Open Evidence, in consortium with EY HealthcareLifeSTech – Universidad Politécnica de Madrid (UPM) will lead a new study for the European Commission (DG SANTE) 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 consortium will provide the evidence base needed to enable informed policy making in the area of cross-border provision of digital health services and goods (eHealth), Artificial Intelligence and the use of health data. The study will also evaluate the Cross-border Healthcare Directive (Directive 2011/24/EU), and more precisely Article 14, which foresees the cooperation and exchange of information among Member States working within a voluntary network connecting national authorities responsible for eHealth designated by Member States. To address the objectives of this study the team will use a mixed methods approach, where different methods, instruments and sources will be triangulated.

For each of the above-mentioned areas of the study the consortium will map and analyse the situation in order to provide the current picture of the topics of the study. The detailed analysis will allow for the identification of the key barriers at EU and national level, pointing the causes and consequences for stakeholders, as well as the potential evolution without EU intervention. The achievement of these specific objectives will enable the definition and identification of best practices and a preliminary list of targeted areas for EU interventions. In addition, a comprehensive mapping of the application of Article 14 of the Directive 2011/24/EU will be conducted. Subsequently, the team will assess its effectiveness, efficiency, coherence, relevance and EU added value, including its impact on cross-border healthcare/patient mobility, the provision of digital health services and products, and national healthcare systems.