Human Biobank Management Act Article 24
When engaging in any of the following violations, an Operator shall be subject to a fine of no less than five hundred thousand New Taiwan Dollars (NT$ 500,000) and no more than two million and five hundred thousand New Taiwan Dollars (NT$ 2,500,000); and may be ordered to undertake timely corrective actions. An Operator who fails to timely undertake such corrective actions shall be subject to an additional fine imposed for each failure:1.violating Article 5, Paragraph 1 or 3 by failing to establish an ethics committee, or failing to submit the management and application matters of the Biobank to the ethics committee for review and supervision, or failing to submit same to the Competent Authority for approval; violating Article 5, Paragraph 2 by allowing unlawful composition of the ethics committee; or violating Article 5, Paragraph 6 by failing to recuse from a conflict of interests.2.violating Article 6, Paragraphs 1-3 or Article 7 by collecting biological specimens; or violating Article 6, Paragraph 4 by failing to submit the agreement of consent to the ethics committee for review and approval.3.violating Article 12 by disclosing any confidences or other personal data or information of a participant that is known or obtained as a result of the work.4.violating Article 13, Paragraph 1 by failing to stipulate or disclose rules regarding information security, or for the reason that the management of biological specimens and related data and information violates any information security regulations; or failing to comply with Article 13, Paragraph 2 requiring that the information security rules pass the review of the concerned ethics committee or submitted to the Competent Authority for records.5.violating Article 18, Paragraph 1 by failing to process the biological specimens and related data and information so that the participant ’ s identity is unable to be determined; or violating Article 18, Paragraph 4 by failing to adopt necessary measures to maintain the confidentiality of information contained in the documents that are unable to be separated from the information which can determine the identity of a participant; or violating Article 18, Paragraph 5.6.violating Article 18, Paragraph 2 by failing to encrypt and independently administer information that can determine the identity of an individual participant, failing to establish a review and control procedure for cross referencing the personal information with the biological specimens and relevant data and information, or failing to immediately restore such information after each necessary use; or violating Article 18, Paragraph 3 by failing to cross reference data with information by means that the participant ’ s identity is unable to be determined, or by failing to immediately restore such information after cross reference.7.violating Article 20 by using biological specimens, derivatives, and related data and information for the purposes other than biomedical research.In the event of any of the violations set forth in the preceding paragraphs, the Competent Authority may order a temporary cessation of the operation of the Biobank pending timely corrective actions; where the circumstances constitute a serious offense, the Competent Authority may also revoke the establishment licensure of the violator.
中文原文 人體生物資料庫管理條例第24條
設置者有下列情形之一者，處新臺幣五十萬元以上二百五十萬元以下罰鍰，並得限期令其改正；屆期未改正者，按次處罰之：
一、違反第五條第一項、第三項規定，未設置倫理委員會，或生物資料庫管理及運用事項未受倫理委員會之審查及監督，或未經主管機關審查通過；違反同條第二項規定，倫理委員會組成不合法；違反同條第六項規定應迴避而未迴避。
二、違反第六條第一項至第三項或第七條規定，進行生物檢體之採集；或違反第六條第四項同意書未經倫理委員會審查通過。
三、違反第十二條規定，洩漏因業務而知悉或持有參與者之秘密或其他個人資料、資訊。
四、違反第十三條第一項規定，未訂定或公開資訊安全規定，或生物檢體及相關資料、資訊之管理違反資訊安全規定；或未依同條第二項經倫理委員會審查通過，或送主管機關備查。
五、違反第十八條第一項規定，處理生物檢體及相關資訊、資料未以無法識別參與者身分之方式；或違反同條第四項規定，對於無法與可辨識參與者資料分離之文件，未採取必要之保密措施；或違反同條第五項規定。
六、違反第十八條第二項規定，未就參與者個人基本資料加密並單獨管理、於相互比對運用時未建立審核及控管程序、於運用後未立即回復原狀；或違反同條第三項規定，於比對時未以無法識別參與者身分之方式為之，未於比對後立即回復原狀。
七、違反第二十條規定，將生物資料庫之生物檢體、衍生物及相關資料、資訊作為生物醫學研究以外之用途。
有前項各款之情形者，主管機關並得令其於改正前停止營運；其情節重大者，並得廢止設置許可。
一、違反第五條第一項、第三項規定，未設置倫理委員會，或生物資料庫管理及運用事項未受倫理委員會之審查及監督，或未經主管機關審查通過；違反同條第二項規定，倫理委員會組成不合法；違反同條第六項規定應迴避而未迴避。
二、違反第六條第一項至第三項或第七條規定，進行生物檢體之採集；或違反第六條第四項同意書未經倫理委員會審查通過。
三、違反第十二條規定，洩漏因業務而知悉或持有參與者之秘密或其他個人資料、資訊。
四、違反第十三條第一項規定，未訂定或公開資訊安全規定，或生物檢體及相關資料、資訊之管理違反資訊安全規定；或未依同條第二項經倫理委員會審查通過，或送主管機關備查。
五、違反第十八條第一項規定，處理生物檢體及相關資訊、資料未以無法識別參與者身分之方式；或違反同條第四項規定，對於無法與可辨識參與者資料分離之文件，未採取必要之保密措施；或違反同條第五項規定。
六、違反第十八條第二項規定，未就參與者個人基本資料加密並單獨管理、於相互比對運用時未建立審核及控管程序、於運用後未立即回復原狀；或違反同條第三項規定，於比對時未以無法識別參與者身分之方式為之，未於比對後立即回復原狀。
七、違反第二十條規定，將生物資料庫之生物檢體、衍生物及相關資料、資訊作為生物醫學研究以外之用途。
有前項各款之情形者，主管機關並得令其於改正前停止營運；其情節重大者，並得廢止設置許可。