S.L. 483.1 Art. 10Data protection and confidentiality.

(1) An establishment shall ensure that all data, including genetic information, collated within the scope of the Act and any regulations made thereunder and to which third parties have access, have been rendered anonymous so that neither donors nor recipients remain identifiable.

(2) For that purpose, the establishment 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;

(c) no unauthorised disclosure of information occurs, whilst guaranteeing the traceability of donations;

(d) the identity of any recipient is not disclosed to the donor or his family and vice versa, without prejudice to any legislation in force on the conditions for disclosure, notably in the case of gametes donation;

(e) the information which is collected for the purposes of these regulations is held securely so that it is -

(i) available for the purpose of, tracing donations;

(ii) not disclosed except in accordance with one or more of the requirements of sub-regulation (3).

(3) The requirements referred to under sub-regulation (2)(e)(ii) are that the disclosure:

(a) shall be in accordance with an order of a court, or as may otherwise be required by law;

(b) is made to an inspector appointed by the Authority.

(4) The responsible person of the establishment shall ensure that the results of the donor evaluation and testing procedures are documented and any major anomalies are reported to the Authority in accordance with the requirements referred to in Schedule I and any amendments thereto.