In the event that the biological specimens, data, or information is stolen, leaked, tampered with, or otherwise infringed, an Operator shall immediately investigate the matter, report same to the Competent Authority, and notify relevant participants in an appropriate manner.
An Operator shall stipulate emergency response measures in relation to matters mentioned in the preceding Paragraph, and submit same to the Competent Authority for approval.

Personnel engaged in the collections, processing, storage, or use of biological specimens shall not disclose any confidences or other personal data or information of the participant, that is known or obtained as a result of their work.

An Operator shall stipulate and disclose its own rules on information security management pursuant to the Biobank information security regulations promulgated by the Competent Authority.
Such rules mentioned in the preceding Paragraph shall be submitted to the Competent Authority for records after being approved by the ethics committee.

An Operator shall not transfer part or entire Biobank to another, unless the transfer is reviewed and approved by the Competent Authority.
In conducting the review mentioned in the preceding Paragraph, the Competent Authority shall consider the following:
1.the rights and interests of the participants.
2.the nature of the concerned Operator and its transferee(s).
3.the transferee’s ability to protect the rights and interest of the participants.
4.the intention of the participants as expressed or may be inferred.
In the event that an Operator plans to cease the operation of the Biobank, a follow-up plan therefor shall be submitted one (1) year in advance to the Competent Authority for approval before such a plan can be enforced.

Biological specimens of the Biobank, other than the derivatives, shall not be exported.
Any international transmission of Biobank data or the export of any derivatives mentioned in the preceding Paragraph shall be submitted to the Competent Authority for approval.
In the event that the use of the Biobank is provided to a third party, the rules set forth in the preceding two paragraphs shall be specified in the contract of use with such third party.