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Regulatory Approaches to AI in Medical Practice

Ulrich M Gassner, Ulrich Juknat


On both sides of the Atlantic, first steps toward a regulation of AI have been taken. This article analyses the differences of both regulatory approaches with a focus on medical devices. In addition to ethical issues, the risk of anti-innovative side effects will be considered. Furthermore, the efficiency of the various regulatory approaches will be discussed especially against the backdrop of an already existing legal framework, such as MDR and GDPR.

Ulrich M Gassner is Professor at the University of Augsburg and heads the Research Centres for Medical Device Law and for E-Health Law. For Correspondence: <>. Ulrich Juknat, LL.M. is Legal Director, Medical Devices Group Germany, Johnson & Johnson Medical GmbH. For Correspondence: <>. Please note that the opinion and viewpoint expressed by the second author does not necessarily reflect the opinions and viewpoints of his organisation.


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