Catalog / Handles health records / LXD-6828

Handles health records, in Taiwan

Human Biobank Management Act (人體生物資料庫管理條例), human biobank operatorsin force7 lines

Human Biobank Management Act (人體生物資料庫管理條例), Laws and Regulations Database of the Republic of China (Taiwan), pcode L0020164, Arts. 4, 6, 8, 11, 15, 18 and 20 · Read the law's page

  • Before establishing a human biobank, apply to the Ministry of Health and Welfare for a permit (Article 4).
  • Collect a participant's biological specimens only after obtaining the participant's written consent, having first told the participant the matters Article 7 lists (Articles 6 and 7).
  • Do not refuse a participant's request to stop providing specimens, withdraw or narrow the scope of use, and destroy the specimens and related data a withdrawing participant provided, notifying any third party holding them to do the same (Article 8).
  • After a theft, leak or tampering with specimens or data, investigate at once, report to the Ministry of Health and Welfare, and notify the participants concerned (Article 11).
  • Encode, encrypt, delink or transform stored, used or disclosed specimens and data so that a participant's identity cannot be determined, and encrypt and separately administer identifying information such as name, identification number and date of birth (Article 18).
  • Do not export biobank specimens other than derivatives, and obtain the Ministry's approval before any international transmission of biobank data or export of derivatives (Article 15).
  • Use specimens, derivatives and related data only for biomedical research, and only within the scope, duration and method the participant agreed to (Articles 16 and 20).

Revisions

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  1. Revision 1, : the entry was first published.

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