Introduction In September 2023, the U.S. Food and Drug Administration (FDA) issued a pivotal guidance document titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance aims to bolster the cybersecurity of medical devices, thus safeguarding patients, healthcare facilities, and the broader healthcare ecosystem … [Read more...] about The Cybersecurity Sword Hanging Over Medical Device Manufacturers
Expert Witness
Choosing an Expert Witness in an AI patent case
This article provides context around the intense interest in intellectual property in the AI or machine learning field and considers what attorneys should look for when they need to retain an expert in this field. We previously considered the algorithm and software landscape for expert witnesses; here we look at the specifics of AI cases. AI patenting land-grab runs the gamut … [Read more...] about Choosing an Expert Witness in an AI patent case
Expert witnessing in Algorithm and Software Patent cases
This article summarizes aspects of algorithm and software patents and suggests factors for lawyers to consider when retaining an expert in this field. Algorithms and their use in Software An algorithm is a set of mathematical instructions or rules that define a sequence of operations. Algorithms can be simple, like those that add numbers in a list, or complex, such as those … [Read more...] about Expert witnessing in Algorithm and Software Patent cases
Voice biometrics expert witness: signal processing enables new forms of identity verification
Defining voice biometrics Biometrics – automated recognition of a person based on a physiological or behavioral characteristic – continues to increase in importance. Smart cards, magnetic stripe cards, photo ID cards, and physical keys can be lost, stolen, duplicated, or left at home. Passwords can be forgotten, shared, or observed. But if well implemented, biometric … [Read more...] about Voice biometrics expert witness: signal processing enables new forms of identity verification
Remote source code review expert witness: options for attorneys
Introduction Often critical issues in technology litigation hinge on review of source code. In many cases, most of the value in highly litigated products lies in their software. Determining whether a product infringes a patent, or if a trade secret has been misappropriated, is increasingly a question of examining software. A previous blog post described reviewing source … [Read more...] about Remote source code review expert witness: options for attorneys