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National Health Act, 2003 (Act No. 61 of 2003)


Regulations relating to Human Stem Cells

Chapter 1

11. Data protection and confidentiality


(1) A stem cell establishment shall ensure that all data, including genetic information, collated within the scope of these regulations and to which third parties have access remain confidential at all times.


(2) For the purposes of subregulation (1), stem cell 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 referral 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.