The essence of a patient's rights and legislation framework requires an answer to the question on how legislation can work towards better defining, respecting, protecting and effectiveness of these rights. First, it is necessary to give a short introduction to patients' rights, their definition and different classifications. In the long list of human rights, patients' rights obviously take one of the very important places. Human life and health are the values, which, in comparison with all other human values, are considered as values of the highest rank. Patients' rights represent a legal expression of something, which every person basically and naturally expects from a doctor, medical staff, and from a health care system in general. The subject of the second part of this paper presents the intention, scope and conception of necessary legislation. How should it be considered - in a wider sense or as a special law? Some theoretical and practical questions regarding interaction between medical ethics regulation, confidentiality, and legislation are discussed as well. In the European context there are numerous examples of laws with the specific purpose of protecting patients' rights. Special attention and critical review will be paid to the situation of patients' rights in Serbia. The paper concludes with the point that the role of legislation is evidently important, but the traditional view should be replaced with a new one, due to the reason that modem health law puts the protection of patients' rights on a higher level. De lege lata, the whole system of health law in its diversity (civil, penal and administrative) is characterized by better understanding of rights, duties and legal relations, either through regulation or the protection of patients' rights.