Article 6, sections 4, 5 and 6 stipulates the regulations regarding the medical file of users of genetic services. It states:
“4. Genetic information that does not have an immediate bearing on the patient’s current status of health – like the information from paternity tests, from zygosity studies in twins and from predictive tests (with the exception of genetic testing to determine the response to drugs), as well as the information from heterozygosity, presymptomatic, prenatal and preimplantation tests – cannot be registered in the medical records, except in the case of genetic services or consultations that keep private separate files.
5. In case the medical records from genetic services or consultations contain genetic information regarding healthy persons, they cannot be accessed, shown or consulted by physicians, other health care professionals or staff of other departments of the health institution in question or of other institutions of the health care system.
6. Genetic information must be subject to legislative and administrative measures of reinforced protection in terms of access, security and confidentiality”.

Article 6, section 9 explicitly refers to the right to know the content of the medical file, as it states:
“Every citizen is entitled to know if a clinical record, a medical file or a medical or research record contains genetic information about himself/herself and his/her family, and is also entitled to know the objectives and the uses of the information in question, as well as the form in which it is stored and the period of time during which the information will be kept before destruction”.

Only information with immediate interest for the patient’s current status of health (diagnostic and pharmacogenetic information) can be entered in general hospital records. Information from presymptomatic, susceptibility, prenatal, preimplantation forensic and identity testing can only be registered in records of genetic services that keep separate files (and these cannot be accessed by other professionals of the same or of other health institutions).

Besides these regulations on the rights regarding the medical file, a definition for “genetic databases” is also provided for. Article 7, section 1 defines this as “any kind of records, computerised or not, that contain genetic information about a group of persons or families.” Furthermore, article 7 stipulates:
“2. The rules of creation, maintenance, management and securing of genetic databases for rendering health care services and relating to the research on health are regulated in accordance with the law regulating the protection of personal data.

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