g). This approach should address the following:
Identification of assets, threats, and vulnerabilities
Assessment of the impact of threats and vulnerabilities on device functionality and operators/patients
Assessment of the likelihood of a threat and of a vulnerability being exploited
Determination of risk levels and suitable mitigation strategies
Assessment of residual risk and risk acceptance criteria.
Medical devices that can connect (wirelessly or hard-wired) to another device, to the internet, to another network, or to portable media (e.g., USB or CD) are more vulnerable to cybersecurity threats than devices that are not connected. The extent to which security controls are needed depends on the device’s intended use, the presence and intent of its electronic data interfaces, its intended environment of use, the type of cybersecurity vulnerabilities present, the likelihood the vulnerability will be exploited, and the probable risk of patient harm due to a cybersecurity breach. To determine whether your device is considered a cyber device, refer to the What does the FDA classify as a cyber device? section.
Per the FDA guidance in Postmarket Management of Cybersecurity in Medical Devices, due to constantly changing nature of cybersecurity risks to medical devices, manufacturers cannot completely mitigate risks through pre-market controls alone. Thus, it is critical that manufacturers implement comprehensive cybersecurity management programs and documentation consistent with the Quality System Regulation (21 CFR part 820), including complaint handling, quality audit, corrective and preventive action, software validation and risk analysis, and servicing.
Cybersecurity risk management programs should address vulnerabilities that will potentially allow the unauthorized access, modification, misuse or denial of use, or the unauthorized use of information stored, accessed, or transferred from a medical device which may result in patient harm. This program should include:
Monitoring cybersecurity information sources for identifying and detecting cybersecurity vulnerabilities and risks.
Maintaining robust software lifecycle processes, including mechanisms for:
monitoring third-party software components for new vulnerabilities throughout the device’s lifecycle
design verification and validation for software updates and patches that are used to remediate vulnerabilities, including for off-the-shelf software
Understanding, assessing, and detecting the presence and impact of a vulnerability
Establishing and communicating processes for vulnerability intake and handling.
Using threat modeling to clearly define how to maintain safety and essential performance of a device by developing mitigations that protect, respond, and recover from cybersecurity risk
Adopting a coordinated vulnerability disclosure policy and practice
Deploying mitigations that address cybersecurity risk early and prior to exploitation.
Per the FDA guidance in Postmarket Management of Cybersecurity in Medical Devices, it is strongly recommended that medical device manufacturers participate in an ISAO that shares vulnerabilities and threats that impact medical devices. Sharing and disseminating cybersecurity information and intelligence pertaining to vulnerabilities and threats across multiple sectors is integral to a successful post-market cybersecurity surveillance program.
In case you weren’t aware, Medcrypt owns an ISAO, MedISAO - we’d love to have you join us in sharing information!
As part of your cybersecurity program, FDA post-market guidance states that manufacturers should define the safety and essential performance of their device, the potential for and severity of patient harm should the device be compromised, as well as the risk acceptance criteria, all of which will enable you to quickly triage vulnerabilities for remediation and mitigation. Threat modeling is critical to helping to you understand and assess the exploitability of a vulnerability, as well as ensuring that your vulnerability remediation can reasonably control the risk of patient harm. Acceptable mitigations will vary depending on the severity of the potential patient harm.
Having a complete SBOM is critical during a data breach, enabling you to quickly detect and analyze the impacted software and to understand the impact of the data breach and which other dependency components might be affected so that you can act quickly to limit the impact to your company, your customers, and their patients. It also helps you identify what critical areas you need to address and what to prioritize first in your cybersecurity plan.
SBOMs are very useful during the detection and analysis phase, providing visibility into what is in the software for context and details that inform the analysis. This drastically reduces wasted time spent gathering information from binary files, which is especially critical during a data breach.
By shifting the process of providing transparency to your entire software supply chain to the left, you can get requisite information from your vendors and third parties to determine their impact in your device’s particular environment. This also enables you to proactively identify necessary patching and communicate that to your customers before exploits occur.
If your SBOM is complete and accurate, your incident response team can more easily understand how an application or API works, enabling them to put an attack in context. It can also help them track down repositories and which people are involved in the project, shortening response time. If your SBOM contains information about services, such as backend connections to databases, queues, APIs, and directories, they can use this to calculate the impact of a breach while it is occurring. They can also seek out impacted or affected components or dependencies in areas that they haven’t begun investigating yet, enabling them to more quickly ensure that they’ve eradicated a particular attack.
After dealing with an exploit, you can use your SBOM in your post-mortem analysis to identify critical areas to address and what needs to be prioritized for the near and longer-term future.
You can upload .zst
SBOM files generated by Yocto on Linux. If you still prefer to convert your .zst
files to a zipped format, follow the steps below.
Although we try to ensure that 3rd-party information is still accurate, you should check Yocto's SBOM documentation to make sure there haven't been any changes since we last checked this.
Inherit create-spdx
class: Ensure that your Yocto configuration file inherits the create-spdx
class by adding the following line:
Build the image: Proceed with building the image using the standard Yocto build process.
Locate the SBOM files: After the build process, you'll see three different outputs. All are provided here to guide you, but you must only use the third one (in bold). These items are copied directly from Yocto documentation.
SPDX output in JSON format as in IMAGE-MACHINE.spdx.json
in tmp/deploy/images/MACHINE
in your build directory.
This top-level file also has an IMAGE-MACHINE.spdx.index.json
containing an index of SPDX files for individual recipes
The compressed archive IMAGE-MACHINE.spdx.tar.zst
, which contains the index and files for the single recipes.
Please note this step is now optional, Helm natively supports the .zst file format.
Navigate to the directory that has the .zst file.
Run this command to unzip this file, which contains your individual SBOM files. Replace filename
with your actual file name (in the bullets above from Yocto's docs, this is their IMAGE-MACHINE
).
tar --zstd -xvf filename.zst
Create a directory with the name of what you want to name your zip file.
Navigate into that directory, then create the subdirectory, packages
, in this directory.
Copy the individual SBOM files into this directory.
Run this command to zip the parent directory. In this example, we've used zst_sbom
as the file name.
Create .tar.gz
Create .zip
When creating a .zip
for Mac, use: -x '**/__MACOSX'
in the command. This does not work for creating a .tar.gz
.
Once you've converted the file to either .tar.gz
or .zip
, you can upload your SBOM to Helm.
You can easily integrate Helm into your CI/CD process to streamline and automate the process of creating product versions and uploading SBOMs to Helm. You can either use our GitHub action independently or integrate it into your existing GitHub action workflow, enabling you to maintain comprehensive and up-to-date documentation of your product's components, dependencies, and vulnerabilities with minimal effort.
Once configured, Helm will automatically add or update SBOMs for the appropriate product versions based on your event trigger when new or updated SBOMs are added to your connected GitHub repository.
Efficiency: Automates the labor-intensive process of maintaining SBOMs, freeing up your team to focus on development.
Accuracy and consistency: Ensures that every change in your codebase is reflected in your SBOMs.
Integration: Fits naturally into your existing GitHub workflows, enhancing your DevOps practices without disrupting them.
Compliance and transparency: Facilitates compliance with regulatory requirements and enhances transparency with stakeholders by providing detailed and up-to-date SBOMs.
What formats are supported? Currently, we only support CycloneDX JSON. If you need SPDX support, .
Our GitHub Action simplifies the management of SBOMs by automating the creation and uploading of product versions and their corresponding SBOM files from your GitHub repository.
To get started, you'll need Helm API access and the API credentials, as well as our Helm API URL (api-base-url).
In your GitHub repository, create a /workflows directory: .github/workflows
Create a new workflow .yml
file under .github/workflows/
if you don’t already have one. If you already have one, just incorporate our step under jobs: > steps.
Create a step to upload your SBOM in the jobs
section.
In the step, you can refer to the parameters in the table below or to the Readme
for each of the parameters you'll need to add.
Provide the product-name
and product-version-name
.
If the product and version don't exist and you want us to create it for you, set create-product-and-version-if-missing
to true
.
Pass in your client-id
and client-secret
. These are your Helm API credentials. client-id
is your email address (for the user that generated the API key) and client-secret
is that user's API key.
Provide your sbom-file-path
.
In our action, we currently set on
to workflow_dispatch
, which enables you to run it manually from the GitHub UI, but you can set it to whatever trigger you want, such as push
, pull_request
, or to run on a schedule.
Using Visual Studio Code editor?
You can install their GitHub actions plug-in, which will enable you to hover over the parameters to get the information in the table below or in the Readme file.
In the uses:
parameter, this is set to /medcrypt/action-helm-sbom-upload@your_version_branch
In the with:
parameter, specify the following information:
Wrap our action up in your own workflow file, then write a reusable workflow using on: workflow_call
to call your workflow.
Just copy and paste the step into that repo's yml file. If desired, you can create your own reusable action to store client-id
and client-secret
, anything that will be the same across your organization.
If there is an error, you can check the action to see where errors occurred.
You can stop using this or modify your action settings at any time, including changing or disconnecting repositories, changing event triggers, and more.
Top navigation bar
In the top navigation bar, you can access your profile, as well as sign out of Helm. You can also search within your vulnerabilities or your SBOMs, as detailed below.
Sidebar
You can access any main page in the sidebar, including Products (SBOMs), Vulnerabilities, Global search discovery, Help, and Admin. If you need help getting started at any time, click Help for some paths to get you started, whether you have an SBOM yet or not.
Product/version selection bar
You can , specifying the product and version that you want to associate this SBOM with. You can then switch between SBOMs by selecting the appropriate product and version you want to work with.
Filter bar
You can or your to quickly drill down to exactly the information you need.
From any page in Helm, you can s (Vuln ID) or on (SBOM) in the global search box in the top navigation bar.
Choose between our dark or light theme. To switch themes, click the sun/moon icon in the main navigation bar.
Take control of how you view and interact with data. You can adjust table column visibility, perform multi-sorts, and choose your preferred display density.
Content refresh setting: Take charge of your data updates by setting auto-refresh intervals or turning it off entirely. You can also refresh manually refresh.
Pagination: Navigate large datasets with ease using our new pagination feature, ensuring you don’t lose your place.
Customizable columns: Tailor your tables to display exactly what you need. Use the Columns link to show or hide specific columns and hover over column headers to drag and drop them into your preferred order with the … icon.
Multi-column sorting: Focus on what’s important by applying complex sorts across multiple columns. Access this feature through the Sort fields link at the top of each table.
Flexible display density: Optimize your view by selecting a compact or expanded display mode and adjusting the number of rows per page to suit your preferences.
Advanced date picker: Gain precise control over date filtering with options for absolute/relative dates, custom ranges, and multi-month views.
If you don't see your columns, that just means that they are currently hidden by default. Click the Columns link in the top of the table to show which columns are available, then toggle on/off columns to display only the ones you need. For example, if you need CVSS v2 scores, just toggle on this column.
Easily access additional information or perform actions directly from tables by clicking on cell values.
Click the path that best describes your needs to get started quickly.
Click Help > About in the sidebar to view version information.
We are always here to help get you unstuck!
Our SBOM vulnerability management product integrates data from multiple sources to ensure you have the most comprehensive and up-to-date information, including frequency of updates. By integrating these sources, our SBOM vulnerability management product ensures you are well-equipped to manage and mitigate risks effectively.
Each vulnerability in Helm shows what data source or sources it was pulled from. Links are provided to the original CVE, as well as to exploitability and threat information.
The National Vulnerability Database (NVD) is the world’s most comprehensive repository of publicly available vulnerability management data. Maintained by the National Institute of Standards and Technology (NIST), the NVD is built on the foundational work of MITRE and other leading cybersecurity entities. The database catalogs vulnerabilities identified as Common Vulnerabilities and Exposures (CVE), offering detailed information on over 100k documented CVEs, reaching back to the 1990s. The NVD not only provides vital intelligence on software flaws and misconfigurations but also includes crucial metadata such as severity scores, impact and exploitability metrics, and remediation steps, making it an indispensable resource for cybersecurity professionals.
You can easily see which vulnerabilities come from the NVD via the NVD badge indicator in the Source column.
In response to the NVD backlog, MedISAO, in collaboration with Medcrypt, has experimented with an AI copilot that leverages. This strategy aims to bridge the gap until NVD and CISA resolve their backlogs.
This system constructs CPE product and version match data to ensure rapid and continuous and continuous vulnerability enrichment.
This AI copilot pulls information from vulnerability databases like NVD, MITRE, and other external sources to stay up-to-date and continuously update vulnerability information.
AI copilot data sources and updates
This AI copilot pulls information from vulnerability databases like NVD, CISA, CVE.org, MITRE, and other external sources to stay up-to-date and continuously update vulnerability information.
CVE.org integration
We are currently adding CVE.org as a data source, and this support should be available in an upcoming release. CVE.org provides a list of publicly disclosed cybersecurity vulnerabilities, each assigned a unique CVE ID. With over 230,000 CVEs identified, defined, and catalogued, CVE.org partners with community members worldwide to grow CVE content. CVE.org has now been tasked with enriching CVEs in the NVD with CPE information to handle the backlog.
Support and integration
Supported by Helm, Medcrypt’s vulnerability management tool, this AI-driven approach uses historical data and a custom grammar parser to minimize inaccuracies and increase reliability. This AI copilot’s output mirrors the NVD data feed, allowing tools compatible with the NVD feed to seamlessly utilize enriched data.
How often is the NVD data feed updated?
This feed is updated daily and is available to MedISAO members and partners. It has thus far analyzed thousands more vulnerabilities than the NVD or CISA and integrated into Medcrypt's Helm product, enabling more enhanced vulnerability identification.
We are currently adding CVE.org as a data source and this support should be in an upcoming release.
This feature is currently being developed and is expected in an upcoming release.
You can add, track, remediate, and resolve private vulnerabilities from other sources such as penetration testing or threat modeling in Helm. These vulnerabilities are identified and reported privately by organizations and cybersecurity firms, and often include zero-day vulnerabilities and proprietary software issues.
The three primary use cases for private vulnerabilities are for organizations:
Tracking vulnerabilities in internally-developed components, whether unique to one product or that spans multiple products across the organization
Documenting security research on an issue before deciding whether to disclose it publicly
Using unmanaged data sources to identify vulnerabilities, such as change logs, commit logs, issue trackers, and social media posts, among others.
Any active exploit retrieved from this database will show either an ExploitDB badge or Metasploit badge, depending on whether it is just an active exploit or whether there is a Metasploit toolkit. Additionally, you can view the impact of each vulnerability, which shows all known exploits and threats and provides links to the original source details.
Helm provides EPSS scores for any vulnerabilities that have a CVSS v3 score, as only CVSS v3 vulnerabilities have been assessed using the EPSS methodology.
Any vulnerability that is considered a top 25 CWE threat will show a Top CWE badge in Helm. You can also view more impact information in the vulnerability details, as well as review original sources.
For the benefit of the cybersecurity community and network defenders—and to help every organization better manage vulnerabilities and keep pace with threat activity—CISA maintains the authoritative source of vulnerabilities that have been exploited in the wild. Organizations should use the KEV catalog as an input to their vulnerability management prioritization framework.
Any vulnerability that is in the CISA KEV list will show a CISA KEV badge in Helm. You can also view more impact information in the vulnerability details, as well as review original sources.
Important updates provide significant benefits, such as improved security and reliability. Optional updates might include, for example, new or updated driver software for devices that you have added to your computer.
Any vulnerability that has a recommended patch update will show an available patch indicator. You will soon be able to view patch recommendations in the vulnerability details as well.
We have partnered with Tidelift and are in the process of integrating relevant open-source component data into Helm.
Tidelift also partners with open-source maintainers to implement industry-leading secure software development practices and commit to these practices so that organization can feel confident in the security of their open source components in their ecosystems both now and in the future.
Components often belong to one or more ecosystems. These ecosystems typically have one or more sources of truth that provide additional data about the components. For example, Maven Central and the NPM repository provide information about Java and Node components respectively.
Vulnerabilities can be identified through the use of three fields: CPE, PURL, and SWID. Helm supports PURL and CPE.
Helm uses PURL in several ways:
Match components to identify vulnerabilities
Reduce false positives and false negatives
Identify outdated components across ecosystems
For any vulnerability that was matched using a package manager, it will show the corresponding package manager name in its badge. If a dependency component is matched with a package manager badge, but also has a NOT IN NVD badge this means that Helm has identified your software in the package manager, but that no vulnerabilities have been reported in the NVD.
PURL is recommended for use in identifying a container, library or framework (package), or operating system package.
Package URL (PURL) standardizes how software package metadata is represented so that packages can universally be located regardless of what vendor, project, or ecosystem the packages belongs to. A PURL is an attempt to standardize existing approaches to reliably identify and locate software packages. It is a URL string used to identify and locate a software package in a mostly universal and uniform way across programming languages, package managers, packaging conventions, tools, APIs and databases.
As mentioned above, we currently support the following PURL package managers: Cargo, NPM, NuGet, and PyPI.
A PURL is composed of 7 components:
scheme:type/namespace/name@version?qualifiers#subpath
The definition for each component is:
scheme
: this is the URL scheme with the constant value of "pkg". One of the primary reason for this single scheme is to facilitate the future official registration of the "pkg" scheme for package URLs. Required.
type
: the package "type" or package "protocol" such as maven, npm, nuget, gem, pypi, etc. Required.
namespace
: some name prefix such as a Maven groupid, a Docker image owner, a GitHub user or organization. Optional and type-specific.
name
: the name of the package. Required.
version
: the version of the package. Optional.
qualifiers
: extra qualifying data for a package such as an OS, architecture, a distro, etc. Optional and type-specific.
subpath
: extra subpath within a package, relative to the package root. Optional.
Examples:
pkg:pypi/django@1.11.1
pkg:nuget/EnterpriseLibrary.Common@6.0.1304
pkg:npm/foobar@12.3.1
NIST defines CPE as a structured naming scheme for IT systems, software, and packages. It is based on the generic syntax for Uniform Resource Identifiers (URI) and includes a formal name format, a method for checking names against a system, and a description format for binding text and tests to a name. The CPE specification was designed for operating systems, applications, and hardware devices. It is maintained by the NVD.
For any vulnerability that was matched using a CPE match, it will show a CPE badge. If a dependency component is matched with a CPE badge, that means that it has at least one vulnerability that has been reported in the NVD. A CPE is only assigned to software when a vulnerability has been reported in the NVD.
CPE follows this format: cpe:<cpe_version>:<part>:<vendor>:<product>:<version>:<update>:<edition>:<language>:<sw_edition>:<target_sw>:<target_hw>:<other>
cpe_version
: This is the version of the CPE definition. As of this writing, the latest CPE definition version is 2.3.
part
: This can be one of three values: a for Applications, h for Hardware, o for Operating systems. It is sometimes referred to as type.
vendor
: This identifies the person or organization that manufactured or created this dependency component.
product
: This is the name of the system/package/component.
version
: This is the version of the system/package/component.
update
: This shows any update or service pack information, also known as minor versions.
edition
: This describes the build of the system/package/component beyond version.
sw_edition
(2.3 only): This indicates the language of the system/package/component, such as en-us for US English.
target_sw
(2.3 only): This indicates the language of the system/package/component, such as en-us for US English.
target_hw
(2.3 only): This indicates the language of the system/package/component, such as en-us for US English.
other (2.3 only): This indicates the language of the system/package/component, such as en-us for US English.
Application:
If the URI is cpe:/a:microsoft:office:2007:sp2:professional
then the CPE string is:
cpe:2.3:a:microsoft:office:2007:sp2:-:*:professional:*:*:*
Operating system:
If the URI is
cpe:/o:microsoft:windows_7:-:sp1:x64
then the CPE string is:
cpe:2.3:o:microsoft:windows_7:-:sp1:-:*:*:*:x64:*
Hardware (not supported in an SBOM):
If the URI is cpe:/h:3com:3c13612
then the CPE string is:
cpe:2.3:h:3com:3c13612:-:*:*:*:*:*:*:*
What does a wildcard in a CPE string indicate? Anything that is a wildcard (*) means that no particular value was provided for that section, so it will encompass any applicable value in that section.
Introducing Helm by Medcrypt
Helm is a comprehensive (SBOM) and vulnerability management tool designed to give you full visibility over your software supply chain and help you manage cybersecurity risks effectively. Helm is designed especially for medical device manufacturers (MDM) to effectively identify and remediate medical device risk, which often have long lifespans and infrequent updates. It enables you to track multiple software versions across devices, ensuring compliance with FDA cybersecurity guidelines. about how Helm helps you meet FDA cybersecurity expectations.
Helm provides a host of features specifically designed to address the cybersecurity guidelines of the FDA:
Vulnerability management: Helm helps MDMs implement robust plans for addressing post-market vulnerabilities. With its proactive approach, Helm identifies and manages potential risks before they pose significant threats. In the event of a major vulnerability like Log4j or Wannacry, Helm can determine which devices could be impacted within seconds.
Software Bill of Materials (SBOM): Helm supports SBOMs from open source software (OSS), commercial software composition analysis (SCA) tools, and even manually created SBOMs. All SBOMs are organized in an intuitive UI to ensure full transparency about all components used in your medical device software, in compliance with FDA guidelines.
Industry specific frameworks: MedCrypt has developed a Cybersecurity Quality tool that provides an easy to follow template and model implementation of a Secure Product Development Framework (SPDF).
Broad software, firmware, and OS awareness: Helm provides visibility into both open source software (OSS) and commercial third party software. It supports tracking operating systems (OS), including real-time operating systems (RTOS), ensuring you have a comprehensive view of your software ecosystem.
Compliant SBOM maintenance: With Helm, you can be assured that your SBOMs meet both NTIA minimum requirements and the FDA’s cybersecurity requirements for human- and machine-readable formats.
In order to match the software in your SBOM to known software in the NVD, we normalize values (e.g, “windows10”, “windows_10”, and “win 10” will all be converted to the official value, such as Windows 10). If you see a status of Matched, that means that the dependency has an exact match in the NVD (once we have normalized values), including having an exact match on a CPE string, alias, dependency component name, or supported PURL package manager.
Helm facilitates continuous monitoring for new vulnerabilities, highlighting those with available exploits or malware kits. It also suggests Windows KB updates for resolution (specific to Windows operating systems) and provides updates from the National Vulnerability Database (NVD).
For any products you have that are running a Windows operating system, you can apply Windows KBs to each of your product versions. For any vulnerabilities associated with a Windows operating system, you'll see suggested KB updates that you can apply to resolve each vulnerability. Alternately, you can collect the KB updates to create tickets for your team to address for your next release. You can also track which KBs have been applied to your digital version of your physical test device, so you can keep these in sync.
Helm supports the ingestion of licensing information from CycloneDX and SPDX SBOMs, and enriches this information via our partnership integration with Tidelift. You can also manually enter or modify license details as needed. For each dependency component, you can view its details or manually modify it to add licensing information. All licensing information displays in the License details section of the dependency component details panel.
You can from the UI or . Removing the product will archive it, so that you can readd it, but if you delete the version, you will no longer be able to access that version's SBOM, and will need to readd it.
Get started or get unstuck quickly with our .
provides a list of publicly disclosed cybersecurity vulnerabilities, each assigned a unique CVE ID. It currently has over 230K CVEs identified, defined, and catalogued. It partners with community members worldwide to grow CVE content. CVE.org has now been tasked with enriching CVEs in the NVD with CPE information, to handle the backlog.
) is an archive of public exploits and corresponding vulnerable software, providing insights into how vulnerabilities can be exploited. ExploitDB provides information on active exploits as well as Metasploits, which are hacker toolkits that less technical users can leverage to exploit a vulnerability. Each vulnerability in Helm provides information on its exploitability and threats, and which source that information was retrieved from.
The is a data-driven effort for estimating the likelihood (probability) that a software vulnerability will be exploited in the wild. They aim to assist companies to better prioritize vulnerability remediation efforts. While other industry standards have been useful for capturing innate characteristics of a vulnerability and provide measures of severity, they are limited in their ability to assess threat. EPSS fills that gap because it uses current threat information from CVE and real-world exploit data. The EPSS model produces a probability score between 0 and 1 (0 and 100%). The higher the score, the greater the probability that a vulnerability will be exploited.
is a list of the most common, widespread, and impactful software weaknesses, which can be exploited by adversaries to steal data, take over a system, or prevent applications from working. and critical software weaknesses.
To create the list, the CWE Team leveraged data found within the National Institute of Standards and Technology (NIST) and the scores associated with each CVE Record, including a focus on CVE Records from the Cybersecurity and Infrastructure Security Agency (CISA) . A formula was applied to the data to score each weakness based on prevalence and severity. The Top 25 CWE list is maintained by the MITRE corporation.
The includes vulnerabilities known to be actively exploited in the wild.
The includes patches and updates for Microsoft products, essential for tracking and managing vulnerabilities in Microsoft software. Microsoft provides a list of important, recommended, and optional updates that can be distributed over a corporate network. You can use it as a one-stop location for finding Microsoft software updates, drivers, and hotfixes.
provides security, maintenance, and licensing information for open source packages, ensuring dependencies are secure and well-maintained. It identifies current versions, as well as highlighting outdated or unstable components and recommending stable versions that will resolve vulnerabilities.
Helm supports (PURL) that provides a flexible way to represent metadata about components and their place in various ecosystems. PURL is supported by the CycloneDX SBOM specification.
Helm natively supports several package managers natively and has extended for open-source components via our partnership with Tidelift.
You can , or , or . After you add your SBOM, Helm immediately begins to find matches from your software, which we call dependency components, matching the names you've provided for your software against known software in the National Vulnerability Database (NVD). If we find a match, you'll see a status with matching badges indicating how the match was made. If we find , you can assess each match to determine which one fits your software. Refer to for more information.
We leverage a number of , including and information you may have included in your SBOM file. We support several Package URL (PURL) package managers, including Cargo, NPM, NuGet, and PyPI. You and your team can also from your dependency component to particular known software in the NVD. These will be automatically matched going forward.
Helm returns the Common Vulnerability Scoring System (CVSS) attributed to vulnerabilities (both CVSS 2.0 and 3.0). CVSS is a public framework for rating the severity of cybersecurity software vulnerabilities, ensuring that manufacturers are consistent in their scoring methodology. These scores are calculated using a formula of Base, Temporal, and Environmental factors to assess the exploitability of a vulnerability. Scores range from 0 to 10, with 0 being least severe, while 10 is most severe. Refer to section for more information on how we use CVSS, and to and for more detailed information on CVSS, in particular.
You can to rescore the CVSS 3.x score for all vulnerabilities across a product version. You can also . As you assess and set these metrics, you'll see the rescored value and CVSS vector string updating accordingly.
Our provides a high-level overview of all of your products and vulnerabilities. Keep track of how many products and versions you have and how many have SBOMs. You can view total dependency components and vulnerabilities across products or per product, as well as zeroing in on critical vulnerabilities and those that have not yet been remediated. You can also view your top 5 impacted products and most vulnerable dependency components.
Never get caught unawares with our notification system. You can get daily, weekly, or monthly email digests.
After creating your SBOM, you can quickly impacts your software supply chain, then jump to impacted products. You can also check which of your products , such as the Windows 10 operating system, then assess which vulnerabilities impact that dependency component.
You can that include or exceed a particular value, enabling you to focus on mitigating your most critical vulnerabilities first.
Get the Medcrypt advantage with the only that ensures you meet FDA SBOM requirements. We also provide a suite of other reports including and to enable you to export exactly what you need to meet regulatory requirements.
Helm provides two ways to export vulnerabilities. You can either all of your known vulnerabilities to a CSV file, or you can export your enriched SBOM, including vulnerabilities, to a CycloneDX or SPDX JSON file.
repository
'https://helm.environment.medcrypt.co/sub-path/'
This is the Root URL of the Helm API, and is provided to you by Medcrypt.
product-name
'your product name'
This is your product name. Quotes are optional.
product-version-name
'1.0'
This is your product version. It must be enclosed in quotes to prevent truncation of numeric values.
create-product-and-version-if-missing
'false'
This indicates if a product or product version should be created if the product or version does not exist in Helm. This is set to false by default. Use this with caution.
client-id
${{ secrets.CLIENT_ID }}
This is the email address of the user that has Helm API access.
client-secret
${{ secrets.CLIENT_SECRET }}
This is the API key of the Helm API.
sbom-file-path
./api_test_sbom.json
This is the path to your SBOM file. This should be the location of the file within your current GitHub workspace, such as after checking out source code, downloading an artifact, etc.
C#
NuGet
JavaScript
NPM
Python
PyPI
Rust
Cargo
Dependency
This is what may be referred to as a component in other systems. It is the firmware, software, patches, or operating system that is installed on the physical representations of your device (e.g., Windows, OpenSSL). In this help center, it is referred to as a dependency component.
Version
This is the dependency component’s version (e.g., 10.1 for Windows).
Supplier
This is the dependency component’s supplier’s name (e.g., Microsoft for Windows).
Chip
Chips are used like tags. In the editable state, they include an x to remove them.
Depending on the use case, some chip states can only be removed by unchecking the drop-down options.
Badge
Badges are used for elements to indicate things like matching sources or that a dependency was not found in the NVD.
Panel
Panels refer to panels that slide-out from the right of the main page. You can close a panel to return to the main (or parent) page from which it was launched.
Contact us for access to our SBOM generation tool
You can use many different open-source tools to generate your SBOM in CycloneDX format. We support CycloneDX 1.4 and JSON and XML formats.
Note: We have not used all of these, so have appended an * to the ones we've used or have seen our clients use successfully.
Generate an SBOM for Java Core projects with the CycloneDX Java Core plugin.
Generate an SBOM for Java Maven projects with the CycloneDX Maven plugin.
Generate an SBOM for Java Gradle projects with th CycloneDX Gradle plugin or Gradle's own CycloneDX plugin.
Generate an SBOM for JavaScript projects with the CycloneDX JavaScript library.
Generate an SBOM for Node.js NPM projects with the CycloneDX Node module.
Generate an SBOM for Node.js NPM projects with the CycloneDX-npm tool.
Generate an SBOM for Node.js Yarn projects with the CycloneDX Node module.
Generate SBOM for CocoaPods projects with the CycloneDX Cocoapod plugin.
Generate SBOM for .NET NuGet projects with the CycloneDX .NET module.
Generate SBOM for Python projects with the GitHub Python SBOM generation tool.
Generate SBOM for Python Pip projects with the CycloneDX Python SBOM generation tool.
Generate SBOM for Python Poetry projects with the CycloneDX Python SBOM generation tool.
Generate SBOM for PHP Composer projects with the CycloneDX PHP Composer plugin.
Generate SBOM for Golang projects with gomod using the CycloneDX-gomod tool.
Generate SBOM for Elixir Mix projects using the CycloneDX SBOM generation Mix task
Generate SBOM for Erlang Rebar3 projects with the CycloneDX Rebar3 SBOM generation tool.
Microsoft's SBOM generation tool (microsoft.sbom.tool) apparently can detect NPM, NuGet, PyPI, CocoaPods, Maven, Golang, Rust Crates, RubyGems, Linux packages within containers, Gradle, Ivy, GitHub public repos, and more. It uses Component Detection to generate your SBOM.
Generate SBOM using Syft's CLI tool and Go library.
Download Microsoft's SBOM tool the tool to your local environment, then give execute permission to the downloaded executable file:
chmod +x ./sbom-tool
Download, then extract the Linux kernel source code from The Linux Kernel Archives. For example, this uses version 5.15.88:
tar xvfJ linux-5.15.88.tar.xz
Run the SBOM generation tool:
./sbom-tool generate -b ./linux-5.15.88 -bc ./linux-5.15.88 -pn kernel -pv 5.15.88 -ps linux.org -nsb https://kernel.org
Locate the generated SPDX file in ./linux-5.15.88/_manifest/spdx_2.2/ folder. It is named manifest.spdx.json. You will now need to convert the SPDX file to CycloneDX.
Generate SBOM for Ruby projects with the CycloneDX-ruby gem.
Contact us for access to our SBOM generation tool
You can now use Medcrypt's SBOM generation tool! Contact us to get access.
Contact us for access to our SBOM generation tool
You can use several different open-source tools to generate your SBOM in SPDX format. We support SPDX 2.2 and 2.3 with JSON format.
spdx-sbom-generator tool enables generation of SPDX SBOMs with current package managers. It automatically determines which package managers or build systems are actually being used by your software dependency components.
Works with Linux, Mac, and Windows.
Comes with a Dockerfile for you to maintain your own image.
has CLI (command-line interface) to generate SBOMs info, including dependency components, licenses, copyrights, and security references of your software supply chain using SPDX v2.2 spec and aligning with NTIA known minimum elements.
Refer to Generate SBOM with Yocto on Linux.
bom is a utility to create, view, and transform your Software Bills of Materials (SBOMs). It can generate SPDX packages from directories, container images, single files, and other sources. It also has a built-in license classifier that recognizes over 400 licenses in the SPDX catalog.
Supports Golang dependency analysis and full .gitignore
support when scanning git repositories.
Microsoft's SBOM generation tool (microsoft.sbom.tool) apparently can detect NPM, NuGet, PyPI, CocoaPods, Maven, Golang, Rust Crates, RubyGems, Linux packages within containers, Gradle, Ivy, GitHub public repos, and more. It uses Component Detection to generate your SBOM.
Generate your SBOM using Syft's CLI tool and Go library.
Although we try to ensure that 3rd-party information is still accurate, you should check Yocto's SBOM documentation to make sure there haven't been any changes since we last checked this.
Inherit create-spdx
class: Ensure that your Yocto configuration file inherits the create-spdx
class by adding the following line:
Build the image: Proceed with building the image using the standard Yocto build process.
Locate the SBOM files: After the build process, you'll see three different outputs. All are provided here to guide you, but you must only use the third one (in bold). These items are copied directly from Yocto documentation.
SPDX output in JSON format as in IMAGE-MACHINE.spdx.json
in tmp/deploy/images/MACHINE
in your build directory.
This top-level file also has an IMAGE-MACHINE.spdx.index.json
containing an index of SPDX files for individual recipes
The compressed archive IMAGE-MACHINE.spdx.tar.zst
, which contains the index and files for the single recipes.
Navigate to the directory that has the .zst file.
Run this command to unzip this file, which contains your individual SBOM files. Replace filename
with your actual file name (in the bullets above from Yocto's docs, this is their IMAGE-MACHINE
).
tar --zstd -xvf filename.zst
Create a directory with the name of what you want to name your zip file.
Navigate into that directory, then create the subdirectory, packages
, in this directory.
Copy the individual SBOM files into this directory.
Run this command to zip the parent directory. In this example, we've used zst_sbom
as the file name.
Create .tar.gz
Create .zip
When creating a .zip
for Mac, add: -x '**/__MACOSX'
after the command. This does not work for creating a .tar.gz
.
Once you've converted the file to either .tar.gz
or .zip
, you can upload your SBOM to Helm.
You can add components to an existing SBOM or you can create an SBOM from scratch by adding each one manually. You can also merge SBOMs to combine all dependency components for multiple systems into one.
If you're just starting your SBOM, click the Add SBOM drop-down button > Add dependency. Note that if you've already created or uploaded any SBOMs, this button will change to Manage SBOM and will have additional options, including checking file status.
In the panel that displays, specify the product and version in the first section.
In the next section, provide any information you have for your component. The only required field is the name, so if you don't have information (e.g., version), you can always add this later. However, Helm will need the version to attempt to accurately identify the matching known software.
Click Add component. Helm will analyze your component for matches in supported package managers and the NVD, so this will take a few seconds. If you've provided a PURL or CPE, Helm will analyze our package managers and other data sources to ensure that you have the correct string. If not, Helm will automatically fix this for you. If you don't see your component display, you can refresh it. If Auto-refresh is on, we will automatically be updating this, but if you're not seeing anything, turn Auto-refresh off, then click the manual Refresh button.
On the component you want to edit, click Actions ... > Manage component.
Click Edit on the section you would like to edit. Note that you cannot edit the Match details section.
If you edit the component details, then save your changes, you will be prompted to reload this component. Note that this will assess the component anew, which will lose any previous metadata, including matching, EOS/EOL, licensing, or review information that you have manually added.
If you edit the lifecycleIn the panel that displays, make any necessary changes, then save. This will automatically reload your component, which will no longer retain any review information you've already added for this dependency component. If you don't see your updated dependency component display, make sure Auto-refresh is on or click Refresh to manually update the page.
To combine SBOMs from various systems into one SBOM, you can simply upload another SBOM to Helm. This will automatically merge that SBOM into your existing one, de-duping any dependency components that are on both SBOMs.
You can add dependency components to an existing SBOM or you can create an SBOM from scratch by adding each one manually. You can also merge SBOMs to combine all dependency components for multiple systems into one.
If you're just starting your SBOM, click the Add SBOM drop-down button > Add dependency component. Note that if you've already created or uploaded any SBOMs, this button will change to Manage SBOM and will have additional options, including checking file status. This will display the Add dependency component modal.
In the panel that displays, specify the product and version in the first section. If you haven't created any products or product versions yet, click the create button in this drop-down. If you've already added products and versions, select the appropriate ones.
In the next section, provide any information you have for your dependency component. The only required field is the name, so if you don't have information (e.g., version), you can always add this later. However, Helm will need the version to attempt to accurately identify the matching known software.
Click Add dependency component. Helm will analyze your dependency component for matches in supported package managers and the NVD, so this will take a few seconds. If you've provided a PURL or CPE, Helm will analyze our package managers and other data sources to ensure that you have the correct string. If not, Helm will automatically fix this for you. If you don't see your dependency component display, try refreshing your browser.
On the dependency component you want to edit, click Actions ... > Manage dependency component.
In the panel that displays, make any necessary changes, then click Save changes. This will automatically reload your dependency component, which will no longer retain any review information you've already added for this dependency component. If you don't see your updated dependency component display, make sure Auto-refresh is on or click Refresh to manually update the page.
To combine SBOMs from various systems into one SBOM, you can simply upload another SBOM to Helm. This will automatically merge that SBOM into your existing one, de-duping any dependency components that are on both SBOMs.
Helm provides many ways to ensure you have a comprehensive and accurate view of your overall risk that is tailored to your product's particular security posture, enabling you to spend your limited time on the vulnerabilities that matter most:
Set rules to automatically update component Level of support and EOS/EOL information across all products, ensuring consistency
Reload components to automatically add missing licenses (only for components that do not have any associated licensing information), ensuring you're not missing valuable license risk that could even impact your IP.
Automatically rescore all vulnerabilities according to your product's security posture, ensuring you're focusing on the most exploitable vulnerabilities. Helm can also automatically update exploitability and fixability changes if you so choose.
If we identify inaccurate CPEs or PURLs in your SBOM, Helm will attempt to provide an enriched CPE or PURL that matches to the correct software
For components we're unable to match, you can create aliases to automatically match these to known software for future SBOMs.
Use our Helm API to automate many tasks, such as creating product versions, uploading SBOMs, returning all vulnerabilities and generating reports, as well as returning only unmatched components or only CISA KEV vulnerabilities.
Integrate our GitHub action your CI/CD process to automate product version creation and SBOM uploads
Export your FDA-ready SBOM to ensure you have everything you need for FDA submission
Data ingestion
Daily
Continual monitoring
Every 2 hours
Ready to upload your first SBOM, or not sure what an SBOM is? We’re here to help! Helm supports both CycloneDX and SPDX SBOM formats, making it easy for you to manage your software components.
Click Add SBOM > Upload SBOM.
If you are uploading a compressed SPDX SBOM file, .
Supported SBOM versions and formats
Versions:
CycloneDX: 1.4, 1.5
SPDX: 2.2, 2.3
Formats:
CycloneDX: .json, .xml
Single SPDX files: .spdx, .json, .yaml, .xml
Compressed SPDX files: .gz, .tgz, .zip, .zst, .tzst
File size: 50MB
Where did my Add SBOM button go?
If you've already uploaded an SBOM, this button changes to Manage SBOM, providing you with additional actions. You can also check your SBOM file upload status from here.
In the modal that displays, specify a product name and version.
Click the Choose file button to browse to your SBOM file.
Click Upload SBOM.
If you're not seeing your SBOM dependency components loading, check that you have Auto-refresh turned on, or manually refresh the page. Larger SBOMs will take a bit more time. If you're still not seeing your SBOM, click Manage SBOMs > View file upload status. If you see a Failed status here, click the icon next to that status for more information. If you can't resolve the issue, for help.
Once you’ve uploaded your SBOM, you will see all of the dependency components that are contained in that product display on the page. We’re already starting to match, drawing data from the NVD, including Package URLs (PURL) of Cargo, NPM, Nuget, or Pypi package manager), CPE strings, dependency component name/version/supplier combo, and alias matches.
If you need to aggregate and merge additional SBOMs to this SBOM, click Manage SBOMs > Upload SBOM. This will add dependency components from that SBOM to your existing SBOM.
If you see any warning or error icons next to your dependency component version, click the icon for more information. You should be able to just edit the version for a warning scenario, but will need to for an error scenario. You'll need to resolve this issue before we can match this dependency component and return any vulnerabilities.
Not ready to add your SBOM yet? No worries!
You can create each of your products and their respective versions, then add your SBOM at any time.
In the Select product drop-down, select the Create product option, specify the product name, then Save. You’ll now see your new product selected. You’ll now need to add a version to upload an SBOM to.
In the Select version drop-down, select the Create version option, specify the version, then Save. Click the Add SBOM drop-down button, then select the Upload SBOM option.
If you have a compressed SPDX SBOM file, follow these steps to upload it:
Prepare your files:
Create a directory named after what you want to name your zip file.
Navigate into that directory and create a subdirectory named packages
in this directory.
Copy your individual SBOM files into the packages
directory.
Compress your files:
Use the following commands to compress your files into a .tar.gz
or .zip
format:
Create .tar.gz: COPYFILE_DISABLE=1 tar -zcvf yourfilename.tar.gz yourdirectory
Create .zip: zip -r yourfilename.zip yourdirectory -x '**/.*'
Upload your file:
In the Select product drop-down, choose Create product, specify the product name, then click Save.
In the Select version drop-down, choose Create version, specify the version, and click Save.
When you have an SBOM ready, just click the Add SBOM drop-down button (Manage SBOM if you already have uploaded other SBOMs), then select Upload SBOM when you’re ready to add your SBOM file.
You may have turned off auto-refresh. You can either turn it back on from the Auto-refresh switch above the table, or you can click Refresh to manually refresh the page.
Have a large SBOM file?
If you have a larger SBOM file, this could take a little longer to upload. Get a cup of coffee or tea while we process your SBOM! We'll automatically start matching to known software in the NVD as soon as your upload is completed successfully.
Don't think your SBOM uploaded successfully?
SBOM contains component hashes
Although you can't currently view masked component hashes in Helm, rest assured that the component hash information in your SBOM has been retained and will be exported intact to any SBOM report.
Have a different SBOM format
Don't know what an SBOM is or not sure where to start
Ready to upload your first SBOM, or not sure what an SBOM is? We’re here to help! Helm supports both CycloneDX and SPDX SBOM formats, as well as manual SBOM creation, making it easy for you to manage your software dependency components.
Click Add SBOM > Upload SBOM.
Supported SBOM versions and formats
Versions:
CycloneDX: 1.4, 1.5
SPDX: 2.2, 2.3
Formats:
CycloneDX: .json, .xml
Single SPDX files: .spdx, .json, .yaml, .xml
Compressed SPDX files: .gz, .tgz, .zip, .zst, .tzst
File size: 50MB
In the modal that displays, specify a product name and version.
Click the Choose file button to browse to your SBOM file.
Click Upload SBOM.
Once you’ve uploaded your SBOM, you will see all of the dependency components that are contained in that product display on the page. We’re already starting to match, drawing data from the NVD, including Package URLs (PURL) of Cargo, NPM, Nuget, or Pypi package manager), CPE strings, dependency component name/version/supplier combo, and alias matches.
If you need to aggregate and merge additional SBOMs to this SBOM, click Manage SBOMs > Upload SBOM. This will add dependency components from that SBOM to your existing SBOM.
Where did my Add SBOM button go?
If you've already uploaded an SBOM, this button changes to Manage SBOM, providing you with additional actions. You can also check your SBOM file upload status from here.
Not ready to add your SBOM yet? No worries!
You can create each of your products and their respective versions, then add your SBOM at any time.
In the Select product drop-down, select the Create product option, specify the product name, then Save. You’ll now see your new product selected. You’ll now need to add a version to upload an SBOM to.
In the Select version drop-down, select the Create version option, specify the version, then Save. Click the Add SBOM drop-down button, then select the Upload SBOM option.
If you have a compressed SPDX SBOM file, follow these steps to upload it:
Prepare your files:
Create a directory named after what you want to name your zip file.
Navigate into that directory and create a subdirectory named packages
in this directory.
Copy your individual SBOM files into the packages
directory.
Compress your files:
Use the following commands to compress your files into a .tar.gz
or .zip
format:
Create .tar.gz: COPYFILE_DISABLE=1 tar -zcvf yourfilename.tar.gz yourdirectory
Create .zip: zip -r yourfilename.zip yourdirectory -x '**/.*'
Upload your file:
Not ready to upload your SBOM yet? No problem! You can create your products and their respective versions now and add your SBOM later.
In the Select product drop-down, choose Create product, specify the product name, then click Save.
In the Select version drop-down, choose Create version, specify the version, then click Save.
When you have an SBOM ready, just click the Add SBOM drop-down button, then select Upload SBOM.
You may have turned off auto-refresh. You can either turn it back on from the Auto-refresh switch above the table, or you can click Refresh to manually refresh the page.
Have a large SBOM file?
If you have a larger SBOM file, this could take a little longer to upload. Get a cup of coffee or tea while we process your SBOM! We'll automatically start matching to known software in the NVD as soon as your upload is completed successfully.
Don't think your SBOM uploaded successfully?
Our expert Services team of former FDA reviewers and analysts can provide expert assessment, guidance, and design of anything from building cybersecurity and continuous improvement into your product development lifecycle to your Public Key Infrastructure cryptography to FDA letters and most anything in between. to see how we can help!
Helm provides many ways to ensure you have a comprehensive and accurate view of your overall risk that is tailored to your product's particular security posture, enabling you to spend your limited time on the vulnerabilities that matter most:
to automatically update component Level of support and EOS/EOL information across all products, ensuring consistency and regulatory compliance.
to automatically add missing licenses (only for components that do not have any associated licensing information), ensuring you're not missing valuable license risk that could even impact your IP.
Automatically according to your product's security posture, ensuring you're focusing on the most exploitable vulnerabilities. Helm can also automatically update exploitability and fixability changes if you so choose.
If we identify inaccurate CPEs or PURLs in your SBOM, Helm will attempt to provide an that matches to the correct software
For components we're unable to match, you can to automatically match these to known software for future SBOMs.
to automate many tasks, such as creating product versions, uploading SBOMs, returning all vulnerabilities and generating reports, as well as returning only unmatched components or only CISA KEV vulnerabilities.
your CI/CD process to automate product version creation and SBOM uploads
to ensure you have everything you need for FDA submission.
Before you've added your first SBOM for a product version, you'll see an Add SBOM drop-down button. If you've already added an SBOM, this will change to Manage SBOMs and will have additional options, including checking SBOM file upload status.
To access these options, click the Add SBOM or Manage SBOMs drop-down button:
View upload status: This displays the SBOMs that have been uploaded for your products and versions. You can view the file name, file ID, when it was uploaded and by whom, the number of entries processed, and the status. If a file has uploaded successfully, you can see the number of dependency components processed from the SBOM. If a file has not uploaded successfully, you will see a red x icon next to the Failed to upload status. For these files, you will see an info icon to get more information on resolving the error.
After or , you can manage your SBOM for each product and version in your software supply chain. Once you've uploaded your SBOM, Helm will match your software against the National Vulnerability Database (NVD), supported Package URLs (PURL) package managers, and CPE strings.
To view your SBOM, ensure you've selected a product and version so that you can .
In the Components table, you can quickly see where you need to complete matching, as well as understand exploitability risk and end-of-support/end-of-life risk, enabling you to prioritize upgrades. You can easily see what needs to be reviewed and catch up on reviews your team has made, as well as understand and manage license risk.
Click to drill-down for more information
Most things in Helm tables are clickable, enabling you to quickly drill down for more information, such as component details, match suggestions, fixing a version, contact us, reviewing a dependency component, and more.
Click the next step for each dependency component
For each dependency component, if there is a clear next step you need to take, that will be in the Actions column. If not, you'll just see the actions overflow ... button.
To view your SBOM, ensure you've selected a product and version so that you can see that version's dependency components.
Name: This is what may be referred to as a component in other systems. It is the firmware, software, framework, library, file, or operating system that is installed on the physical representations of your device (e.g., Windows, OpenSSL).
Version: This is the version for this dependency component name (e.g., 10.1 for Windows).
Supplier: This is the organization that supplied the dependency component. The supplier may often be the manufacturer, but may also be a distributor or repackager (e.g., Microsoft for Windows).
Level of support: Indicates whether the component is supported. Can be date or text value.
EOS/EOL: Indicates whether the component has a known end-of-support or end-of-life date or other information. Like Level of support, this can also be a date or text value. If there is a date, this indicates that the component will no longer be supported or maintained after this time, thus it will potentially become more vulnerable and less reliable over time. You should either upgrade to a supported version or replace it with an alternate component to reduce risk.
Review status: Indicates whether the dependency component has been reviewed or needs to be reviewed.
Licenses: Displays the dependency component's licenses.
Manage component: This will display all details for this dependency component in view mode. This will also show how Helm matched the dependency component, as well as any review information from your team. If you edit the dependency component, you'll be prompted to confirm this change. This is because Helm will reload the dependency component and rematch it, which will discard any review information you may have added.
Add review note: Add a review note, then change the review status to Reviewed. You'll see this updated status in the Review status column, along with a note icon.
Review history: This will show any analysis notes or review status changes your team has made. You can also add a review note from here.
Reload component: If a dependency component is in an error state that is not caused by an inaccurate or unsupported version, you can reload it, but you should rarely, if ever, need to do this. This is a backup action in case you run into an error state. Helm will discard any previous information for the dependency component, and attempt to match it to known software.
Delete component: If you have appropriate permissions, you can remove a particular dependency component. To avoid accidentally removing something that you wanted to keep, you’ll then be prompted to confirm this action.
Click the Filters drop-down on the Components page to filter quickly to what you need.
Component details: Search by component name or component review status
Match details: Search by component match status
License details: Search by SPDX license ID or custom license name
Lifecycle details: Search for components with upcoming or expired end-of-support/end-of-life (EOS/EOL) dates, or search for components that will expire within a particular date range.
Follow these steps to ensure you've completed your dependency component matching and identified all possible vulnerabilities across your SBOM.
Match status
The match status of each of your dependency components is indicated in the Match status column of the dependency components table. You can click directly on this status badge itself to begin the resolution process, or you can select an action from the Actions column.
To ensure that you complete matching, filter on Select match first. Helm has provided strong match suggestions for these, so you should be able to match these relatively quickly. Click Select match on any of these statuses to start matching.
For users with Admin role, we highly recommend that you create an alias for each dependency component you match. This will ensure that these are automatically matched for future SBOMs. If you're not sure whether to create an alias during the match, you (or your Admin) can always create one later.
If you want to complete matching, filter on Not found next. This indicates that Helm was unable to find an exact match in the NVD. Click the Not found badge to view the match suggestions Helm has identified. If you don't see the correct match, make sure you create an alias so that this will be automatically matched for future SBOMs.
Match source
Lifecycle details
Be confident that you're using actively maintained and supported components when building a new product or updating an existing one. Filter quickly on the support status of your components, as well as the timeframe for components that are nearing their end-of-support or end-of-life dates, enabling you to prioritize updates effectively, thereby ensuring the stability and security of your device throughout its lifecycle.
License details
Filter your dependency components by license, including those with specific licenses, no license, or unknown license status. This filtering capability helps quickly identify and mitigate license-related risks, such as copyleft licenses or unknown license statuses that may impact IP.
You can filter on GPL licenses and other restrictive licenses to quickly evaluate legal risk, enabling you to quickly prioritize updating or changing components that have licensing that could impact your IP and legal compliance. You can also filter on which components have at least one license, those that don't currently have any license information, as well as those that are specifically set to No license or NONE or Unknown or NOASSERTION (the values in caps are SPDX values), ensuring you understand your legal risk for every component in your product.
If you have an SBOM that is already in a CSV file, you have a few options that you can use to convert it to a CycloneDX file, including using an open-source tool, writing a custom script, or adding each dependency manually. If you run into issues or aren’t comfortable doing this, .
The one that we’ve used is . You will have to install and run this locally, so if this is outside your realm of expertise, so we can get your SBOM converted.
Install CycloneDX-CLI.
Add these metadata columns shown in this into your CSV file: Supplier, Type, Name, Version. You may already have these columns. They are required in order for Helm to be able to successfully identify matches for your dependency components.
Add the metadata field to your CSV file. See the for more information.
Run the tool, using the “--output-format json” option. This will output the file as a JSON file format. For example, from your directory (ours is ./bin/linux-x64/cyclonedx), you would enter the following in the command line (in our example, we used source_sbom_cyclonedx.csv as our source CSV file, then destination_sbom_cyclonedx.json as the output JSON file that we were creating from the CSV file): convert --input-file source_sbom_cyclonedx.csv -–output-format json > destination_sbom_cyclonedx.json
You can write a custom script in Python or your favorite language to convert the file from CSV to CycloneDX JSON.
You can view details about a dependency components, including its licenses, how it was matched, and any review information. In the Software Bill of Materials (Products) page, select Actions ... > Manage component to modify dependency component details.
Product name: This is your product name.
Product version: This is your product version.
Name: This is the firmware, software, framework, library, file, or operating system that is installed on the physical representations of your device (e.g., Windows, OpenSSL).
Version: This is the version for this dependency component name (e.g., 10.1 for Windows).
Supplier: This is the organization that supplied the dependency component. The supplier may often be the manufacturer, but may also be a distributor or repackager (e.g., Microsoft for Windows).
Original CPE: This is the original PURL assigned to this component in your SBOM file. Example format: (e.g., cpe:2.3:part:vendor:product:version:update:edition:language:sw_edition:target_sw:target_hw:other)
Enriched CPE: This is the PURL that was added or enriched from the respective package manager during the component matching process. This will only display if populated. You cannot edit this.
Original PURL: This is the original CPE assigned to this component in your SBOM file. Example format: (e.g., scheme:type/namespace/name@version?qualifiers#subpath)
Enriched PURL: This is the CPE that was added or enriched by our AI copilot during the component matching process. This will only display if populated. You cannot edit this.
This is how Helm matched or attempted to match your dependency component.
Match status: This shows the current , as well as what were matched on.
Vuln source: This is the source where we located this dependency component. This is currently always NVD. If it was not in the NVD, it will show a badge.
Matched by:
System: Helm automatically matched this dependency component based on an exact match in the NVD, which could be from a CPE, PURL package manager, name/version/supplier, or alias.
User name: This user manually matched this dependency component to a suggested match or created a new alias to link it to known software.
This shows the last review added for this dependency component. You can also add your own review or view all review information.
Review status: Shows whether the dependency component has been reviewed or needs to be reviewed. You can click this badge to set a new status.
Last reviewed: Shows who last reviewed this dependency component and when.
Last review: This is the last review note made on this dependency component to inform the team or progress, final status, or critical risk.
On the component you want to edit, click Actions ... > Manage component.
Click Edit on the section you would like to edit. Note that you cannot edit the Match details section.
If you edit fields in the Component details section, then save your changes, you will be prompted to reload this component. Note that this will assess the component anew, which will lose any previous metadata, including matching, EOS/EOL, licensing, or review information that you have manually added.
f you don't see your updated dependency component display, make sure Auto-refresh is on or click Refresh to manually update the page.
Click Actions > Remove (Delete) component. You will be prompted to confirm, as you cannot recover deleted components. This will only delete this component from this product version.
To keep track of various versions of your SBOM and to ensure that your SBOM is accurate for each product release to meet FDA requirements and protect your customers and their patients, you should create a new version of your SBOM whenever your team:
Updates the device or application
Adds or removes a dependency component or changes a dependency component version
Adds one or more Windows KBs to a device version
Adds a Windows KB to a vulnerability
Upgrades the version of a dependency componen
This will help ensure your readiness for your pre-market FDA submission, while ensuring that customers post-market understand whether they are affected by vulnerabilities associated with a particular version of your product. Refer to for more information.
To ensure that changes you make to a component in one product version is persisted throughout your product portfolio, users with privileges can create specific rules for each component directly in the Rules manager, or can automatically create rules when updating the component details.
For each rule, you can set conditions around the supplier name, component name, and component version. You can then set effects that will be applied when all of the conditions are true to persist the specified Level of support and EOS/EOL (End-of-Support and End-of-Life) information across all of your products.
If you haven't created any rules yet, you'll see a Create rule button. Click this to switch to the Edit rules mode to begin creating your rule. If you need to add more rules later, you'll need to be in this edit mode.
If you already have rules, click the Add another rule button to create a new rule at the top of the list. You can rearrange the rule's priority by dragging it lower in the list.
For each condition, make sure that the Enabled switch is turned on (is blue).
Set each condition by selecting the corresponding field and comparator, then specifying the expected matching value. As you add conditions, the rule name will be automatically updated in the following format, provided that particular condition is set: [Supplier name]/[Component name]/[Version]
. For version ranges, the name will reflect the conditions specified in the following format: [Supplier name]/[Component name] [less than 10.1],
such as Google Chrome less than 10.1. You cannot currently edit rule names. If this is important to you, !
Click Add version condition to add additional version conditions. Each condition uses the AND
logic, so everything must be true in order to apply the effects. You can set the version as either an exact match or set conditions for a version range. For an exact match, set the version as is equal to
. For version ranges, you can set the following conditions: is less than
and/or is greater than
. You can specify either a version exact match or up to two version conditions for a version range.
Set each effect below the conditions by selecting the corresponding field, comparator, then specifying the expected matching value. For Level of support and EOS/EOL (end-of-support and end-of-life) information, you can specify either is equal to date
, then select a specific date, or set it as is equal to text
, then provide the respective text value.
When you're finished adding rules, updating rules, and/or changing rule priority, click Save & apply. Note that unsaved changes will only persist during your Helm session, so make sure to save and apply anything you don't want to be discarded.
After you confirm these changes, Helm will begin applying them to your existing SBOMs, and will apply them to any future SBOMs.
Click the Edit rules toggle button to edit rules.
Make any modifications to conditions and/or effects.
To change rule priority, click the drag icon next to the rule name to drag it to a different position in the list. Rule priority is determined by the order of the rules in the Rules manager. If multiple rules impact a component, the one highest in the list takes precedence.
To delete a rule, click the Delete action. You will be prompted to confirm, but this deletion will not take effect before you click Save & apply. Deleted rules will be unapplied from existing SBOMs, and will no longer be applied to future SBOMs. You cannot recover a deleted rule. Note that if you decide to delete the only rule you have, any unsaved changes that you have made will be automatically applied and the rule will be deleted. In that case, you'll now see a blank rule, so that you can add more rules in the future.
When you're finished making changes, click Save & apply. Note that unsaved changes will only persist during your Helm session, so make sure to save and apply anything you don't want to be discarded.
After you confirm these changes, Helm will begin applying them to your existing SBOMs, and will apply them to any future SBOMs.
Once compressed, go to Helm and upload your .tar.gz
or .zip
compressed file following the above.
Once you’ve uploaded your SBOM, Helm will automatically start matching your components with known software in the NVD (National Vulnerability Database). This leverages several , such as Package URLs (PURLs), CPE strings, dependency component names, and alias matches. Refer to Match statutes and Resolve match statuses for more information.
Check out for more information on sources we consult, and to understand how we determine match statuses and suggest possible matches.
If Helm can’t find an exact match in the NVD, refer to for further instructions.
If you're still not seeing your SBOM, check the status of your SBOM file upload via the Manage SBOMs drop-down button > View file upload status. In the status modal, click the icon next to the Failed status to get more information. If you need help, .
If you have another format (e.g., Word, CSV), so we can convert it for you. We’re in the process of adding more complete support for all of the data in your CycloneDX format of SBOM, as well as adding support for the SPDX SBOM format.
Don’t worry – we’ve got you covered! We can of anything from building cybersecurity and continuous improvement into your product development lifecycle to your Public Key Infrastructure cryptography to FDA letters and most anything in between.
Take our to start down your path to a smooth FDA submission process!
If you are uploading a compressed SPDX SBOM file, .
If you're not seeing your SBOM dependency components loading, check that you have Auto-refresh turned on, or click Refresh to manually refresh the page. Larger SBOMs will take a bit more time. If you're still not seeing your SBOM, click Manage SBOMs > View file upload status. If you see a Failed status here, click the error icon next to that status for more information. If you can't resolve the issue, for help.
If you see any warning or error icon next to your dependency component version, click the icon for more information. You should be able to just edit the version for a warning scenario, but will need to for an error scenario, so that we can add support for that version format. You'll need to resolve this issue before we can match this dependency component and return any vulnerabilities.
Once compressed, go to Helm and upload your .tar.gz
or .zip
compressed file following the above.
Once you’ve uploaded your SBOM, Helm will automatically start matching your components with known software in the NVD (National Vulnerability Database). This leverages several , such as Package URLs (PURLs), CPE strings, dependency component names, and alias matches.
Check out for more information on sources we consult, and to understand how we determine match statuses and suggest possible matches.
If Helm can’t find an exact match in the NVD, refer to for further instructions.
If you're still not seeing your SBOM, check the status of your SBOM file upload via the Manage SBOMs drop-down button > View file upload status. In the status modal, click the icon next to the Failed status to get more information. If you need help, .
If you have another format (e.g., Word, CSV), so we can convert it for you. We’re in the process of adding more complete support for all of the data in your CycloneDX format of SBOM, as well as adding support for the SPDX SBOM format.
Don’t worry – we’ve got you covered! We can of anything from building cybersecurity and continuous improvement into your product development lifecycle to your Public Key Infrastructure cryptography to FDA letters and most anything in between.
We've worked with a lot of open-source tools ourselves and have also provided any other tools we know of for generating a or a .
Take our to start down your path to a smooth FDA submission process!
Match status: Shows component's , along with the corresponding used to perform the match.
For any dependency components that have a next step you need to perform to complete matching and vulnerability identification, you'll see that primary action button in the Actions column, such as fixing a version or selecting a unique match. All other actions are in the ... button to the right of this action. If you don't see a particular option, that means that you have for SBOMs.
Helm uses many to precisely identify your dependency components and ensure that you have a comprehensive view of your vulnerabilities. Each Matched status or Select match status displays the sources where the match was found.
Get started
Don't have an SBOM yet?
Getting around Helm
Match to known software
Automate & integrate
Auto-enrich missing licenses for comprehensive license risk view
Manage SBOMs
Prioritize vulnerabilities
Rescore vulnerabilities
Resolve Windows vulnerabilities
Remediate vulnerabilities
Check out the latest updates!
API
Administration
From any page in Helm, you can search on dependency components (SBOM) across all products using the global search box in the top navigation bar. For example, you may want to find all products that are running the Windows 10 operating system.
In the global search box on any page, select SBOM from the search drop-down. Alternately, you can go directly to the Discover page to run searches. Either way, your last search results will display on this page, if you need to return to them.
Type in a dependency component name, such as Windows 10, then press Enter to run the search.
From Actions > …, you can then jump to either viewing Products (SBOM) or Vulnerabilities.
If you jump to this product, you’ll be able to see which product and product versions contain that dependency component and version. From the Actions > … button, you can choose to view more details, add a review note, view review history, and more.
If you jump to vulnerabilities for this dependency component, you can view the applicable vulnerabilities. From the Actions > … button, you can manage each vulnerability, including adding review notes and setting the Resolution. If you change this resolution, it will update the Review status.
You may see the following match sources: NVD, Alias, Name, CPE, User, or one of our supported PURL package managers: PyPI, NPM, NuGet, and Cargo. If you’re in the Dependency details panel, you’ll see any of our supported package managers, NVD or NOT IN NVD, Alias, User, Exact, Name, CPE, and System. You can use these to gauge the strength of a match and your corresponding confidence in the match by the source.
Alias: This displays if a user on your account created an alias for this software component/version/supplier combo. You can hover over the token for more information on whether the alias was created by a user in this session (Matched by user) or automatically matched by our system (Matched by system).
Cargo: This was exactly matched to a component in the Cargo package manager from a Package URL (PURL) uploaded in your SBOM file.
CPE: This was exactly matched to a component from a CPE string uploaded in your SBOM file. CPE is considered the strongest match.
Name: This dependency name/version/supplier combo exactly matches an existing dependency name/version/supplier combo in our system.
NuGet: This was exactly matched to a dependency in the NuGet package manager from a Package URL (PURL) uploaded in your SBOM file.
NPM: This was exactly matched to a dependency in the NPM package manager from a Package URL (PURL) uploaded in your SBOM file.
NVD: This dependency/version/supplier combo had an exact match in the National Vulnerability Database (NVD).
PyPI: This was exactly matched to a dependency in the PyPI package manager from a Package URL (PURL) uploaded in your SBOM file.
User: This was exactly matched by a user on this account to a possible match suggestion our system provided, or the user created an alias in this session. If the user created an alias in a previous session, that will be considered an automatic match, and will have a System token.
System: This was exactly matched to an alias that was created by you or the Helm team.
Your dashboard provides an overview of your overall security posture. You can get to your dashboard by clicking the home icon on the sidebar.
This represents your total SBOMs and vulnerabilities across all time. The date range filter does not apply to these widgets.
Total products all time
This shows the total number of products that you have managed since you began using Helm.
In Helm, you can manage a different SBOM for each product and version, to ensure that you understand and can effectively manage and communicate risk mitigation efforts across your total software supply chain.
Product versions with SBOMs
You can either upload an SBOM .json file, then specify the product and version all in the same step, or you can add your products and versions, then upload an SBOM for each product/version combo. This percentage shows you the number of product versions that you or someone on your team has uploaded SBOMs for.
These widgets represent your vulnerabilities for a selected date range. You can view this over all versions within a product or for a particular product version.
Total vulnerabilities
This shows the number of vulnerabilities that you have for the selected criteria.
Critical severity vulnerabilities
This shows the number of critical-level (CVSS score of 9-10) vulnerabilities that you have for the selected criteria.
Unremediated vulnerabilities
This shows the number of unremediated vulnerabilities that you have for the selected criteria.
Each donut chart represents the total number of vulnerabilities that have been detected in each of your products across all of their respective SBOM dependency components, within the selected date range, products, and versions, as well as the percentage of vulnerabilities in each level of severity.
You can view these widgets across all of your products and versions, or filter down to view particular products and versions.
Get more details:
Hover over the donut chart to display a View details button. Click that button to drill down into details for that product.
If you haven’t added a product yet, you’ll see an Add new product button in this section.
Click this to specify the product name, then click Save.
To view your new product, click the Products option in the sidebar. Your new product will be selected in the products drop-down.
You’ll now need to add a version for this product. In the version drop-down, select Create version.
Specify the version, then click Save. Your new product version will be selected. You’re now ready to upload your SBOM.
Total vulns (in donut chart)
This is the total number of vulnerabilities across this product within the selected date range.
Critical severity
This is the number of critical severity vulnerabilities that have been detected in each of your products across all of their respective SBOM dependency components, within the selected date range, products, and versions.
Critical items have CVSS scores on a dark red background.
High severity
This is the number of high severity vulnerabilities that have been detected in each of your products across all of their respective SBOM dependency components, within the selected date range, products, and versions.
High items have CVSS scores on a light red background.
Medium severity
This is the number of medium severity vulnerabilities that have been detected in each of your products across all of their respective SBOM dependency components, within the selected date range, products, and versions.
Medium items have CVSS scores on a light orange background.
Low severity
This is the number of low severity vulnerabilities that have been detected in each of your products across all of their respective SBOM dependency components, within the selected date range, products, and versions.
Low items have CVSS scores on a light green background.
This shows your top 5 most vulnerable dependency components within the selected date range, products and versions.
Dependency name
This shows the name of the dependency component that is contained within your selected products and versions.
Version
This shows the version for the dependency component that is contained within your selected products and versions.
Supplier
This shows the supplier for the dependency component that is contained within your selected products and versions.
Total vulnerabilities
This shows the total number of vulnerabilities that you have not yet remediated for this dependency component.
Products impacted
This shows the number of your products that are impacted by this dependency component, meaning that the corresponding SBOM contains this dependency component. If you are viewing one product, this will show 1/1, but if you are viewing all of your products, this will show 1/n, with n being your current number of products.
Products impacted %
This shows the number of your products impacted by this dependency component across your selected products. If you are viewing 1 product, this will show 100%, but if you are viewing all of your products, this will show the percentage of your products that are impacted.
Actions
You can click the View button to drill down to view how many times a dependency component is used across your selected products and versions. From the search results, click Jump to product or Jump to vulnerabilities.
If you jump to this product, you’ll be able to see which product and product versions contain that dependency component and version. From the Actions > … button, you can choose to view more details, add a review note, view review history, and more.
If you jump to vulnerabilities for this dependency component, you can view the applicable vulnerabilities. From the Actions > … button, you can manage each vulnerability, including adding review notes and setting the Resolution. If you change this resolution, it will update the Product impact status.
The match status of each of your components is indicated in the Match status column of the components table. For most statuses, you can click directly on this status badge itself to begin the resolution process, or you can select an action from the Actions column. We use a variety of metadata and match sources to identify a match, including the NVD, CPE, alias, name, and supported package managers (Cargo, NPM, NuGet, PyPI).
This status means the component has an exact match with software listed in the National Vulnerability Database (NVD). This means there was an exact match for your dependency component in the NVD, and that it has associated vulnerabilities, so you can start prioritizing and remediating these risks.
If the component has a correct CPE or PURL identifier but incorrect supplier information, our system will automatically correct it and create a match. If we're able to identify the PURL that exists for your component, but is missing in your SBOM, we'll automatically add that for you to ensure a unique match.
This status shows that a component is matched to a package manager but is not found in the NVD, thus it will not show any vulnerabilities. Note that sometimes package managers might use different names or PURLs than the NVD, so you should check the NVD to make sure your component isn’t listed under a different name. Refer to Resolve match statuses for more information.
If you see a component that has a Matched status with an NVD token and CPE token, that means that there this component has at least one vulnerability that has been reported in the NVD. A CPE is only assigned to software when a vulnerability has been reported in the NVD. Refer to Resolve match statuses for more information.
This status indicates that Helm has found multiple potential matches using identifiers like CPE, PURL, alias, or name. You can click the badge or the primary action link to review and assess the suggested matches. Refer to Resolve match statuses for more information.
This indicates that the component does that match any known software in the NVD or supported package managers will have this status. Refer to Resolve match statuses for more information.
You can use aliases to match any dependency components in your SBOM that have multiple matches or are unmatched to known software components in the NVD. Administrators can create new aliases.
Scanning: This is an interim status that indicates that Helm is processing this match. If you have been waiting and haven't seen this update, try refreshing the page.
Fix version: The software version provided for this dependency component does not match the expected version. This issue should be rare. If you see this, you will also see a warning icon next to the version. Refer to Resolve match statuses for more information on resolving this issue.
Contact us: Helm was unable to parse this version. We have logged this issue and will work to resolve it quickly. Refer to Resolve match statuses for more information on resolving this issue.
Error: Some other error occurred while trying to parse this dependency component. Contact us for help in resolving this issue.
Helm checks CPE and PURL IDs to determine if a dependency component is unique. If a duplicate is detected, it will automatically be removed to streamline your SBOM management.
You can archive and unarchive products, as well as remove product versions.
In the Software Bill of Materials product drop-down list , hover over the product you want to archive, then click the trash icon. This will archive the product.
To unarchive a product, simply add the product again with the exact same name. This will automatically unarchive the product, its associated versions, and all dependency components. If you don't want to unarchive the product, add the product with a slightly different name.
In the Software Bill of Materials version drop-down list, hover over the version you want to delete, then click the trash icon. This will display a confirmation dialog. If you need to re-add the version and SBOM, just create the same version again.
You can assess the likelihood that this is the correct match by viewing the trend of reported vulnerabilities over time and the known versions for this match suggestion. Multiple matches that have a trend of reported vulnerabilities and that match your dependency’s versions (or at least version formats) are considered stronger matches.
Match details modal sections
Reported vulnerabilities over time
Multiple matches that have a trend of reported vulnerabilities indicate that this is a frequently-used dependency. If you don’t see many reported vulnerabilities over time, it is likely that this is not the correct match. Check that the dependency’s versions (or at least version formats) are considered strong matches.
Known versions
These are the known versions for this suggested match that are coming from the CVE vulnerability ID. Check that your dependency’s versions (or at least version formats) match these.
You can determine the likelihood of this potential match by checking the sample versions for the expected format, checking how many and which sources were used to identify the suggested match, and the type of match. A match based on CPE is considered the strongest match.
If the match was suggested via multiple sources, such as Alias and a PURL package manager, that is an even stronger match. Alias and User matches indicate that a user manually assessed this dependency to find the right match. Name is considered the weakest match.
Match suggestions modal
Supplier
This is the organization that supplied the dependency component. The supplier may often be the manufacturer, but may also be a distributor or repackager (e.g., Microsoft for Windows).
Details icon
Click this icon to view more details about this possible match, including reported vulnerabilities over time, as well as known versions from the CVE. If these versions match those of your dependency and there are vulnerabilities that have been reported, this is likely the correct match.
Product name
This is what may be referred to as a component in other systems. It is the firmware, software, patches, or operating system that is installed on the physical representations of your device (e.g., Windows, OpenSSL).
Matched on
This shows the strength of the match. Refer to for more information.
Type
This shows the reliability of the match.
Exact match: This has an exact match in the NVD, which could include a PURL string (Cargo, NPM, Nuget, or Pypi package manager), CPE string, or name match.
Alias match: This dependency matches an existing alias.
Possible match: This dependency has a match in one or more sources. Check the Matched on column, then hover over those matching tokens for more information.
You can use aliases to match any dependency components in your SBOM that have multiple matches or are unmatched to known software components in the NVD. These can be created by your Administrators.
To view aliases, click the Aliases item in the sidebar. If you have appropriate , you will see an Aliases table with the original name of the dependency component in your SBOM, the linked (aliased) name of the known software in the NVD.
In the Software Bill of Materials (Products) page, you will see a Matched status with an ALIAS token in the Match status column for all aliased matches.
When resolving, , and other , users with an can create an alias for a dependency component in your SBOM to a particular software that exists in the NVD. If you're not an Administrator, but have identified a likely match, contact one of your administrators to have the alias created for you.
There are two ways you can create aliases: directly from the unmatched dependency component or from the Aliases page (detailed above).
To create an alias directly from the dependency component:
Navigate to the Software Bill of Materials (Products) page, then click Resolve in the Actions column. This will display the Resolution options modal.
Click the Create alias button to display the Create alias modal.
The scope is defaulted to Organization, which means that this alias you create for this dependency component will be linked in the future any time anyone else in your company uploads an SBOM that contains this dependency component. There isn’t another option for this currently.
Enter the Dependency name that you’re creating the alias link for, then click Next. You’ll then be prompted to enter the dependency name.
Enter all or part of your dependency name. Select the supplier/dependency combo that best matches your dependency, then click Create. You’ll be prompted to confirm this alias.
When you’re ready to confirm the alias, click Confirm. This will change any Not found or Select match statuses to Matched. Going forward, whenever you or anyone else in your organization uploads this dependency component in an SBOM, this alias will be applied.
IMPORTANT: Aliases are not applied retroactively to SBOM dependency components that have already been uploaded, only to those created or uploaded in the future.
If you find that your team has added an incorrect alias, you can easily remove it if you are an Administrator.
Click the row that you want to remove to highlight it, then click Remove. You'll be prompted to confirm the removal.
Administrator: Users with an Administrator role can view and edit all products, as well as create aliases and use existing aliases to link software in their SBOMs to known software in the NVD.
User with edit permissions for a product: Users who have edit permissions for a particular product, but are not Administrators, will be able to view and use existing aliases for that product to link software in their SBOM to known software in the NVD, but will not be able to create aliases unless they have an Administrator role.
User with read-only permissions for a product: These users will be able to view aliases for that product, but will not be able to use these aliases to link software.
You can use this export function, or you can take advantage of our enhanced , as well as the only that ensures you meet FDA SBOM requirements!
There are two ways to export your SBOM:
Click the item in the sidebar, then click the corresponding export button on the report card.
Click the Manage SBOM drop-down button, then click Export SBOM.
When downloading (exporting) your SBOM to share with others or for auditing purposes, you can either export your original SBOM or your enhanced SBOM (with matches our system made automatically or that your team matched). You can also choose to include vulnerabilities and any associated CPE or PURL information in your export. SBOMs are currently exported in CycloneDX 1.4 format. If you are interested in exporting in another format, .
Export as file name: This is the filename that will be generated with your exported data.
Export details: You can choose to export your original SBOM or your enriched SBOM. Your enriched SBOM can include vulnerabilities, enriched CPE and PURL information, and more.
Export as file type: For your original SBOM, you can export in CycloneDX JSON, SPDX JSON or XML, and CSV. For your enriched SBOM, you can export in CycloneDX or SPDX JSON.
Include vulnerabilities: Check this box to export all of the vulnerabilities associated with this SBOM. This will include the source name (currently always the NVD), a link to the vulnerability, both its v2 and v3 CVSS scores and vector strings, when the vulnerability was first detected, when it was updated, and more.
Include enriched CPEs and PURLs from matching: Your original SBOM export will include all CPE/PURL information, but you can check this box to export all enriched CPE/PURL data, including those identified by Helm or during the matching and analysis process or that you manually matched or added.
SBOM contains component hashes
If your SBOM contained any component hashes when uploaded, that information was retained and will be exported intact to any SBOM report.
Helm supports the ingestion of licensing information from CycloneDX and SPDX SBOMs, and enriches this information via our partnership integration with Tidelift. You can also manually enter or modify license details as needed.
For each dependency component, you can view its details or manually modify it to add licensing information. All licensing information displays in the License details section of the dependency component details panel.
For active SPDX licenses, these will be automatically linked to the corresponding license URL from the .
If you have deprecated SPDX licenses in your SBOM, Helm will retain the URL.
Helm also handles .
Helm populates license information from the following sections in a CycloneDX SBOM:
components > licenses
: The primary source for license information. Each dependency component must include either a license ID, name, or SPDX expression.
components > pedigree > notes
: This will be populated into the License comments field. Because this notes
field applies to all components in a CycloneDX SBOM, the information in this field will be applied to all licenses for a particular dependency component.
Helm does not support license information populated from other sections of a CycloneDX SBOM. Any such information will be retained in exports but ignored in the UI.
A SPDX SBOM contains packages, each of which could be a file or set of files, grouped by the SBOM author. These files could be one or more files of any type including but not limited to source, documents, binaries, etc. Helm processes each package as a dependency component. A SPDX SBOM can contain licensing information at the package, file, or even code snippet level. For every package that contains licensing, Helm populates that license information into the dependency component's details in the Licenses section.
Helm processes each package as a dependency component and populates license information from the following fields:
PackageLicenseConcluded
: The primary field for populating the license name. If missing, Helm will use the PackageLicenseDeclared
field.
ExtractedLicensingInfo
: If present, this section provides license names and text for custom or non-SPDX licenses. When a custom license is added, you can manually enter the license name, but the URL will not display.
SPDX spec version
If your SPDX version or license list version is different, SBOM section names or field names may differ, you should check your particular SPDX spec version.
Helm has partnered with Tidelift to enrich license information for open-source components that lack licensing details:
Component license is set to No license (NONE in SPDX): If a dependency component in your SBOM lacks a license but has a unique PURL or Helm can generate the correct PURL, Helm will check with Tidelift to determine if any licenses are associated with that component. If so, Helm will add those licenses to provide you with a comprehensive view of licensing info and identify licensing risks across your supply chain.
Component license is set to Unknown (NOASSERTION in SPDX): If your SBOM component license is set to Unknown (NOASSERTION in SPDX), but Tidelift indicates that there is one or more licenses associated with that component, we will add those licenses for you.
For existing components, you can have Helm automatically add license information. In the Components table, click Actions > Reload component. Note that reloading will discard any metadata you may have added to this component, such as review information, and will re-identify associated vulnerabilities, so you may see some discrepancy in your number of vulnerabilities for that component. This reduces your manual effort of tracking down licensing information, ensuring you have the latest license information available from our data sources.
The Licenses section of the component details panel displays the following fields:
License type: This field is populated from the license information in your SBOM.
License expression:
For components combining multiple SPDX licenses with AND
or OR
, or using a SPDX license exception.
Individual licenses: If your SBOM component contains multiple SPDX licenses that are not combined with AND or OR (or +) or if your component has custom licenses, choose this option.
No license (NONE in SPDX): If you are certain that your SBOM component does not have an associated license, choose this option. In a SPDX SBOM, this is indicated with the NONE
value.
Unknown (NOASSERTION in SPDX): If you are not sure whether your SBOM has an associated license, choose this option. In a SPDX SBOM, this is indicated with the NOASSERTION
value. In a CycloneDX SBOM, if your SBOM does not contain licensing information or licensing info is empty, it will display as Unknown
Individual licenses: For components with multiple SPDX licenses not combined, or for custom licenses.
No license (NONE in SPDX): The component has no associated license. In a SPDX SBOM, this is indicated with the NONE value.
CycloneDX SBOM: There is no corresponding value for this in CycloneDX 1.4 or 1.5 specs. If you manually add this for a license, then export your CycloneDX SBOM, the licensing information for this component will have this value in the components > licenses > license name field.
SPDX SBOM: Indicates that the SPDX SBOM author provided NONE
as the package-level license information. The SPDX spec requires that when the info is not provided, it be set to NOASSERTION
.
For open-source dependency components, Helm will attempt to identify if there actually is an associated license for you.
Unknown (NOASSERTION in SPDX):
Use this if you are unsure whether the component has an associated license. For open-source dependency components, Helm will attempt to identify this license for you.
SPDX SBOM: Indicates that the SPDX SBOM author provided NOASSERTION
or did not provide package-level license information.
CycloneDX SBOM: Indicates that the CycloneDX SBOM did not contain any licensing information or the licensing information was empty.
License name:
SPDX SBOMs
For SPDX SBOMs, this field is populated from the SBOM’s PackageLicenseConcluded
, PackageLicenseDeclared
, or ExtractedLicensingInfo
sections. PackageLicenseDeclared will only be used if PackageLicenseConcluded field in the SBOM is blank or omitted.
If the package-level licensing has a LicenseRef[idstring]
and that LicenseRef[idstring]
matches one in the ExtractedLicensingInfo
section, the license name and full license text will be populated from that section into License name and License text, respectively. If the license name is missing, the term Custom license will be used as the license name.
Non-SPDX license in your SPDX SBOM: If your SPDX SBOM contained the ExtractedLicensingInfo section, the License name field will be populated with the corresponding license name from ExtractedLicensingInfo > name
field.
SPDX SBOM has NONE or NOASSERTION in the package: If the PackageLicenseConcluded
field contains NONE
or NOASSERTION
, that value will be populated here. If the component is open-source and has a unique PURL, then we will check whether there is license information for that component and if so, enrich it with the missing information.
SPDX SBOM contains no package-level licensing information: NOASSERTION
will be populated into the License name field.
SPDX license exceptions: If you need to add a SPDX license exception, type WITH after your first SPDX license, such as GPL-2.0-or-later WITH Bison-exception-2.2.
Make sure to observe spacing. After you type WITH, followed by a space, then you can either click the drop-down to view only valid SPDX license exceptions or start typing to filter the exceptions.
CycloneDX SBOMs
This field is populated from the components > licenses > license > id
field if the id
field in used in the SBOM, or the components > licenses > license > name
field if it exists.
CycloneDX SBOM does not contain licensing info or licensing info is empty: Since there is no corresponding defined term for missing CycloneDX licensing information, this will show as Not set.
License URL:
For SPDX licenses, this field is automatically populated from the SPDX license list and is uneditable.
CycloneDX SBOM: This is populated from the components > licenses > license ur
l field.
License text:
SPDX SBOM: For custom licenses, this will be populated from the ExtractedLicensingInfo > text
section of SPDX SBOMs.
You can add or modify license text for both SPDX and custom licenses.
License comments:
SPDX SBOM: This is only populated from the package-level PackageLicenseComment
field.
CycloneDX SBOM: There is at least one SPDX license ID in the components > pedigree > notes
field. Some automatic scanning tools will automatically populate either the SPDX license full name or an AND/OR SPDX expression here. If the notes
field exists in your SBOM file, it will be added as License comments for all of the licenses for that particular SBOM component.
You can add or modify license comments for both SPDX and custom licenses.
Comments are applied to all licenses associated with a dependency component.
License source:
SBOM: The license information was populated directly from your SBOM.
User: License was added or modified by a user.
What does it mean to have a unique PURL?
A component's unique PURL could be either the original PURL for that component that was in your SBOM file, or a PURL that Helm added or enriched during the component matching process.
Click Add dependency component from the Add SBOM (Manage SBOMs) drop-down button.
Specify the required fields.
In the License details section, select a License type. Choose License expression if you have one or more SPDX licenses in an expression (e.g., connected with AND, OR, or WITH) or Individual licenses if you have one or more SPDX or custom licenses (not in an expression) that you want to add to a component. You can also select Unknown or No license.
If you want to add a nested expression, such as MIT AND (LGPL-2.1-or-later OR BSD-3-Clause)
, type (
to display the SPDX license list or start typing to filter the list. Note that the expression in the parentheses will be processed first.
If you want to add a SPDX license exception, type WITH
after the license, then select the exception from the drop-down (e.g., GPL-2.0-or-later WITH Bison-exception-2.2
). Make sure to observe spacing.
If you're adding one or more individual licenses, click the License name drop-down to show the SPDX license list, start typing to filter the list, or keep typing to enter a custom license.
If you need to clear a license value, click the x icon in the field.
If you need to remove a license before you've saved, click Remove in the license section.
For individual custom licenses, specify any license text. You cannot add text for a SPDX license.
Add any license comments in the License comments field. License comments will be associated with all licenses for that component.
For individual licenses, click Add another license to add a new license. You cannot add individual licenses to a License expression. You can add as many licenses as you want. Your first license will show License 1, then your second will show License 2. When you save, these section names will change to the license name or expression itself.
Click Add component. You'll see a success message. If you don't see your component, you may have a sort applied.
Click Actions > Edit details to open the component details.
In the License details section, click Edit in the license section you want to edit.
If you just want to edit license type, license text or license comments, click the edit icon next to that field. Any edits you make to the license comments will be applied to all other licenses for this component.
Make any changes, then click Save changes. You'll see a success message. If you don't see your component, you may have a sort applied.
Click Actions > Edit details to open the component details.
In the License details section, click Edit in the license section you want to edit. This will display a Delete action.
Click Delete, then confirm the deletion. You cannot recover a deleted license or its related data. If you are deleting the only license associated with this component, this will also delete any license comments.
Click Close. The deletion has already been performed and cannot be cancelled. You'll see a success message. If you don't see your component, you may have a sort applied.
Deprecated licenses:
You can ingest or manually add or edit deprecated SPDX licenses. Deprecated SPDX licenses are available in the Deprecated licenses section of the License type drop-down.
You can filter licenses on the SBOM page to narrow down your view:
SPDX license ID
No license (NONE
for SPDX)
Unknown (NOASSERTION
for SPDX)
You can export your SBOM with enriched license information in the following formats. Click Reports in the sidebar, then select your preferred format.
FDA SBOM: Excel format.
Vulnerability Disclosure Report (VDR): JSON format. Missing license information will be noted as Unknown (NOASSERTION in SPDX)
in the export.
CycloneDX SBOM: JSON format. Missing license information will be noted as Unknown (NOASSERTION in SPDX)
in the export.
SPDX SBOM: JSON or XML format. Any file-level licensing details will also be included in the export, though they will not display in the Helm UI.
CSV format: Export your SBOM data, including CPE/PURL and license information, as a CSV file.
After you’ve matched SBOM dependency components to software components in the NVD, which could be one or more , you’ll be able to see any reported vulnerabilities for those dependency components.
IMPORTANT: If you have a Matched status that does not have an NVD badge, this has not been matched in the NVD, which means that it either does not have vulnerabilities or has a different name in the NVD. Refer to for more information. You must identify an exact match in the NVD in order to see vulnerabilities for that dependency component.
In the Vulnerabilities page, select the product and version that you want to filter on.
Filter down to just what you need:
Narrow down vulnerabilities by criteria such as severity, exploitability, and threat information.
Select "Any" or specific parameters in filter drop-downs.
Use text filters for direct input.
If you don't have a product and version selected in the Vulnerabilities page, you'll see all vulnerabilities for all products across all versions.
Click the Aliases item in the sidebar. If you have appropriate , you will see an Aliases table with the original name of the dependency component in your SBOM, the linked (aliased) name of the known software in the NVD.
Helm does not currently handle file-level licensing. If you need this, ! If your SBOM includes file-level license information, it will be included in the export but not displayed in the UI.
Although Helm supports SPDX 2.2 and 2.3, this article uses the with license list 3.17. Helm supports SPDX license exceptions, deprecated SPDX license IDs, and all version lists.
Component has one or more licenses: If your SBOM component has at least one license, but Tidelift shows that it is inaccurate or that there are additional licenses associated with this component, we will not update this license information. If this is something that you would like us to add, .
If you'd like us to consider adding the ability to prompt you with license replacement suggestions, .
SPDX licenses combined with +: We do not currently support adding licenses combined with a +, such as Apache-2.0+MIT
. However, we will import it from your SBOM. However, if you need to edit this, Helm will automatically convert the + expression to use AND. If you need support for +, !
The URL does not display for custom licenses. If this is something that you would like us to add, .
System: For open-source components that have unique PURLs but do not have license information, Helm checks Tidelift to determine if there are known licenses for those components. If so, Helm enriches the component with that information. Helm will only for components that do not have any license information; it will not add licenses to components that already have one or more licenses, nor will it replace existing licenses.
If you're adding a license expression, click the License expression drop-down to show the or start typing to filter the list. You can use AND
, OR
, or WITH
. For example, typing Ap
would give you applicable Apache licenses for the first half of the expression, while typing Apache-2.0 AND MI
would give you any available MIT licenses for the second half. Make sure to observe spacing.
Product name
This is the product that contains all of the dependency components from that product’s SBOM. This column will only display if you have not selected a particular product and version.
Version
This is the product version. This column will only display if you have not selected a particular product and version.
Dependency info
This includes the dependency component name, version, and supplier combo.
Dependency component name: This is what may be referred to as a component in other systems. It is the firmware, software, patches, or operating system that is installed on the physical representations of your device (e.g., Windows, OpenSSL).
Dependency component version: This is the dependency version (e.g., 10.1 for Windows).
Dependency component supplier: This is the supplier name (e.g., Microsoft for Windows).
Vuln ID
This is the vulnerability ID. You can click on the vulnerability to open the CVE details in the NVD database. Currently, all of these are CVEs from the NVD, but we are working on adding more vulnerability types, including showing which information is coming from a CNA, such as Microsoft.
Base score
This indicates the CVSS v2 and v3 scores. If you have an older device, you may not have v3 scores. For newer devices, they may not have v2 scores. If you have both scores, it is recommended that you use the v3 score.
Rescore
Once you've applied a rescore profile to the product version that is impacted by a vulnerability or you've manually rescored a vulnerability, you'll see a Rescore column. The Base score value for any vulnerabilities that have been rescored directly or indirectly will be grayed out.
To further reduce the risk of a vulnerability associated with a Windows operating system, you can apply a KB directly to that vulnerability or to the corresponding product version.
Source
Displays the source from which this vulnerability was retrieved:
NVD: Vulnerabilities retrieved directly from the National Vulnerability Database (NVD).
AI: Vulnerabilities enriched by our Large Language Model (LLM) AI. When a vulnerability from the NVD lacks CPE data, our AI enriches it, identifying the vulnerability as impacting your product. These AI badges highlight vulnerabilities that would otherwise go unnoticed, ensuring you have a complete view of your overall risk.
Exploits/Threats
If there are known exploits and threats corresponding to this vulnerability, you will see indicators:
CISA KEV: This vulnerability is in the Cybersecurity & Infrastructure Security Agency's Known Exploited Vulnerabilities list
TOP CWE: This vulnerability meets the criteria of the top 25 CWE list.
EXPLOIT DB: This vulnerability has a known exploit in the Exploit Database
METASPLOIT: This vulnerability is in the Exploit Database and has a kit available in the Metasploit hackers' tool, making it easier to attack.
EPSS
This indicates the Exploit Prediction Scoring System likelihood that this vulnerability will be exploited. The higher the score, the greater the probability that a vulnerability will be exploited in the next 30 days. This percentage is based on a number of sources and data calculations from first.org.
Detected on
This initially just shows the date on which the vendor detected the vulnerability in their software. If the vendor, NIST, or someone else makes an update to the vulnerability, you’ll see an Updated on date that displays beneath the Detected on date.
CycloneDX status
This indicates whether your selected product version is impacted by this vulnerability.
Statuses include:
resolved: Your team has remediated this vulnerability so that it no longer affects any dependency components for this product version.
resolved_with_pedigree: Your team has remediated this vulnerability so that it no longer affects any dependency components for this product version. If you select this, you need to provide information in the Evidence field. Evidence of the changes made to resolve this vulnerability for the affected components' pedigree must contain verifiable commit history and/or diff(s).
exploitable: The vulnerability does affect one or more dependency components, and may be directly or indirectly exploitable.
in_triage: You or someone on your team is investigating this vulnerability.
false_positive: The vulnerability does not affect any dependency components and was falsely identified.
not_affected: No dependency component is affected by the vulnerability. If you select this status, you need to include Justification.
Where did my Review information go?
If you have previously been using our Review functionality for vulnerabilities, this information has been migrated over to our more robust Remediate functionality. This means that any interim statuses you have will now be reflected in the VEX status column. Any review notes that you have provided will now be in the Evidence field when you remediate a vulnerability.
Can I have a CycloneDX status without a VEX status? Yes, when remediating a vulnerability, you can specify either a CycloneDX or VEX status, or both.
VEX status
This indicates whether your product is impacted by this vulnerability. This is the VEX profile of CycloneDX, so the statuses are a little less robust than those of OpenVEX. Let us know if you would like us to offer OpenVEX in the near future.
Statuses include:
affected: This vulnerability impacts one or more dependency components in this product version's SBOM. If you haven’t reviewed these yet, click Actions > Remediate.
unknown: Your team does not currently have an answer as to whether this vulnerability impacts this product. Click Remediate to assess it further.
not_affected: This vulnerability does not have a known impact to any of your dependency components in this product version's SBOM.
Where did my Review information go? If you have previously been using our Review functionality for vulnerabilities, this information has been migrated over to our more robust Remediate functionality. This means that any interim statuses you have will now be reflected in the VEX status column. In VEX, Affected replaces Impacted, Unknown remains the same, and Not affected replaces None. Any review notes that you have provided will now be in the Evidence field when you remediate a vulnerability. Can I have a VEX status without a CycloneDX status? Yes, when remediating a vulnerability, you can specify either a CycloneDX or VEX status, or both.
Shield icon
For products running Windows operating systems, you'll see a shield icon next to any vulnerabilities that you have applied Windows KBs to.
CVSS...
Search for all CVSS scores greater than or equal to the whole number you enter. For example, searching on 8 will give you 8-10.
Critical scores: 9 to 10
High scores: 7-8
Medium scores: 4-6
Low scores: 1-3
None: 0
Vulnerability ID...
Search for a particular vulnerability ID
Supplier...
Search for vulnerabilities that impact a particular supplier, such as Microsoft.
Dependency component...
Coming soon! Search for vulnerabilities that impact a particular dependency component, such as Windows.
Any score
If you're only interested in one CVSS version, you can filter on only CVSS v2 scores or only CVSS v3 scores. If a particular version's score is not available, the other version will display. If one or both scores do not exist, this will show as a blank in the CVSS column.
Any KB patch
Filter on vulnerabilities that have or have not been patched by Windows KB patches, or that have patches available:
Patched: Vulnerabilities for which a Windows KB patch has been successfully applied.
Unpatched: Vulnerabilities that still lack a corresponding Windows KB patch.
Patch available: Vulnerabilities for which a Windows KB patch is available, but has not yet been applied.
Any exploit
Filter down on exploits and threats to see vulnerabilities:
CISA KEV: Vulnerability is listed in the Cybersecurity and Infrastructure Security Agency (CISA) Known Exploited Vulnerabilities (KEV) list.
Top CWE: Ensure that the vulnerability meets the criteria of the top 25 Common Weakness Enumerations (CWE) list, indicating common software security weaknesses.
ExploitDB: Verify if the vulnerability is documented in the Exploit Database, a valuable resource for information on security vulnerabilities and exploits.
Metasploit: Vulnerability has a corresponding Metasploit toolkit to exploit the vulnerability. Metasploit is a penetration testing framework that aids in the development, testing, and use of exploit code.
Any source
Helm currently retrieves vulnerabilities from the NVD and enriches vulnerabilities with CPE data, ensuring you have a complete view of your total vulnerabilities. Any enriched vulnerabilities will have an AI badge in the Source column.
EPSS...
Search for all EPSS scores greater than or equal to the whole number you enter. For example, searching on 80 will give you everything 80% or above. You do not need to enter a % in the value.
Date range
Select a date range to see all vulnerabilities added or updated in external sources during that timeframe. This does not include updates made by your team during security review and analysis.
To ensure you're focusing on the most exploitable vulnerabilities, you can create and apply a reusable rescore profile to rescore all vulnerabilities across a product version. You can also rescore individual vulnerabilities manually.
Once you've rescored your vulnerabilities, you can then prioritize the remaining vulnerabilities by filtering down on those that have a combination of high CVSS scores with high exploitability (EPSS) scores, as well as having exploits or threats publicly available.
In the Vulnerabilities page, you can export all vulnerabilities for a particular product, as well as all notes your team has made in identifying the risk each vulnerability poses to your organization.
There are two ways to export vulnerabilities, either from the Reports page or directly from the Vulnerabilities table.
Export vulnerabilities from Reports
Click the Reports item in the sidebar to display the Reports page.
Click the Export vulnerabilities button on the Vulnerabilities CSV card.
Export vulnerabilities from the Vulnerabilities page
In Vulnerabilities, select the product name and either all versions or a particular version.
Click Export vulnerabilities. This will export any vulnerabilities that you have not otherwise filtered out.
Depending on your organization, you’ll likely want to start with the most critical vulnerabilities first, so that you can assess their severity given your particular device, its environment and its use. In the Base score column, you’ll see both a v2 and a v3 score. Older devices may not have a v3 score, while newer devices may not have a v2 score. We recommend that you mitigate the v3 score first.
You can individually rescore any vulnerability associated with a particular product version. If you've already applied a rescore profile to this product version, this individual rescore will override the profile rescore. Refer to Rescore an individual vulnerability for more information.
Initially, all of your vulnerabilities will have a Status of blank. For CycloneDX status, you'll ultimately want to remediate each of these to either Exploitable or Not affected. For VEX status, you’ll ultimately want to remediate each of these to either Affected or Not affected. Refer to Rescore an individual vulnerability for more information.
Depending on your organization, you’ll likely want to start with the most critical vulnerabilities first, so that you can assess their severity given your particular device, its environment and its use. In the Base score column, you’ll see both a v2 and a v3 score. Older devices may not have a v3 score, while newer devices may not have a v2 score. We recommend that you mitigate the v3 score first.
If you’ve previously assessed a vulnerability, but you see an Updated on date display in the Detected on column, this indicates that the vulnerability has been updated. You’ll want to check to make sure that this doesn’t increase its severity or exploitability for your particular case.
Helm returns the Common Vulnerability Scoring System (CVSS) to provide numerical ratings corresponding to critical, high, medium, and low scores to ensure you understand your current vulnerability risk. Because older devices may only have a CVSS v2 score, while newer devices may only have a v3 score, Helm provides both CVSS v2 and v3 scores, enabling you to assess risk across the spectrum of your legacy and new devices.
This score incorporates a number of factors assessing the exploitability of a vulnerability.
For CVSS v3 scores, you can use a number of calculators to understand how the CVSS score for a particular vulnerability was calculated:
Hover over each metric classification value to get more information on how to determine which value applies to your situation. For your convenience, we've also provided those metric and value definitions below.
You can rescore all vulnerabilities associated with a particular product version or rescore individual vulnerabilities.
Every vulnerability in the NVD starts with a base CVSS score. You cannot modify this base score, but you can modify the temporal and environmental scores by assessing your particular device's situation. Every metric in these two sections is set to Not defined (X) by default, which has the highest impact on the CVSS score.
All definitions are extracted from first.org's CVSS 3.1 calculator.
The Temporal metrics measure the current state of exploit techniques or code availability, the existence of any patches or workarounds, or the confidence that one has in the description of a vulnerability.
These metrics enable the analyst to customize the CVSS score depending on the importance of the affected IT asset to a user’s organization, measured in terms of complementary/alternative security controls in place, Confidentiality, Integrity, and Availability. The metrics are the modified equivalent of base metrics and are assigned metric values based on the component placement in organization infrastructure.
Every vulnerability in the NVD starts with a base CVSS score. The base metric group captures the characteristics of a vulnerability that are constant with time and across user environments. The Access Vector, Access Complexity, and Authentication metrics capture how the vulnerability is accessed and whether or not extra conditions are required to exploit it. The three impact metrics measure how a vulnerability, if exploited, will directly affect an IT asset, where the impacts are independently defined as the degree of loss of confidentiality, integrity, and availability. For example, a vulnerability could cause a partial loss of integrity and availability, but no loss of confidentiality.
You cannot modify this base score, but you can modify the temporal and environmental scores by assessing your particular device's situation. Every metric in these two sections is set to Not defined (X) by default, which has the highest impact on the CVSS score.
All definitions are extracted from first.org's CVSS v2 calculator.
CVSS base score is divided into Exploitability and Impact metrics. Exploitability metrics include Attack vector, Access complexity, and Authentication, while Impact metrics include Confidentiality impact, Integrity impact, and Availability impact.
The threat posed by a vulnerability may change over time. Three such factors that CVSS captures are: confirmation of the technical details of a vulnerability, the remediation status of the vulnerability, and the availability of exploit code or techniques. Since temporal metrics are optional they each include a metric value that has no effect on the score. This value is used when the user feels the particular metric does not apply and wishes to "skip over" it.
Different environments can have an immense bearing on the risk that a vulnerability poses to an organization and its stakeholders. The CVSS environmental metric group captures the characteristics of a vulnerability that are associated with a user's IT environment. Since environmental metrics are optional they each include a metric value that has no effect on the score. This value is used when the user feels the particular metric does not apply and wishes to 'skip over' it.
CVSS environmental score is divided into General modifiers and Impact subscore modifiers. General modifers include Collateral damage potential and Target distribution, while Impact subscore modifiers include Confidentiality requirement, Integrity requirement, and Availability requirement.
Stay on top of the latest vulnerabilities to impact your sofware supply chain. You can choose to receive daily, weekly, and/or monthly digests. These alerts ensure that you stay updated on potential risks and can take prioritize and mitigate risk promptly.
Click on your user avatar located in the top navigation area of Helm.
Select My profile from the dropdown menu.
Toggle on the Send me vulnerability email digests switch if it's not already on.
Check one or more frequencies.
If you prefer not to receive email alerts, toggle off the Send me vulnerability email digests switch.
Click Save.
Daily: You’ll receive your first daily vulnerability email on the next business day.
Weekly: You’ll receive your first weekly vulnerability email on the next Monday.
Monthly: You’ll receive your first monthly vulnerability email on the 1st of every month.
As you know, the base CVSS score isn't tailored to your particular product's environment and usage. To ensure that you're spending your limited time resolving the vulnerabilities that matter most to your company, patient safety and your bottom line, you can create and apply rescore profiles to your various product versions.
While applying a rescore profile to rescore all vulnerabilities across a product version, you can eliminate the need to manually track and update any exploitability changes, which are reflected in the CVSS v3 Temporal metrics. If there is any change to the metrics of Exploit Code Maturity, Remediation Level, and/or Report Confidence, your vulnerabilities will be automatically rescored based on this updated data.
After setting the Temporal and Environmental metrics that apply to particular product version, you can preview a sample of vulnerabilities to see how this will impact their scores, as well as how many vulnerabilities will be rescored. You can then apply it all vulnerabilities associated with this version.
Enabling this auto-update feature streamlines your vulnerability management processes, reduces manual effort, and ensures your CVSS severity scores are accurate and up-to-date:
Reduced effort: Save time and effort spent manually tracking and updating these metrics for each vulnerability.
Improved accuracy: Ensure that the CVSS Temporal metrics accurately reflect your vulnerabilities' current state, reducing the risk of human error during manual updates.
Simplified tracking: Eliminate the need to add information to the Evidence field for manual changes to these metrics.
You can enable or disable the auto-updating of these Temporal exploitability metrics either while you're creating or editing a rescore profile. To do so:
Select the product and version, then click the Rescore drop-down button.
Choose the Edit rescore profile option. This will display the rescore panel.
In the Temporal section, toggle the Auto-update this vulnerability with exploitability changes switch. If you enable auto-update, the Temporal score metrics will become read-only, as they will be automatically updated based on exploitability changes. You can still individually rescore any vulnerability associated with this product, if desired. Note that the last change to a vulnerability, whether by a rescore profile or an individual rescore, will take precedence.
Click Save and apply changes.
You can individually rescore any vulnerability. If you've already to this product version, this individual rescore will override the profile rescore. The last change made to a vulnerability, whether by a rescore profile global change or an individual vulnerability rescore will take precedence.
In the product/version selection bar of Vulnerabilities, you'll see a Rescore drop-down action link.
Expand the Temporal score section, then modify the appropriate metric values.
Expand the Environmental score section, then modify the appropriate metric values. You'll see the rescored value display in both the Temporal and Enviromental sections, as well as in the summary information below these sections.
Assess how this rescoring will impact the CVSS score of this vulnerability. If you're satisfied with this rescoring, click Save & apply.
In the context of vulnerability assessment, Helm provides a practical framework for understanding and prioritizing vulnerabilities based on severity, exploitability, and potential threats. This article outlines how Helm utilizes CVSS v2 and v3 scores, along with EPSS scores and threat sources, including indicating if vulnerabilities are on the CISA KEV list, whether they are in the Exploit Database (exploit-db.com) or have a Metasploit toolkit available to make attacks easier, and whether they meet the criteria of the top 25 CWEs (Common Weakness Enumerations).
Our advanced Large Language Model (LLM) now enriches vulnerability data from the National Vulnerability Database (NVD). Unfortunately, the NVD has not kept pace with CPE and other data enrichment for the past six months, leaving those of us in the cybersecurity space in a bit of quandary.
To remedy this issue, our LLM is now identifying vulnerabilities impacting your products and automatically enriching the information retrieved from the NVD with CPE data, aiding in more precise identification of vulnerabilities. This provides you with a more complete view of your overall risk, and ensures that you're focusing your time and effort on the most exploitable vulnerabilities that are affecting your product. Vulnerabilities that came from the NVD, and through our CPE enrichment, were identified as impacting your products will have an AI badge in the new Source column on the page.
You can across an entire product version based on your device's environment and usage, or . Customize vulnerability scores based on your device's unique environment and usage, recalibrating severity, exploitability, and threat information for a tailored assessment that minimizes false positives while pinpointing your more exploitable and critical vulnerabilities, thereby strengthening your cybersecurity defenses.
You can easily stay on top of new and updated vulnerabilities:
Get email notifications of new vulnerabilities impacting your software supply chain.
Identify those with available exploits or malware kits.
Consider suggested Windows KB updates (Windows operating systems only).
Stay updated with information from the National Vulnerability Database (NVD).
To ensure you're focusing on the most exploitable vulnerabilities:
If you’ve previously assessed a vulnerability, but you see an Updated on date display in the Detected on column, this indicates that the vulnerability has been updated. You’ll want to check to make sure that this doesn’t increase its severity for your particular case.
You can to rescore the CVSS 3.x score for all vulnerabilities across a product version. You can also rescore individual vulnerabilities. As you assess and set these metrics, you'll see the rescored value and CVSS vector string updating accordingly.
Unlike upgrading to a new version of applying a patch, rescoring does not require you to .
By rescoring, you can concentrate on the dependency components impacted by the most exploitable vulnerabilities first, ensuring that you've assessed the fixability of a vulnerability, your overall level of confidence on the information reported for a particular vulnerability, the importance of the affected dependency component based on its placement in your infrastructure.
By rescoring based on your particular device's environment and usage, you can often reduce the severity of a particular vulnerability or of all vulnerabilities that impact a particular product version. You can save and apply a profile, giving you the benefit of a scalable, repeatable vulnerability scoring method to help you analyze and mitigate risk more quickly, ensuring patient safety and paving your way to FDA cybersecurity approval for your product submissions.
More automated rescoring removes bias from your risk assessment methodology, while incresaing efficiency. It frees your engineers up to concentrate on your company's future, rather than spending weeks and months manually rescoring vulnerabilities, a task which also contributes to attrition.
You can also identify and implement strategic changes to your risk mitigation strategies to maximize ROI and reduce unexpected delays, helping to improve business outcome, timelines, and product security design scope.
Ensure that you understand the impact of the recent regulatory changes included in the Patch Act, as well as the likelihood that the FDA will flag your submissions for connected devices due to cybersecurity deficits.
to rescore all vulnerabilities across a product version
Once you've rescored your vulnerabilities, you can then by filtering down on those that have a combination of high CVSS scores with high exploitability (EPSS) scores, as well as having exploits or threats publicly available.
You can down to just what you need.
From any page in Helm, you can search on dependency components (SBOM) across all products using the global search box in the top navigation bar. For example, you may want to find all products that are running the Windows 10 operating system.
In the global search box on any page, select SBOM from the search drop-down. Alternately, you can go directly to the Discover page to run searches. Either way, your last search results will display on this page, if you need to return to them.
Type in a vulnerability ID (e.g., CVE-123-4567), then press Enter to run the search.
From Actions > …, you can then jump to either viewing Software Bill of Materials (SBOM) or Vulnerabilities.
If you jump to this product, you’ll be able to see which product and product versions contain that dependency component and version. From the Actions > … button, you can choose to view more details, add a review note, view review history, and more.
If you jump to vulnerabilities for this dependency component, you can view the applicable vulnerabilities. From the Actions > … button, you can manage each vulnerability, including adding review notes and setting the resolution. If you change this resolution, it will update the Status for that vulnerability.
In the Vulnerabilities table, you'll see an update indicator next to Windows OS Vuln IDs that can be resolved by applying a Windows KB.
Note: Depending on the degree of completeness of your SBOM, it may be in a draft or interim state, in which you are still applying Windows KBs to the digital twin of your product version in order to stay in sync with what you've already applied to your physical test device. If so, you may be able to apply a KB to resolve this vulnerability to this current version. If you're dealing with an SBOM in a final state or already released, you'll want to make a ticket to apply this KB to the next version of your SBOM, so that your digital and physical device versions stay in sync.
For each vulnerability that is not resolved, you can set an in progress status in the Status column -- this exact status will vary depending on what specification type you are using. For example, in CycloneDX, you could set it to In triage to indicate to your team that you're in the process of analyzing this. Once you’ve determined which KBs you need to apply to resolve a vulnerability, click the KB indicator next to the Vuln ID. This will display the Resolve panel panel.
In this panel, you'll see a list of suggested KBs. The top one is the one that is most recently released and contains the most rollups of the subsequent KBs. You can click each KB link to go to the Microsoft MSRC site to determine which KBs matches what you are applying to your physical test device to align your digital digital twin record accordingly.
Click Resolve with selected KB when you've chosen which KB you want to apply. You’ll see a success message letting you know which KB was applied, as well as how many and which vulnerabilities it resolved.
Next to the Vuln ID, you'll see a new shield indicator to indicate that a KB has been applied. You can hover over this to see what KB was applied to resolve this vulnerability.
Applying this KB will gray out the row, and will set the corresponding status to fixed.
Get the Medcrypt advantage with the only FDA expert-crafted SBOM that ensures you meet FDA SBOM requirements. We also provide a suite of other reports to enable you to export exactly what you need to meet auditor requirements.
You can export your SBOM from your dependency components page or from the Reports page.
From the components page, click Manage SBOM > Export SBOM. If you want to take advantage of our expert FDA SBOM, select the Export FDA SBOM option. From the Reports page, click the Export SBOM button for the SBOM format you need.
In the export panel that displays, specify your file name.
Select to export either your original or enriched SBOM.
If you select Enriched SBOM, this will display the Enriched SBOM details section. Customize the details you want (as detailed in the fields below), then click Export SBOM.
Your FDA SBOM contains the data in your SBOM as well as your vulnerabilities, but can also be enriched with additional CPE/PURL, license, or vulnerability remediation data.
Export as file format:
Your FDA SBOM is only available as an Excel file.
CPE/PURL source:
Your FDA SBOM includes both CPE/PURL information from your SBOM and additional data identified by Helm to enrich your SBOM. This cannot be changed.
Vulnerabilities:
Your FDA SBOM report includes all of your vulnerabilities, but you can now include CycloneDX and VEX remediation.
Review information:
You can further enrich your FDA SBOM with the review status and notes of each dependency component.
In the Software Bill of Materials (Products) page, if you have a product version selected that is running a Windows operating system, you will see an Apply Windows KBs action link next to the Manage SBOMs drop-down button.
Note: Depending on the degree of completeness of this SBOM, it may be in a draft or interim state, in which you are still applying Windows KBs to the digital twin of your product version in order to stay in sync with what you've already applied to your physical test device. If so, you may be able to apply a KB to resolve this vulnerability to this current version. If you're dealing with an SBOM in a final state or already released, you'll want to make a ticket to apply this KB to the next version of your SBOM, so that your digital and physical device versions stay in sync.
You can assess these KBs on your physical test devices, or you can apply them here to understand which vulnerabilities applying them will fix, before starting the physical testing. This will give you a clearer understanding of your overall current risks and an accurate digital record of your device’s current state, and will enable you to quickly answer the question of whether your business is at risk for a particular vulnerability, as well as to confidently communicate recommended patched for your customers to apply, providing you and your customers a clear understanding of your overall current risks.
To apply KBs:
In the Products (SBOM) page, click the Apply Windows KBs action link next to the Manage SBOMs drop-down button. This will display the Apply Windows KBs modal. This enables you to keep your Windows KB patching in Helm aligned with your internal Windows KB testing and recommendations to your customers.
Copy and paste the KBs into the KBs to apply list box. Make sure all values are separated with a comma. If you’re pasting from a spreadsheet, you can use the JOIN function in Excel or Google Sheets. This uses the Google Sheets example: JOIN(“,”, A2:A20), where cells A2-A20 contain the patch (KB) numbers you want to comma separate. Copy and paste that calculated string directly into the Patches (KB) field. Any patch (KB) number that is comma-separated will automatically be converted into a chip. Note that you do not need to include the “KB” in front of the Windows patch (KB) numbers, but if you do, our system will strip those out.
If there are already KBs applied, they display in the box to the right, KBs already applied. You can remove any erroneously applied KBs from here in order to keep your device version aligned with your ideal patch recommendations to your customers.
Click Apply changes. This will add the new KBs to this product version. If you removed any KBs, they will be removed. We do not do any validation on these KBs beyond numeric value validation, as there could be non-security related KBs that you have applied, or the KB could have been released after we’ve performed a daily sync with the Windows sources we use to extract updated KB information.
After applying KBs, you’ll see a success message letting you know which KBs were applied, as well as how many vulnerabilities they resolved.
You can send the details of any vulnerability to your R&D team for future prioritization. To do so:
In Vulnerabilities, click Actions > ... > Email vulnerability. This will display an email with the vulnerability information.
Add any information you need to help your team assess and prioritize this vulnerability accordingly, then send it to your R&D team.
Our VDR (Vulnerability Disclosure Reports) report offers comprehensive insights into identified vulnerabilities, these reports equip you with proactive mitigation strategies, bolstering your defense against emerging threats. Your VDR report contains all of your dependency components, as well as all of your vulnerabilities, regardless of their remediation status.
Click the Reports item in the sidebar.
In the Export VDR report card, click Export VDR report. This will export your VDR in JSON format.
Note: As of this update on Nov 1, 2023, these are the current FDA requirements. You should check FDA resources for the most current information.
The Consolidated Appropriations Act for 2023 was signed into law December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA), also known as Omnibus. Section 3305 of Omnibus - Ensuring Cybersecurity of Medical Devices amended the FD&C Act by adding a new section, 524B(c).
The Omnibus Act finalized guidance on reasonable patch and update cycles and moving medical devices towards being "secure by design" throughout the device lifecycle. To learn more about the specifics, refer to the below page.
The new section 524B(c) of the FD&C Act - Ensuring Cybersecurity of Devices defines a cyber device as a device that:
Includes software validated, installed, or authorized by the sponsor as a device or in a device;
Has the ability to connect to the internet; and
Contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats.
This applies to prospective submissions for “cyber devices” under the 510(k), de novo, HDE, PDP, PMA, HDE, and IDE pathways.
It is effective 90 days after signing, or March 29, 2023. Check the FDA medical device cybersecurity FAQS for more information.
Section 524B(a) requires that a sponsor of an application of the submission types above provide the requisite documentation detailed in section 524B(b).
Section 524B(b) requires manufacturers of cyber devices to:
Submit to the Secretary a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures;
Design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure, and make available postmarket updates and patches to the device and related systems to address –
On a reasonably justified regular cycle, known acceptable vulnerabilities; and
As soon as possible out of cycle, critical vulnerabilities that could cause uncontrolled risks;
Provide to the Secretary a software bill of materials, including commercial, open-source, and off-the-shelf software components; and
Comply with other such requirements as the Secretary may require through regulation to demonstrate reasonable assurance that the device and related systems are cybersecure.
According to the FDA medical device cybersecurity FAQS as of October 12, 2023:
Section 524B(c) of the FD&C Act defines "cyber device" as a device that (1) includes software validated, installed, or authorized by the sponsor as a device or in a device, (2) has the ability to connect to the internet, and (3) contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to the cybersecurity threats. If manufacturers are unsure as to whether their device is a cyber device, they may contact the FDA.
This means that if you device has an electronic interface of any type, such as wi-fi or USB, regardless of whether it was intended to be connected to the internet or not, you need to provide proof that the device cannot be connected to the internet.
Medcrypt expert tip: Your device is considered to be connectable unless you can prove otherwise via threat modeling and a Secure Product Development Framework. If you didn't design it specifically to not be connected, then it can be. If, in your eSTAR submission, you have a USB port that you do not report, but the FDA reviewer does a quick search for USB and finds this discrepancy, they will put an automatic hold on your submission. Don't feel comfortable going this alone? You don't have to! Contact us so we can optimize your FDA readiness.
Risks increase if the device contains one or more of these interfaces:
Wired: USB, ethernet, RF, inductive, cloud, etc.
Wireless: wi-fi, Bluetooth, RF, inductive, cloud, etc.
Cybersecurity considerations apply for the entire system, not just the end device. Examples include:
Software update infrastructure
Cloud applications
Commercial devices (phones, tablets, computers, etc.)
"The future of cybersecurity is not in building higher walls but in building smarter systems that can adapt and learn from each new challenge".
-Dan Schulman, CEO of Paypal
This is not intended to be an exhaustive list. We recommend that you consult FDA resources to plan and implement better risk mitigation strategies.
According to the FDA, you must have a strategy for identifying, monitoring, and addressing cybersecurity vulnerabilities and potential exploits, a plan for addressing vulnerability disclosures and for establishing incident response protocols, as well as a plan for post-market updates and patches on a routine basis.
Strict cybersecurity breach notifications coming soon!
The FDA will soon require that you report major cyber incidents to the Cybersecurity and Infrastructure Security Agency (CISA) within 72 hours after the incident. For ransomware payment cyber attacks, you will have 24 hours to report this to CISA. These requirements will likely go into effect late in 2024 or 2025.
They also require that you report major cyber incidents to the Cybersecurity and Infrastructure Security Agency (CISA) within 72 hours after the incident. For ransomware payment cyber attacks, you have 24 hours to report this to CISA.
Need more detail on FDA requirements?
Here's the government-speak for you!
Postmarket cybersecurity vulnerabilities and exploits: Section 524B(b)(1) of the FD&C Act requires that you provide a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures.
Known acceptable vulnerabilities: Section 524B(b)(2) and 524B(b)(2)(A) requires that you make available postmarket updates and patches to the device and related systems to address these, on a reasonably justified regular schedule.
Critical vulnerabilities that could cause uncontrolled risks: Section 524(b)(2) and 524(b)(2)(B) requires that you make available postmarket updates and patches to the device and related systems to address these, as soon as possible out of cycle.
"The pace of technological change requires us to rethink our strategies for security, and embrace a proactive, not reactive, mindset."
-Bruce Schnier
The FDA 2014 Premarket Cybersecurity Guidance recommended that manufacturers provide the following:
Hazard analysis, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with your device, including:
A specific list of all cybersecurity risks that were considered in the design of your device;
A specific list and justification for all cybersecurity controls that were established for your device.
A traceability matrix that links your actual cybersecurity controls to the cybersecurity risks that were considered.
It also recommends managing the device postmarket and providing the plans as part of the premarket submission in Section 6, Items 3 and 4.
Plan for continuing support: How your company will monitor and maintain cybersecurity
Plan for malware-free shipping: How your company will ensure malware isn’t introduced in the manufacturing process or while devices are being updated in the field.
Section X of the Postmarket Management of Cybersecurity in Medical Devices guidance also makes recommendations about the elements of an effective postmarket cybersecurity program.
MITRE also provides a Medical Device Cybersecurity Regional Incident Preparedness and Response playbook and the Playbook for Threat Modeling Medical Devices.
You should also address labeling as part of your cybersecurity program, including device instructions for use and product specifications related to recommended cybersecurity controls appropriate for the intended use environment (e.g., antivirus software, use of firewall). This should be consistent with your risk controls, including any configuration on the computer or platform (e.g., popup blocker recommendation). It should also include instructions to ensure the safe and effective use of the device, including interfaces and functionality, security controls that the user interacts with (e.g., password, software updates, etc.), your Manufacturer Disclosures Statement for Medical Device Security (if you provide it to customers), also called MDS2., your SBOM (if you provide it to customers), and logging capabilities and forensic log capture.
This list isn't exhaustive, but should help you get started on created your cybersecurity strategy.
Understand the regulatory requirements for medical devices
Choose encryption tools
Determine encryption algorithms
Key management
Auditing data
Speed of the encryption
Consider hardware resource constraints
What does a medical device encompass?
"The definition of a medical device encompasses not only capital equipment, but also surgical instruments, patient monitoring, and even software. The breadth and variety of the field, combined with the critical importance of med devices to life and safey, requires a deliberate, focused approach to cybersecurity to ensure that they are resilient throughout their lifecycle."
-Nancy Brainerd (CISSP/CIPP), Senior Director of Product Security
Get the Medcrypt expert inside scoop!
In our experience with several clients, we have found the following to be common risks to mitigate to improve likelihood of obtaining FDA submission approval:
Using authentication by proprietary means: The FDA and Medcrypt have found that “proprietary” often means that it has not been widely or thoroughly tested.
Not using unique keys on each device: If one device’s secret is compromised, now all devices are compromised. This has already led to at least one recall.
Impacts caused by unexpected, non-standardized, or malformed NFC/RFID exposure
Designs that did not initially implement channel authentication and communication signing and encryption.
No matter how accurate and timely the patching recommendations you make to your clients are, you know that some customers won’t patch up to the recommended level.
To manage multiple patch levels across your devices in the field:
Export your current SBOM from Helm before you start applying KBs.
Upload your SBOM again, modifying its name slightly, such as SBOM_productname_v1.2 to SBOM_productname_v1.2.1.
In this new version, you can then apply the Windows KB patching that matches what you’re applying to your physical test devices. This will enable you to track your device’s vulnerability level at various patching levels, enabling you to provide the requisite proof to the FDA that you are proactively managing risk levels across all devices.
After ingesting your SBOM, Helm will automatically match your dependency components to known software in the NVD and package managers, which will bring forth potential vulnerabilities. Your VEX report contains all of your vulnerabilities that you have added a CycloneDX VEX status to, as well as any rescore information for your vulnerabilities.
Click the Reports item in the sidebar.
In the Export VEX report card, click Export VEX report. This will export your VEX in JSON format.
Helm provides you with detailed FDA-ready reports, including VEX, VDR, and the only FDA expert-crafted SBOM to ensures you meet FDA SBOM submission requirements.
Medcrypt FDA SBOM: This is the only SBOM that ensures you meet FDA requirements, specially crafted by our team of FDA experts. You will need to have both SBOM and vulnerability access for this product version to export this report.
CycloneDX SBOM: Exports an enriched version of your SBOM in CycloneDX JSON format, including any CPE/PURL matching data that was identified through automatic or manual matching, or that you specified manually, as well as vulnerabilities and license data. You will need to have SBOM access for this product version to export this report, and also vulnerability access to export it with vulnerabilities.
SPDX SBOM: Exports an enriched version of your SBOM in SPDX format, including any CPE/PURL matching data that was identified through automatic or manual matching, or that you specified manually, as well as vulnerabilities and license data. You will need to have SBOM access for this product version to export this report, and also vulnerability access to export it with vulnerabilities.
SBOM CSV: Exports an enriched version of your SBOM, including any CPE/PURL matching data that was identified through automatic or manual matching, or that you specified manually. You will need to have SBOM access for this product version to export this report.
CycloneDX VDR: Export your Vulnerability Disclosure Report (VDR), containing all SBOM and vulnerability data, including analysis and remediation plans for all of your product's vulnerabilities. Offering comprehensive insights into identified vulnerabilities, these reports equip you with proactive mitigation strategies, bolstering your defense against emerging threats. You will need to have both SBOM and vulnerability access for this product version to export this report.
CycloneDX VEX: Export your Vulnerability Exploitability eXchange (VEX) report to easily and confidently report on exploitability and potential impact for all vulnerabilities that have a VEX status. You will need to have both SBOM and vulnerability access for this product version to export this report.
Vulnerabilities CSV: Export all of your vulnerabilities in CSV format. You will need to have vulnerability access for this product version to export this report.
Make sure that you have a product and version selected, which will enable you to access the reports, providing that you have the appropriate permissions for them. If you still see these report "cards" and buttons grayed out (disabled), that means that you do not have permissions to export that report. Hover over the disabled button to see what user role, then contact your administrator.
Helm provides you with detailed FDA-ready reports, including VEX, VDR, and the only FDA expert-crafted SBOM to ensures you meet FDA SBOM submission requirements.
Make sure that you have a product and version selected, which will enable you to access the reports, providing that you have the appropriate permissions for them. If you still see these report "cards" and buttons grayed out (disabled), that means that you do not have permissions to export that report. Hover over the disabled button to see what user role, then contact your administrator.
Will existing SBOM component hash information be exported?
If your SBOM contained any component hashes when uploaded, that information was retained and will be exported intact to any SBOM report.
Depending on your organization, you’ll likely want to start with the most critical vulnerabilities first, so that you can assess their severity given your particular device, its environment and its use. The CVSS v3 column in shown by default in the Vulnerabilities table. You can click the Columns link above the table header row to customize your data display, including adding the CVSS v2 column.
Initially, all of your vulnerabilities will have a Status of blank. For CycloneDX status, you'll ultimately want to remediate each of these to either Exploitable or Not affected. For VEX status, you’ll ultimately want to remediate each of these to either Affected or Not affected. Some MDMs use CycloneDX for assigning internal statuses, while using the CycloneDX VEX profile to assign external statuses that will be communicated to customers and other external stakeholders.
To do so:
If you're not familiar with a particular vulnerability, click Actions > View details to get all vulnerability information. Close this panel when you're ready to remediate this vulnerability.
Click Actions > ... > Remediate vulnerability.
If you're still investigating a vulnerability, choose the interim status for CycloneDX of In triage. If you have any information about the vulnerability that will help triage it, you will be able to add that to the Evidence field once you have chosen a status.
If you're ready to remediate the vulnerability to a final status, choose the appropriate status. For CycloneDX, depending on the status, you may also need to select a remediation and justification for that remediation.
If you'd also like to add a VEX status, click the Add CycloneDX VEX status link. Note that this is the CycloneDX profile of VEX, not OpenVEX, so the statuses are a subset. If you're still investigating a vulnerability, choose the interim status for CycloneDX VEX of Unknown.
If you select any status besides an interim status for either CycloneDX or CycloneDX VEX, you'll need to provide information to explain this status change in the Evidence field. This will provide you with an audit trail for this vulnerability
Click Apply remediation. In the Vulnerabilities table, you'll see the respective status(es) display in the CycloneDX status and VEX status columns, respectively.
This status indicates that the component has an exact match with software listed in the National Vulnerability Database (NVD). This status confirms that the software has reported vulnerabilities, which are visible on the Vulnerabilities page for the respective product version. Components with a correct CPE or PURL identifier but incorrect supplier information are automatically corrected and matched by our system.
This status indicates that Helm found multiple potential matches using one or more match sources. Refer to Resolve match statuses to try to uniquely identify this component.
This status indicates that a dependency component is matched to a package manager but is not found in the NVD. Refer to Matched statuses and Resolve match statuses for more information.
For components that do not match any known software in the NVD or supported package managers, refer to Resolve match statuses to try to identify this component.
You can use aliases to match any components in your SBOM that have multiple matches or are unmatched to known software components in the NVD. Administrators can create new aliases.
Scanning: This is an interim status that indicates that Helm is processing this match. If you have been waiting and haven't seen this update, try refreshing the page.
Fix version: The software version provided for this dependency component does not align with the expected version. If you see this, you will also see a warning icon next to the version. Refer to Resolve match statuses for more information on resolving this issue.
Contact us: Helm was unable to process this version. We have logged this issue and will try to rectify it quickly. Refer to Resolve match statuses for more information on resolving this issue.
Error: Some other error occurred while trying to process this component. This should be extremely rare. Contact us for help in resolving this issue.
Helm checks CPE and PURL IDs to determine if a dependency component is unique. If a duplicate is detected, it will automatically be removed, streamlining your SBOM management.
Verification and Validation methods are used to ensure that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. V&V are critical to a quality management system (such as ISO 9000). The Project Management Book of Knowledge (PMBOK) defines them thusly:
“Validation: The assurance that a product, service or system meets the needs of the customer and other identified stakeholders. It often involves acceptance and suitability with external customers.”
“Verification: The evaluation of whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition. This is often an internal process.”
Validation checks whether the product/service/system meets the operational needs of the user. For new products, this could involve modeling the product workflows and using simulations to predict gaps or issues.
Verification checks whether the product/service/system meets a set of design specs. In the development phase, this involves performing tests to model or simulate a portion or the entirety of the product/service/system, then performing a review or analysis of the modeling results. In post-development, it involves repeating tests to ensure that the product/service/system continue to meet the design specs, regulations, and requirements.
Use the color-coded CVSS severity levels to focus on the most important vulnerabilities.
Critical (dark red)
9-10
This may allow attackers to access sensitive data and run code on your software.
High (red)
7-8
This may allow attackers to access sensitive data in your software.
Medium (orange)
4-6
Under some conditions, this may allow attackers to access sensitive data in your software.
Low (green)
1-3
Your software could expose some data that allows vulnerability mapping. This can be used to chain vulnerabilities to attack your software.
None (gray)
0
There is no known attack risk for this software at this time.
After uploading your SBOM (Software Bill of Materials) or manually adding a dependency component, you may encounter different statuses indicating that your software component, version, and supplier combination could not be automatically matched to an existing entry in the NVD (National Vulnerability Database). These statuses are designed to help you identify and resolve issues, ensuring accurate vulnerability tracking for your components.
To view vulnerabilities for your dependency components, you'll need to resolve any statuses other than Matched. By following these steps to resolve these statuses, you can ensure accurate matching of your software components to known vulnerabilities, enhancing the security and reliability of your software inventory.
A Select match status means that your software dependency, version, and supplier combination has multiple potential matches, making it unclear which one is the correct match.
A Not found status means that your software dependency, version, and supplier combination could not be automatically matched to an existing entry in the NVD. This could mean there are no vulnerabilities for this component, or it could mean the component is named differently in the NVD.
To resolve either of these statuses, you have several options:
Review potential matches Click the badge to open the Resolution options modal, then click the View suggestions button in the Select match box. This will display the Multiple matches modal, where you can based on the following details:
Supplier: The name of the supplier associated with the potential match.
Name: The name of the software component.
Sample versions: Versions that were extracted from the CVE vulnerability data.
Type of match: This shows sources used to determine a possible match, such as Alias, Name, CPE (Common Platform Enumeration), PURL (Package URL), or a particular package manager match.
If you need more information to make a decision, click the details icon. This will open the Match details modal, where you can view more versions of the dependency component and see reported vulnerabilities over time. A trend of reported vulnerabilities that aligns with your dependency versions suggests a strong match.
Create an alias: Once you determine the correct match, you can create an alias that links this match to your dependency. This alias ensures that future uploads of an SBOM containing this software dependency, version, and supplier combination will automatically use this alias.
Add a review note: You can also add review notes to keep your team informed about the status of the assessment, suggest further review, or highlight any critical risks associated with the software dependency.
After uploading your SBOM or manually adding a component, you might see a warning icon next to the component version, as well as a Fix version match status. This indicates that the version format doesn’t match the expected supplier version format.
Click Actions > Fix version for the component with the warning icon.
Check the version format to ensure it matches the known version number, make any necessary modifications, then save.
After uploading your SBOM or manually adding a component, you might see an error icon next to the component version, along with a Contact us match status. This indicates that we do not have a version parser for this specific version format.
If you see this icon, we're aware of the issue. However, if you need this resolved more quickly, please contact us for expedited assistance.
What happens when we add this version parser?
When we add support for a new version parser format, we will automatically reload any impacted SBOMs and their components to attempt to match them to known software in the NVD. You will be notified once the issue has been resolved.
How does this impact you?
If we find an exact match, any known vulnerabilities from the NVD will be brought forward. If you notice a discrepancy in the number of vulnerabilities, don’t be alarmed—this process is part of ensuring accurate tracking and reporting.
If we find multiple possible matches, you'll need to review these suggestions to determine the correct match.
If an exact match cannot be found in the NVD, it may indicate that the component does not exist in the NVD (implying no known vulnerabilities) or that it is listed under a different name. In these cases, you should:
Check the NVD to find the correct match.
Create an alias if needed, to link your software component correctly going forward.
If you notice a discrepancy in the number of vulnerabilities, don’t be alarmed—this is part of the process to ensure that your components are accurately matched and that vulnerability data is correctly reported.
If the issue persists, for assistance.
"Resilience is the capacity to recover quickly from difficulties. This should be the essence of your cybersecurity strategy"
-Stephane Nappo, 2018 CISO of the year
As you know, cybersecurity teams need to keep track of a myriad of things, including:
legacy debt
technology debt
dependency relationships
evolution of technology
doing more with less (smaller budget, fewer resources and tools)
medical devices that are always, periodically, or accidentally connected to the internet (Internet of Things (IoT))
last-minute priorities
unscheduled downtime
product evolution
zero-day vulnerabilities
auditibility
constantly evolving cybersecurity threats which necessitate a paradigm shift from putting cybersecurity responsibility on customers to ensuring security on the MDM side
issues getting the proper information from vendors to identify vulnerabilities and assess risk
This list is not exhaustive and is constantly growing. It's not something that your team can handle without everyone's cooperation and collaboration in identifying cybersecurity risk.
There are many nuances of medical device cybsecurity that you team needs to handle, including (but not limited to):
Development (Software Development Lifeycle (SDLC)
Shadow IT
Connected devices
Encryption of device communication to ensure data integrity and privacy
Data protection
Patient safety
"Resilience is how we go on the offensive in Information Security."
-Leigh McMullen, Gartner
To ingrain cybersecurity into your company culture, here are some suggestions:
Teach people about security and how to identify security concerns. Make them comfortable talking about security.
Ensure that everyone understands that they are each a stakeholder in protecting your company from cyber attacks
Hold people accountable for identifying cybersecurity concerns. Empower them to take quick action to resolve problems
Provide clear paths for people to escalate and de-escalate cybersecurity concerns
Institute a practice of continual risk assessment and management
CPE follows this format: cpe:<cpe_version>:<part>:<vendor>:<product>:<version>:<update>:<edition>:<language>:<sw_edition>:<target_sw>:<target_hw>:<other>
cpe_version
: This is the version of the CPE definition. As of this writing, the latest CPE definition version is 2.3.
part
: This can be one of three values: a for Applications, h for Hardware, o for Operating systems. It is sometimes referred to as type.
vendor
: This identifies the person or organization that manufactured or created this dependency component.
product
: This is the name of the system/package/component.
version
: This is the version of the system/package/component.
update
: This shows any update or service pack information, also known as minor versions.
edition
: This describes the build of the system/package/component beyond version.
sw_edition
(2.3 only): This indicates the language of the system/package/component, such as en-us for US English.
target_sw
(2.3 only): This indicates the language of the system/package/component, such as en-us for US English.
target_hw
(2.3 only): This indicates the language of the system/package/component, such as en-us for US English.
other (2.3 only): This indicates the language of the system/package/component, such as en-us for US English.
Anything that is a wildcard (*) means that no particular value was provided for that section, so it will encompass any applicable value in that section.
Examples
Application:
If the URI is cpe:/a:microsoft:office:2007:sp2:professional
then the CPE string is:
cpe:2.3:a:microsoft:office:2007:sp2:-:*:professional:*:*:*
Operating system:
If the URI is
cpe:/o:microsoft:windows_7:-:sp1:x64
then the CPE string is:
cpe:2.3:o:microsoft:windows_7:-:sp1:-:*:*:*:x64:*
Hardware (not supported in an SBOM):
If the URI is cpe:/h:3com:3c13612
then the CPE string is:
cpe:2.3:h:3com:3c13612:-:*:*:*:*:*:*:*
What does a wildcard indicate? Anything that is a wildcard (*) means that no particular value was provided for that section, so it will encompass any applicable value in that section.
You can filter down on vulnerabilities that are most likely to be exploited.
In the SBOM page, select the Any exploits filter, then select the exploit and threat information you want to focus on, including vulnerabilities that:
are on the CISA KEV list
are in the Exploit Database
have a Metasploit toolkit available
meet the criteria of the top 25 CWE list
You can also filter on vulnerabilities above or equal to a particular EPSS threshold. To do so, enter a number, such as 80, into the EPSS filter. This will return any vulnerabilities with an EPSS score of 80% or above.
Contact us if you would like access to our Helm API.
You can use the Helm API SDK to perform a variety of functions, including uploading one or multiple SBOMs, returning all unmatched SBOM entries, returning all vulnerabilities or just CISA KEV vulnerabilities, and generating FDA SBOM or CycloneDX reports.
The Helm API is currently available as a Python SDK. It is in protobuf, with the API SDK providing Python bindings as well as helper bash scripts with which to call the SDK.
SDK Version: 2.74.2
Download the API SDK file below, then verify that the MD5 checksum is `b65e44c7c6c11b740237a146b044f91e . Note that our API documentation is hosted on Gitbook, thus you will see an interim page that Gitbook is verifying the safety of this file -- this page unfortunately does not go away, but your file will complete downloading successfully.
Need C#? Our C# SDK is currently in feature preview. If you'd like to use this instead of our Python SDK, contact us.
Once you have been granted access to our Helm API, you'll need to download our API SDK, then generate your API key to make calls to the API.
To do so:
Click the Developers option on the sidebar. This will display the Developers page.
If you haven't followed the download instructions in the section above yet, do so now. If you're in the UI, you can also click the Get API SDK button (which will take you to this page).
Click the attached file in the section above to download it. Note that the Gitbook file security verification page does not go away, but the file does download successfully.
Verify that the SDK MD5 checksum is 550bee6dd3d7a5d80e5fb72bcebf16bc
After uncompressing this file, you will find a readme.txt
document that contains the rest of the steps to execute the API.
Make sure that you have the Python libraries that are in the requirements.txt
file installed before continuing.
In the Helm UI, you'll see your API user name which is also the Helm email address that you have API access for. This will be your client_id
that you will update in the scripts in the next steps.
In the Helm UI, click Generate API key. This will be your client_secret
that you will update in the scripts in the next steps.
We'll now switch over to the command line. From the command line, cd
to the directory api/run
. You'll need to update client_id
, client_secret,
and other parameters in four scripts: run_upload_sbom.sh
, run_unmatched_sbom_entries.sh
, run_vuln_list.sh
, and run_product_version_report.sh
.
In the run_upload_sbom.sh
script, update your client_id
and client_secret
.
Specify any other necessary parameters in this file. Refer to each script for specific parameters to update.
Run ./run_upload_sbom
.
Repeat steps 10-12 for the run_unmatched_sbom_entries.sh
and run_vuln_list.sh
scripts.
These are the API methods and definitions available in this API.
listorganizations: Lists the organizations that the user has access to.
listorganizationproducts: Lists the products a given organization has.
listorganizationproductversions: Lists the product versions of a particular product for that organization.
createorganizationproduct: Creates a new product under that organization with the provided product name. The user will have access to this product.
createorganizationproductversions: Creates a new product version under a selected product with the provided version name.
submitsbom:
Uploads an SBOM provided in the --sbom_files
parameter.
Allows the user to upload an SBOM under an existing product and product version.
Users can create a new product, product version, and upload an SBOM under this new version.
listunmatchedsbomentries: This lists all of your unmatched SBOM entries for a given SBOM product and version.
listvulnerabilities: This lists all vulnerabilities for a given SBOM product and version. You can also filter this down via --exploit_source
to CISA KEV vulnerabilities only, as detailed below.
requestreport: This issues a request to generate a product version report. The report generation process is asynchronous, so this may take a moment.
getreportrequeststate: This checks on the status of a requested report.
getreportfile: Once a report request is completed (report_request_state=4), the report file will be available for download.
There are four scripts for the Helm API:
run_upload_sbom.sh
run_unmatched_sbom_entries.sh
run_vuln_list.sh
run_product_version_report.sh
You can upload one or multiple SBOMs using the run_upload_sbom.sh
script. The following command-line parameters are available:
--client_id
: This is your API account username. In the Helm UI, this is the API user name.
--client_secret
: This is your API key that you will generate from the Helm UI.
--sbom_files
: This is the path to the SBOM file on your system.
--product_name
: This is the name of the product that you want to create a version for.
--version:
This is the product version that you want to create and upload an SBOM for.
--createProdVers
: If your product version doesn't already exist, you can create a new product version for a given SBOM product.
--api_url
: This is the API URL provided by Medcrypt.
--file_type
: This is the file type you'll be uploading. It only needs to be set if you are uploading a SPDX SBOM. If so, set to SPDX
.
When you've set your parameters, run ./run_upload_sbom.sh
.
You can return all unmatched SBOM entries for a given product and version using the run_unmatched_sbom_entries.sh
script. The following command-line parameters are available:
--client_id
: This is your API account username. In the Helm UI, this is the API user name.
--client_secret
: This is your API key that you will generate from the Helm UI.
--product_name
: This is the name of the product that you want to create a version for.
--version:
This is the product version that you want to create and upload an SBOM for.
--api-url
: This is the API URL provided by Medcrypt.
When you've set your parameters, run ./run_unmatched_sbom_entries.sh
.
You can return all vulnerabilities or just CISA KEV vulnerabilities for a given product and version using the run_vuln_list.sh
script. The following command-line parameters are available:
--client_id
: This is your API account username. In the Helm UI, this is the API user name.
--client_secret
: This is your API key that you will generate from the Helm UI.
--product_name
: This is the name of the product that you want to create a version for.
--version:
This is the product version that you want to create and upload an SBOM for.
--api-url
: This is the API URL provided by Medcrypt.
--start_date
: This is the start date at which to begin filtering vulnerabilities.
--end_date
: This is the end date at which to begin filtering vulnerabilities.
--exploit_source
: You can specify CISA_KEV
to get just vulnerabilities on the CISA KEV list. If you don't specify this, you will get all of your vulnerabilities. The default value is UNDEFINED.
When you've set your parameters, run ./run_vuln_list.sh
.
You can create and download an FDA SBOM or CycloneDX VEX report for a given product and version using the run_product_version_report.sh
script. The following command-line parameters are available:
--client_id
: This is your API account username. In the Helm UI, this is the API user name.
--client_secret
: This is your API key that you will generate from the Helm UI.
--product_name
: This is the name of the product that you want to create a version for.
--version:
This is the product version that you want to create and upload an SBOM for.
--api-url
: This is the API URL provided by Medcrypt.
--file_path
: This is the path where you would like a generated report to be saved to.
--report_type
: Specify either FDA_EXCEL
or CDX_VEX
to generate your FDA SBOM in Excel format or CycloneDX VEX report.
When you've set your parameters, run ./run_product_version_report.sh
.
If you need your organization name modified to accommodate company name changes, mergers, or acquisitions, just contact us!
This was pulled from the FDA Cybersecurity in Medical Devices - Frequently Asked Questions on October 12, 2023:
As provided by the Omnibus, the cybersecurity requirements do not apply to an application or submission submitted to the Food and Drug Administration (FDA) before March 29, 2023. If a cyber device was previously authorized, and the manufacturer is making a change to the device that requires premarket review by the agency, the law would apply for the new premarket submission.
Medcrypt expert tip:
There are some exceptions that you should be aware of: 1) If there is a change to your device that warrants a new pre-market submission (510(k)) or if you have a Class III device, almost all changes must be reviewed. If those changes are not reviewed, all changes must still be reported annually. 2) Post-market requirements for risk management all apply from a Quality System perspective. If you don't follow the guidance in how you manage risk, we strongly suggest that you should. Regardless, you still are required per 820 and 806 (corrections and removals) to deal with post-market issues, to which the post-market guidance applies.
In the Products (SBOM) page, select the product and version that you want to filter on. If you don't have a product and version selected. If not, you should be prompted to select one.
In the Vulnerabilities page, select the product and version that you want to filter on.
If you don't have a product and version selected in the Vulnerabilities page, you'll see all vulnerabilities for all products across all versions.
Risk management encompasses many areas:
Threat modeling: MDIC/MITRE Threat Modeling Playbook
Cybersecurity risk assessment: Postmarket Cybersecurity Guidance
Controls
SBOM and supporting info: NITA SBOM Framing Document
Testing: FDA Recognized standards AAMI/UL 2900-1:2017, Clauses 13-19 or IEC 81001-5-1: 2021, Clauses 5.5-5.7
Unresolved anomalies: Premarket Software Guidance
Traceability
A Quality Management System (QMS) is a structured system that documents processes, procedures, and responsibilities for continuously delivering high-quality products and services that meet regulatory and customer requirements. Its objective is to provide a framework that improves communication, collaboration, and consistency across your company, while also reducing waste and promoting a culture of continuous improvement.
Compliance with quality standards and regulations applicable to your company
Improved quality via continual improvement and streamlining of your quality processes
Increased customer satisfaction: Provide good quality products and services to keep your customers happy and less likely to churn.
Improved efficiency: Eliminating waste and streamlining processes increases efficiency and productivity.
Reduced costs associated with rework, waste, customer complaints, and employee attrition.
Improved communication and collaboration across your company, as well as between team members.
Versioning schema
In order to get new features to you as quickly as possible, if you are tracking versions in QMS, note that we currently have a web UI version and a core infrastructure version. Versions are depicted with web UI version first, followed by core infrastructure version, e.g., v3.2.0 | 2.71.1
How can I see my Helm versioning?
Click Help > About in the sidebar to view version information.
Dec 13, 2024
View and manage level of support and EOS/EOL data for all components
Specify lifecycle details for each component
Set component rules to consistently apply lifecycle information across all components in your portfolio
Enhanced component filtering
Export lifecycle information to FDA SBOM or CycloneDX SBOM
Bug fixes and UI improvements
We’ve added columns for Level of support and EOS/EOL to the components table, as well as providing color-coded badges to let you know what’s currently actively supported and what’s nearing or has passed its support or maintenance date. We’ve also begun ingesting lifecycle information from our partner, Tidelift, as well as the endoflife.date site, and will likely provide some automation for this in an upcoming release.
You can specify Level of support and EOS/EOL information in a date or text format for each component in the new Lifecycle details section of the component details panel. You can then set component rules to apply this information across all products, so you only have to do this once!
You can now create rules to set conditions for supplier name, component name, and version, then automatically apply the Level of support and EOS/EOL information across all of your products when conditions are met. With consistent EOS/EOL data, you minimize discrepancies across your portfolio, ensuring accurate reporting and compliance. Stay tuned for more rules-based workflow enhancements!
After applying your Level of support and EOS/EOL information across your components, quickly export your FDA SBOM to ensure you have everything you need for FDA submission! You can also export it to a CycloneDX SBOM.
To enable you to quickly find what you need, we’ve enhanced our filtering mechanism and added lifecycle management filters. You can now filter components on Level of support and EOS/EOL information to ensure you understand which are supported and which are nearing end-of-life, enabling you to prioritize upgrades in critical areas. Stay tuned for more filtering updates soon!
All CycloneDX remediation justification values should now be accurately exported in your FDA SBOM report.
All products should now display accurately on the components page.
Global search improvements
Fixed issue wherein components from archived products were being returned in the global search.
Global search results table display now extends to the bottom of the page.
A huge thank you to all of our customers who take the time to provide feedback on how we can continue to improve your SBOM vulnerability management experience! We’d love to hear your feedback on these features, as well as other features you’d like to see in the future!
November 21, 2024
Automatically generate component license information
Encode pURLs with spaces during exports
Import and export component hashes
Filter on CISA KEV and remediation through our API
Updated terminology from Vendor to Supplier in SBOM CSV export
You can now have Helm automatically add license information for your components. For any component that you want to enrich with license information, click Actions > Reload component. Note that reloading will discard any metadata you may have added to this component, such as review information, and will re-identify associated vulnerabilities, so you may see some discrepancy in your number of vulnerabilities for that component. This reduces your manual effort of tracking down licensing information, ensuring you have the latest license information available from our data sources.
If your SBOM has a Package URL (pURL) that contains spaces, we'll now automatically encode those when exporting. This ensures compatibility with third-party tools and eliminates issues caused by improperly formatted pURLs.
You can now import and export component hashes in your SBOMs, and can export them in any SBOM format, as well as our FDA SBOM, improving validation and tracking of SBOM component integrity across products.
You can now filter vulnerabilities that are the CISA KEV list or based on their remediation via our Helm API, making it easier than ever for you to identify and prioritize high-impact vulnerabilities.
To align with industry standards, the SBOM CSV export now labels the Vendor column as Supplier. This terminology update improves consistency and clarity.
November 7, 2024
Export EOS/EOL data to FDA SBOM report
Enhanced CPE parsing and matching
Added ability to filter dependency components by licenses
Re-added match and review information to dependency component details
Bug fixes and performance enhancements
If you have uploaded an SBOM that contains end-of-support (EOS) or end-of-life (EOL) data, this information will be automatically populated in your FDA SBOM report. We're in the process of adding the ability to manually add EOS/EOL info, so stay tuned!
We've enhanced CPE parsing to enable the matching of incomplete CPEs to dependency components. Although a CPE has 13 segments, not all CPEs contain all of those segments, thus Helm will now interpret CPEs that have at least 5 of the expected segments, filling in missing segments with a wildcard (*).
We've enhanced CPE enrichment to enable dependency component matching even in scenarios where the dependency components have the scenario wherein CPEs have multiple vendors.
You can now filter your dependency components by license, including those with specific licenses, no license, or unknown license status. This filtering capability helps quickly identify and mitigate license-related risks, such as copyleft licenses or unknown license statuses that may impact IP.
The match and review details have been re-added to the dependency component details panel to help you quickly access key information.
Resolved intermittent failure of large CycloneDX and SPDX SBOMs due to timeouts.
Improved load time of vulnerability and dependency component pages.
Fixed display issue with rescored CVSS vector strings, ensuring accurate low, high, and none values.
October 4, 2024
Enhanced dependency component panel
License management is now available!
Customize your FDA SBOM export
Bug fixes, UX enhancements, and help updates
Manage your dependency components more easily with our unified details panel, providing a comprehensive view of each dependency component. You can now quickly scan information in view mode, then switch to edit mode if you need to make any modifications.
Helm now supports the ingestion of licensing information from CycloneDX and SPDX SBOMs. Via our partnership integration with Tidelift, Helm will analyze your dependency components to determine if you are missing license information, then will automatically fix that for you, ensuring you have a comprehensive view of your legal risk. We support both SPDX and custom licenses. You can also manually enter or modify license details as needed. Check out Manage licenses for complete information on our new licensing feature!
We've just made our expert FDA SBOM even better! When exporting your FDA SBOM, you can now include CycloneDX and VEX vulnerability remediation analysis, as well as review information for dependency components. These enhancements will help ensure you're ready for your FDA submission. Thank you to our customers for highlighting their need to include review statuses and notes! We very much appreciate your insights and expertise in continuing to enhance your SBOM vulnerability management and streamline your FDA submission process!
Bug fixes:
Fixed the date filter on the Vulnerabilities page such that the start date is now midnight and end date is 11:59:59 pm. This fixes both the date range presets as well as the timeframes covered in the new vulnerability emails.
UI enhancements
Improved dependency component matching to handle dependency component names prepended with special characters, such as "@".
Updated dependency component lists to show all dependency components, even when they match the same NVD product and version. Your SBOM export will also include this higher level of specificity.
Help updates: To quickly get you up to speed on these new updates, we've added or extensively revised the following topics:
September 24, 2024
Implemented human-readable URL parameters
Bug fixes and performance enhancements
We've implemented human-readable URL parameters across the entire UI, which now reference unique IDs of products, product versions, components, and vulnerabilities, as well as applied filters and searches, and more. You'll also see this improvement when you sign in to Helm from new vulnerability emails you receive. This deep linking enables you to more easily share information. These enhancements prepare Helm for upcoming features like breadcrumb navigation and expanded bulk actions, beginning with bulk remediation.
Resolved a performance issue to enable Helm to handle large volumes of vulnerabilities, minimizing timeouts and unexpected errors.
Fixed issue wherein some SPDX exports were failing under specific conditions, particularly with larger SBOMs.
Enhanced SBOM dependency component rescanning and matching, improving reliability when the initial scanning process fails during an SBOM upload or when the dependency component is manually added.
September 9, 2024
Enhanced matching for Linux packages
We’re excited to announce a major improvement to our Linux package matching process, increasing efficiency by reducing manual work for users.
Previously, some Linux packages without identifiers in SBOMs were challenging to match. After collaborating with customers to address this issue, we’ve just released a solution that delivers a 29% improvement in matching accuracy.
As shown in the graph below, you can see a significant reduction in unmatched components and a clear increase in matched components after applying this enhancement. This means fewer manual interventions and more streamlined package management.
August 30, 2024
Helm's new design system is live: Work smarter and stay focused
Multi-task and remediate risk faster across multiple Helm tabs
Help updates
We’re thrilled to announce that Helm’s new design system is now live! 🎉
When you next sign in to Helm, you’ll notice a refreshed look-and-feel to enhance your experience and streamline your workflow. Here’s a quick overview of what you’ll see:
Light and dark themes: Choose between our newly updated dark theme or our brand-new light theme. To switch themes, click the sun/moon icon in the main navigation bar.
More intuitive badges and colors: We’ve standardized and enhanced our badges and color schemes for quicker component matching and vulnerability prioritization.
Enhanced UI elements: Enjoy a cleaner and more intuitive interface with refined controls, error handling, and new icons to improve navigation and usability.
Customizable data display: Take control of how you view and interact with data. You can now adjust table column visibility, perform multi-sorts, and choose your preferred display density.
Contextual actions: Easily access additional information or perform actions directly from tables by clicking on cell values.
Our new design offers even more flexibility in how you view and manage your data:
Content refresh setting: Take charge of your data updates by setting auto-refresh intervals or turning it off entirely. You can also refresh manually refresh.
Pagination: Navigate large datasets with ease using our new pagination feature, ensuring you don’t lose your place.
Customizable columns: Tailor your tables to display exactly what you need. Use the Columns link to show or hide specific columns and hover over column headers to drag and drop them into your preferred order with the … icon.
Multi-column sorting: Focus on what’s important by applying complex sorts across multiple columns. Access this feature through the Sort fields link at the top of each table.
Flexible display density: Optimize your view by selecting a compact or expanded display mode and adjusting the number of rows per page to suit your preferences.
Advanced date picker: Gain precise control over date filtering with options for absolute/relative dates, custom ranges, and multi-month views.
If you’ve tried to have multiple Helm tabs open, you may have found yourself signed out. Great news! You can now work in Helm across multiple browser tabs.
As part of our new design system, we've completely revised several related topics to help you match dependency components and remediate vulnerabilities faster:
August 13, 2024
Automated enrichment of missing CPEs and PURLs
Automated enrichment of missing licenses for open-source components
During the component matching process, if a component in your SBOM does not have a CPE or PURL (not ingested or manually added), Helm's AI copilot will now automatically generate and assign the appropriate enriched CPE or PURL to that component. You can view any Enriched CPE or Enriched PURL in the component details. This information will be included see this information in the components table in now export this enriched info for any FDA reports that include SBOM components, including your enriched SBOM, FDA SBOM, or VDR report.
For your open-source SBOM components that have PURLs, but do not have licenses identified yet, Helm will check whether those components have licenses. If so, Helm will automatically enrich those components with that license information. Helm will not change the license information for any components that already have one or more licenses identified. This information will be included in any FDA reports that include SBOM components, including your enriched SBOM, FDA SBOM, or VDR report. As mentioned in our last release, we are in the process of adding this functionality to the UI, and you will soon be able to view, edit, and track software licenses across your supply chain.
July 15, 2024
Export license information in SBOM
Bug fixes
You can now export license information for any FDA reports that include SBOM components, including your original or enriched SBOM, your FDA SBOM, or your VDR report. We are in the process of adding this functionality to the UI, and you will soon be able to view, edit, and track software licenses across your supply chain.
Fixed issue where CPE or PURL information would not display in some instances
June 21, 2024
Added remediation evidence to vuln export
Enhanced severity filtering
Ingest CycloneDX SBOM entries that have an empty or omitted Type field
Ignore vendors set to OpenEmbedded() in SPDX SBOMs generated with Yocto Linux
Bug fixes and UX improvements
We've enhanced our vulnerability export functionality to include remediation evidence for each vulnerability. This provides a clearer picture of the actions taken to address vulnerabilities, enabling you to more easily demonstrate compliance and the remediation steps taken or planned to secure your products.
We've refined vulnerability severity filtering to prioritize rescores over base scores. This ensures that you can better prioritize vulnerabilities based on their actual risk, helping you focus on the most exploitable issues first.
We now support the ingestion of CycloneDX SBOM entries that have an empty or omitted Type field.
If you are generating your SPDX SBOM using Yocto on Linux, it will often generate OpenEmbedded() as a vendor, which is not helpful for matching purposes. We will now ignore this value, maintaining a cleaner and more relevant database.
Fixed exporting CVSS scores in VEX and VDR reports for SBOM entries that do not have a CVSS score. Our exports now reflect a blank score field instead of the previous default of -1.0 when a CVSS score is not available.
Enhanced new vulnerability email subject to handle edge cases, including ensuring that vulnerability emails are sent on the expected day, regardless of time zone.
June 6, 2024
Automatic enrichment of CVE vulnerabilities with CPEs
Automatically create product versions and upload SBOMs with our GitHub action
Enhanced information in vulnerability emails
Fixes for SPDX SBOM upload failures
Support for SPDX SBOMs with NOASSERTION in supplier field
Added CycloneDX and VEX remediation status filters
Added Source column for vulnerabilities
Support for .zst SBOMs generated by Yocto on Linux
Bug fixes and UX improvements
Our advanced Large Language Model (LLM) now enriches vulnerability data from the National Vulnerability Database (NVD), which has not kept pace with CPE and other data enrichment for the past six months, leaving those of us in the cybersecurity space in a bit of a quandary.
To remedy this issue, we have fine-tuned an LLM to replicate and possibly enhance the data processing traditionally performed by the NVD. Below you can see how this interim approach can help you to deal with this gap. Refer to our blog for more details.
Our approach identifies vulnerabilities impacting your products and automatically enriches the information retrieved from the NVD with CPE data, aiding in more precise identification of vulnerabilities. This provides you with a more complete view of your overall risk, and ensures that you're focusing your time and effort on the most exploitable vulnerabilities that are affecting your product. Vulnerabilities that came from the NVD, and through our CPE enrichment, were identified as impacting your products will have an AI badge in the new Source column on the Vulnerabilities page.
You can easily integrate Helm into your CI/CD process to streamline and automate the process of creating product versions and uploading SBOMs to Helm. You can either use our GitHub action independently or integrate it into your existing GitHub action workflow, enabling you to maintain comprehensive and up-to-date documentation of your product's components, dependencies, and vulnerabilities with minimal effort.
If you're one of the cybersecurity experts who doesn't have any new vulnerabilities for the day/week/month cycle, congratulations! These updates include handling the scenario of zero new vulnerabilities and providing clearer details on the period covered by each email.
We've made a number of back-end improvements to help ensure that your SPDX SBOMs upload successfully.
We now treat suppliers set to NOASSERTION
in SPDX SBOM files as undefined when importing this information into Helm, thus the Supplier column for that vulnerability will show as a blank.
You can now filter vulnerabilities based on their CycloneDX and CycloneDX VEX remediation statuses, enabling more precise vulnerability management.
We've added a Source column to the Vulnerabilities page. This allows you to identify whether a vulnerability originated from an external data source (currently only NVD) or came from the NVD, but was enriched via our LLM AI. Vulnerabilities enriched with CPE data and identified as impacting your products will display an AI badge in this column on the Vulnerabilities page.
Helm now supports SPDX SBOMs that are in .zst
compressed files, which are automatically created when using Yocto Linux native SBOM generation capabilities."
Fixed issues with multiple toast notifications for some SBOM uploads
May 13, 2024
Auto-update vulnerability temporal metrics across product version
Enhanced dependency component matching for fewer unmatched components
Purl and cpe id’s now considered in sbom entry uniqueness
Enhanced CycloneDX SBOM and VDR reports with bom-refs for unmatched components
Performance improvements on SBOM page loading
Enhanced CycloneDX VEX and VDR reports with vulnerability rescores
New sign in page
Bug fixes and UX improvements
Let us take some of the load of managing vulnerabilities off of you! When you create or modify a rescoring profile for product version, you can set all V3 vulnerabilities for that version to automatically rescore with any changes to their temporal score metrics coming from the NVD. This enhancement streamlines your vulnerability management process, ensuring that temporal scores reflect the most up-to-date information, saving you time spent manually monitoring and updating this information, thereby reducing the risk of missing critical updates, so you can ensure you're focusing on the vulnerabilities that matter most.
You can also set individual vulnerabilities to automatically update their temporal scores based on NVD data refreshes. This timesaving feature ensures your vulnerability information stays current with minimal manual effort.
We've improved our dependency component matching algorithm to better handle scenarios where a vendor of an unknown dependency component doesn't directly match known software. We will now automatically match unknown dependency components that have CPE and PURL matches, but have an incorrect supplier. Previously, these dependency components were initially marked with a Not found in NVD status, but could actually be resolved to the correct component via our match suggestions. Helm now identifies the corresponding known software, which will either be uniquely identified or will have a Multiple matches status (if there are still multiple possibilities). Our enhanced matching process should result in fewer unmatched components, thus ensuring more accurate and efficient component resolution.
We have added CPE and PURL IDs when determining if an SBOM dependency component is unique or is a duplicate.
In response to feedback, we've added the CycloneDX bom-ref
parameter to all dependency components in your SBOM export, enabling you to point each vulnerability back to a dependency component, regardless of whether it is matched to known software. Initially, the bom-ref only displayed for matched dependency components. For any unknown (unmatched or not uniquely matched) software, this will be the unique ID that was generated for that SBOM dependency component when it was added to Helm. This will now be in your SBOM or VDR report.
We've made a number of coding and query improvements to load SBOMs more quickly, which may also improve load time for your vulnerabilities.
If you've rescored your vulnerabilities either across a product version or individually, your CycloneDX VEX and VDR reports will now include vulnerability rescore information. This will now align with the Vulnerabilities report. You will now see a ratings
section in your JSON file that will include a rating for any rescore on that vulnerability. For vulnerabilities rescored both at the product version level and individually, all associated scores will be included. While CVSS v2 scores remain static, they are also included in the ratings
section to provide a comprehensive view. The source for all score data is set to Medcrypt Helm.
We've replaced our initial sign in page with a new look-and-feel. After clicking Sign in, you'll be prompted to enter your username and password on our authentication page.
April 30, 2024
Rename products and versions
Enhanced granularity for CVSS score filtering
UX improvements
In response to customer feedback, we've added the ability for you to rename products and versions right from the product and version drop-downs on each page of Helm. Simply hover over the product or version in the respective drop-down to display the edit icon, then edit the product name or version.
We've improved the CVSS score filtering functionality to support floating-point values, allowing you to pinpoint vulnerabilities with greater precision. Now you can filter vulnerabilities using specific scores like 7.9, which will return everything from 7.9 to 10. This will enable you to precisely target and remediate vulnerabilities that fall within a more granular threshold.
Enhanced API key generation from the UI
Improved loading performance
April 11, 2024
Enhanced support for large SBOMs
CycloneDX 1.5 support
Daily and monthly digests for new vulnerabilities
Bug fixes, UX and doc improvements
Our platform now let you upload SBOMs of up to 50MB in size. This significant enhancement enables organizations with larger software inventories to efficiently manage and analyze their software bill of materials within our platform.
You can now upload your CycloneDX 1.5 SBOM to Helm. Any information in your file that is not currently supported in Helm will still be retained if you want to export either your original or enhanced SBOM.
In response to customer feedback on our new weekly email digests that keep you informed of the latest new vulnerabilities impacting your products, we've expanded this offering to include daily and monthly digests. You can choose one or more email frequencies based on your needs, and can manage your email preferences in your user profile.
Fixed issue where loading page status displayed on the Vulnerabilities table after sorting columns. The Vulnerabilities Detected/Updated field now sorts only by date detected and not by date updated.
Resolved caching issue where some dependency components would not display when the SBOM page was filtered.
Adjusted permissions to allow non-admin users with SBOM and Vulnerability modification access to create rescore profiles for product versions.
Numerous UI improvements
Updated doc: Get email updates on new vulnerabilities
March 22, 2024
Processing modals
Bug fixes and UI improvements
New & updated docs
For larger SBOMs that can take longer to load, we've added a processing modal so you'll know when your upload is completed and whether it was successful. Similarly, we've added a processing modal for other operations that could take longer, including when you're rescoring a lot of vulnerabilities across an entire product version or if you've just added a dependency component manually and we're attempting to automatically match it to known software in the NVD or package manager.
We've improved performance when filtering your SBOM. We also fixed a bug where filters were not persisting if you copied a Helm URL that included a match status to another tab, or if you navigated from a filtered item from the global search results (Discover) page.
We've added and enhanced "empty state" pages to help you get started quickly, improved visibility of system status, enhanced our RBAC permissions, and made other UI improvements.
Since we're continually adding and enhancing great new features, we want to make sure you can take advantage of all the new functionality, so we'll let you know any important doc updates in this section.
Enhanced docs:
Manage users: Added user roles to help you manage user permissions
Link unmatched software to known software: Added new info on aliasing and removing an alias.
March 14, 2024
Added VDR (Vulnerability Disclosure Report) report
Email notifications for new vulnerabilities
Support for CycloneDX XML SBOMs
Enhanced API documentation
Bug fixes and other improvements
As part of our continuous commitment to fulfill your FDA SBOM and cybersecurity vulnerability needs, we've added VDR (Vulnerability Disclosure Reports) to our suite of reports. Offering comprehensive insights into identified vulnerabilities, these reports equip you with proactive mitigation strategies, bolstering your defense against emerging threats.
Never miss a beat with our new vulnerability email notification system. Stay ahead of the curve by receiving timely alerts for any new vulnerabilities impacting your software supply chain. Manage your preferences effortlessly through your user avatar > My profile in the top navigation area of Helm.
You can now upload your CycloneDX in XML format for improved compatibility and versatility.
Automate your calls to our Helm application using our robust API. You can upload an SBOM for a new or existing product and version, get a list of all unmatched entries, and a list of all vulnerabilities.
We've made numerous enhancements to improve the UI and SBOM loading performance.
Thank you for your continued support and feedback as we strive to deliver top-notch solutions to meet your evolving cybersecurity needs! Let us know if you have suggestions on how to improve your experience!
February 15, 2024
VEX reports
Improved vulnerability query performance
Introducing VEX (Vulnerability Exploitability eXchange) reports – the latest addition to your cybersecurity arsenal! These reports focus on vulnerability exploitability, ease of exploitation, and potential impact. Now, effortlessly communicate vulnerabilities with a VEX remediation status, empowering your customers to focus on fixing the vulnerabilities that matter most.
Stay tuned! As a part of our continuous commitment to fulfill your FDA SBOM and cybersecurity vulnerability needs, we will be adding VDR (Vulnerability Disclosure Reports) to our suite of reports soon. Offering detailed insights into identified vulnerabilities, VDR reports equip you with comprehensive understanding and proactive mitigation strategies, ensuring robust security posture against emerging threats.
January 29, 2024
FDA-ready reports
Export SDPX SBOM
New About modal
Get the Medcrypt advantage with the only FDA expert-crafted SBOM that ensures you meet FDA SBOM requirements! In addition, you'll now get a suite of reports to make meeting FDA cybersecurity requirements a breeze, including your enhanced SBOM in CycloneDX or CSV format, as well as your vulnerabilities in CSV format.
In our continuous commitment to fulfill your FDA SBOM and cybersecurity vulnerability needs, we will also be adding VDR (Vulnerability Disclosure Reports) and VEX (Vulnerability Exploitability eXchange) reports to our suite of reports soon. VDR reports provide detailed insights into identified vulnerabilities, providing a comprehensive understanding of vulnerability details, impact, and mitigation strategies to proactively respond to potential security threats. VEX reports focus on the exploitability of vulnerabilities, how easily they can be exploited, and their potential impact.
You can now export your original or enhanced SPDX SBOM in JSON. For an enhanced SBOM, you can also include PURL and CPE info for any matches, as well as include all associated vulnerabilities.
You may have noticed that the bottom bar where your Helm version displays has been removed. Don’t worry, you can still get to your version from the sidebar > Help > About. This will launch an About modal, where you can see your current Helm version.
January 4, 2024
Added ability to remediate vulnerabilities
Bug fixes, UI, and performance improvements
You can now remediate vulnerabilities to add granular status information, including tracking remediation changes and providing evidence for why changes were made. For each vulnerability, you can now set a CycloneDX 1.4 and/or CycloneDX 1.4 VEX status, or both. We're adding a more robust audit trail, and you can see the next step toward this in the Vulnerability details modal. You can see any interim statuses and notes you provided manually, as well as automatic tracking of any new remediation changes. If you set any interim statuses, the last one you set will now be reflected in that vulnerability's VEX status.
Fixed issue where a rescore profile would fail when rescoring large numbers of vulnerabilities
Several UI and experience improvements
December 7, 2023
Rescore all vulnerabilities in a product version via rescore profiles
Rescore individual vulnerabilities
Support for SPDX SBOMs
Enhanced SBOM export now includes CPE and PURL data
New exploits and threats info, including EPSS and CISA KEV
Bug fixes and other improvements
You can create and apply rescore profiles to a product version based on your product's particular environment and usage, ensuring you're focusing on the most exploitable and impactful vulnerabilities. Any newly detected vulnerabilities for that product version will be automatically rescored with that profile.
You can now rescore the CVSS v3 score of any individual vulnerability associated with a particular product version so that it reflects your product's particular environment and usage. This will override any rescore profile already applied to the associated product version.
You can now upload SPDX SBOM files, including those generated using Yocto on Linux. You can take all of your generated SPDX files, zip them using WinZip or gzip, then upload that zipped file to Helm. We'll do the rest!
When you upload your SBOM, we'll attempt to find exact matches in the NVD, as well as in supported package managers. If we find an exact CPE or PURL match in a package manager or if you manually specify the CPE and/or PURL for a dependency component, you'll now be able to export an enhanced SBOM that includes CPE and PURL data.
You can now benefit from robust exploit and threat information from a variety of sources, including CISA KEV, ExploitDB, Metasploit, and Top 25 CWEs. You can also ensure that you're focusing on the most impactful and exploitable vulnerabilities via EPSS scores.
Improved performance when loading SBOM and vulnerability information
Improved onboarding to get you started or unstuck quickly. We now provide in-page guidance to help you upload an SBOM, view dependency components for a particular product version, or expand your search criteria when there are no results. You'll see these in our SBOM, Vulnerabilities and Discover (Global search) pages.
Numerous user interface improvements
November 2, 2023
Windows KB patch support
In-app status notifications
Performance and user experience improvements
Although a lot of medical devices run on Microsoft Windows operating systems, the NVD does not account for vulnerabilities having been patched by Windows KBs, making it very difficult to understand what vulnerabilities might still be impacting your device. You can now add KBs to your devices running a Windows OS, aligning your digital product version with your physical test device and thus ensuring that you have an accurate list of vulnerabilities that impact your Windows device.
You’ll now see in-app status notifications in the top-right corner to let you know that an action has been completed, such as uploading an SBOM or applying KBs to a product version.
We’ve made significant performance improvements, as well as several enhancements to improve your user experience.
We welcome your feedback on these new features, and would love to hear about other feature suggestions that would further enhance your experience.
If you would like a V&V report for your QMS, contact support.
November 2023
Allowing SBOMs that pass NTIA minimum requirements
Performance improvements and bug fixes
We improved our capabilities to handle SBOMs that pass NTIA minimum requirements. If the SBOM you are uploading is an invalid CycloneDX SBOM, Helm will still accept it and process it for vulnerabilities.
This release has improvements to performance and a few bug fixes on the dashboard page.
November 2023
Performance improvements and bug fixes
Online help documentation added
This release has a lot of improvements to performance and a few bug fixes. You should be having a faster, more responsive experience.
We’ve added a lot of great information to ensure you can get started, get your SBOM dependency components matched quickly, and begin (or continue) to assess and mitigate your vulnerability risk across your software supply chain. Check it out on helm.docs.medcrypt.com!
November 2023
New Get started modal
Export SBOM with vulnerabilities
Combined Upload SBOM modal
Improved feedback when SBOM fails to upload
Other usability improvements and bug fixes
If you haven’t uploaded any SBOM yet or created one manually, you will see a new Get started modal pop up when you sign in to Helm. You’ll have four different options:
You need help with your FDA submission: You can request help from our expert Services team and leverage our best practices, templates, and checklists in improving your FDA submission.
You have a CycloneDX format. You can upload your SBOM file all in one step.
You have an SBOM in another format. You can contact us and we’ll get right back to you to get you moving.
You don’t know what an SBOM is or don’t have one yet. We’re here to help. Our expert Services team will help you create your SBOM, assess your current state, and help you identify and mitigate cybersecurity risks.
You can now choose to export your original SBOM or your enhanced SBOM with identified vulnerabilities. This will include the source name (currently always the NVD), a link to the vulnerability, both its v2 and v3 CVSS scores and vector strings, when the vulnerability was first detected, when it was updated, and more. Refer to Export your SBOM for more information.
We’ve simplified your upload experience. If you’re uploading your first SBOM, you’ll see an Add SBOM drop-down button, from which you can select Upload SBOM. You can now browse to your SBOM file and specify your product name and product version in one step. Once you’ve uploaded at least one SBOM, this drop-down button changes to Manage SBOMs. In that case, you’ll be able to either select an existing product name and version, or create a new product name/version pair.
If you upload an SBOM file, you can hover over the FAIL status to get more information on why the file failed to upload, including scenarios such as: missing required fields, additional fields present that are not defined in the JSON schema when the schema does not allow additional properties, and field values not matching expected data types.
October 2023
Added match status tokens and enhanced status indicators
Added CPE and PURL package manager support
Enhanced details for dependency components
Enhanced filters for SBOMs
In-product help added
In response to customer feedback on the importance of knowing whether a dependency component is or is not found in the NVD, we’ve added two tokens: NVD and NOT IN NVD. We’ve changed the NVD status column to Match status, and improved the status labels. You’ll now see:
Green checkmark next to Matched status when you have an exact match. You’ll also see the respective tokens that we used to make that match or that a user matched via selecting a match suggestion or creating an alias.
Yellow indicator next to Multiple matches status when you have multiple strong matches. You’ll be able to see the sources that the match suggestions are coming from, and will need to resolve this by selecting one of our suggestions or creating your own alias.
A red error indicator next to Not found status and NOT IN NVD token indicates that weren’t able to find a match in the NVD. This could mean that there are no known vulnerabilities or that your software has a different name in the NVD, so you’ll need to resolve these to make sure that you understand whether it is a risk or not.
Our valued customers asked for this and we delivered! We now support CPE and PURL (Package URL) matching. We support the following PURL package managers: Cargo, NPM, NuGet, and PyPI. If you upload an SBOM, you'll automatically find any matches in these package managers. You'll see a token, such as NPM, next to each dependency component that matches a package manager. See Match sources for more information.
Note: This is not retroactive, so in order to take advantage of this cool new feature, you'll need to upload a new version of your SBOM.
We’ve added a lot of information to your dependency component details, so that you can tell exactly how it was matched as well as letting you know the last review note any of your team members added. You can hover over any token
You can now filter by match source, such as NVD, CPE, Alias, one of our supported package managers, user-selected matches, and NOT IN NVD. You can also filter on review status.
We’ve added help icons to many columns and fields throughout the UI to get you started and unstuck. If you need more clarification on the help or if you have a question on something that doesn’t currently have help, let us know so that we can get it clarified or added.
If you run into issues or would like to request new features or feature enhancements, we'd love to hear from you! Thank you so much for taking the time to help us improve your experience!
We are working on adding some great new functionality, including:
Windows KB patching,
a customer-facing API to automatically ingest SBOMs as part of your CI/CD process,
the ability to copy/paste from a CSV or other file to create an SBOM,
more human-readable information,
complete CycloneDX ingestion and export,
SPDX support,
and other cool new things.
We'd love to get your feedback on these to make sure what we're creating will improve your management and mitigation of your software supply chain risk. It will also give you a great opportunity to let us know features and feature enhancements you'd like us to consider adding! Note that this link will create a support ticket that will let us know you're interested, then we'll contact you directly to set up some time to do some feature walkthroughs. Thank you so much for your insights and expertise!
September 2023
Enhanced global search
Changed date first detected time
Added date dashboard was last updated
Removed character restrictions on input fields
Added SSO support for PingID
Global search is now expanded to include searching across all your Product SBOMs for a particular dependency component. You can still search for a specific CVE via CVE-ID, now you get a summary of the vulnerability as well as a list of any products that might be potentially impacted.
The first detected date in Helm on the Vulnerabilities page now reflects the date when Helm detected the vulnerability for your dependency component.
On the Metrics dashboard you can now see when the dashboard was last updated.
Helm had strict character restrictions in input fields that have now been removed.
Helm supports SSO for organizations on the enterprise plan. We now have a working integration with PingID.
September 2023
Enhanced look-and-feel with new page layouts
Performance improvements and bug fixes
Both the Products page and the Vulnerabilities page now have a new look and feel as well as some new functionality for vulnerability filters.
This release has a lot of improvements to performance and a few bug fixes. You should be having a faster, more responsive experience.
CA
Certificate Authority. This is the organization which issues a certificate.
CEP
Component Environment Profile. This includes characteristics such as maximum impact of the component, whether the component is on the attack surface, whether there is data flow (and what data) to the component, etc.
CeQ
Our Cybersecurity-Enabled Quality System is a Medcrypt service offering.
CISA KEV
Cybersecurity & Infrastructure Security Agency Known Exploit Vulnerabilities
COTS
Commercial Off-the-Shelf Software. This is a software or hardware product that is commercially ready-made and can be bought, licensed, or rented by the general public. This is also referred to as Off-the-Shelf Software. See that definition in this table for more information.
CNA
CVE Numbering Authority, such as Microsoft.
CPE
Common Platform Enumeration.
Vulnerabilities can be identified through the use of three fields: CPE, PURL, and SWID. Helm supports CPE and PURL.
NIST defines CPE as a structured naming scheme for IT systems, software, and packages. It is based on the generic syntax for Uniform Resource Identifiers (URI) and includes a formal name format, a method for checking names against a system, and a description format for binding text and tests to a name. The CPE specification was designed for operating systems, applications, and hardware devices. It is maintained by the NVD.
CPE is recommended for use in identifying a client or server application, firmware, or operating system.
CQI
Continuous Quality Improvement
CSAF
Common Security Advisory Framework is a standard for machine-readable security advisories developed by the OASIS Open CSAF Technical Committee.
CSR
Certificate signing request
CycloneDX
This is derived from CycloneDX specification and use case information.
CycloneDX is a machine-readable SBOM format that describes the following types of components: applications, containers, devices, libraries, files, firmware, frameworks, operating systems. It also describes services. Helm supports CycloneDX.
CWE
Component Weakness Enumeration
EPSS
Model that tries to predict how often a vulnerability could be exploited in the wild.
HDO
Health Delivery Organization, such as a group of physicians working together.
HSM
Hardware Security Module. An HSM is a special 'trusted' computer performing a variety of cryptographic operations such as key management, key exchange, encryption/decryption etc.
NTIA
National Telecommunications and Information Administration
OSS
Open-Source Software. The FDA wants to make sure that you know what components are COTS or OSS. OSS and SOUP are often incorrectly used interchangeably. If you have OSS components, you will need to provide documentation to the FDA that it is either being actively maintained, or if it not being actively maintained or is EOL, you’ll need to provide information on how you are mitigating any vulnerabilities with that component.
OTS
Off-the-Shelf Software.
This information is derived from the FDA’s “Off-the-Shelf Software Use in Medical Devices” guidance.
As the use of general-purpose computer hardware becomes more prevalent, OTS software is being used more often in medical devices. However, it may not be appropriate for a specific use in a medical device. As an MDM, you give up software lifecycle control with OTS, but are still responsible for your device to continue to operate safely and effectively.
What do I need to document?
This will differ depending on your medical device and the impact on the patient, operator, or bystander safety if the OTS software fails. You will need to do a risk analysis to determine the level of documentation detail you need to provide to the FDA and the level of lifecycle control you will need as the severity of harm from OTA software increases.
PKI
Public Key Infrastructure provides secure encrypted communications and mutual authentication between devices, services and users. Through the use of digital certificates every connected 'thing' can be bound, by the use of public keys, to entities such as people and organizations. The use of these certificates creates a chain of trust between the connected device and a certificate authority that issued the certificates.
For PKI to work, you need a randomly generated cryptographic key pair to be generated for every single device manufactured. The key pair must be provisioned into the Root of Trust (RoT) of the microcontroller. The private key must be protected by the hardware RoT and the public part is held in a certificate, both of which are provisioned during manufacturing. The certificate will be signed by a certificate authority, thus providing a means of authentication for the identity.
Thus, the identity is not a unique ID or a Universal Unique Identifier (UUID), but the way in which the device or other component is identified by a randomly generated key pair. The public part of the key pair is provided in the form of a certificate which has been signed (authenticated) by a trusted certificate authority. The private part of the key pair is used to prove the identity.
PURL
Vulnerabilities can be identified through the use of three fields: CPE, PURL, and SWID. Helm supports CPE and PURL.
Package URL (PURL) standardizes how software package metadata is represented so that packages can universally be located regardless of what vendor, project, or ecosystem the packages belongs to. A PURL is an attempt to standardize existing approaches to reliably identify and locate software packages. It is a URL string used to identify and locate a software package in a mostly universal and uniform way across programming languages, package managers, packaging conventions, tools, APIs and databases.
QMS
Quality Management System. This is a structured system that documents processes, procedures, and responsibilities for continuously delivering high-quality products and services that meet regulatory and customer requirements. Its objective is to provide a framework that improves communication, collaboration, and consistency across your company, while also reducing waste and promoting a culture of continuous improvement.
QSR
Quality System Regulations
RA
Registration Authority
RDP
Remote Desktop Protocol. Allows users to remotely connect to and control another computer or device.
RoT
Root of Trust
SBOM
Software Bill of Materials. This encompasses all components that exist across your software supply chain, including components, licenses, copyrights, and security references.
SMB
Server Message Block is Windows computers in file, port, and printer sharing and other network services. If these protocols are not properly secured, an attacker could potentially gain access to a network and cause significant damage.
SOUP
Software of Unknown (or Uncertain) Pedigree (or Provenance) is a term often used in the context of safety-critical and safety-involved systems such as medical software. SOUP is software that has not been developed with a known software development process or methodology, or which has unknown or no safety-related properties.
SPDX
Software Package Data Exchange. SPDX is an international open standard from Linux enabling communication of SBOM information, including provenance, license, security, and other related information. It provides a machine-readable SBOM, as well as a human-readable one enabling you to share important data about your software ecosystem and improve transparency and cybersecurity risk mitigation.
SPDX is recognized as the international open standard for security, license compliance, and other software supply chain artifacts as ISO/IEC 5962:2021.
Helm does not currently support SPDX, though it is currently in design.
SSVC
Stakeholder-Specific Vulnerability Categorization. This is derived from CISA’s Stakeholder-Specific Vulnerability Categorization document.
This vulnerability analysis methodology accounts for a vulnerability’s exploitation status, impacts to safety, and prevalence of the affected product in a singular system.
CISA uses its own SSVC decision tree to prioritize relevant vulnerabilities into four possible decisions:
Track: Vulnerability does not require action at this time. Continue to track the vulnerability and reassess if new information becomes available. CISA recommends remediating these vulnerabilities within standard update timelines.
Track*: Vulnerability contains specific characteristics that may require closer monitoring for changes. CISA recommends remediating these vulnerabilities within standard update timelines.
Attend: Vulnerability requires attention from your internal supervisors, including requesting assistance or information about the vulnerability. This may involve publishing an internal or external notification. CISA recommends remediating these vulnerabilities sooner than standard update timelines.
Act: Vulnerability requires attention from internal supervisors and leaders, including requesting assistance or information about the vulnerability. This may involve publishing an internal or external notification. CISA recommends remediating these vulnerabilities as soon as possible.
These decisions are based on the following values: exploitation status, technical impact, automatable, mission prevalence, and public well-being impact.
SWID
Software ID (SWID) as defined in ISO/IEC 19770-2:2015 is used primarily to identify installed software.
Vulnerabilities can be identified through the use of three fields: CPE, PURL, and SWID. Helm supports CPE and PURL Helm does not currently support SWID.
SWID is recommended to be used for a container (as is PURL, which we do support), firmware (as is CPE, which we do support), library or framework (non-package), operating system (as is CPE), and operating system package (as is PURL).
TQM
Total Quality Management. This focuses on quality throughout your company, from design to customer satisfaction.
UUID
Universally Unique ID that is readable from most microcontrollers available today. This is not an identity, only an identifier. See PKI definition for more information.
V&V
Verification and Validation methods are used to ensure that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. V&V are critical to a quality management system (such as IO 9000).
VEX
Vulnerability Exploitability eXchange. This is the security advisory that a supplier will communicate regarding their analysis on a particular vulnerability as it relates to their software. Suppliers’ customers, such as hospitals, need to know whether this vulnerability is impacting the use of the device or not. Helm does not use VEX status conventions, but it is currently in design.
A VEX provides additional information on whether a product is impacted by a specific vulnerability in a dependency. If so, recommends actions to remediate. For example, a vulnerability in an upstream dependency is likely not exploitable in the final product for reasons including the affected code not being loaded by the computer or inline protections existing elsewhere in the software. Dependency suppliers issue a VEX to assert the status of a vulnerability in specific products. These statuses are:
Not affected: No remediation is required for this vulnerability
Affected: Actions are recommended to remediate or address this vulnerability.
Fixed: These product versions contain a fix for the vulnerability.
Under investigation: It is not yet known whether these product versions are affected by this vulnerability. An update will be provided in a future release.
VEXes are machine-readable, so users can integrate dependency data from SBOMs with vulnerability status information from VEXes to provide a current view of vulnerability status. This enables users to take a much more targeted approach to finding and remediating vulnerabilities in their software.
A VEX can cover more than one vulnerability in a product or across multiple products.
These are defined by CSAF, and can provide information such as remediation, workarounds, restart/downtime required, scores, and risks provided from vendors, system integrators, and operators.
VLCDB
Vulnerability Lifecycle Database
Vulnerabilities can be identified through the use of three fields: CPE, PURL, and SWID. Helm supports CPE and PURL. CPE stands for Common Platform Enumeration.
NIST defines CPE as a structured naming scheme for IT systems, software, and packages. It is based on the generic syntax for Uniform Resource Identifiers (URI) and includes a formal name format, a method for checking names against a system, and a description format for binding text and tests to a name. The CPE specification was designed for operating systems, applications, and hardware devices. It is maintained by the NVD.
If you have the Admin role in Helm, you’ll see an Administration icon on the sidebar. You can manage both your users and your products from here.
You can view all of your products, how many users have permissions to access each product, and change user permissions for each user. You can also find a particular product by searching on its name.
Product name: This is the name of your product.
Number of users: This shows the number of users that have access to this product.
You can click the edit icon in the Actions column to:
Add users that are already on your account to a particular product. You cannot add users that are not already on your account. If you need to add new users, contact us.
Set permissions for each user to view or modify SBOMs and Vulnerabilities. These permissions will also impact what reports this user will be able to export.
If you have the role of Admin in Helm, you’ll see an Administration icon on the sidebar. You can manage both your users and your products from here.
Contact us if you need SSO support.
You can view all users and their current permissions, indicated by their role. You can also find a particular user by searching on their name.
How do I add new users?
You can't currently add new users in Administration. Contact us to get them added for you!
Username: This is the user’s full name, followed by a role token that indicates their permission level. It cannot be changed by the user or admin. Helm has the following roles:
Admin: This user has access to everything in Helm, including products. If you do not want a user to have access to all products, make them a user, then edit their permissions for the appropriate products. Only Administrators can create aliases to link software in their SBOM to known software in the NVD. An admin may not change their own role, but they can change the role of other admins.
User: This user only has the permissions one of the Admins has specified, as detailed in User roles below.
Email: This is the user’s email address. It cannot be changed by the user or admin.
Actions: Click the edit icon to modify the user’s role.
You can assign users full privileges as Admins, or you can configure their permissions to view and modify your SBOM and vulnerabilities using these roles and permissions. You can set the SBOM role and Vuln role to combine permissions across SBOMs and vulnerabilities.
This role has full access to all products and vulnerabilities in the organization and is the only role that can:
Manage users
Create and remove products
Create and remove aliases (permanent links to known software)
Users can be granted permissions to view or modify SBOMs and vulnerabilities.
Requires SBOM modify and Vuln modify permissions. This role has full access to all products and vulnerabilities.
Requires SBOM modify and Vuln view permissions. This role has full access to all products, including:
View vulnerabilities
View recommended Windows KB patches for vulnerabilities
View full Dashboard
Export all FDA-ready reports
Requires SBOM modify and Vuln modify permissions. This role has full access to all products, including:
View vulnerabilities
View recommended Windows KB patches for vulnerabilities
View full Dashboard
Export all FDA-ready reports
Requires SBOM view and Vuln view permissions. This role can:
View products and SBOMs
View suggested matches for dependency components
View full Dashboard
Export all FDA-ready reports
Requires SBOM modify and Vuln none permissions. This role has full access to all products, and can:
View product information on Dashboard
Export these FDA-ready reports: SBOM in JSON, SBOM in CSV
Requires SBOM none and Vuln modify permissions. This role has full access to all vulnerabilities, and can:
View vulnerability information on Dashboard
Export these FDA-ready reports: VEX, vulnerabilities CSV
This role cannot apply Windows KB patches to vulnerabilities.
Requires SBOM view and Vuln none permissions. This role can:
View products and SBOMs
View suggested matches for dependency components
View product information on Dashboard
Export these FDA-ready reports: SBOM in JSON, SBOM in CSV, VDR
Requires SBOM none and Vuln view permissions. This role can view all vulnerabilities, and can:
View recommended Windows KB patches to resolve vulnerabilities
View vulnerability information on Dashboard
Export these FDA-ready reports: VEX, vulnerabilities CSV
An Admin can change the role of any other admin, but cannot change their own role. If you change an Admin to a User, you’ll then be able to set that user’s permissions to view and modify SBOMs, Vulnerabilities, which will impact what they will see on the Dashboard home page.
After creating a team member with the User role, you can set the appropriate product permissions for this user. Users can be given view or edit access to the SBOM and Vulnerabilities information for selected products. In the Manage users tab, click the edit icon next to the user you want to modify.
Change the role (Org role type) to Admin or User. This change will take place immediately as soon as you change the role value.
Click the Manage products tab, then click the edit icon next to the product that you want to add or modify user permissions to access.
If you want the user to have edit permissions for the SBOM, select Modify in the SBOM role column. This means that they will be able to: modify existing SBOM dependency components for any product and version, manually add new dependency components to any product and version, upload new SBOMs, apply KBs to products running a Windows operating system or to the corresponding vulnerabilities, select possible matches and create aliases for Multiple matches or Not found statuses, and add review notes for any dependency component. If you only want them to be able to view SBOM information, select View.
If you want the user to have edit permissions for vulnerabilities, select Modify in the Vuln role column. This means that they will be able to: resolve a vulnerability by changing its Product impact status. If you only want them to be able to view vulnerabilities, select View.
Click Save.