Telemedicine and the European Health Data Space: a new paradigm for healthcare in the EU

Abstract

Background: Telemedicine has emerged as a transformative tool for remote healthcare, taking advantage of information and communication technologies to simplify the access to healthcare by patients. With the publication of Regulation (EU) 2025/327 on the European Health Data Space (EHDS), telemedicine has gained new momentum, particularly in the context of MyHealth@EU. Objectives: This article explores the framework for cross-border telemedicine under the EHDS, with a focus on real-world applications. It also aims to identify the enablers and barriers in several key domains, including legal, regulatory, organizational, financial, clinical, cultural, and technical aspects. The article also aims to discuss innovations in the field of telemedicine, namely the application of artificial intelligence. Methods: This review was conducted, focusing on cross-border telemedicine applications and the impact of the EHDS. The review also included studies related to telemedicine implementations in different medical disciplines, presenting the key successes and the challenges associated with these methods. Results: It is highlighted the initial progress made in cross-border telemedicine, where various approaches have been used, including teleconsultation, tele-expertise exchange, telemonitoring, telepathology, teleradiology, and remote surgery. Despite challenges such as legal uncertainties, financial constraints, and technical barriers, the integration of EHDS, supported by MyHealth@EU, has proven beneficial in building trust in secure, reliable telemedicine applications. The lessons learned and recommendations offer valuable insights for scaling cross-border telemedicine services. With the implementation of the EHDS and the use of MyHealth@EU, services can significantly improve access to healthcare and clinical outcomes by enabling more informed decision-making. As these services continue to evolve, they will contribute to a more integrated, and patient-centered healthcare system.

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