Singapore legislation
Regulation 31
of Healthcare Services (Human Tissue Banking Service) Regulations 2023
Regulation 31
Keeping of records — enabling identification of donor
Subregulation 1
A licensee must keep records of —
the identity of the donor of each human tissue the licensee collects or receives;
the identity of the recipient of each human tissue that the licensee has distributed human tissue to; and
every human tissue bank that the human tissue was stored in from the time the human tissue was collected to the time the human tissue was transplanted or used for any other clinical use.
Subregulation 2
A licensee must ensure that the records mentioned in paragraph (1)(a) and (b) are kept in a manner that enables the licensee to identify the donor for each human tissue received by a recipient.
Subregulation 3
The licensee must keep every record mentioned in paragraph (1) (called an applicable record) confidential and ensure that —
the confidentiality, integrity and security of every applicable record are maintained at all times; and
every personnel handling any applicable record is aware of his or her role and responsibility in maintaining the confidentiality, integrity and security of the applicable records.
Subregulation 4
In addition, where any information in an applicable record is in the form of an extract or aggregated compilation, the licensee must ensure that the confidentiality, integrity and security of the information in the extract or aggregated compilation are maintained at all times.
Subregulation 5
The licensee must —
implement adequate safeguards and appropriate protocols and processes to protect the applicable records against accidental or unlawful loss, modification or destruction, or unauthorised access, disclosure, copying, use or modification; and
periodically monitor and evaluate the safeguards, protocols and processes mentioned in sub-paragraph (a) to ensure that they are effective and being complied with by the personnel involved in handling the applicable records.