Navigating SBOM: What Are The Implications for Device Manufacturers and Healthcare Providers

In an increasingly interconnected world, the Internet of Things (IoT) has become a significant driver of innovation across various industries. Healthcare institutions were early adopters of IoT technology, leveraging it to improve patient care, streamline operations, and enhance data management. However, this surge in IoT adoption brings with it new challenges, including the FDA’s requirement for medical device manufacturers to self-attest to the accuracy of a comprehensive list of software used in their medical devices offering more transparency and security in the supply chain of connected medical devices. The introduction of Software Bill of Materials (SBOM) is a requirement of such including The White House Executive Order 14028 and EU Cyber Resilience Act is poised to reshape the landscape for device manufacturers and healthcare providers. This blog post explores the implications of SBOM legislation for these stakeholders and highlights how solutions like Device Authority can assist in navigating this new regulatory terrain. 

The Rise of IoT in Healthcare: 

Medical institutions have been at the forefront of IoT adoption, recognizing the potential for connected devices to revolutionize patient care and operational efficiency. From remote patient monitoring to smart medical devices that collect real-time patient data, healthcare providers have harnessed IoT to deliver better services and improve outcomes. However, this rapid expansion of IoT in the healthcare sector has led to concerns about security, especially regarding the software and firmware that power these connected devices. 

Understanding SBOM Legislation: 

The Software Bill of Materials (SBOM) is a regulatory framework that mandates the disclosure of detailed information about the software components used in a device. It acts as a digital inventory, listing all the software elements and their dependencies within a device. This legislation is a critical step toward improving transparency in the IoT supply chain, as it enables manufacturers, healthcare providers, and regulatory bodies to track and verify the software components embedded in medical devices. 

Implications for Device Manufacturers: 

Device Manufacturers should be cognizant of when SBOM becomes a requirement, this has significant implications for device manufacturers, particularly those in the healthcare industry. Here are some key considerations: 

• Transparency and Accountability: Manufacturers must be prepared to disclose the software components and dependencies in their devices, allowing stakeholders to assess their security and functionality. This transparency not only builds trust but also helps manufacturers to identify vulnerabilities and address them promptly. 
• Supply Chain Management: Manufacturers need to establish clear procedures for tracking and verifying the software components that go into their devices. This includes collaborating closely with software vendors to ensure their products meet the required security standards. 
• Regulatory Compliance: Compliance with SBOM legislation is essential to avoid penalties and ensure the continued sale of medical devices. Manufacturers must understand the regulatory requirements and implement them effectively. 

Implications for Healthcare Providers: 

Healthcare providers also need to adapt to the changing landscape brought about by SBOM legislation: 

• Security and Risk Assessment: SBOM data can be used by healthcare providers to evaluate the security of the medical devices they use. They can assess potential vulnerabilities and take steps to mitigate risks, thus safeguarding patient data and maintaining the integrity of their systems. 
• Vendor Selection: When acquiring new medical devices, healthcare providers can now consider SBOM information as a crucial factor in their vendor selection process. They can choose manufacturers who prioritize transparency and security in their products. 
• Response to Vulnerabilities: With a clear understanding of a device’s software components, healthcare providers can respond more effectively to emerging vulnerabilities. They can apply patches or updates as needed to secure their IoT infrastructure. 

How Device Authority Can Help: 

As a leading provider of security solutions for connected devices, Device Authority’ KeyScaler platform plays a crucial role in helping device manufacturers and healthcare providers navigate SBOM legislation requirements: 

• Secure Device Onboarding: Device Authority offers solutions for secure device onboarding and lifecycle management. This ensures that only trusted devices are connected to the network, reducing the risk of unauthorized or compromised devices. 
• Automation and scaling for certificate lifecycle management Key Management: Device Authority’s KeyScaler platform automates and simplifies key management for IoT devices. Our automation essentially takes human error out of the equation. This is essential for ensuring the security and authenticity of devices in compliance with SBOM legislation. 
• Enhanced Security: Device Authority’s solutions help protect against unauthorized access and data breaches, ensuring the integrity of connected devices and patient data. 
• Automation and Compliance: Device Authority provides automation capabilities to streamline compliance with SBOM legislation, making it easier for manufacturers to meet regulatory requirements. 
• Ensure the most up to date SBOM on each device. If a device attempts to get authorization and it’s SBOM is out of date, our KeyScaler platform will detect that notify your security admin. 

 SBOM legislation represents a significant shift in the IoT landscape, affecting both device manufacturers and healthcare providers. While it introduces new challenges, it also presents an opportunity to enhance security and transparency within the IoT supply chain. Early adopters of IoT, such as medical institutions, are well-positioned to lead the way in implementing SBOM requirements and ensuring the integrity of connected medical devices. With the support of solutions like Device Authority KeyScaler,  stakeholders can address these challenges effectively and maintain the highest standards of security in healthcare IoT.  

Find out more about SBOM requirements and how KeyScaler can help.