The applicability of existing Union legislation to telemedicine services

Close up of a hand holding a smartphone displaying a call with a doctor, photo by greenbutterfly/Adobe Stock

Photo by greenbutterfly/Adobe Stock

What is the issue?

Telemedicine in the EU has seen significant growth, driven by advancements in digital technology, policy support, and an increasing demand for accessible healthcare, particularly following the COVID-19 pandemic. The use of telemedicine services is expected to grow significantly over the next decade. Though telemedicine is not predicted to replace traditional in-person visits, it is expected to act as a significant ancillary tool to address changing demands for accessible healthcare and new ways of working for healthcare professionals across Europe, and therefore, will become an important component of the future landscape of healthcare delivery. Though the level of teleconsultations as a proportion of all consultations has decreased in the EU since the COVID-19 pandemic as in-person consultations became possible again, research shows that telemedicine has radically changed the nature of healthcare practice and remains an integral part of healthcare systems across the EU.

Telemedicine is considered both a healthcare service and an information society service under EU law. EU level legislation addresses telemedicine; however, its delivery is heavily circumscribed by national legislation. While each member state determines the licensing and registration requirements for healthcare professionals within their jurisdiction for the use of telemedicine services, these national requirements must align with the following EU level legislation: Directive 2005/36/EC, Directive 2011/24/EU and Directive 2000/31/EC.

The EU legal frameworks governing telemedicine provide a foundation for the free movement of telemedicine services in cross-border care. However, national differences and harmonisation are not a primary objective, as member states remain in control of organising their healthcare systems. Although most member states have established some foundational legislation for telemedicine, national regulatory frameworks are still evolving. There are notable gaps and barriers, and the approach to telemedicine varies significantly across European countries. National variations in telemedicine regulations and implementation highlight the different pace and ways in which countries are adapting to and integrating telemedicine, which reflects contextual differences and countries’ particular priorities and challenges.

How are we helping?

ICF and RAND Europe are conducting a study examining the multifaceted dimensions of telemedicine, focusing on its legal foundation in the EU and across EU member states and EEA countries. The study will provide insights on its general application including its effectiveness in providing mental health care and psychological support, and its implications and opportunities for health workforce.

RAND Europe research tasks include:

  • In-depth desk research, collating and analysing information from existing sources, to complete a legal review of existing telemedicine legislation and regulation. This will include a review on the impact on mental health, implications on the healthcare workforce, and technological mapping.
  • Case studies focusing on the following topics: regulatory landscape; mental health; healthcare workforce; and technological solutions. These case studies will facilitate a deeper exploration of these topics, enabling the identification of effective or promising practices and the generation of targeted insights. These insights will provide context, offer solutions, and inform decision making to advance telemedicine in the EU. Additional desk research and, where needed to fill any information gap, stakeholder interviews, will be carried out for each of the four case studies.
  • Focus groups with stakeholders from relevant groups across the EU, including representatives from EU institutions, member state and regional authorities, health professionals, and civil society. The aim is to gather in-depth qualitative insights on telemedicine in the EU. The focus groups will enable participants to discuss and reflect on the evidence compiled through the desk research, interviews, surveys, and case studies.