Singapore legislation

Regulation 63

of Healthcare Services (Assisted Reproduction Service) Regulations 2023

Regulation 63

Donor records

Subregulation 1

A licensee must keep and maintain an accurate, complete and up‑to‑date record of the following information in relation to each donor whose reproductive cell or embryo is used in the licensee’s provision of an assisted reproduction service to a patient:

(a)

the donor’s gender;

(b)

the donor’s date of birth;

(c)

every investigation report and laboratory test result for an investigation or a test required under these Regulations;

(d)

the number of live birth events that have resulted from the use of the donor’s reproductive cells (including when used in the creation of an embryo) —

(i)

in the course of the licensee’s provision of the assisted reproductive service; and

(ii)

by any other person who provides an assisted reproduction service, if the information is known to the licensee;

(e)

where the donor is known to the patient, or donates reproductive cells directly at any of the licensee’s approved permanent premises —

(i)

the donor’s name; and

(ii)

the donor’s national registration identification number or passport number;

(f)

where the licensee receives an anonymous sample from a foreign assisted reproduction service provider or another licensee — the unique identifier assigned to the anonymous sample by the foreign assisted reproduction service provider or other licensee, as the case may be.

Subregulation 2

A licensee must take all reasonable steps to ensure the confidentiality and security of the records mentioned in paragraph (1).

Subregulation 3

In this regulation —

Definition

“anonymous sample” means any reproductive cell or embryo in respect of which the identity of the donor of the reproductive cell or the reproductive cells from which the embryo is created, is not known;

Definition

“foreign assisted reproduction service provider” means a person in a foreign jurisdiction that is licensed, registered, approved or otherwise allowed to provide an assisted reproduction service or to carry on the activities of a reproductive cell or embryo bank under the laws of the foreign jurisdiction.