The Human Biobank Management Act (hereinafter “Human Biobank Act”) is specifically stipulated to regulate the establishment, management, and applications of the human biobank (hereinafter “Biobank”), ensure the rights and benefits of biological database participants, and promote medical development and public welfare.

The "competent authority” as referred to herein means the Ministry of Health and Welfare.

Definitions:
1.Biological specimen: This term refers to derivatives, such as the cells, tissues, organs, or body fluids, which are collected from a human body or produced by experimental operations and are sufficient to provide adequate information for identifying the participant’s biometrics.
2.Participant: This term refers to any natural person who provides his/her biological specimens, personal information, and other related data and information to the Biobank.
3.Biomedical research: This term refers to medical research on basic biometrics, such as genes.
4.Biobank: For the purpose of biomedical research, the Biobank contains participants’ biological specimens, natural persons’information and other related data and information based on human population or specific groups. These biological specimens, derivatives, or relevant data are stored in the Biobank without delinking websites for the need of follow-up applications.
5.Coding: Codes are used to substitute for the participant’s personal information, such as name, ID card number, and medical records number, to protect his/her privacy and identity.
6.Encryption: This term refers to the process of making the participant’s personal data and information unidentifiable.
7.Delinkage: This term refers to the operation of permanently disabling encoded biological specimens, data, and information from being linked to or matching them with the participant's personal data or information.
8.Operator: This term refers to a person that establishes and manages the Biobank.
9.Transfer: This term refers to the process where an operator transfers the Biobank and the rights and obligations between the operator and the participant to a third party.