Embracing FIPS Validation in Medical Device Security

By Loren Shade

Vice President of Marketing

Allegro Software

April 15, 2024


Embracing FIPS Validation in Medical Device Security
Image Credit: Allegro Software

This article examines the security and connectivity of IoMT devices, focusing on manufacturers' approaches to integrating these technologies.

As the amount of data being produced every day continues to increase, with estimates of 463 exabytes (EB) being created globally by 2025, the need to securely transmit and store data becomes more pressing. Cryptography is utilized to secure embedded trust in IoT devices, applications, and ecosystems, minimizing the risks and liabilities associated with data breaches. Embedded trust and cryptographic security are crucial for satisfying the requirements of the Federal Information Processing Standards (FIPS) and safeguarding data. As the digital landscape evolves, the importance of robust security measures for medical devices cannot be overstated.

Medical Device Security and FIPS Validation

What is FIPS Validation?

FIPS, or Federal Information Processing Standards, are a set of standards developed by the National Institute of Standards and Technology (NIST) for use in computer systems by non-military American government agencies and government contractors. FIPS 140-2 and FIPS 140-3, in particular, focus on the security requirements for cryptographic modules. The essence of FIPS validation lies in its rigorous testing to ensure that a cryptographic module meets these stringent standards, providing a high level of security assurance.

[Read More on FIPS]

 The Role of Cryptographic Modules

Cryptographic modules, the cornerstone of secure communications, have evolved significantly since their early incarnations, such as the World War II-era Enigma machine. Today, they encompass a variety of forms, including hardware, firmware, and software implementations, supporting a vast range of cryptographic algorithms. These modules are vital for safeguarding data integrity, confidentiality, and authentication, especially in sensitive environments like medical device networks.

Why is FIPS Validation Important?

In the healthcare sector, where privacy and data protection are paramount, FIPS validation emerges as a critical standard. It not only ensures that cryptographic modules perform as intended but also serves as a benchmark for regulatory compliance and market acceptance. For instance, VA hospital systems mandate FIPS-validated cryptography for connected medical devices, emphasizing the need for certified security measures.

IoMT Unique Requirements for Implementing Cryptography

FIPS validation offers independent assurance that cryptographic practices meet high standards and are essential for mitigating privacy and safety risks in medical devices. When addressing VA and other markets, FIPS is essential. However, implementing cryptography in IoMT devices can be challenging due to their resource constraints, so flexibility and configurability are required to secure these devices effectively.

Commitment to FIPS Validated Security

At Allegro, we understand the unique challenges faced by developers of Internet of Medical Things (IoMT) devices, particularly in resource-constrained environments. Our Ace Cryptography Module, backed by FIPS validation, offers a comprehensive solution that meets the highest standards of security. Integrated with a suite of connectivity and security toolkits, it provides a robust foundation for developing secure medical devices, ensuring compliance, and facilitating faster time to market.

As the industry continues to recognize the importance of FIPS validation, Allegro remains at the forefront, offering expertise and solutions that empower manufacturers to meet these critical security requirements. For more insights into implementing FIPS-validated cryptography in your IoMT devices or to learn more about our solutions, feel free to reach out. Together, we can achieve the highest standards of security and protect the integrity of medical devices and patient data.

Visit allegrosoft.com to learn more.




Allegro Software’s VP of Marketing, Loren Shade, has been involved in the embedded industry for over 25 years. He has worked with numerous industrial, military, and commercial clients to integrate and adopt networking and connectivity into their embedded products.

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