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Biobanks are covered by the Act on Prcessing of Personal Data

The Danish Data Protection Agency has previously stated that collections of human biological materials can be considered as covered by the Act on Processing of Personal Data’s definition of a manual register/“filing system”, cf. section 1 (1) of the Act. The Danish Data Protection Agency’s statement to the Ministry of Interior and Health is reprinted in its 2000 annual report.

In this regard, a biobank is defined as: A structured collection of human biological material, which is accessible according to certain criteria and in which information that is contained within the biological material can be tied to individual persons.

Biobanks that fulfil these criteria are covered by the Act on Processing of Personal Data’s regulations, including the Act’s security requirements and various protection rules. This includes the rules stipulating that registration and transmission and other forms of processing may only occur when special conditions are met, as well as the rules regarding registered persons’ rights. Biobanks must also be notified  to the Danish Data Protection Agency in accordance with the rules on notification and authorisation in chapters 12 and 13 of the Act.

Public authorities with biobanks must notify these to the Danish Data Protection Agency and must also obtain the opinion of the Danish Data Protection Agency. The notification must always clearly indicate that it includes a biobank.

Biobanks at the regional hospitals are notified centrally from the region.

Private companies, e.g. sperm banks and private researchers who have biobanks must also notify to the Danish Data Protection Agency and need authorisation to keep the register (biobank). In the authorisation, the Danish Data Protection Agency stipulates a number of conditions, including that the biobank must be protected against unauthorised persons, etc. and conditions regarding deletion and destruction. A biobank notification does not have to be composed as a separate notification, but will typically be part of a notification of e.g. a research project that also involves the collection of biological material.

The notifications are published along with all other notifications in the Danish Data Protection Agency’s register of processing operations notified under the Act.