Independent cybersecurity leadership for medical device and SaMD companies: board advisory, transaction due diligence, and FDA premarket and postmarket security.
Preprint: doi:10.5281/zenodo.21313736 , working draft, corrections welcome. Code and data: github.com/theorlandog/gpc-census . The setup I run security and infrastructure engineering for a medical-imaging company. My degrees are in math and physics, but that was years ago; my day job is Terraform, threat models, and FDA compliance documentation. I am not a professional…
Introduction On September 27, 2023, the Food and Drug Administration (FDA) finalized it's cybersecurity guidance for medical devices titled, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions ( link ). Medical devices under review for FDA clearance use the published guidance as a framework to demonstrate that effective policies and processes…
Introduction Authentication is hard. The selection pressure from Cheeto finger basement hackers, sophisticated criminal organizations, and everyone in-between has led to the development of new ideas and standards in web security in recent years. Among these developments are two similarly named standards, OATH and OAUTH . OATH is an open standard for Authentication (AuthN), while OAUTH is a…