The aim: To identify the role of evidence-based medicine, its principles and approaches to patients' rights protection and the provision of medical service optimization, the skills of medical staff improvement, increasing the objectivity of court decisions in cases of non-providing quality care or death. Materials and methods: The authors used the decisions by the European Court of Human Rights (ECtHR) on the statements of victims of unprofessional actions by doctors, international and domestic regulations on patients' rights, statistics on the results of criminal proceedings on violations of patients' rights over the past 5 years, case law of criminal and civil jurisdiction in this category of cases, the results of surveys of prosecutors, as well as the results of research by scientists in the field of medical law and criminalistics. The research is carried out on the basis of a harmonious combination of philosophical approaches, general scientific and special methods of scientific knowledge, the complex of which is chosen taking into account the goals and objectives, object and subject of research. Conclusions: In order to implement the patients' rights by legal means in accordance with the Convention for the Protection of Human Rights and Fundamental Freedoms, the European Charter of Patients' Rights and other international regulations in the field of medicine, the authors argue the need for greater implementation of evidence-based medicine into the practice of medical institutions as a means of improving the level of medical care and an obvious source of relevant information for litigation to protect the rights of patients and doctors. For patients' rights protection in the diagnosis and treatment of diseases, it is proposed to regulate a set of such measures: 1) to include in the educational programs of pharmacy and medicine such disciplines as «Evidence-Based Medicine» and «Rights of the patient and medical worker's rights»; 2) to oblige the doctor to explain to the patient or to his/her representative the differences of treatment protocols, to provide information to patients about official sources, which contain information on unified and updated treatment protocols and diagnosis of certain diseases, to obtain informed consent by the patient (his/her representative) on certain medical guideline; 3) to recognize medical guidelines as sources of law in criminal and civil proceedings as a kind of benchmarks for clarifying and assessing the facts of non-performance or improper performance of professional duties by a medical or pharmaceutical worker, violation of patients' rights, as well as means for doctors' legal protection and etc.