The Human Tissue (Quality and Safety for Human Application) Regulations 2007

Information and confidentiality

13.—(1) It shall be a condition of every licence under Schedule 1 that all necessary arrangements are made to ensure that all information which is collected in pursuance of the licence or a third party agreement in relation to the licence—

(a) is available for the purpose of tracing donations;

(b) is kept up-to-date and corrected without delay where any discrepancy relating to such information is identified; and

(c) is held securely and subject to safeguards against unauthorised additions, deletions, modifications or transfer of information.

(2) Any information which is collected in pursuance of a licence under Schedule 1 or a third party agreement, and from which a donor (living or deceased) or recipient of tissue or cells may be identified, shall not be disclosed except where such disclosure—

(a) is of information which has been rendered anonymous so that neither the donor nor recipient is identifiable,

(b) is made in accordance with an order of a court,

(c) is otherwise required by law,

(d) is made to a person as a member or employee of the Authority,

(e) is made to a person who is otherwise acting on behalf of the Authority in the exercise of its functions under these Regulations, including in particular its functions under Part 5 of these Regulations,

(f) is made to a tissue establishment for the purpose of tracing a donation from donor to recipient or recipient to donor,

(g) is made to a licence holder or a person to whom a licence applies for the purposes of his functions under the licence,

(h) is made to a third party in relation to a licence for the purposes of his functions under a third party agreement,

(i) is made pursuant to any consent to disclosure given by the person, being the donor or recipient of the tissue or cells, whose identity would be disclosed,

(j) is necessary—

(i) for any purpose preliminary to proceedings,

(ii) for the purpose of, or in connection with, any proceedings,

(iii) for the purpose of reporting a suspected offence,

(iv) for the purpose of cooperating with a police investigation,

(v) for the purpose of investigating a serious adverse event or serious adverse reaction,

(k) is made by a licence holder or designated individual in accordance with directions given to that person by the Authority under section 23(1) or 24(1) of, or paragraph 2(4) of Schedule 3 to, the 2004 Act, as applied by regulation 8, or

(l) is of information which has been lawfully made available to the public before the disclosure is made.

(3) References to proceedings in paragraph (2)(j) include any formal procedure for dealing with a complaint.

(4) Where a disclosure is made to a person pursuant to paragraph (2)(d) or (e), that person shall not further disclose the information received unless the disclosure—

(a) is made in accordance with paragraph (2), or

(b) is made by the Authority for the purpose of its obligations under regulations 17 and 20.