Study on cross-border digital healthcare in the EU with particular focus on potential regulatory gaps and barriers to the cross-border provision of digital health services and products

The study, commissioned by the European Commission’s DG SANTE, seeks to provide the evidence base needed to enable informed policy making in the area of cross-border provision of digital health services and goods, specifically for the deployment of Artificial Intelligence (AI) systems in healthcare. Specifically, the study aims to provide an up-to-date and comprehensive mapping and detailed analysis of the current regulatory and legal situation in the EU and its Member States with regard to the cross-border provision of digital health (eHealth) services and products, the adoption and use of Artificial Intelligence in the healthcare sector (including liability issues) and the use of health data, taking into account their potential to improve the quality, accessibility and sustainability of healthcare. Furthermore, relevant stakeholders are involved via individual online interviews to investigate the presence of different rules between the Member States, the lack of relevant national legislation or shortcomings in the implementation of applicable EU legislation that can potentially compromise the provision and safety of digital health services when provided in a cross-border context, as well as to gain insights of the impact on daily practices from the point of view of the relevant actors involved.