Regulatory Approaches to AI in Medical Practice journal article Ulrich M Gassner, Ulrich Juknat European Pharmaceutical Law Review, Volume 3 (2019), Issue 4, Page 176 - 183 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.
Are You AI’S Favourite? EU Legal Implications of Biased AI Systems in Clinical Genetics and Genomics Anastasiya Kiseleva, Paul Quinn
A Case of Unforeseen Adverse Side-Effects? The Ireland/Northern Ireland Protocol and Medicines Regulation George Peretz, Xisca Borrás