The Telemedicine Paradox: Why Data Moves but Care Does Not.

Area of Science:

• Health Law
• Digital Health Policy
• European Union Law

Background:

• Digital health technologies enable cross-border telemedicine, but the EU legal framework remains fragmented.
• Existing regulations, like the 2011 Patients' Rights Directive, have limitations in facilitating seamless cross-border healthcare services.
• Tension exists between the EU's internal market principles and Member States' authority over health system organization.

Purpose of the Study:

• To examine the EU's fragmented legal framework for cross-border telemedicine.
• To evaluate the potential of the European Health Data Space (EHDS) Regulation and European Health Union to create a coherent regulatory foundation for digital health mobility.
• To analyze legal frictions in professional licensing and reimbursement mechanisms impacting cross-border telemedicine.

Main Methods:

• Legal analysis of EU directives and regulations, specifically the 2011 Patients' Rights Directive and the EHDS Regulation.
• Examination of the conflict between EU internal market logic and Member State health competence (Article 168(7) TFEU).
• Focus on key legal barriers: professional licensing and reimbursement for cross-border telemedicine services.

Main Results:

• The current EU legal framework presents significant fragmentation for cross-border telemedicine.
• The 2011 Patients' Rights Directive offers limited solutions for digital health mobility.
• The EHDS Regulation and European Health Union are evaluated for their potential to address these regulatory gaps.

Conclusions:

• The success of the EHDS Regulation hinges on resolving underlying legal-ethical conflicts concerning digital sovereignty, not just technical interoperability.
• A coherent regulatory foundation for digital health mobility requires addressing professional licensing and reimbursement mechanisms.
• The EU needs to reconcile internal market principles with Member State health competencies to fully enable cross-border telemedicine.