Biobank Act to be updated to meet requirements of EU General Data Protection Regulation
The Government proposes that the Biobank Act be amended to comply with the EU General Data Protection Regulation (GDPR). In addition, some technical amendments would be made to the Act. The aim is to make it easier for biobanks to carry out their duties, and to protect the right to self-determination of persons being tested.
The amendments would increase the flexibility of data processing in biobanks and make the grounds for processing personal data consistent with other research legislation. The current Biobank Act was adopted before the General Data Protection Regulation entered into force, which is why the Act will now be amended to meet the requirements of the Regulation.
The proposal would change the grounds for processing personal data in biobank activities. Currently, the processing of personal data is based on a consent from the person tested. This means a broad consent in the context of biobank activities. In future, the Act would lay down provisions on the right to self-determination of persons tested by introducing two separate safeguards. The first safeguard would be a consent to the taking of samples and the other a consent to the processing of the samples and personal data in biobank activities.
Data subjects would retain their rights under the Regulation, such as the right to access data, the right to rectify data and the right to object to data processing. The legislative amendments would enter into force on 1 January 2024. The amendments would not apply to samples taken before the amendments’ entry into force.
Sini Tervo, Senior Specialist, tel. +358 295 163 529, [email protected]