The FDA has released new cybersecurity regulations for medical device suppliers

The Food and Drug Administration (FDA) has announced that medical devices must now meet specific cybersecurity guidelines. Cyber-attacks against healthcare organizations increased by 74% last year, and attacks on the software supply chain have increased an average of 610% per year since 2020.

These new security requirements were introduced as part of a $1.7 trillion federal omnibus spending bill signed by President Joe Biden in December. The FDA must update its medical device cybersecurity guidance every two years.

What’s in the new requirements?

Device manufacturers must now submit plans to monitor, identify, and address post-market cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosures and plans, within a reasonable timeframe.  Suppliers must also make security updates and patches available on a regular schedule and in critical situations

The requirement for vulnerability disclosure is in line with what we are seeing from NIST, CIS and other standards organizations.  Unfortunately, many medical device suppliers do NOT currently have vulnerability disclosure programs.

If you want to learn more about DevSecOps and how it can help your teams embed security into the software development processes you can check out our blog post.

Medical device suppliers must also include a software bill of materials (SBOM) containing all commercial, open-source, and off-the-shelf software components while complying with other FDA requirements “to demonstrate reasonable assurance that the device and related systems are cyber secure.”

SBOMs need to be up-to-date, accurate and validated by a third party.  If you want to learn more about medical device SBOMs, you can check out our blog post on the subject.

So, how do can you address these new requirements?

Medical device suppliers who are building custom software and/or firmware will need to implement several technologies to address the new FDA requirements.  Let’s go through each of these one at a time:

• Asset discovery & management – The first place to start is with a asset discovery and management solution that will give you insight into what you have and is it internet connected.
• Application security analysis – Once you know what your assets are you need to make sure that the software you are building is secure.  Software composition (SCA) tools are a great place to start as they help you understand what open-source libraries are in your applications.
• Vulnerability management – Next up is implementing a vulnerability management platform that will find all vulnerabilities in your hardware and software and prioritize them for you.  This helps you prioritize what to focus on and what’s not really a problem.
• SBOM – The final part to addressing the FDA’s requirements is implementing an automated third-party SBOM program.  This can be added to your software development automation so that everytime a new release is built for your medical device its been tested and a SBOM has been created.

Paul McCarty

Founder of SecureStack

DevSecOps evangelist, entrepreneur, father of 3 and snowboarder

Forbes Top 20 Cyber Startups to Watch in 2021!

 Mentioned in KuppingerCole's Leadership Compass for Software Supply Chain Security!

Cyber attacks on medical devices are increasing

Cyber-attacks against healthcare organizations increased by 74% last year, and attacks on the software supply chain have increased an average of 610% per year since 2020.  These attacks can take various forms that attack the functionality and reliability of medical devices and the software that runs on these devices. This in turn, unfortunately, can lead to mistrust of the device and its manufacturer and ongoing brand damage.

Most medical devices have software running on them and often connect to software on computers, smartphones or mobile apps to share and exchange data.  Having multiple software components in these different places adds security challenges that many medical device suppliers aren’t properly prepared to address.  This is one of the reasons that the US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have partnered to create new regulations for medical device suppliers.

Traditionally, manufacturers of medical devices have not had visibility into what went into the software and firmware running on their devices.  This has led many organizations to try and find better ways for them, and their users, to find confidence in the security of medical equipment.

Government creates rules to address attacks

According to new government requirements, all medical device suppliers must submit a plan to monitor, identify, and address cybersecurity issues. They must also create a process that provides reasonable assurance that their device is protected. Additionally, applicants must make security updates and patches available on a regular schedule and in critical situations. Finally, they must provide the FDA with a software bill of materials, including any open-source or other software components their devices use.

SBOMs can help address software supply chain risks in medical devices

One way that medical device manufacturers can improve visibility is by implementing a Software Bill of Materials, also known as an SBOM.  An SBOM is a comprehensive list of all the software components running on a medical device.  This includes:

• Open-source and third-party software components
• Firmware and binaries
• Cloud resources
• APIs the device interacts with, or sends data to

The implementation of SBOMs is especially crucial for the medical device industry. Due to the potential risks of medical device software vulnerabilities, regulatory bodies such as the FDA, have made SBOMs mandatory for medical device manufacturers.

With an SBOM in place, manufacturers can identify vulnerabilities and take action to address them before they can be exploited by attackers. This can help reduce the risk of harm to patients and ensure that medical devices are safe and reliable.

Government and industry requirements for SBOM

• US Federal Government:  On December 29, 2022, the White House signed H.R. 2617, the Consolidated Appropriations Act 2023, which included several cybersecurity provisions.  This bill introduces new requirements for medical device manufacturers to ensure that their devices meet certain minimum cybersecurity standards. These requirements will take effect 90 days after the bill is enacted and include:
  • This involves monitoring, identifying, and addressing cybersecurity vulnerabilities and exploits that arise after a product has been released to the market. This includes coordinated vulnerability disclosure, as well as requiring the release of software and firmware updates and patches to address these vulnerabilities.
  • It also requires medical device manufacturers to provide a Software Bill of Materials (SBOM) to the FDA Secretary, which includes all off-the-shelf, open-source, and critical components used by the devices.
• FDA:  The Food and Drug Administration (FDA) has published the “Cybersecurity in Medical Devices” guidance document.  You can find all of the FDA’s guidance on cybersecurity here.
• IMDRF:  The International Medical Device Regulators Forum has published two documents about SBOM.  The first is the “Principles and Practices for Medical Device Cybersecurity” and the second is the “Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity“.
• US Department of Health and Human Services:  HHS has published the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients (HICP)” document.
• Australian Department of Health and Aged Care:  The Australian TGA has released the “Medical Device Cyber Security Guidance for Industry” document.

How do medical device suppliers get started with SBOM?

All federal agencies mentioned above believe that SBOMs should be automatically created during the software development process.  Moreover, these SBOMs should be as descriptive of the actual application running on, or connected to, the medical device it supports.  To do this, organizations need to have a process that identifies the different steps involved in software development, creates the SBOM and then makes them available for the business to gain value from.  We believe the best way to do that is to create a SBOM lifecycle policy.

There are five stages in the SBOM lifecycle: Asset discovery, application data analysis, SBOM creation, SBOM storage and SBOM searchability.

Let’s go through each of these stages one at a time.

Many SBOM tools don’t support medical device SBOMs

Most SBOM tools that exist right now, focus on showing customers some of the open-source libraries that they are using in their applications.  Moreover, most SBOMs are stand-alone JSON documents and by themselves don’t provide much value.  Even worse, many SBOMs are created once and then never updated so they quickly become out of sync with the actual device and applications they are supposed to describe.  Medical device manufacturers need to make sure their SBOMs are up-to-date and accurate.

Automate SBOMs for medical devices and client applications!

SecureStack automates the whole process of collecting data and building SBOMs from beginning to end.  We sign and attest our SBOMs so you can provide our reports and data to the government, partners, auditors, or anyone else you choose to.  Our platform delivers all stages of the SBOM lifecycle in a fully integrated solution that is incredibly easy to onboard.  We find all your application assets, automate the creation of your SBOMs, store them for you in a secure central repository, and make them searchable.

Paul McCarty

Founder of SecureStack

DevSecOps evangelist, entrepreneur, father of 3 and snowboarder

Forbes Top 20 Cyber Startups to Watch in 2021!

 Mentioned in KuppingerCole's Leadership Compass for Software Supply Chain Security!

SecureStack is excited to announce that we now support Azure DevOps through the use of our native Azure Pipelines templates!

SecureStack provides comprehensive security coverage with our brand-new Azure DevOps integration.  Our customers asked us to support Azure DevOps so we’ve delivered!  You can now generate a custom pipeline template document right from the SecureStack SaaS web portal and copy that directly into an Azure pipeline and have it work.  No changing it to work or customization is necessary.  Just drop it in and it runs!

One Pipeline: Complete security coverage

SecureStack provides complete coverage for your Azure DevOps Pipelines and the associated secure software development lifecycle (SSDLC).  As part of our native Azure DevOps Pipeline workflows we provide:

• Secrets and sensitive scanning
• Scanning for vulnerable third-party or open-source libraries
• Dynamic application security testing for any web or API endpoints
• Scanning for misconfiguration in your public cloud resources
• Asset discovery and attack surface mapping for your public assets

Once all those tests pass, SecureStack will package up a software bill of materials (SBOM) for the application environment, and there you have it: Complete Security Coverage for your SDLC!

Paul McCarty

Founder of SecureStack

DevSecOps evangelist, entrepreneur, father of 3 and snowboarder

Forbes Top 20 Cyber Startups to Watch in 2021!

 Mentioned in KuppingerCole's Leadership Compass for Software Supply Chain Security!

Comprehensive SBOMs can help address software supply chain risks

One way to address the risks inherent to the complex applications we are building is to use “Software Bill of Materials” also known simply as “SBOM”.  At its simplest, a SBOM is a list of all the different component parts of an application. This typically includes several types of information about each component: Its name, who supplied the component, what license it uses, the version number, any known vulnerabilities, and a list of all the component’s dependencies.

Application complexity is increasing

The reality is that modern applications are complex and dynamic, and therefore hard to secure. They use programming languages that run entirely in the browser, they talk directly to their dependencies on the internet and they use technologies like containers, serverless and public cloud. All of these bring their own challenges, so we need visibility into all these other application components and dependencies as well. What third-party APIs and public cloud components is it using? Is it using an identity provider like Auth0 or Cognito? What infrastructure is required to make the app run? All of these things need to be understood to really be able to better represent what is in an application and how to secure it.

Traditional SBOM tools do not produce accurate results

Most SBOM tools that exist right now, simply focus on showing customer the open-source libraries that they are using in their applications.  Moreover, most SBOMs are stand-alone XML or JSON documents.   By themselves these documents don’t provide much value.  Even worse, most SBOMs are point in time generated and then never updated.  So, these “static” SBOMs quickly become out of sync with the actual application they are supposed to describe.

Application complexity forces SBOM to evolve

The reality is that existing SBOM implementations are not accurately describing the applications they are supposed to represent.  Instead, they represent a part of the application: open-source libraries.  There is a drive within the industry right now to provide a better, more comprehensive SBOM that does a better job of describing the complex modern web apps that we are building.  To do this, you need to use data from other sources than package manifest files.

The comprehensive SBOM is a document that describes this type of application fully.  Moreover, a truly comprehensive SBOM will also be up to date and searchable.  Let’s drill into this a bit more.

SBOMs need three things to be comprehensive:

1. Data from source code, third-party APIs and SaaS dependencies as well as any cloud-native and identity providers that the application requires.
2. Timely.  SBOMs need to truly represent what the application looks like and that means that any time there is a change to the application the SBOM needs to be updated.  The only thing worse than no SBOM is an incorrect SBOM.
3. Finally, SBOMs need to be searchable.  There’s no point to generating SBOMs if all you do with them is store them somewhere.  What happens the next time there’s a Log4shell-type incident?  You need to be able to search your SBOMs so you can find vulnerable technologies quickly.

The business value

Building a complete SBOM lifecycle can be a challenge, but in the end, the value that it provides to organizations is enormous.  Simply having the ability to quickly find all the software and application components in your estate of apps is huge.   But even better, being able to query that data for vulnerable components could save organizations millions of dollars in lost productivity.

Automated SBOM platform

SecureStack automates the whole SBOM process from end to end.  Our platform delivers all stages of the SBOM lifecycle in a fully integrated solution that is incredibly easy to onboard.  SecureStack integrates easily into your CI/CD pipelines and workflows so that SBOMs are generated, stored and made searchable, automatically.  Because they are generated directly at build and deploy time you know that they are accurate and provide the most business value for your organization.

Paul McCarty

Founder of SecureStack

DevSecOps evangelist, entrepreneur, father of 3 and snowboarder

Forbes Top 20 Cyber Startups to Watch in 2021!

 Mentioned in KuppingerCole's Leadership Compass for Software Supply Chain Security!