Overview of the EU regulatory field, its interconnectedness and challenges for national adaptation

Abstract Artificial Intelligence (AI) and new technologies are directly linked to public health, in terms of quality of care and sustainability of resources. In the field of Public Health, according to the Treaty on the Functioning of the European Union (TFEU), articles 6 and 168 are the legal basis for assigning responsibilities between the European Union (EU) and Member States (MS). Under the title “Public Health”, article 168 reflects the principle of subsidiarity, prescribing that the EU action would complement national policies, encourage cooperation, and respect the responsibilities of the MS. On their turn, MS would coordinate their policies and programmes among themselves. At the law-making level, public health issues were regulated via directives. Article 288 of the TFEU states that a directive is binding, as to the result to be achieved in the MS to whom it is addressed, while leaving national authorities the power to choose the form and methods to achieve the result. However, recently, public health has become more related to common safety concerns and internal market considerations (Articles 4 and 118 TFEU), which both reflect areas where competence is shared between the EU and its MS (Article 4 TFEU). The dual nature of the competencies in the area of public health is reflected in the development of the law-making model, as now the legal tool of regulation is used in order to implement EU policies into national law. Regulations are legal acts defined by Article 288 of the Treaty on the Functioning of the European Union (TFEU). They have a general application, are binding in their entirety, and are directly applicable to all European Union (EU) Member States. This presentation will highlight the emerging challenges for internal implementation that the switch has created, as MS have to adapt to the immediate and direct effect of the regulation by quickly reshaping internal legislation or by creating new institutions.