Abstract
In Bulgaria, the processing of personal data for research purposes, including genetic and biometric data, is regulated by various laws and regulations, in particular, the Bulgarian Data Protection Act and the Bulgarian Health Act.
Personal data may also be processed for the purposes of the National Archive Fund, including scientific purposes, purposes of historical research and statistical purposes, even if the data were originally collected for another purpose. In such cases, the controller shall apply appropriate technical and organisational measures to protect the rights and freedoms of the data subject in accordance with Article 89 GDPR.
In some cases, clear procedures, rules and policies can be found for the processing and use of personal data, such as the processing of genetic data for research purposes, which may only be carried out by accredited genetic laboratories.
The storage of tissues is regulated in the Act on Organ, Tissue and Cell Transplantation, which refers to the Act on Medical Institutions as well as numerous EU directives. There is no retention period in the Law on Organ, Tissue and Cell Transplantation. However, Decree No. 21 of 3 May 2007 regulates the circumstances and data entered in the registers of the administering transplant agency as well as the procedure for entering and using such information. Accordingly, Art. 2 para. 2 of Decree No. 21 of 03.05.2007 establishes a retention period of 30 years for all the information in Art. 2 para. 1 of Decree No. 21 of 03.05.2007. There are no special laws for biohacking activities.
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Notes
- 1.
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance), O.J. 4.5.2016 L 119/1.
- 2.
See additional provisions pursuant to § 1 No. 11 BG-DPA.
- 3.
- 4.
Article 9 (4) of the GDPR gives Member States legislative competence to adopt or maintain additional conditions and restrictions for the processing of genetic biometric and health data.
- 5.
- 6.
On medical institutions in Bulgaria, see the Law on Medical Institutions. https://www.mh.government.bg/media/filer_public/2018/10/25/zlz.pdf.
- 7.
The law expressly provides that the results of genetic testing and screening shall not be the basis for discrimination against the persons tested. There is an explicit prohibition on sharing this data with employers, health insurance companies and insurers.
- 8.
It obviously includes medical prescriptions, instructions, protocols and certificates (examples of medical documentation listed in Article 27 (1) HA). It may also include ‘health documentation’, which is defined in Article 1 No. 1 of the Supplementary Provisions of the HA as ‘all forms for the registration and storage of health information’.
- 9.
In view of this, health information falls within the scope of the Data Protection Act. Therefore, the general data protection regime is applicable to health information as are the specific rules of the Health Act that develop and complement it.
- 10.
The persons who process health information pursuant to Article 27 para. 2 HA are obliged to take security precautions by protecting this information from unauthorised access (Article 28 para. 3 HA). In addition, they are prohibited from disclosing patient information obtained in the course of their official duties (Article 28 (‘v’) HA, corresponds to Article 28 (‘в’) HA).
- 11.
- 12.
This Regulation controls the rights and obligations of health care institutions and national health care system bodies and does not apply to the processing of health information by third parties. It mainly concerns medical, statistical and health information. When information is provided, the data identifying the patient must be deleted unless there is a legal basis for the use of this information and provided that the rights of individuals are protected, and the information is protected from unauthorised access.
- 13.
- 14.
- 15.
- 16.
- 17.
- 18.
‘Amniotic tissue means a membrane composed of epithelial and connective tissue cells which surrounds the embryo and forms the amniotic chamber’.
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Margitin, M., Rusev, M. (2023). Bulgaria. In: Colcelli, V., Cippitani, R., Brochhausen-Delius, C., Arnold, R. (eds) GDPR Requirements for Biobanking Activities Across Europe. Springer, Cham. https://doi.org/10.1007/978-3-031-42944-6_49
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