S.L. 483.2 Art. 9Data protection and confidentiality.

(1) A blood establishment and the person responsible for management of a hospital blood bank shall ensure that all information which is collected for the purposes of these regulations is held securely so that it is -

(a) available for the purpose of tracing donations;

(b) not disclosed except:

(i) in accordance with one or more of the requirements of sub-regulation (2), or

(ii) where they have been rendered anonymous, so that donors are no longer identifiable;

(c) subject to safeguards against unauthorised additions, deletions or modifications.

(2) The requirements referred to under sub-regulation (1)(b)(i) are that:

(a) the disclosure is made in accordance with an order of a court or is otherwise required by law;

(b) the disclosure is to an inspector appointed by the Authority; or

(c) the disclosure is for the purpose of tracing a donation from donor to recipient or recipient to donor.

(3) The responsible person of the blood establishment and the person responsible for management of the hospital blood bank shall ensure that they put in place a procedure to ensure that any discrepancies relating to data which are brought to their attention are resolved without delay.