European healthcare is undergoing a profound transformation, driven by greater citizen mobility, advances in digital technology, and the need for consistent evaluation of medical innovations. The latest EU legislative acts — Directive 2011/24/EU, Implementing Decision (EU) 2019/1765, and Regulation (EU) 2021/2282 — lay the foundation for this transformation. They establish a framework that strengthens patient rights, develops connected digital health systems, and harmonises the assessment of health technologies. This article examines how these initiatives are shaping the future of healthcare in Europe and what they mean for health professionals and for the National Health Information System (NHIS) in Bulgaria.
Patient Rights in Cross-Border Healthcare Directive 2011/24/EU guarantees EU citizens the right to receive healthcare services in another member state and to be reimbursed by their home country. Patients may travel abroad for treatment if it falls within the scope of their national health system. Reimbursement is at the same level as for treatment in their own country, but cannot exceed the actual cost of the service. In some cases — such as hospital stays or highly specialised treatment — prior authorisation may be required. The directive also defines the responsibilities of the country of affiliation and the country of treatment. The former is responsible for reimbursement and follow-up care, while the latter must ensure safe and high-quality services under equal conditions for foreign patients. Beyond individual rights, the directive promotes cooperation through European Reference Networks for rare diseases and through digital initiatives that are today reflected in European health systems such as Bulgaria's NHIS.
Building the Digital Backbone: The eHealth Network Implementing Decision (EU) 2019/1765 sets out the rules for the operation of the eHealth Network — a voluntary cooperation platform for national health authorities across EU member states. Its goal is to ensure that citizens' medical data can be securely exchanged between countries, facilitating access to healthcare services throughout the EU. The network aims to ensure the interoperability of electronic health records and to create conditions for the development of telemedicine, mobile applications, artificial intelligence, and big data analytics in healthcare. Security and personal data protection are core principles, with strict cybersecurity standards introduced. The network proved its importance during the COVID-19 pandemic, when it supported the interoperability of national contact-tracing applications. By 2025, all 27 member states actively participate in this network. For Bulgaria, through the NHIS, this means integration into the European digital infrastructure and access to cross-border health data exchange through the National Contact Points for eHealth.
The Health Technology Assessment Regulation Regulation (EU) 2021/2282 introduces a pan-European framework for Health Technology Assessment (HTA). The goal is for new medicines, medical devices, and therapies to be evaluated in a scientifically sound and consistent manner across the EU. Instead of each country conducting its own separate analyses, joint clinical assessments will be carried out — particularly for new oncology medicines, therapies for rare diseases, and high-risk medical devices. This reduces duplication of effort and accelerates patient access to innovations. Manufacturers will be able to receive scientific consultations at the European level to design clinical trials that meet the needs of HTA bodies. Although pricing decisions remain a national competence, countries will work from a common scientific basis. For Bulgaria, this means that the NHIS and related institutions will be able to use these assessments as part of the process of integrating new technologies into the health system.
The Road Ahead: Digital Transformation of Health Systems The European Commission emphasises that digital technologies must be seen as an essential part of healthcare. Successful transformation requires solutions tailored to both patient needs and the specific characteristics of health systems. It calls for the sharing of best practices, investment in integrated infrastructure, and the development of digital skills among healthcare professionals and citizens alike. In Bulgaria, through the NHIS, these processes are being woven into national practice, enabling better access to data, higher quality services, and participation in European networks. The NHIS should evolve not merely as an administrative system, but as a primary instrument for health data exchange and integration into the European digital health space. For Bulgarian specialists, these legislative acts point to a future in which clinical practice, patient access, and the adoption of innovations will be better aligned at the European level. Understanding these rules is key — not just for compliance, but for active participation in the transformation of healthcare through the NHIS.
References
Directive 2011/24/EU
Implementing Decision (EU) 2019/1765
Regulation (EU) 2021/2282
National Health Information System (NHIS)