Human Biobank Management Act Article 18

Any storage, use, or disclosure of the concerned operator’s entire biological specimens and related data and information shall be encoded, encrypted, delinked, or transformed so that the participant’s identity is unable to be determined.An Operator shall encrypt and independently administer information that can determine the identity of an individual participant, such as his/her name, identification number, and date of birth. An Operator shall establish a review and control procedure for cross referencing the aforesaid personal information with the biological specimens and relevant data and information. Such information shall be restored immediately after each necessary use.When an Operator cross references data or information of different sources, the Operator shall comply with Paragraph 1 hereof and restore the information immediately after the cross-reference is complete.Documents that are unable to be separated from the information which can determine the identity of a participant, such as the agreement of consent and declarations of participation termination, are not subject to the rules set forth in the preceding three paragraphs. Nevertheless, the Operator shall adopt other necessary measures to maintain the confidentiality.Article 5, Paragraph 3 hereof shall apply to the cross reference and application procedures referred to in Paragraphs 2 and 3.