Elektroninis sveikatos įrašas ir teisinė aplinka: esama situacija ir problemos
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Electronic health record systems are becoming a reality. However, emerging electronic health record systems present numerous challenges, including challenges for legal systems. Therefore, the legal regulation of electronic health record is one of the most relevant problems in the sphere of e-health in the world, including Lithuania. So far, the analysis of legal problems related to electronic health record in scientific literature has been rather limited. Despite the fact that several foreign scientists have analysed electronic health records and the legal regulation, the author of this paper has not succeeded in finding any scientific article with analysis of Lithuanian legal regulation situation in the area of electronic health record. The main goal of the thesis paper is to analyze and compare the legal regulation of electronic health record in the EU and several EU countries, including Lithuania. Special focus is put on strategical documents, legal status of electronic health record and protection of privacy and data protection and electronic health record. Several different approaches have been used in the research. The author has used a comparative method to investigate the laws/legal frameworks and strategic documents of the EU, several EU countries, including Lithuania, in the area of electronic health records. The empirical analysis of legal documents was used to determine the legal regulation of the legal status of electronic health record and also to determine problems on privacy and data protection. Having analyzed the official documents, the method allows identifying and describing the relationship between the valid legal regulations accurately. Using literature resources, the author has used the deductive method, which allows drawing sufficiently reliable conclusions. The latest scientific literature and dictionaries have been used to study the definitions. The article consists of four parts. The first part deals with the comparative aspect of strategic documents – the programs governing electronic health records in the EU, EU countries, including Lithuania. The second part of the article examines the legal status of electronic health record in fundamental legal norms. It was found that there is a lack of Lithuanian law related to electronic health records. The third part of the article examines legal protection of privacy and personal data in the case of using electronic health records. It was found that in principle, legal norms in Lithuania (which has implemented EU general data protection directive No. 95/46/EC) are enough to protect privacy and personal data of patients in electronic health records systems. In the fourth part, the author mentions other main areas of legal regulation problems, related to electronic health records. Those problems need to be analysed in the nearest future.
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