ABSTRACT

There are three different laws that regulate data protection in the field of medical research in Slovenia. Personal data protection is dealt with by the Personal Data Protection Law (PDPL) of 1990 and 1991, as amended in 1999, of which the 2001 and 2002 amendments have put it into accordance with EU Directive 95/46/EC. This law regulates the protection of any personal data and is hence, of a general nature. There are two additional laws relating to data in medical research: the Health Activity Law regulates health activities in general and some of its provisions deal with personal medical data and its processing. The Law on Data Files in the Health System lists the data files in the health system that refers to personal data. The expression 'the health system' refers to the system of all health and medical activities carried out by public or private agencies.