TaiwanHuman Biobank Management Act (人體生物資料庫管理條例), human biobank operators
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
In force.
A sensitive categories rule binding public and private bodies.
- Enforcement body
- Ministry of Health and Welfare
- Obligation class
- Consent, Data subject rights, Breach notice, Transfer, Security, Prohibition
- Audit expectation
- none
What it requires
- 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).
These lines are LexLint's reading of the law's text.
If you get it wrong
Penalty structure
Administrative fines run from NT$2,000,000 to NT$10,000,000 for operating without a permit, for an unapproved transfer or closure, and for an unapproved export (Article 23), NT$500,000 to NT$2,500,000 for consent, de-identification and purpose violations (Article 24), NT$200,000 to NT$1,000,000 for refusing a withdrawal (Article 25) and NT$60,000 to NT$300,000 for failing to report a breach (Article 26). The fixed cap is the highest band.
- Rule
- Fixed only
- As of
- Currency
- TWD
- Fixed cap
- 10,000,000
What it makes you log
Logging duty
Article 11 has a biobank operator investigate and report a theft, leak or tampering with specimens or data, and Article 18 has it set up a review and control procedure for cross-referencing identifying information. Neither article requires a log or a record to be kept for inspection, so none is coded.
- Kind
- None
- As of
What this law does
A person that establishes and manages a human biobank must apply to the Competent Authority for a permit. A participant's biological specimens may be collected only after the participant's written consent is obtained. A biobank operator must destroy the specimens and related data a withdrawing participant provided. A biobank operator must investigate a theft or leak of specimens or data, report it to the Competent Authority, and notify the participants concerned.
Biobank specimens, other than derivatives, may not be exported. Specimens and related data must be encoded, encrypted, delinked or transformed so that a participant's identity cannot be determined. Biobank specimens, derivatives and related data may not be used for any purpose other than biomedical research.
When LexLint raises it
When your app profile says your app handles health records or processes personal data.
Back to the example · Lint your app
Page updated .