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Rules for the Tissue Use Register are laid down

Official title (in Danish): Bekendtgørelse om Vævsan­vendelses­reg­ister­et

Executive order · BEK nr. 361 af 04.04.2019 · Indenrigs- og Sund­hedsmin­is­ter­iet

In short

Reading time: 1 min
  • What it sets out:
    • The executive order states that the Danish Health Data Authority runs the Tissue Use Register.
    • The register records patients' decisions that their biological material and genetic information may only be used for their own treatment and purposes directly related to it.
  • Who: The rules apply to patients who want to sign up for or withdraw from the register. They also apply to the Danish Health Data Authority, which runs the register, to healthcare professionals responsible for a biobank, and to the National Genome Center.
  • When: The executive order entered into force on 1 May 2019.

Written by AI from verbatim quotes from the source and checked by code and AI. Dates, tables and the fact box are calculated by fixed rules. Unofficial translation. Always read the original.

The Danish Health Data Authority runs the Tissue Use Register. The register records patients' decisions that their biological material may only be used for their own treatment and purposes directly related to it. The same applies to genetic information stored at the National Genome Center.

The patient signs up by filling in and signing a sign-up form from the Danish Health Data Authority. The patient withdraws in the same way, with a withdrawal form. The forms can be on paper or electronic.

A healthcare professional responsible for a biobank can get information from the register upon showing proof of authorisation. This applies to the extent necessary to comply with the duty to search for information in the register. The National Genome Center has the same access upon showing proof of authorisation.

The registered person has the right of access under Article 15 of the General Data Protection Regulation. The right of access can be restricted under Section 22 of the Danish Data Protection Act. The register gives the Ministry of Health and Senior Citizens anonymised information about, among other things, the scope of registration.

Sources and original

Read the official text (in Danish) →

Source: Retsinformation.dk

Translated from Danish · The Danish version and the original source apply.

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  1. Issued · 4 April 2019
  2. Published in the Danish Law Gazette (Lovtidende) · 6 April 2019
  3. In force · 1 May 2019