The digitalization and connectivity of the healthcare systems of EU member states are progressing too slowly to jointly improve the quality, efficiency, and accessibility of healthcare services. Digital health has long been viewed as a facilitator for transitioning to evidence-based, patient-centered, and prevention-focused healthcare. However, the introduction of technologies such as electronic patient records (EPR), remote care, mobile health applications, and artificial intelligence (AI) has proven to be more challenging than anticipated, primarily due to data interoperability issues and the complexity of healthcare systems (Olesch 2022; Orăștean et al. 2022).

The equality of healthcare systems is crucial for building the future European Health Union. It is necessary to ensure that every European citizen can obtain prescribed medicinal products through electronic prescriptions, regardless of their location within the European Union, and to be assured that their health data will not be misused. With this objective, the European Commission proposed the creation of the European Health Data Space, subsequently reaching an agreement in the European Parliament on a proposal for a Regulation of the European Parliament and the Council on the European Health Data Space (European Commission 2022).

The proposal aims to improve individuals’ access to and control over their personal electronic health data (primary use of data), both at the national level and at the EU level, and to facilitate the use of data for research, innovation, regulatory purposes, and public policy goals across the EU (so-called secondary use of data). Additionally, it aims to enhance the functioning of the single market, particularly for the development, marketing, and use of digital health services and products (e.g., electronic health record systems (EHRs)). To this end, the proposal provides for a health-specific data environment, including common rules, infrastructure, and a governance framework. (European Commission 2023)

The proposal seeks to harmonize data flows to help individuals benefit from the protection and free movement of electronic health data, especially personal data. On the other hand, the proposal does not intend to regulate how healthcare is provided by member states, particularly concerning sensitive topics for member states such as telemedicine and online pharmacies, which remain within the competence of the EU member states.

A fundamental provision is Article 3, paragraph 1 of the proposed regulation, which states, “Individuals have the right to access their personal electronic health data, processed in the context of the primary use of electronic health data, immediately, free of charge, and in an easily readable, summarized, and accessible format.” The proposed regulation stipulates that healthcare professionals will have access to the electronic health data of the individuals they treat, regardless of the member state of insurance and the member state of treatment. To ensure this connectivity, the European Commission will create a centralized platform for digital health, MyHealth@EU, which will provide services to support and facilitate the exchange of electronic health data between national contact points for digital health in the member states. Additionally, the regulation ensures that pharmacies operating in their territory, including online pharmacies, are enabled to dispense medicinal products based on electronic medical prescriptions issued by other member states. After dispensing medicinal products based on an electronic medical prescription from another member state, pharmacies report the dispensed medicines’ data to the member state where the medical prescription was issued through MyHealth@EU (Julesz 2023).

Despite significant progress in the use of personal electronic health data for primary purposes in several member states, the process of cross-border healthcare remains slow. The MyHealth@EU platform has been implemented in only 10 member states and currently supports only two services (electronic medical prescription and patient summary). It is expected that by 2025, most member states will have implemented the MyHealth@EU platform. Only after the platform is implemented by more member states and they develop the necessary tools will the use, development, and maintenance of these tools become more efficient across the EU (Bruthans and Jiráková 2023).

In the national development program of the Republic of Bulgaria 2030, significant emphasis is placed on the development of e-health, making it a primary focus of healthcare policy (Council of Ministers 2020). Targeted efforts in this area contribute to improving access to and quality of healthcare services, transparency in financial management, reducing patient service time, enhancing the quality of healthcare services, and activities related to organization, control, planning, and forecasting within the healthcare system (Odone et al. 2019).

The measures outlined in the National Development Program of Bulgaria 2030 for the digitization of the healthcare sector include the creation of the National Health Information System (NHIS) using modern technological solutions focused on preventing chronic and non-communicable diseases to ensure effective and efficient care and achieve better health outcomes. The goal is to integrate all software applications related to human health.

Another measure in the national program is the development and implementation of telemedicine (especially for patients in hard-to-reach and remote areas, as well as patients with specific needs—chronically ill patients, elderly people, etc.) and the introduction of innovative applications for mobile health monitoring services. Telemedicine services will include online consultations to clarify diagnoses and discuss patient conditions based on diagnostic test results, remote medical activities, and more. The ultimate goal is to improve access to quality healthcare services for the population (Council of Ministers 2020).

According to the regulatory framework, the NHIS was established by the Health Act and operates under Ordinance No. N-6 of December 21, 2022, regarding the functioning of the national health information system. The system is maintained by the Ministry of Health and aims to collect, process, and store information about the health status of the population as a whole and for each individual. NHIS includes data on electronic health records of all citizens, as well as information obtained from registers, databases, and systems maintained by the Ministry of Health, its secondary budget holders, healthcare facilities, the National Health Insurance Fund (NHIF), insurance companies, and others (Ministry of Health 2022). Since 2020, numerous modules and functionalities of NHIS have been developed and implemented, including:

• The health information portal (HIP) provides a single entry point for access to NHIS.
• A unified environment for the exchange of medical data.
• Electronic medical dossier (EMD), electronic health record (EHR), electronic prescription, and electronic referral.

The introduction of electronic prescriptions is part of the government’s program (adopted by Council of Ministers Decision No. 506 of July 26, 2023) and the “Management Program of the Republic of Bulgaria for the period June 2023–December 2024” (Council of Ministers 2023). The electronic prescription as a component of NHIS was realized in Phase-2 of NHIS development and has been functioning since June 2021. It covers the prescription and dispensation of products with so-called “white” prescriptions (appendix 2 of Ordinance No. 4 of March 4, 2009, on the conditions and procedures for prescribing and dispensing medicinal products), as well as medicinal products partially or fully reimbursed by NHIF (mandatory for this type of prescription since then). As of June 2023, electronic prescriptions are mandatory for medicinal products with a special prescription and dispensing regime (so-called yellow and green prescriptions according to Appendix No. 2 to Art. 3, item 2, and Appendix No. 3 to Art. 3, item 3 (Ministry of Health 2009, 2011).

A primary motive for the digitalization of medical prescriptions is that therapy prescribed on a paper prescription is not recorded in the patient’s health dossier, making it impossible to retrospectively track, which compromises the therapeutic process and, in the case of antibiotics, contributes to antibiotic resistance alongside their widespread use.

Electronic prescriptions in Bulgaria were introduced in mid-2021, initially mandatory for medicinal products fully or partially reimbursed by the NHIF. In June 2023, the fully electronic prescription of medicinal products dispensed with yellow or green prescriptions was introduced. In October 2023, it became mandatory for anti-diabetic medications and systemic anti-infective medicinal products to be prescribed only via electronic prescription. The main reasons for mandating electronic prescriptions for these two groups of medicinal products—antibiotics and anti-diabetic medications—are to prevent shortages of these drug groups in the country, address antimicrobial resistance, and promote rational drug use. According to a literature review conducted in 2023 by Lebanova et al., the most common cause of antibiotic resistance is the irrational use of antibiotics (Lebanova et al. 2023). Data indicates an increasing trend in the use of anti-infective medicinal products in Bulgaria in recent years, necessitating conditions for rationalizing the use of this type of medication (Vankova et al. 2023).

The dispensing of these two groups of medications solely with e-prescriptions ensures transparency throughout the process, control over frequency and misuse without medical prescription, and effective tracking of the stock of medicinal products from these two therapeutic groups (Majcherek et al. 2024). These changes also comply with a decision adopted at the Health Committee meeting held on August 7, 2023, stating: “The Minister of Health should prepare the necessary amendments and additions to Ordinance No. 4 of 2009 on the conditions and procedures for prescribing and dispensing medicinal products as soon as possible to expand the scope of medicinal products that are prescribed and dispensed with an electronic prescription” (Committee on Health 2023).

Furthermore, the introduction of electronic prescriptions significantly facilitates the dispensing of medicinal products in pharmacies by reducing the risk of misreading prescriptions (Ditya and Adisasmito 2019).

Since early March 2023, all medical professionals can issue electronic prescriptions anytime and from any location via the dedicated eRx mobile application. The issued prescription immediately appears in the patient’s electronic health dossier and can be filled out by any pharmacy. The app aims to assist doctors, dentists, and veterinarians in issuing electronic prescriptions when they do not have access to a computer with medical software. Thanks to this, during home visits or other emergencies outside the doctor’s office, an electronic prescription can be issued, complying with good medical practices, applicable laws, and NHIS requirements (Ministry of Health 2023).

According to a study published in 2022 during the Varna Medical Forum, Alexandrova et al. concluded that pharmacists feel confident when working with electronic prescriptions (Alexandrova et al. 2022).

To illustrate the widespread use of electronic prescriptions in Bulgaria, the following graph reflects the dynamics of prescribed and dispensed electronic prescriptions by type:

1. Ordinary (white) prescription;
2. One-month prescription reimbursed by NHIF;
3. Three-month prescription reimbursed by NHIF;
4. Green electronic prescription;
5. Yellow electronic prescription.

Regarding electronic prescriptions on the so-called “white” prescription forms, there is a significant increase in the issued and dispensed electronic prescriptions in the second quarter of 2024 compared to the first quarter of 2024. It is important to note that since the beginning of April 2024, all medicinal products falling within the pharmacological groups “medicinal products for the treatment of diabetes” and “antibacterial medicinal products for systemic use” according to the anatomical therapeutic chemical (ATC) classification of the World Health Organization (WHO) are required to be prescribed only by electronic prescription. The number of issued and fulfilled electronic prescriptions for medicinal products dispensed on yellow and green electronic forms remains relatively constant.

In Fig. 2, it is noticeable that electronic prescriptions are widely used across all age groups. The highest number of issued electronic prescriptions is for patients aged 70–74 years, followed by those aged 65–69 years. Additionally, during the first six months of 2024, there will be a significant number of electronic prescriptions issued for patients aged 0–9 years. This is largely due to the mandatory requirement that antibiotic prescriptions be issued exclusively electronically.

In Fig. 3, it is evident that nearly 16 million electronic prescriptions were issued in the first six months of 2024. A significant portion of these prescriptions are funded by the National Health Insurance Fund, meaning they are partially or fully reimbursed by the NHIF. About one-quarter of the issued electronic prescriptions are in the so-called “white” prescription form.

From a pharmacovigilance perspective, the extensive patient information available, including prescribed medications, dosages, and observed adverse drug reactions (ADRs) in electronic health records, can be analyzed automatically using machine learning and artificial intelligence algorithms to detect potential ADRs more quickly and effectively than traditional methods (Coste et al. 2022). Additionally, electronic health records allow healthcare professionals quick access to the patient’s complete medical history, which includes information on previous ADRs and medications used, crucial for preventing repeated adverse reactions and optimizing therapy (Davis et al. 2023).