scholarly journals Artificial intelligence as a medical device in radiology: ethical and regulatory issues in Europe and the United States

2018 ◽  
Vol 9 (5) ◽  
pp. 745-753 ◽  
Author(s):  
Filippo Pesapane ◽  
Caterina Volonté ◽  
Marina Codari ◽  
Francesco Sardanelli
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.


2020 ◽  
Vol 29 (4) ◽  
pp. 436-451
Author(s):  
Yilang Peng

Applications in artificial intelligence such as self-driving cars may profoundly transform our society, yet emerging technologies are frequently faced with suspicion or even hostility. Meanwhile, public opinions about scientific issues are increasingly polarized along the ideological line. By analyzing a nationally representative panel in the United States, we reveal an emerging ideological divide in public reactions to self-driving cars. Compared with liberals and Democrats, conservatives and Republicans express more concern about autonomous vehicles and more support for restrictively regulating autonomous vehicles. This ideological gap is largely driven by social conservatism. Moreover, both familiarity with driverless vehicles and scientific literacy reduce respondents’ concerns over driverless vehicles and support for regulation policies. Still, the effects of familiarity and scientific literacy are weaker among social conservatives, indicating that people may assimilate new information in a biased manner that promotes their worldviews.


2018 ◽  
Vol 04 (02) ◽  
pp. 241-258 ◽  
Author(s):  
You Wang ◽  
Dingding Chen

Both China and the United States are international leaders in artificial intelligence (AI). Although there remains a significant gap between them in cutting-edge technologies, and they have adopted different methods of planning and implementation, both countries have been mobilizing national resources and formulating policies to promote AI development, so as to achieve a strategic advantage over the other, especially against the backdrop of ever more intense and complicated strategic competition between them in recent years. As an epitome of their changing relationship, Sino-U.S. competition in AI development is manifested in economic, political, security, technological and other fields. It is expected that artificial intelligence will become an even more important field of competition between China and the United States, and that the trends of AI development and competition will to some extent determine the future dynamics of their bilateral relations.


2020 ◽  
Vol 28 (3) ◽  
pp. 536-546
Author(s):  
Marina S. Reshetnikova

The rapid acceleration of scientific and technological progress, which started at the beginning of the 21st century, has become a decisive factor in influencing the global economy. Who will lead the global innovation race? This problem is especially relevant in the field of artificial intelligence (AI). At the moment, the United States and China are the main participants in the battle for dominance in this area. The author assesses Chinas innovative potential in the field of AI and identifies its achievements in this area. Based on the statistics provided, Chinas AI leadership has reached a critical point. China is confidently leading the new fundamental research of artificial intelligence, forming its theoretical base and applied research and development, which will contribute to the creation of new high-tech innovative products and services. However, in terms of the number and quality of AI specialists (AI Talents) and the number of companies engaged in AI, China is still lagging behind its main rival, namely the United States. The author proved that, despite the obvious successes of China, the United States still has an equal lead in the global innovation race.


2022 ◽  
pp. 5-12
Author(s):  
Margaret A. Goralski ◽  
Krystyna Górniak-Kocikowska

2020 ◽  
pp. 97-102
Author(s):  
Benjamin Wiggins

Can risk assessment be made fair? The conclusion of Calculating Race returns to actuarial science’s foundations in probability. The roots of probability rest in a pair of problems posed to Blaise Pascal and Pierre de Fermat in the summer of 1654: “the Dice Problem” and “the Division Problem.” From their very foundation, the mathematics of probability offered the potential not only to be used to gain an advantage (as in the case of the Dice Problem), but also to divide material fairly (as in the case of the Division Problem). As the United States and the world enter an age driven by Big Data, algorithms, artificial intelligence, and machine learning and characterized by an actuarialization of everything, we must remember that risk assessment need not be put to use for individual, corporate, or government advantage but, rather, that it has always been capable of guiding how to distribute risk equitably instead.


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