FDA Cybersecurity in Medical Devices—A New Approach for Deploying Firmware & Software Updates

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Presented by

Andrew Lamkin, Intel & Kim D. Crawford, Dedicated Computing & Matt Grubis, GE HealthCare & Erik Nordmark, ZEDEDA

About this talk

In late 2023, the Food & Drug Administration issued new considerations for cybersecurity in medical devices. These recommendations cover everything from authentication, to cryptography, to firmware and software updates. Medical device makers are now looking to meet these requirements, while ensuring ongoing operations are scalable. A common traditional approach employed for deploying firmware and software updates in the field has been utilizing a software agent which has its drawbacks and limitations. A new approach to solving this update challenge is to leverage an edge focused software architecture, such as EVE-OS from the Linux Foundation, and leverage an API for orchestration of the software and underlying hardware. In this panel, you’ll hear from experts about: • Foundational security considerations for embedded software running at the edge • The EVE-OS architecture and how it addresses the new FDA considerations • Considerations for scaling firmware and software updates Moderator: Andrew Lamkin Health and Life Sciences Solutions Architect INTEL Panelists: Kim D. Crawford VP of Global Sales and Business Development Dedicated Computing Matt Grubis Chief Engineer, Monitoring Solutions GE HealthCare Erik Nordmark Co-founder and CTO ZEDEDA
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