2004/23/EC - Human Tissues and Cell Directive

Directive 2004/23/EC deals with the legal conditions bound to donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Recital 24 of the Directive refers to the 95/46/EC Data Protection Directive. It indicates that the processing of personal data in application of the Human tissues and Cells Directive should be in line with Directive 95/46/EC. Article 14 of the Human tissues and Cells Directive deals with data protection and confidentiality.

The Directive obliges Member States to take the necessary precautionary measures to prevent that the identity of the donor becomes known. The measures to be taken relate to security measures and preventing unauthorized access. Data processing in this directive especially relates to human beings acting as donors for specific tissues and the data needed to keep track of donors and tissues donated.