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Directive 2004/23/EC of the European Parliament and of the CouncilShow full title
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
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- Revised 07/08/20090.09 MB
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Changes over time for: Article 14
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Article 14U.K.Data protection and confidentiality
1.Member States shall take all necessary measures to ensure that all data, including genetic information, collated within the scope of this Directive and to which third parties have access, have been rendered anonymous so that neither donors nor recipients remain identifiable.
2.For that purpose, they shall ensure that:
(a)data security measures are in place, as well as safeguards against any unauthorised data additions, deletions or modifications to donor files or deferral records, and transfer of information;
(b)procedures are in place to resolve data discrepancies; and
(c)no unauthorised disclosure of information occurs, whilst guaranteeing the traceability of donations.
3.Member States shall take all necessary measures to ensure that the identity of the recipient(s) is not disclosed to the donor or his family and vice versa, without prejudice to legislation in force in Member States on the conditions for disclosure, notably in the case of gametes donation.
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