Protection of personal medical data in the context of GDPR implementation Anzhela B. Berzina, Serhii S. Rozsokha, Olena P. Makhmurova-Dyshliuk, Alina O. Pletenetska Polski Merkuriusz Lekarski, 2026 Aim: To analyse the challenges of protecting personal medical data in European Union (EU) Member States and other European countries during the implementation of Regulation 2016/679 (General Data Protection Regulation [GDPR]). Materials and Methods: The study is based on an analysis of international and national legal frameworks governing personal medical data protection, focusing on the GDPR, the case law of the European Court of Human Rights (seven relevant judgments), and national data protection legislation. Statistical data from reports of national Data Protection Authorities were analyzed to identify dominant categories of infringements related to unlawful processing, storage, disclosure, and security breaches of medical data. The methodology included a comparative analysis of European Court of Human Rights judgments and an overview of enforcement activities of data protection authorities in 27 EU Member States. Dialectical, hermeneutic, comparative, analytical, and systemic analysis methods were applied. Conclusions: To comply with the GDPR, healthcare institutions must ensure lawful and secure processing of personal medical data: organize internal procedures, appoint a Data Protection Officer, implement technical and organizational measures, obtain informed consent from patients, and guarantee their rights to access and protect such sensitive information. The protection of personal medical data is ensured through a multi-level system that combines the GDPR, the European Court of Human Rights case law, and national institutions. It is essential to develop and implement clear data protection policies that define responsibilities, data handling procedures and incident response. Many countries still have low awareness among medical personnel regarding personal data protection.
Legal regulation of health care management based on forensic medical assessment of early in-hospital mortality Alina O. Pletenetska, Anzhela B. Berzina, Ruslan A. Volynets, Oksan. O. Cherniak, Oleksandr V. Felyk, et al. Wiadomosci Lekarskie Warsaw Poland 1960, 2026 Aim: To analyze the legal regulation of health care management based on the analysis of forensic medical examinations concerning the quality of medical care in cases of early in-hospital mortality. Materials and Methods: A retrospective forensic medical examination was conducted of 51 cases of patient mortality occurring within the first 24 hours after hospital admission in a multidisciplinary hospital in Kyiv. Organizational and legal aspects of medical care delivery were analyzed for compliance with legislation and clinical protocols. Results: Systemic deficiencies included the absence of electrocardiographic examination in 90,2 ± 4,2% of cases, regardless of diagnostic accuracy. Significan trends were identified as the hospital stay duration increased: the absence of oxygen therapy showed a downward trend (from 86,7 ± 8,8% to 38,5 ± 13,5%; = 0,006), while diagnostic discrepancies demonstrated an upward trend (from 6,7 ± 6,4% to 46,2 ± 13,8%; p = 0,016). The median number of defi ptrend ptrend ciencies doubled from 2 (1–3) in the <3 h group to 4 (3–4) in the 12–24 h group (p = 0,002). A moderate direct correlation was established between patient age and the total number of deficiencies (. = 0,462; p < 0,001). Conclusions: The identified deficiencies correlate with non-compliance with mandatory regulatory requirements. The accumulation of medical errors with increasing length of stay and patient age indicates systemic violations of organizational and legal standards, necessitating stricter public administration control over medical care quality.
Administrative-legal assurance of the reliability and ethics of medical decisions in wartime Serhii S. Rozsokha, Anzhela B. Berzina, Olena P. Makhmurova-Dyshliuk, Oleksandr V. Felyk, Oleksandr V. Halunko, et al. Polski Merkuriusz Lekarski Organ Polskiego Towarzystwa Lekarskiego, 2026 Aim: This study aims to provide a comprehensive analysis of the administrative-legal assurance of the reliability and ethics of medical decision-making in wartime conditions, combining normative analysis with empirical data from a frontline Ukrainian hospital. Materials and Methods: The normative framework includes international standards of the World Health Organization, the International Committee of the Red Cross, professional medical associations, the European Charter of Patients’ Rights (2002), European Union legislation, and the national healthcare and wartime legislation of Ukraine. The empirical component comprised a cross-sectional anonymous survey conducted between May and September 2025 among 40 healthcare workers at a rural hospital located near the active frontline in the Dnipropetrovsk region. The questionnaire assessed decision-making complexity, perceived probability of errors, stress impact, resource availability, preparedness, and willingness to report incidents. Results: Wartime conditions significantly increase the perceived complexity of clinical decision-making, particularly in resource allocation, evacuation prioritization, and surgical interventions. Respondents reported elevated stress levels and increased risk of errors, primarily associated with limited resources, disrupted logistics, and administrative constraints. The reliability and ethical integrity of medical decisions were found to depend on the availability of updated clinical protocols, state monitoring mechanisms, organized evacuation systems, and guaranteed minimum healthcare services. Conclusions: Effective administrative-legal support is a prerequisite for ensuring both the reliability and ethical soundness of medical decisions in wartime. Strengthening institutional safeguards, resource allocation mechanisms, and clear regulatory guidance is essential to maintain medical standards under extreme conditions.
Forensic medical and legal analysis of cases of improper performance of professional duties by medical employees, including incorrect prescription of medical products Anzhela B. Berzina, Alina O. Pletenetska Polski Merkuriusz Lekarski, 2025 Aim: To conduct a forensic medical and legal analysis of cases of improper performance of professional duties by medical employees, including incorrect prescription of medical products. Materials and Methods: The article is based on the analysis of defects in the performance of professional duties by medical employees, particularly according to data from commission forensic medical examinations, as well as an analysis of international and national legal acts and national judicial practices of Ukraine. Dialectical, hermeneutic, comparative, analytical, synthetic, and system analysis research methods were used. Results: Although the total number of forensic medical examinations tends to decrease, these examinations remain the focus of attention in cases of improper performance of professional duties by medical employees. A more detailed analysis of cases involving violations of treatment strategies revealed instances of incorrect treatment method selection (whether conservative or surgical), along with cases of improper or unjustified prescription of medicinal products. Incorrect prescription of medical products is one significant way medical employees fail in their professional duties. Conclusions: Understanding the general dynamics of forensic medical examinations is important, as it helps establish practical cause-and-effect relationships between the performance of professional duties by medical employees and adverse consequences for patients (including cases involving incorrect prescription of medical products).
Compliance and due diligence in healthcare: international experience and implementation challenges Anzhela B. Berzina, Tetiana B. Pozhodzhuk, Ivan S. Demchenko, Yurii M. Sereda, Iryna Y. Khmil Wiadomosci Lekarskie Warsaw Poland 1960, 2025 Aim: To analyse the international experience of applying compliance and due diligence procedures in healthcare and to identify the main challenges to their implementation. Materials and Methods: The study is based on the systematisation and comparative analysis of regulatory and empirical data on the implementation of compliance and due diligence procedures in healthcare. The empirical base includes data from the U.S. Sentencing Commission and the U.S. Department of Justice Fraud Section (2019–2025), illustrating the influence of compliance and ethics programmes on organisational accountability, supplemented by legis lative frameworks and case law from the United States, the European Union, and Ukraine. The assessment covered eight indicators. Dialectical, hermeneutic, comparative, analytical, synthetic, and systems analysis methods were used. Conclusions: The main challenges to implementing compliance and due diligence procedures include the absence of a legislative mandate for healthcare institutions and a low level of corporate culture and ethical awareness.
Healthcare fraud in the United States of America and Ukraine: A comparative legal research Anzhela B. Berzina, Pavlo S. Berzin, Ruslan A. Volynets, Olga M. Koval, Nataliia V. Marushchak, et al. Wiadomosci Lekarskie Warsaw Poland 1960, 2025 Aim: To conduct a comparative legal study of healthcare fraud in the United States of America and Ukraine. Materials and Methods: This study is based on the analysis of the US federal regulatory legislation (False Claims Act, Anti-Kickback Statute, Stark Law); data from the Fraud Section of the US Department of Justice for the last five years; case law in Ukraine (more than 30 court verdicts were analysed); data from the National Health Service of Ukraine. Dialectical, hermeneutic, comparative, analytical, synthetic, and systems analysis research methods were used. Results: The criminal legislation acts that provide for criminal liability for healthcare fraud under the laws of the United States and Ukraine are analysed; the criteria for identifying types of healthcare fraud and related criminal offences are defined. It is determined that healthcare fraud has a multidimensional nature, which can manifest itself in different ways, but the common purpose in these manifestations of criminal behaviour is deception or intentional distortion of facts to obtain money or property that is under the control of or owned by any healthcare benefit programme (in the US) or medical guarantees programme (in Ukraine). There are various illegal manipulations with the state programme of medical guarantees. Starting from 2021, the judicial practice of Ukraine lacks a single acceptable approach to the criminal legal assessment of such illegal manipulations. Conclusions: The experience of the United States in determining the types of criminal offences that constitute healthcare fraud and establishing criminal liability for their commission is appropriate to borrow.
The specifics of the interpretation of non-performance or improper performance by medical or pharmaceutical employees of their professional duties, taking into account the practice of the ECHR Anzhela B. Berzina, Alina O. Pletenetska, Polina P. Marshall, Inna V. Berdnik, Olena H. Kozynets Wiadomosci Lekarskie Warsaw Poland 1960, 2024 Aim: To find out the specifics of the interpretation of non-performance or improper performance by medical or pharmaceutical employees of their professional duties, taking into account the practice of the ECHR. Materials and Methods: This article is based on the analysis of the international legal acts, the practice of the ECHR, national judicial practice, court statistics, criminal and medical law legal doctrine, official statistics of the Office of the Prosecutor General of Ukraine, analytical data based on the results of cooperation with the “Main Bureau of Forensic Medical Examination of the Ministry of Health of Ukraine”. Dialectical, comparative, analytical, synthetic and system analysis research, hermeneutic methods were used. Results: In each specific case it is necessary to establish whether there is non-performance or improper performance of professional duties by medical or pharmaceutical employees, the result of which is the failure to fulfil his direct professional duties, provided for by regulatory and legal acts, job instructions, qualification requirements and standards of treatment. The patient’s right to health care is not ensured by the guarantees provided for by national legislation, so patients file complaints with the ECHR. Conclusions: A single approach to the interpretation of such terms as “non-performance or improper performance by a medical or pharmaceutical employee his professional duties” is a guarantee of the uniformity of their enforcement and the formation of stable judicial practice in this category of criminal cases.
Problems of harmonization of the criminal legislation of the certain continental law countries to ensure the protection of the circulation of medicinal products A. Berzina, Olena H Frolova, Andriy M Orlean, Yuriy V Onishchyk, Olga M Golovko, et al. Wiadomosci Lekarskie Warsaw Poland 1960, 2024 OBJECTIVE Aim: To find out the problems of the harmonization of the criminal legislation of the certain continental law countries to ensure the protection of the circulation of medicinal products. PATIENTS AND METHODS Materials and Methods: This study is based on the analysis of the international legal acts, in particular, the Directives of the EU, as well as Medicrime Convention, national acts of criminal legislation of the certain continental law countries (Germany, Austria, Switzerland, Ukraine, etc.), national judicial practice, data on the number of criminal proceedings in the courts of Ukraine, criminal and medical law legal doctrine (38 normative legal acts and 15 court judgments), data of the Office of the Prosecutor General of Ukraine. Dialectical, hermeneutic, comparative, analytical, synthetic and system analysis research methods were used. RESULTS Results: The problems of harmonizing the criminal legislation of the certain continental law countries to ensure the protection of the circulation of medicinal products depend on: a) the level of legal regulation of the field of health care at the national level; b) availability of effective mechanisms for implementing the provisions of international and regional standards. CONCLUSION Conclusions: The formation of a model of criminal law protection of the circulation of medicinal products in continental law countries depends on harmonization with the basic international legal and regional standards and their implementation at the national level.
THE PROBLEMS OF CRIMINAL LIABILITY OF PHARMACEUTICAL EMPLOYEES IN THE CONTEXT OF CERTAIN FORMS OF COLLABORATIVE ACTIVITIES Pavlo Berzin, Ivan Demchenko, Anzhela Berzina Wiadomosci Lekarskie Warsaw Poland 1960, 2023 The aim: Based on the specifics of the criminal legislation, which provides liability for collaborative activity, it is necessary to offer an adequate understanding of the limits of the criminal liability of pharmaceutical employees for these criminal offenses, as well as to determine the characteristics of the components of these criminal offenses related to the pharmaceutical activities carried out by pharmaceutical employees. Materials and methods: The conducted research is based on the analysis of the provisions of the criminal legislation of Ukraine and Georgia. Conclusions: The main problems of criminal liability for collaboration activities by pharmaceutical employees are connected to the following: without clari¬fication of the aforementioned criminal offenses, it is impossible to specify the limits of criminal liability.
THE PROBLEMS OF DEFINITION OF THE ABETTING IN THE COMISSION OF THE OFFENCES INVOLVING THREATS TO PUBLIC HEALTH (PART 1 OF ARTICLE 9 OF THE COUNCIL OF EUROPE CONVENTION ON THE COUNTERFEITING OF MEDICAL PRODUCTS AND SIMILAR CRIMES INVOLVING THREATS TO PUBLIC HEALTH) Pavlo S. Berzin, Ivan S. Demchenko, Anzhela B. Berzina Wiadomosci Lekarskie Warsaw Poland 1960, 2021 The aim: based on the features of the notion of “abetting the commission of crimes established in accordance with the Convention” provided for in Part 1 of Art. 9 of the Medicrime Convention, it is necessary to offer an adequate understanding of the notion of “abetting” and define the types of criminal offenses (crimes) that are the “subject” of such abetting. Materials and methods: the research is based on an analysis of the provisions of the Medicrime Convention and the criminal law of Ukraine. The following methods were used: dialectical method; hermeneutic method; systemic-and-structural method; and comparative-legal method. Results: at the legislative level, there is a problem of designating the relevant socio-legal phenomena with adequate concepts and interpretations of these concepts. In the current criminal legislation of Ukraine, there is no definition of the concept of “abetting”, which is used in Part 1 of Art. 9 of the Medicrime Convention. Therefore, in the implementation of the requirements provided for in Part 1 of Art. 9 of the Medicrime Convention, each Party takes the necessary legislative and other measures to recognize abetting in committing any crimes, established under this Convention, as a crime, therefore we should take into account the existence of two alternative ways to explain the meaning of “abetting”: 1) to recognize at the legislative level that “abetting” and “incitement” are synonyms, and therefore the meaning of the term “abetting” can be explained by using the term “inclination”; 2) to recognize at the legislative level that the concept of “abetting” has a meaning different from the concept of “incitement”, and covers not only “inclination”, but also “coercion”, “motivation” and “encouragement”. Conclusions: the main disadvantage of using the concept of “abetting” in the text of the Ukrainian translation of the Medicrime Convention is that without an independent explanation of this concept at the legislative level, its content should be determined depending on the meaning of the term “inciter” under Part 4 of Art. 27 of the Criminal Code of Ukraine), and means inciting a person to commit any of the crimes specified in the Medicrime Convention.
