Ethical and legal reconfiguration of clinical practice in the European Union (1997–2020): a hermeneutic analysis from a principle-based perspective. From the Oviedo Convention to the General Data Protection Regulation: informed consent, regulatory harmonization, and data governance

This article analyzes, from the perspective of Gadamerian legal hermeneutics, the reconfiguration of the ethical and legal foundations of clinical practice in the European Union during the period 1997–2020, using as its interpretive framework the tension between the four principles of bioethical principlism—autonomy, beneficence, non-maleficence, and justice—and the regulatory harmonization process articulated by the Oviedo Convention (1997) and the General Data Protection Regulation (2016/679). Methodologically, a qualitative-documentary design of a hermeneutic-comparative nature was adopted, based on the critical analysis of scientific articles indexed, preferably, in WOS and Scopus, official regulatory documents, and philosophical and legal works of international reference. The results reveal that regulatory harmonization between the two instruments produced a partial and tense reconfiguration of patient rights, highlighting profound discrepancies in the underlying ethical values among member states and a progressive dissociation between the formality of consent and its moral substance. It is concluded that health data constitutes an informational extension of the human person and, as such, requires the same level of protection that dignity imposes on any other dimension of the human being, demanding regulatory frameworks that are philosophically grounded and not merely procedural.