Genome Editing in Human Gametes and Embryos: The Legal Dimension in Europe

To date, the legal aspects of the ongoing debate on the application of genome editing in human gametes and early embryos have attracted little attention. In Europe, this seems to have changed with a recent official position that clarifies the meaning of the relevant provision of the common legal instrument on Human Rights and Biomedicine (Oviedo Convention). This provision explicitly prohibits modifications to the genome of future persons and adoptes a precautionary stance with regard to genetic interventions in the human reproductive material. In this article, we examine relevant interpretative options, following the new official clarifications, focusing on the research/clinical application distinctions that characterize their approach. From this viewpoint, we propose an approach that favors basic research activities involving genome editing, even for exploring potential clinical applications under conditions of safety, which may justify a future legislative amendment. Furthermore, we explore the patenting issue, based on the current approach of European case law, and give reasons that may justify patent rights in this ethically sensitive area

Artificial Intelligence in Biomedicine: A Legal Insight

The involvement of artificial intelligence in biomedicine promises better support for decision-making both in conventional and research medical practice. Yet two important issues emerge in relation to personal data handling, and the influence of AI on patient/doctor relationships. The development of AI algorithms presupposes extensive processing of big data in biobanks, for which procedures of compliance with data protection need to be ensured. This article addresses this problem in the framework of the EU legislation (GDPR) and explains the legal prerequisites pertinent to various categories of health data. Furthermore, the self-learning systems of AI may affect the fulfillment of medical duties, particularly if the attending physicians rely on unsupervised applications operating beyond their direct control. The article argues that the patient informed consent prerequisite plays a key role here, not only in conventional medical acts but also in clinical research procedures