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.
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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.
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.
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.
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.
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
No matter where you are in the regulatory submission process, we have a variety of services that can meet your needs when and where you need us.
The Guardian platform is a secure and scalable cryptographic solution that simplifies security processes and incident response.