Telemedicine has emerged as a promising tool in modern healthcare delivery, offering opportunities for improved patient outcomes, increased efficiency, and cost savings. Within the European Union (EU), where citizens frequently move across borders, the potential for cross-border telemedicine services is particularly significant.
The newly adopted European Health Data Space (EHDS) regulation aims to advance interoperability and data exchange, addressing some existing limitations in both cross-border and intra-national telemedicine. This post explores the potential implications of the EHDS for telemedicine across Europe.
First proposed in 2022 and adopted in April 2024, the EHDS regulation establishes a comprehensive framework for the secure and interoperable exchange of health data across the EU. The agreed text anticipates further legislative elaborations through implementing acts that will detail specific requirements related to many of the Articles in the EHDS Regulation.
The EHDS Regulation uses the European Electronic Health Record Exchange Format (EEHRxF) to ensure secure and interoperable exchange of electronic health data across the EU. The EEHRxF comprises a set of requirements and technical specifications that support both structured and unstructured data types.
The EEHRxF covers six priority categories of personal electronic health data in the EHDS: patient summaries; electronic prescriptions; electronic dispensations; medical imaging studies and related reports; medical test results, including laboratory and diagnostic results; and discharge reports. These categories encompass numerous use cases and can support various digital health applications. However, some digital health applications, including potentially those within telemedicine, might currently fall outside the EEHRxF’s scope. Thus, understanding telemedicine’s position within the EHDS Regulation is crucial.
Telemedicine in the New EHDS Regulation
The adopted EHDS regulation acknowledges telemedicine’s potential to enhance healthcare, as highlighted in several provisions: Recitals 21 and 22, and Article 13. Below is an overview of the implications of these provisions.
Recital 21
Recital 21 states: “Telemedicine is becoming an increasingly important tool that can provide patients with access to care and tackle inequities. It has the potential to reduce health inequalities and reinforce the free movement of Union citizens across borders. Digital and other technological tools can facilitate care in remote regions. When digital services accompany physical healthcare, they should be integrated into the overall care provision. Under Article 168 of the Treaty on the Functioning of the European Union (TFEU), Member States are responsible for their health policies, including the regulation of online pharmacies and telemedicine. However, different healthcare policies should not create barriers to the free movement of electronic health data in cross-border healthcare, including telemedicine and online pharmacy services.”
While Member States remain responsible for domestic health policies, they are advised to avoid creating barriers to the free movement of electronic health data in cross-border healthcare, including telemedicine. Recital 21 reinforces the expectation that the EEHRxF will soon apply to data movements related to telemedicine services, initially focusing on cross-border cases. It also recognizes telemedicine’s role in providing care in remote regions, suggesting that the EEHRxF may be used for intra-national telemedicine cases as well.
On online pharmacies, Article 12 (6) explicitly equates them with physical pharmacies. It directs Member States to treat them equally in terms of dispensing ePrescriptions from other Member States and reporting dispensations back to the issuing Member State.
Recital 22
Recital 22 mentions: “Regulation (EU) No 910/2014 establishes rules for the mutual recognition of electronic identification means across Member States. The EHDS requires secure access to electronic health data, including in cross-border scenarios. Telemedicine services should support the identification of individuals using any electronic identification means recognized under Regulation (EU) No 910/2014. In cross-border situations, supplementary access tokens or codes may be needed to address identity matching challenges. The Commission will adopt implementing acts for interoperable, cross-border identification and authentication of individuals and health professionals, including any necessary supplementary mechanisms.”
Recital 22 emphasizes secure access to electronic health data and the need for telemedicine services to support electronic identification across Member States. It suggests using the eIDAS framework, which governs electronic identification and trust services for transactions. This Recital also highlights the need to securely identify healthcare professionals, a topic currently under scrutiny in another EU project, Joint Action Xt-EHR.
Article 13
Article 13 (1) states: “Member States may provide supplementary services through MyHealth@EU that facilitate telemedicine, mobile health, access to translated health data, and exchange or verification of health-related certificates, including vaccination card services. These services aim to achieve a high level of trust and security, enhance continuity of care, and ensure access to safe, high-quality healthcare. The Commission will set out the technical aspects of these services through implementing acts.”
Telemedicine is identified as a primary supplementary service that Member States may offer through MyHealth@EU. This represents an initial step towards expanding the EHDS scope, with further details to be provided by implementing acts. Thus, telemedicine is expected to be among the first areas to benefit from the EHDS expansion. Additionally, since the EEHRxF will govern the exchange of personal electronic health data through the EHDS’ MyHealth@EU platform, telemedicine will likely fall within the EEHRxF’s scope.
Use Cases of EHDS-Empowered Telemedicine
Integrating telemedicine within the EHDS scope offers several potential benefits:
- Tele-consultation: Patients can access healthcare providers remotely, reducing travel, particularly for those in remote areas. For example, a rural patient can have a video consultation with a city specialist, discuss symptoms, receive diagnoses, and get prescriptions without leaving home. This supports the EU’s Digital Decade eHealth target of 100% access to electronic health records by 2030.
- Provider Communication: Tele-consultation facilitates communication between healthcare providers, allowing a general practitioner to consult with a specialist for second opinions or specialized insights, ensuring comprehensive patient care.
- Tele-monitoring: Wearable devices can track vital signs, physical activity, and sleep patterns, enabling healthcare providers to monitor early signs of health issues and encourage timely interventions. Continuous monitoring is beneficial for chronic conditions like diabetes and hypertension, improving treatment and reducing hospitalizations.
- Emergency Monitoring: Continuous tele-monitoring can be crucial in emergencies, such as cardiac arrest. Alerts sent to healthcare providers enable rapid response and potentially life-saving interventions. In intensive care units, tele-monitoring provides additional oversight, improving patient outcomes.
The EHDS regulation marks a significant milestone for telemedicine in the EU. Future implementing acts will detail technical specifications and operational guidelines, focusing on identity verification, data security, and patient privacy. The integration of telemedicine into MyHealth@EU suggests a broader vision where advanced tele-health services become commonplace, improving continuity of care and overall healthcare quality.
XpanDH and similar EU projects, such as Xt-EHR, focused on advancing digital health, will play a pivotal role in shaping the future of telemedicine in Europe. Preparing for related developments in policy and practice will be essential.
About the Authors:
Simon Lewerenz, Alberto Zanini, Diogo Martins, XpanDH Project.
ECHAlliance – The Global Health Connector takes the lead role in Work Package 7 (WP7) for Dissemination and Communication Efforts at XpanDH. For more information, visit the project website here.
