Research, not marketing

No single entity is going to “fix” medical device cybersecurity. We are dedicated advancing our collective understanding of the challenges and opportunities we face through research.

The documents below are free to download, and we’re not going to do that thing where we ask for your email address in order to download them. We love feedback - so tell us if you love it, hate it or want to enhance it together.

Latest research

Decrypting Cryptography

Decrypting Cryptography

Implementing cybersecurity for modern medical devices requires compliance with complex regulations as well as adoption to a changing healthcare ecosystem where hospital networks are considered inherently hostile, devices are increasingly integrated, and data is moving into the cloud. Getting cybersecurity right requires mature processes, careful design considerations, and finding the right balance between the desired level of security and a device’s capabilities and utility. Getting cybersecurity wrong can have significant ramifications for patient safety, regulatory compliance and approval, and business and reputation. Read more for an introduction to achieving device security through cryptography.

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Impact of monitoring on medical device vulnerabilities

Impact of monitoring on medical device vulnerabilities

The root causes associated with medical device cybersecurity disclosures to date, reveals 81.8% of the related root causes would be impacted by the implementation of monitoring practices.

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Tool and Processes for Medical Device Cybersecurity

Tool and Processes for Medical Device Cybersecurity

The Food and Drug Administration (FDA) issued an updated draft of the Premarket Cybersecurity Guidance in April 2022 which, when combined with existing finalized Postmarket Management of Cybersecurity in Medical Devices Guidance, specifies process and technical requirements to ensure medical devices are “secure by design” and that their security posture can be maintained over the lifetime of the device. In this paper we propose a hypothetical medical device vendor’s mature cybersecurity program that complies with FDA guidance, and we will analyze the processes and tools that aid in their success.

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What the medical device industry can learn from past cybersecurity vulnerability disclosures

What the medical device industry can learn from past cybersecurity vulnerability disclosures

In the 2022 update of our annual ICS-CERT cybersecurity disclosure analysis, we found that the rate of medical device advisories has increased by 490% since the release of the FDA Postmarket Cybersecurity Guidance in 2016, but appears to have plateaued. Read about the latest medical device vulnerability data trends and predictions for the future.

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Benefiting from Software Transparency: From SBOM to Vulnerability Management

Benefiting from Software Transparency: From SBOM to Vulnerability Management

Software bills of material (SBOM) capture software used in products. SBOMs are prerequisites to proactive product security, as well as vulnerability and risk management programs. However, extracting the full potential value of SBOMs at scale will take sustained effort, requiring tooling to overcome inherent complexities.

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Understanding the constraints of healthcare cybersecurity

Understanding the constraints of healthcare cybersecurity

The sobering reality is that all the promise held in technology advancing healthcare is foundationally reliant on security. Unfortunately, not only does the healthcare supply chain inherit what makes information security hard, healthcare additionally inherits economic constraints that allow security debt to pass to consumers. Watch the webinar where Seth explores the six constraints: https://youtu.be/1pYlbqkM9Ew

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More resources

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Our latest thoughts on medical device cybersecurity

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FDA, RTA and eSTAR - oh my!

Watch our latest webinar that discusses regulatory updates and the impact for medical device development and post-market management.

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Gain visibility across your software supply chain to detect, prioritize, and remediate cybersecurity risk.

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