PART I | 1. These Regulations may be cited as the Private Hospitals and Medical Clinics Regulations. |
2.—(1) In these Regulations, unless the context otherwise requires —| “community health centre” means a medical clinic in which only services in support of any treatment by a medical practitioner (such as services rendered by any health professional other than a medical practitioner) are provided for the management of any chronic illness or disability; [S 450/2013 wef 01/08/2013] |
| “electronic licensing system” means the electronic licensing system provided by the Ministry of Health for the purposes of application or renewal of a licence under the Act; [S 411/2003 wef 01/09/2003] |
| “licence” means the licence referred to in section 2 of the Act; |
| “licensee” means the holder of a licence; |
| “living donor”, in relation to a living donor organ transplant, means the living person from whom a specified organ is or will be removed for the purpose of transplantation into the body of another living person; [S 73/2021 wef 01/05/2021] |
| “living donor organ transplant” and “specified organ” have the meanings given by section 2 of the Human Organ Transplant Act (Cap. 131A); [S 73/2021 wef 01/05/2021] |
| “organ”, in relation to a human body, means any organ of the human body; [S 73/2021 wef 01/05/2021] |
“part”, in relation to a human body —| (a) | includes tissues, eyes, bones and blood vessels of a human body; but | | (b) | excludes blood and other fluids; [S 73/2021 wef 01/05/2021] |
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| “registered midwife” means a person registered as a midwife under the Nurses and Midwives Act (Cap. 209); |
| “registered nurse” means a person registered as a nurse under the Nurses and Midwives Act; [S 430/2017 wef 01/08/2017] |
| “registered pharmacist” means a person registered as a pharmacist under the Pharmacists Registration Act (Cap. 230); [S 103/2018 wef 28/02/2018] |
| “renal dialysis centre” means a medical clinic used by a medical practitioner that has been approved under regulation 37 to provide renal dialysis; [S 414/2018 wef 01/07/2018] |
“transplant-related clinical services” means the following:| (a) | the selection and evaluation for suitability, for the purposes of a proposed living donor organ transplant, of an individual as a living donor or recipient of a specified organ; | | (b) | the medical evaluation and screening of an individual who is to undergo a transplant of any organ or part of a human body; | | (c) | the medical care and management of an individual who is undergoing or has undergone a transplant of any organ or part of a human body, including the recipient of a specified organ; | | (d) | the medical care and management, after a living donor organ transplant has been carried out, of a living donor of a specified organ; [S 73/2021 wef 01/05/2021] |
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| “working day” means any day other than a Saturday, Sunday or public holiday. [S 430/2017 wef 01/08/2017] |
| (2) For the purpose of these Regulations, the reference to the number of beds of a private hospital shall include beds which are located in the premises of another licensed private hospital but which, under an arrangement between the first and second mentioned private hospitals, are intended for the use of patients who are admitted to and who are under the management and care of the first mentioned private hospital. |
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| 3.—(1) Every application for the issue or renewal of a licence shall be made to the Director in the appropriate form set out in the electronic licensing system of the Ministry of Health at http://elis.moh.gov.sg. [S 450/2013 wef 01/08/2013] | (2) The Director may make any modification or amendment necessary to the form for an application or renewal of a licence for the purpose of facilitating the submission of that form. |
(3) The form for the application or renewal of a licence and any document accompanying the application shall be submitted to the Director —| (a) | using the electronic licensing system; | | (b) | by post; | | (c) | by telefax; or | | (d) | in person. [S 411/2003 wef 01/09/2003] |
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4.—(1) Every licensee of a private hospital, medical clinic, clinical laboratory or healthcare establishment shall comply with such directions or guidelines as may be given or issued by the Director from time to time in respect of any matter relating to the management, operation, maintenance or use of any private hospital, medical clinic, clinical laboratory or healthcare establishment.| (2) The licensee of a private hospital, medical clinic, clinical laboratory or healthcare establishment shall notify the Director of any changes in the appointment of any person as its manager or deputy manager, within 7 working days from the date of appointment of that person. |
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5.—(1) The fee payable for any licence or any renewal thereof shall be as specified in the Fourth Schedule, and shall be paid by inter-bank GIRO or such other method of payment as the Director may specify.| (2) [Deleted by S 450/2013 wef 01/08/2013] |
| (3) Where any licence is revoked, the Director may, if he considers appropriate, remit or refund any part of the fee paid under this regulation in respect of the licence. [S 450/2013 wef 01/08/2013] |
| (4) Where an application for a licence is withdrawn before the application has been approved, the applicant shall pay an administrative fee of 20% of the licence fee payable for the licence or $100, whichever is the greater, and such administrative fee may be deducted from any licence fee already paid for the licence. |
(5) An applicant for a licence may, at any time before the licence is issued, apply to the Director to —| (a) | amend the name of the private hospital, medical clinic, clinical laboratory or healthcare establishment which appears on the application form he has submitted; or | | (b) | include another person as a proposed licensee. |
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| (6) Where an application for any amendment under paragraph (5) is made after the application for a licence has been approved by the Director, the Director may, on payment of an administrative fee of $100, approve the application for the amendment and issue a licence incorporating such amendment. |
| (7) Subject to paragraph (7A), an application for any amendment to a licence which has been issued shall be made by way of an application for a fresh licence and shall be accompanied by the appropriate fee specified in the Fourth Schedule. [S 450/2013 wef 01/08/2013] |
| (7A) Where the application referred to in paragraph (7) is for an amendment to the name of the private hospital, medical clinic, clinical laboratory or healthcare establishment appearing on the licence, the Director may, on payment of a fee of $100 by the licensee, issue a licence incorporating such amendment. [S 450/2013 wef 01/08/2013] |
| (8) Where a licence is lost, damaged or destroyed, the Director may, on the application of the licensee and on payment of a fee of $100, issue a duplicate licence. |
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6.—(1) Any application for the renewal of a licence shall be made to the Director not later than 2 months before the date of the expiry of the licence.| (2) Where an application for the renewal of a licence is made after the date mentioned in paragraph (1), the applicant shall pay a late payment fee which shall be 20% of the fee payable for the renewal of the licence or $100, whichever is the greater. |
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| 7. Every person to whom a licence is issued shall display the current licence issued in a conspicuous place at the private hospital, medical clinic, clinical laboratory or healthcare establishment, as the case may be. |
| Advertisement of services |
| 8. All advertisements of the services of every private hospital, medical clinic or clinical laboratory shall be in accordance with the guidelines issued by the Director. |
| Notification of cessation, etc., of private hospital, medical clinic, clinical laboratory or healthcare establishment |
9.—(1) Where a licensee intends to cease operating, or intends to let, sell or in any way dispose of a private hospital, medical clinic, clinical laboratory or healthcare establishment, he shall notify the Director of his intention in writing not less than 30 days before the cessation of operation, letting, sale or disposal of the hospital, clinic, laboratory or healthcare establishment, as the case may be.| (2) Any licence issued to the licensee shall upon the cessation of operation, letting, sale or disposal of the private hospital, medical clinic, clinical laboratory or healthcare establishment be deemed to be revoked. |
(3) Every licensee of a private hospital, medical clinic or healthcare establishment who intends to cease operating or to let, sell or in any way dispose of the private hospital, medical clinic or healthcare establishment shall —| (a) | take all measures as are reasonable and necessary to ensure that, until the cessation of operation, letting, sale or disposal of the private hospital, medical clinic or healthcare establishment is completed, every person who remains a patient thereof continues to be provided with adequate and proper accommodation and care; | | (b) | take all measures as are reasonable and necessary to ensure that the medical records of every patient in the hospital, medical clinic or healthcare establishment are properly transferred to the hospital, medical clinic or healthcare establishment to which such patient is to be transferred; and | | (c) | comply with such directions as the Director may give with regard to the accommodation, medical records and care of the patients in the hospital, medical clinic or healthcare establishment pending the completion of the cessation of operation, letting, sale or disposal of the private hospital, medical clinic or healthcare establishment, as the case may be. |
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| (4) Every licensee of a clinical laboratory shall comply with any directions as the Director may give with regard to the completion of testing of specimens already received, acceptance of new specimens and other ancillary matters before the cessation of operation, letting, sale or disposal of the clinical laboratory. |
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| Persons who may manage private hospital, etc. |
10.—(1) The person who shall manage a maternity home, nursing home, medical clinic, clinical laboratory or healthcare establishment shall be as follows:| (a) | in the case of a maternity home, a medical practitioner, a registered nurse or a registered midwife; | | (b) | in the case of a nursing home, a medical practitioner or a registered nurse; | | (c) | in the case of a medical clinic used by a medical practitioner other than a renal dialysis centre, a medical practitioner; [S 414/2018 wef 01/07/2018] | | (ca) | in the case of a renal dialysis centre, a medical practitioner or a registered nurse; [S 414/2018 wef 01/07/2018] | | (d) | in the case of a medical clinic used by a dentist, a dentist; | | (e) | in the case of a clinical laboratory, a person who has any of the qualifications specified in regulation 49; and | | (f) | in the case of a healthcare establishment, a suitably qualified person approved by the Director. |
| (2) The person who shall manage a private hospital, other than a maternity home or a nursing home, shall be the manager or a person responsible for the administration or management of the hospital. |
| (3) A person who is responsible for the management of a private hospital, maternity home, nursing home, medical clinic, clinical laboratory or healthcare establishment shall not be absent therefrom for any length of time, unless arrangements are made for the private hospital, maternity home, nursing home, medical clinic, clinical laboratory or healthcare establishment to be placed under the supervision of a person who is similarly qualified to manage that hospital, home, clinic, laboratory or healthcare establishment. |
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| Duty of manager of private hospital |
| 11. Every manager of a private hospital shall ensure that every patient be informed, on or before his admission to the private hospital, of the estimated total charges which are likely to be incurred in respect of his hospitalisation and treatment. |
12.—(1) Every licensee of a private hospital, medical clinic or healthcare establishment shall keep and maintain proper medical records and shall in addition cause to be recorded therein in respect of each patient such particulars as may be specified in any guidelines issued by the Director from time to time.(1A) The licensee under paragraph (1) shall —| (a) | take all reasonable steps, including implementing such processes as are necessary, to ensure that the medical records in paragraph (1) are as accurate, complete and up-to-date as are necessary for the purposes for which they are to be used; | | (b) | implement adequate safeguards (whether administrative, technical or physical) to protect the medical records against accidental or unlawful loss, modification or destruction, or unauthorised access, disclosure, copying, use or modification; | | (c) | periodically monitor and evaluate the safeguards in sub-paragraph (b) to ensure that they are effective and being complied with by the persons involved in handling the medical records; | | (d) | ensure that each person handling the medical records is aware of his role and responsibility in maintaining the confidentiality, integrity and availability of the medical records; and | | (e) | take reasonable care in the disposal or destruction of the medical records so as to prevent unauthorised access to the records. [S 189/2011 wef 15/04/2011] |
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| (2) Every licensee of a clinical laboratory shall keep and maintain laboratory records of all specimens received and examinations conducted by him and the results thereof. |
| (3) The records referred to in paragraphs (1) and (2) shall be retained by the licensee of the private hospital, medical clinic, clinical laboratory or healthcare establishment for such periods as may be required by the Director. |
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