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The Law n°12/2005 of 26 January 2005 on personal genetic information and health information contains in article 6, section 1 and 2 a broad definition of what constitutes “genetic data”. It stipulates:
“1. Genetic information is the health information that deals with the hereditary characteristics of one or more persons, who are related or who have common characteristics of the genetic type, excluding, for the purposes of the present definition, the information obtained through blood relation tests or zygosity studies in twins, through studies of genetic identification for criminal purposes as well as the study of somatic genetic mutations in cancer.
2. Genetic information can result from genetic tests carried out by means of molecular biology, but also by means of cytogenetic, biochemical, physiological or imagiological tests, or through the simple collection of family information, registered as a family tree or in any other form, each of these tests being capable of expressing, by itself, the genetic status of a person or his/her family members”.
Article 17 of this law contains a so called duty of protection.
Article 7, section 1 of the Act on the Protection of Personal Data (Law 67/98 of 26 October 1998) makes an explicit reference to genetic data, when stipulating:
“The processing of personal data revealing philosophical or political beliefs, political party or trade union membership, religion, privacy and racial or ethnic origin, and the processing of data concerning health or sex life, including genetic data, shall be prohibited”.
Whereas section 4 of article 7 stipulates that:
“The processing of data relating to health and sex life, including genetic data, shall be permitted if it is necessary for the purposes of preventive medicine, medical diagnosis, the provision of care or treatment or the management of health-care services, provided those data are processed by a health professional bound by professional secrecy or by another person also subject to an equivalent obligation of secrecy and are notified to the CNPD under article 27, and where suitable safeguards are provided”.
Finally, article 15, section 3 imposes special security measures:
“The systems must guarantee logical separation between data relating to health and sex life, including genetic data, and other personal data.”
Consequently, the regulations about data protection, as explained in III, § 7. Right to privacy/ protection of private life, are also applicable for use of genetic data.
Under the law, anybody can ask for and have access to personal information that is contained in personal data files”.
Article 6 also contains some sections on the right to confidentiality. It reads in the following sections:
“6. Genetic information must be subject to legislative and administrative measures of reinforced protection in terms of access, security and confidentiality.
7. The use of genetic information is to be decided between the patient and his/her physician and it is subject to the rules of ethics, professional conduct and confidentiality that are binding to physicians and other health care professionals.
8. The existence of a working link or other type of relation between a physician or other health care professional and any other sector of activity – including insurance companies, professional entities or suppliers of goods and services of any kind – does not constitute a justification to the failure to comply with the obligation of confidentiality that binds the physicians and all other health care professionals”.
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