The unrelenting proliferation of data, entwined with the prevalence of mobile devices, has given birth to an unprecedented growth of information obscured by noise. With the Internet of Things and myriad endpoint devices generating vast volumes of sensitive and critical data, organizations are tasked with extracting actionable intelligence from this deluge. Governments and enterprises alike, even under pressure from regulatory boards, have strived to harness the power of data and leverage it to enhance safety and security, maximize performance, and mitigate risks. However, the adversaries themselves have capitalized on the unequal battle of big data and artificial intelligence to inflict widespread chaos. Therefore, the demand for big data analytics and AI/ML for high-fidelity intelligence, surveillance, and reconnaissance is at its highest. Today, in the cybersecurity realm, the detection of adverse incidents poses substantial challenges due to the sheer variety, volume, and velocity of deep packet inspection data. State-of-the-art detection techniques have fallen short of detecting the latest attacks after a big data breach incident. On the other hand, computational intelligence techniques such as machine learning have reignited the search for solutions for diverse monitoring problems. Recent advancements in AI/ML frameworks have the potential to analyze IoT/edge-generated big data in near real-time and assist risk assessment and mitigation through automated threat detection and modeling in the big data and AI/ML domain. Industry best practices and case studies are examined that endeavor to showcase how big data coupled with AI/ML unlocks new dimensions and capabilities in improved vigilance and monitoring, prediction of adverse incidents, intelligent modeling, and future uncertainty quantification by data resampling correction. All of these avenues lead to enhanced robustness, security, safety, and performance of industrial processes, computing, and infrastructures. A view of the future and how the potential threats due to the misuse of new technologies from bandwidth to IoT/edge, blockchain, AI, quantum, and autonomous fields is discussed. Cybersecurity is again playing out at a pace set by adversaries with low entry barriers and debilitating tools. The need for innovative solutions for defense from the emerging threat landscape, harnessing the power of new technologies and collaboration, is emphasized.

This essay explores how AI can enhance clinical research and, particularly, its pivotal role in the development of medical devices. A data-driven approach to medical device development that can streamline regulatory compliance and quality assurance is discussed. Methods that generate insights from pre-stage data and utilize it during development are detailed. The effectiveness of this approach in compliance audits, 510(k) submissions, and quality system audits - reducing time, effort, and risks is analyzed. The findings are illustrated with practical examples and takeaway recommendations. When reading a scientific article, how many times have you judged the quality of the research by looking at the methodology section? Artificial intelligence algorithms can be developed with the most robust and innovative technology, but if they are not properly validated, they will be worthless in the eyes of regulatory authorities. Conversely, outdated and simplistic models can still gain regulatory clearance if robustness is effectively demonstrated. For better or worse, ethics, economics, and robustness are often sacrificed in the constant government struggle to keep up with the technological edge of AI development. The slow crawl of lawmakers is constant in every field. Automating small tasks can save time and reduce risks when playing catch-up with a changing regulatory framework so the rest of the AI development can continue uninhibitedly. This dives into using FDA open data to collaborate with a food and drug law company and develop several bottom-up initiatives that supply knowledge needed for regulatory compliance and quality systems development. Methods that input pre-stage data and output actionable insights as models are provided. By sharing these resources and advice as academic researchers, efficiency in streamlining processes is maximized, thereby letting more time and resources be allocated to the actual development [1].