Electronic health record and legal environment: existing situation and problems

Darius Štitilis


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, including in Lithuania. So far analysis of legal problems, related to electronic health record in scientific literature has been rather limited. Despite, several foreign scientists have analysed electronic health records and the legal regulation, the author 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 to compare the legal regulation of electronic health record in EU and several EU countries, also in Lithuania. Special focus is made 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 have used a comparative method to investigate the laws/legal frameworks and strategic documents of EU, several EU countries and Lithuanian 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, 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 dealt with the comparative aspect of strategic documents - the programs governing electronic health records in EU, foreign EU countries and in Lithuania.

The second part of the article examines the legal status of electronic health record in fundamental legal norms. It was found the lack of Lithuania 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) is enough to protect privacy and personal data of patients in electronic health records systems.

In the fourth part author mentions other main areas of legal regulation problems, related to electronic health records. Those problems must to be analysed in the nearest future. 


electronic health record; legal regulation

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DOI: http://dx.doi.org/10.13165/SPV-14-1-6-05

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"Health Policy and Management" ISSN online 2029-9001 / ISSN print 2029-3569