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The need for a system view to regulate artificial intelligence/machine learning-based software as medical device

The need for a system view to regulate artificial intelligence/machine learning-based software as medical device

FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition

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Data Structures Succinctly Part 1

Data Structures Succinctly Part 1

Data Structures Succinctly Part 1 is your first step to a better understanding of the different types of data structures, how they behave, and how to interact with them. Starting with simple linked lists and arrays, and then moving to more complex structures like binary search trees and sets, author Robert Horvick explains what each structure’s methods and classes are and the algorithms behind them. Horvick goes a step further to detail their operational and resource complexity, ensuring that you have a clear understanding of what using a specific data structure entails.

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When Autonomous Vehicles Are Hacked, Who Is Liable?

When Autonomous Vehicles Are Hacked, Who Is Liable?

Who might face civil liability if autonomous vehicles (AVs) are hacked to steal data or inflict mayhem, injuries, and damage? How will the civil justice and insurance systems adjust to handle such claims? RAND researchers addressed these questions to help those in the automotive, technology, legal, and insurance industries prepare for the shifting roles and responsibilities that the era of AVs may bring.

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Standardisation in support of the Cybersecurity Certification

Standardisation in support of the Cybersecurity Certification

The document presents the value of the cybersecurity standardisation efforts for certification, the roles and responsibilities of Standards Developing Organisations (SDOs) in this context, and discusses various ways how standardisation can support efficiently the process of certification schemes creation by following a step by step methodology.

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ICT security certification opportunities in the healthcare sector

ICT security certification opportunities in the healthcare sector

Digital solutions for healthcare open a plethora of new possibilities in this area. They provide a technical base for easy testing, they improve significantly the quality of service by allowing immediate access to medical data – results of tests, history of treatment; they facilitate correct diagnosis by easier analytics and correlation of data and easier monitoring of patients’ health parameters. They facilitate setting up appointments with appropriate doctors at a convenient time

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