ABSTRACT

In Bulgarian legislation the general principle of privacy of the patient is stipulated in the health law. A Law on Data Protection was adopted on 21 December 2001. Data processing can be performed only for a purpose specified in advance and cannot be anonymized and further used, as anonymization is not viewed as a process by the law. The law has no specific provisions for data protection in medical research in relation to exemptions from Article 11, to the processing conditions for sensitive data, or to the rights of access and rectification or by using Article 13. Practice in our country considers human biological material (including DNA samples) used for research as well as for diagnosis as personal data. There is no legal regulation in this field for the time being. Information required for fair processing in relation to uses and disclosures of genetic data and material includes personal, health status and pedigree data.