Healthcare Services (General) Regulations 2021

No. S 1035

Healthcare Services Act 2020

(ACT 3 OF 2020)

Healthcare Services
(General) Regulations 2021

In exercise of the powers conferred by section 57 of the Healthcare Services Act 2020, the Minister for Health makes the following Regulations:

Citation and commencement

1. These Regulations are the Healthcare Services (General) Regulations 2021 and come into operation on 3 January 2022.

Definitions

2. In these Regulations, unless the context otherwise requires —

“abuse”, “emotional or psychological abuse”, “neglect”, “physical abuse” and “wellbeing” have the meanings given by section 2(1) of the Vulnerable Adults Act 2018;

“calendar day” includes Saturday, Sunday and every public holiday;

“clinical incident” means an event or a circumstance that has resulted, or is likely to result, in harm to a patient;

“clinical risk” means the impact of a clinically unsafe environment or situation on the safety and wellbeing of patients and persons who perform or are engaged in any work relating to the provision of a licensable healthcare service;

“collaborative practice agreement”, “collaborative prescribing practitioner” and “collaborative prescribing service” have the meanings given by regulation 2 of the Healthcare Services (Collaborative Prescribing Service) Regulations 2023 (G.N. No. S 398/2023);

[S 414/2023 wef 26/06/2023]

“electronic licensing system” means the electronic licensing system established and maintained by the Ministry of Health for the purposes of the Act, that is accessible on the Ministry’s website;

“enterprise risk”, in relation to a licensee’s business of providing a licensable healthcare service, means the risk to service delivery and continuity;

“expiry date”, in relation to any product or material, means —

(a)	the date after which; or
(b)	the month and year after the end of which,

as the case may be, the product or material should not be used;

[S 414/2023 wef 26/06/2023]

“health product” has the meaning given by section 2 of the Health Products Act 2007;

“healthcare professional” means —

(a)	an allied health professional who is registered under the Allied Health Professions Act 2011 and holds a valid practising certificate under that Act;
(b)	a dentist or an oral health therapist who is registered under the Dental Registration Act 1999 and holds a valid practising certificate under that Act;
(c)	a medical practitioner who is registered under the Medical Registration Act 1997 and holds a valid practising certificate under that Act;
(d)	a nurse or midwife who is registered, or an enrolled nurse who is enrolled, under the Nurses and Midwives Act 1999 and holds a valid practising certificate under that Act;
(e)	an optometrist or optician who is registered under the Optometrists and Opticians Act 2007 and holds a valid practising certificate under that Act;
(f)	a pharmacist who is registered under the Pharmacists Registration Act 2007 and holds a valid practising certificate under that Act; or
(g)	a traditional Chinese medicine practitioner who is registered under the Traditional Chinese Medicine Practitioners Act 2000 and holds a valid practising certificate under that Act;

“infectious disease” has the meaning given by section 2 of the Infectious Diseases Act 1976;

“licence”, in relation to a licensee, means a licence granted under the Act and that is in force, authorising the licensee to provide the licensable healthcare service specified in the licence;

“licensable healthcare service”, in relation to an applicant or a licensee, means a licensable healthcare service that the applicant intends to provide under a licence or the licensee is authorised by a licence to provide, as the case may be;

“licensee”, in relation to a licensable healthcare service, means the person who is authorised by a licence to provide that licensable healthcare service;

“medical certificate”, in relation to a patient, means a document issued by a medical practitioner or dentist certifying the state of the patient’s health;

[S 780/2024 wef 14/10/2024]

“medicinal product” has the meaning given by section 3 of the Medicines Act 1975;

“medisave account” means a medisave account maintained under section 13 of the Central Provident Fund Act 1953;

“MediShield Life Scheme” means the MediShield Life Scheme established by section 3 of the MediShield Life Scheme Act 2015;

“patient health record” means a record containing the personal data and medical information of a patient that is maintained by a licensee in relation to the provision of a licensable healthcare service to the patient;

“personnel”, in relation to a licensee, means any individual employed or engaged by the licensee to assist the licensee in providing the licensable healthcare service;

[Deleted by S 414/2023 wef 26/06/2023]

“simple in vitro diagnostic test” has the meaning given by paragraph 2 of the First Schedule to the Act;

[S 414/2023 wef 26/06/2023]

“specimen” means any matter derived, obtained or excreted from the body of an individual for use in, or in connection with, the provision of a licensable healthcare service.

[S 414/2023 wef 26/06/2023]

Meaning of licensable healthcare services

2A. For the purposes of these Regulations, any reference to a licensable healthcare service is a reference to that licensable healthcare service within the meaning of paragraph 2 of the First Schedule to the Act.

[S 414/2023 wef 26/06/2023]

PART 1

ELECTRONIC LICENSING SYSTEM

Electronic licensing system

3.—(1) The Director-General may —

(a)	require or permit any person to carry out any transaction with the Director-General under the Act or these Regulations; and
(b)	issue any approval, licence, notice, determination or other document pursuant to or connected with a transaction mentioned in sub‑paragraph (a),

using the electronic licensing system.

[S 414/2023 wef 26/06/2023]

(2) Despite paragraph (1), the Director-General may, in any particular case —

(a)	require or permit a person to carry out any transaction mentioned in paragraph (1)(a) in any other manner specified by the Director-General; or
(b)	issue any document mentioned in paragraph (1)(b) in any other manner that the Director-General thinks fit. [S 414/2023 wef 26/06/2023]

(3) In this regulation —

“document” includes any application, form, report, certification, notice, declaration, return or other document (whether in electronic form or otherwise) filed with or submitted to the Director-General;

[S 414/2023 wef 26/06/2023]

“transaction” means —

(a)	the filing of any document with the Director-General, or the submission, production, delivery, providing or sending of any document to the Director-General; [S 414/2023 wef 26/06/2023]
(b)	the making of any application, submission or request to the Director-General; [S 414/2023 wef 26/06/2023]
(c)	the provision of any declaration or undertaking to the Director-General; or [S 414/2023 wef 26/06/2023]
(d)	the extraction, retrieval or accessing of any document, record or information maintained by the Director-General. [S 414/2023 wef 26/06/2023]

Made on 28 December 2021.

CHAN YENG KIT

Permanent Secretary,
Ministry of Health,
Singapore.

[MH 78:44/1; AG/LEGIS/SL/122E/2020/1 Vol. 1]

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