No. S 1035 HEALTHCARE SERVICES ACT 2020 (ACT 3 OF 2020) HEALTHCARE SERVICES (GENERAL) REGULATIONS 2021
First published in the Government Gazette, Electronic Edition, on 30 December 2021 at 7 pm.
In exercise of the powers conferred by section 57 of the Healthcare Services Act 2020, the Minister for Health makes the following Regulations:
ARRANGEMENT OF REGULATIONS Regulation 1. Citation and commencement 2. Definitions 2A. Meaning of licensable healthcare services PART 1 ELECTRONIC LICENSING SYSTEM 3. Electronic licensing system PART 2 LICENSING MATTERS 4. Application for licence 5. Application for approval under section 11A or 11C of Act 6. Amendment of licence 7. Transfer of licence 8. Voluntary cessation of licensable healthcare service or surrender of licence PART 3 GOVERNANCE OF LICENSEES 9. Compliance with Act, etc. 10. Appointment of and change in key appointment holders, Principal Officer and Clinical Governance Officers 11. Change in majority of key appointment holders 12. Period for appointment of replacement Principal Officer or Clinical Governance Officer 13. Functions and duties of Principal Officer 14. Appointment of Clinical Governance Officers Regulation 15. Functions and duties of Clinical Governance Officer 16. Licensee’s duty to ensure continued suitability of Principal Officer and Clinical Governance Officers 16A. Step-in arrangements PART 4 PERSONNEL 17. Employment or engagement of suitable personnel 18. Healthcare professionals PART 5 COMMITTEES APPOINTED BY LICENSEES Division 1 — Definitions 19. Definitions for this Part Division 2 — Quality assurance committees 20. Licensees required to appoint QAC 21. Quality assurance 22. Appointment of supervisor of quality assurance activities 23. Participation of non-QAC licensee in quality assurance activities Division 3 — Service review committees 23A. Licensees required to appoint SRC 23B. Service review Division 4 — Clinical ethics committees 23C. Licensees required to appoint CEC 23D. Prescribed medical treatments for ethics review 23E. Ethics review 23F. Duties of CEC licensee PART 6 PREMISES, CONVEYANCES AND EQUIPMENT, ETC. 24. Premises, conveyances and equipment, etc. 25. Security of equipment data 26. Use of approved permanent premises or approved conveyance for other purposes PART 7 MEDICINAL PRODUCTS AND HEALTH PRODUCTS Regulation 27. Purchase of medicinal products and health products 28. Prescription of medicinal products and health products 29. Preparation of medicinal products and health products, and dispensing and administration before expiry date 30. Storage and disposal of medicinal products and health products 31. Delivery and transportation of medicinal products and health products PART 8 SPECIMENS 32. Collection of specimens 32A. Testing of specimens 32B. Tests must have clinical utility 33. Packaging and transportation of specimens PART 9 SERVICE STANDARDS 34. Privacy and dignity of care 35. Safeguard against abuse and neglect 36. Communications with patients 37. Information to be contained in patient health records 38. Protection of patient health records 39. Continuity of care where licensee intends to cease provision of licensable healthcare service or transfer care of patient to another licensee PART 10 PRICE TRANSPARENCY 40. Issuance of bill PART 11 INFECTION CONTROL, INCIDENT MANAGEMENT AND EMERGENCY PREPAREDNESS 41. Infection control Regulation 42. Notification of infectious diseases 43. [Deleted] 44. Management of biohazardous materials and sharps 45. Incident escalation 46. Emergency preparedness 47. Business continuity PART 12 MISCELLANEOUS 48. Display of business name 49. Restrictions on use of name 50. Offence The Schedules
These Regulations are the Healthcare Services (General) Regulations 2021 and come into operation on 3 January 2022.
“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; “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]
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]
(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]
(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]
“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]
(a) approval to provide a licensable healthcare service at any permanent premises; (b) approval to provide a licensable healthcare service using a conveyance; (c) approval to provide a licensable healthcare service by any other service delivery mode; (d) approval to provide a specified service.
(a) in relation to an approval mentioned in paragraph (1)(a), (b) or (c) — 2 months before the licensable healthcare service is provided at the permanent premises, using the conveyance or by the service delivery mode, or the expiry of any such approval, as the case may be; or (b) in relation to an approval mentioned in paragraph (1)(d) — 2 months before the specified service is provided, or the expiry of any approval for the specified service, as the case may be. [S 414/2023 wef 26/06/2023]
Where there is a change of the licensee because of a transfer or an assignment of a licence, or of any rights, benefits or privileges under a licence, under section 16(1) of the Act, the original licensee must apply to the Director-General to amend the name of the licensee in the licence no later than one month before the transfer or assignment is to take effect. [S 414/2023 wef 26/06/2023]
(a) ensure that every patient of the licensee continues to receive adequate and proper care or accommodation by another licensee; [S 414/2023 wef 26/06/2023] (b) ensure that the measures in regulation 39(1)(a), (b) and (c) are taken; (c) comply with every direction given by the Director-General in relation to the accommodation, care and medical information of the patients until the cessation of the licensable healthcare service or surrender of the licence, as the case may be. [S 414/2023 wef 26/06/2023] [S 414/2023 wef 26/06/2023]
(a) the provisions of the Act and these Regulations, the licence conditions and all directions and codes of practice given or issued under the Act that are applicable to the licensee; and (b) the provisions of any other written law regulating or relating to the provision of any licensable healthcare service in a safe and proper manner, that are applicable to the licensee.
(a) the licensee must ensure that the Principal Officer and every Clinical Governance Officer appointed by the licensee have the necessary authority and are adequately empowered to carry out their duties under the Act and these Regulations; and (b) the licensee must not obstruct the licensee’s Principal Officer or any of the licensee’s Clinical Governance Officers from carrying out his or her duties in compliance with the Act and these Regulations.
(a) at the same time that the application for the grant or renewal of the licence, or approval for the specified service, is made; or (b) no later than 10 calendar days before the appointment. [S 414/2023 wef 26/06/2023]
(a) in relation to the key appointment holder in respect of which the notice is given — about the matters mentioned in section 2(3)(a) to (d) of the Act; and (b) in relation to the Principal Officer in respect of which the notice is given — (i) that the person to be appointed as the Principal Officer is a suitable person to act as the licensee’s Principal Officer; and (ii) about the matters mentioned in section 2(3)(a) to (d) of the Act. [S 414/2023 wef 26/06/2023]
(a) that the person to be appointed as the Clinical Governance Officer is a suitable person to act as the licensee’s Clinical Governance Officer; and (b) about the matters mentioned in section 2(3)(a) to (d) of the Act. [S 414/2023 wef 26/06/2023]
Without affecting regulation 10(1), if at any time a licensee intends to remove or substitute more than half in number of the licensee’s key appointment holders, the licensee must notify the Director-General of the proposed change one month before the removal or substitution takes effect. [S 414/2023 wef 26/06/2023]
(a) the prescribed period for the appointment of another Principal Officer is 10 calendar days after the removal of the previously appointed Principal Officer; and (b) the prescribed period for the appointment of another Clinical Governance Officer is 20 calendar days (inclusive of the period for the application for the Director-General’s approval of the Clinical Governance Officer) after the removal of the previously appointed Clinical Governance Officer.
(a) the prescribed period for the appointment of another Principal Officer is 10 calendar days after the previously appointed Principal Officer stops acting, or is unable to act, as Principal Officer; and (b) the prescribed period for the appointment of another Clinical Governance Officer is — (i) where the licensee had fewer than 10 calendar days’ prior notice of the previously appointed Clinical Governance Officer’s stopping, or inability, to act as Clinical Governance Officer, whether due to death or otherwise — 20 calendar days (inclusive of the period for the application for the Director-General’s approval of the Clinical Governance Officer) after the previously appointed Clinical Governance Officer stops acting, or is unable to act, as Clinical Governance Officer; and (ii) in any other case — one calendar day (inclusive of the period for the application for the DirectorGeneral’s approval of the Clinical Governance Officer) after the previously appointed Clinical Governance Officer stops acting, or is unable to act, as Clinical Governance Officer. [S 414/2023 wef 26/06/2023]
(a) to exercise oversight over the day-to-day provision of the licensable healthcare service by the licensee; (b) to ensure that the licensable healthcare service is, at all times, provided in a manner that ensures the safety, welfare and continuity of care of the licensee’s patients and customers; (c) where the licensee is approved to provide the licensable healthcare service at any permanent premises, at any premises other than permanent premises (called in this sub‑paragraph temporary premises) or using any conveyance — to ensure the safe operation of every approved permanent premises, temporary premises and approved conveyance, and the safety of persons at every approved permanent premises, temporary premises and approved conveyance; [S 414/2023 wef 26/06/2023] (ca) where the licensee is approved to provide the licensable healthcare service by remote provision and a patient is required to use any structure, facility, equipment or device provided by the licensee to receive the licensable healthcare service — to ensure the safe operation of the structure, facility, equipment or device and the safety of persons in the vicinity of the structure, facility, equipment or device; [S 414/2023 wef 26/06/2023] (d) to oversee the implementation of processes to review and manage any clinical risk and enterprise risk that may arise in the provision of the licensable healthcare service, and ensure that the licensee and every personnel comply with the processes.
(a) where a matter requires the Principal Officer’s attention — (i) the Principal Officer must be available to handle the matter; or [S 414/2023 wef 26/06/2023] (ii) if the Principal Officer cannot be so available, the Principal Officer must appoint a suitably qualified and competent employee of the licensee to handle the matter on the Principal Officer’s behalf; [S 414/2023 wef 26/06/2023] (b) the Principal Officer must at all times be contactable by any personnel.
(a) if one or more Clinical Governance Officers are appointed — the Clinical Governance Officer who oversees the subject that the clinical matter relates; and (b) in any other case — any key appointment holder of the licensee who is a healthcare professional with clinical experience that is relevant to the licensable healthcare service.
(a) to provide clinical governance and technical oversight over the licensable healthcare service or specified service, as the case may be; (b) to assist the licensee in the day‑to‑day management of the clinical and technical aspects of the licensable healthcare service or specified service, as the case may be; (c) to ensure the implementation and regular review of policies and systems for clinical governance, clinical risk management, effective quality management systems and any other clinical and technical related matters for the licensable healthcare service or specified service (as the case may be), so as to detect and address in a timely manner any risks affecting the safety and welfare of, or the continuity of care provided to, patients; (d) to ensure that any weakness or inadequacy related to any clinical or technical aspect of the licensable healthcare service or specified service (as the case may be) is promptly identified and remedied, including informing the licensee of the weakness or inadequacy, and proposing and implementing measures to prevent the recurrence of the weakness or inadequacy; (e) to ensure that the licensee’s personnel involved in the clinical or technical aspects of the licensable healthcare service or specified service (as the case may be) comply with the appropriate policies and processes concerning clinical and technical standards; (f) to ensure that there is close supervision, adequate training and regular competency assessments of the licensee’s personnel involved in the clinical or technical aspects of the licensable healthcare service or specified service (as the case may be), to enable them to perform their work effectively and safely; (g) to immediately notify the licensee of any matter within the Clinical Governance Officer’s purview that may affect compliance with any licence condition applicable to the licensable healthcare service or specified service, as the case may be.
(a) where a matter requires the Clinical Governance Officer’s attention — (i) the Clinical Governance Officer must be available to handle the matter; or (ii) if the Clinical Governance Officer cannot be so available, the Clinical Governance Officer must appoint a suitably qualified and competent personnel of the licensee to handle the matter on the Clinical Governance Officer’s behalf; (b) the Clinical Governance Officer must at all times be contactable by any personnel.
For the purposes of section 24(7) of the Act, a licensee must ensure that the individual appointed to act as the Principal Officer and every individual appointed to act as Clinical Governance Officer are, during the term of the respective individuals’ appointments, resident in Singapore so as to be able to effectively carry out the functions and duties of a Principal Officer or Clinical Governance Officer, as the case may be.
(a) a licensee authorised to provide an acute hospital service; (b) a licensee authorised to provide a community hospital service; [S 414/2023 wef 26/06/2023] [S 848/2023 wef 18/12/2023] (c) a licensee authorised to provide a nursing home service. [S 848/2023 wef 18/12/2023]
A licensee must establish and implement a policy, and establish and maintain the appropriate processes, for the suspension, termination, limitation or reduction of the clinical privileges to which the healthcare professionals employed or engaged by the licensee are entitled, in the event that any such healthcare professional is found guilty of professional misconduct in any disciplinary proceedings or is subject to disciplinary proceedings.
“CEC licensee” means a licensee who is required to appoint a clinical ethics committee under regulation 23C; [S 414/2023 wef 26/06/2023] “clinical appropriateness”, in relation to a licensable healthcare service provided by a QAC licensee to a patient, means the appropriateness of the clinical care that is provided to the patient, as determined by — (a) the extent to which the relevant clinical care plans and clinical procedures are properly executed by the QAC licensee in relation to the patient; and (b) whether there is evidence that those clinical procedures are beneficial to the patient; “clinical ethics committee” or “CEC” means a clinical ethics committee appointed pursuant to regulation 23C; [S 414/2023 wef 26/06/2023] “mortality and morbidity review” or “MMR” means a review of the circumstances surrounding either of the following: (a) the death of a patient, except where the event that caused the patient’s death is a serious reportable event; (b) any clinical incident with other adverse consequences, but is not death or a serious reportable event; [S 414/2023 wef 26/06/2023] “peer review learning” or “PRL” means the encouragement of learning and improvement of quality of care through a documented review and evaluation of a specialist’s competencies and performance by one or more other specialists in the same branch of medicine, including identifying the areas for improvement; “prescribed programme or activity” means any programme or activity set out in Part 2 of the Third Schedule; [S 414/2023 wef 26/06/2023] “QAC licensee” means a licensee who belongs to any of the categories of licensees specified in the first column of Part 1 of the Third Schedule that is required to appoint a quality assurance committee; [S 414/2023 wef 26/06/2023] “quality assurance committee” or “QAC” means a quality assurance committee appointed pursuant to regulation 20; “referring licensee”, in relation to a CEC, means a licensee who is not a section 25 licensee and who refers or causes to be referred any proposed prescribed medical treatment to the CEC for an ethics review under section 26(2)(b) of the Act; [S 414/2023 wef 26/06/2023] “serious reportable event” means an adverse event occurring, or that has occurred, during the care or treatment of a patient that — (a) has caused, or is likely to cause, death, serious injury or other harm to the patient; and (b) is not an intended or expected outcome of any examination, procedure or treatment provided to the patient; “service review committee” or “SRC” means a service review committee appointed pursuant to regulation 23A; [S 414/2023 wef 26/06/2023] “specialist” means a person who is registered as a specialist in the Register of Specialists under section 22 of the Medical Registration Act 1997 or section 14C of the Dental Registration Act 1999; [S 414/2023 wef 26/06/2023] “SRC licensee” means a licensee who is required to appoint a service review committee under regulation 23A. [S 414/2023 wef 26/06/2023]
For the purposes of section 25 of the Act, the category of licensees specified in the first column of Part 1 of the Third Schedule must appoint one or more quality assurance committees specified in the second column of Part 1 of that Schedule opposite that category of licensees. [S 414/2023 wef 26/06/2023]
(a) to devise and maintain a quality assurance programme for the purposes of evaluating and monitoring — (i) the quality and clinical appropriateness of the licensable healthcare service provided by the QAC licensee to patients; and (ii) the procedures and practices of the QAC licensee in relation to the provision of the licensable healthcare service; (b) to identify — (i) any serious reportable event; or (ii) any case for peer review learning or mortality and morbidity review (called in this Part a PRL case or an MMR case, respectively), (b) as the case may be, that has occurred or may occur in the course of providing, or in relation to the provision of, the licensable healthcare service by the QAC licensee; (c) to evaluate any serious reportable event, PRL case or MMR case (as the case may be) mentioned in sub‑paragraph (b), so as to assess whether the quality of the licensable healthcare service provided by the QAC licensee is, in the opinion of the QAC, acceptable; (d) to identify and develop solutions for any problem that has arisen or may arise in connection with any serious reportable event, PRL case or MMR case (as the case may be) mentioned in sub‑paragraph (b); (e) to make recommendations to the QAC licensee to improve the quality of the licensable healthcare service provided by the QAC licensee and to prevent the occurrence or recurrence of any serious reportable event, PRL case or MMR case (as the case may be) mentioned in sub‑paragraph (b), that was identified previously; (f) to monitor the implementation by the QAC licensee of the recommendations mentioned in sub‑paragraph (e); (g) to ensure that the requirements relating to QAC in these Regulations and any directive issued by the DirectorGeneral to the QAC licensee are complied with; [S 414/2023 wef 26/06/2023] (h) to conduct such other quality assurance activity or programme as the Director-General requires. [S 414/2023 wef 26/06/2023]
(a) maintain an ongoing quality assurance programme in accordance with the licence conditions applicable to the QAC licensee; (b) ensure the timely identification and reporting of such cases for peer review learning and mortality and morbidity review and such serious reportable events as may be specified in the licence conditions; and (c) in the case of a QAC for MMR cases or serious reportable events, ensure that the QAC institutes an effective system for a root cause analysis of every MMR case or serious reportable event (as the case may be), and recommends appropriate solutions in a timely manner to prevent a further recurrence.
(a) participate in such quality assurance activities as the Director-General may specify; and (b) provide to the Director-General such information as the Director-General may require in relation to any quality assurance activity that the licensee has participated. [S 414/2023 wef 26/06/2023]
(a) a licensee approved under section 11D of the Act to provide a collaborative prescribing service; (b) a licensee approved under section 11D of the Act to provide proton beam therapy. [S 414/2023 wef 26/06/2023]
(a) to identify any trend or pattern of events in connection with the SRC licensee’s undertaking of a prescribed programme or activity that does not comply with any requirements under the Act or code of practice applicable to that prescribed programme or activity; (b) to identify the benefits and risks to patients in connection with the SRC licensee’s undertaking of a prescribed programme or activity; (c) to review — (i) the trend or pattern of events referred to in paragraph (a) and make recommendations to the SRC licensee in relation to compliance with the requirements under the Act or code of practice mentioned in that paragraph; and (ii) the benefits and risks mentioned in paragraph (b); (d) to monitor the implementation by the SRC licensee of the recommendations made under paragraph (c)(i) and assess the effectiveness of the implemented recommendations; (e) if patient safety and outcomes are jeopardised, to recommend to the licensee to stop the prescribed programme or activity. [S 414/2023 wef 26/06/2023]
(a) at least 6 members who are healthcare professionals each with at least 10 years of practice experience and who are in active practice, of whom at least 3 must each be an independent member; and (b) at least 3 other members who are not healthcare professionals.
(a) who is not employed by the licensee; and (b) who does not have any interest (whether personal, professional or otherwise) in the outcome of the ethics review. [S 414/2023 wef 26/06/2023]
For the purposes of section 26 of the Act, the treatments specified in Part 3 of the Third Schedule are prescribed medical treatments. [S 414/2023 wef 26/06/2023]
(a) to conduct an ethics review of — (i) every prescribed medical treatment relating to the care and treatment of a patient of the CEC licensee; and (ii) every prescribed medical treatment relating to a patient of a referring licensee; (b) to conduct an ethics review of any case (other than a case mentioned in paragraph (a)) referred to it by the CEC licensee or any other licensee; (c) to advise the CEC licensee on the formulation of clinical ethics policies and guidelines; (d) to recommend appropriate education and training for healthcare professionals providing any healthcare service at any of the CEC licensee’s approved permanent premises on the provision of the healthcare service in an ethical manner; (e) to assist the CEC licensee in ensuring that ethical misdemeanours are reviewed and addressed promptly and appropriately; (f) to document every discussion and decision by the CEC; (g) to establish criteria for an ethics review conducted for a prescribed medical treatment; (h) within 10 calendar days after a CEC completes the review of any case mentioned in paragraph (a) — inform the Director-General whether the CEC is of the opinion that it is ethically appropriate to administer the prescribed medical treatment as proposed by the CEC licensee or referring licensee. [S 414/2023 wef 26/06/2023]
(a) deploy appropriate and adequate personnel to provide secretariat support to each CEC that the licensee appoints; (b) provide adequate training and educational resources to the members of each CEC that the licensee appoints to enable the members to carry out their functions and duties; (c) establish a system to audit the procedures and decisionmaking of each CEC that the licensee appoints; and (d) periodically review — (i) the system for referring licensees to refer cases to; and (ii) the processes adopted by, (d) each CEC that the licensee appoints, and take appropriate measures to rectify any deficiencies detected. [S 414/2023 wef 26/06/2023]
(a) every premises or conveyance used in the provision of the licensable healthcare service is safe, sanitary, accessible and appropriately equipped; [S 414/2023 wef 26/06/2023] (b) where the licensee provides the licensable healthcare service by remote provision — every structure, facility, equipment or device provided by the licensee for a patient’s use is sanitary and safe for the patient’s use; [S 414/2023 wef 26/06/2023] (c) all medical and surgical equipment, instruments, appliances, materials and facilities — (i) are installed, and used or operated, in accordance with the instructions of the manufacturer; and (ii) are checked regularly, maintained and repaired properly and according to the specifications of the manufacturer, (c) so as to ensure that they are adequate, functional and effective and the licensable healthcare service is provided safely; and [S 414/2023 wef 26/06/2023] (d) any medical or surgical equipment, instrument, appliance, material or facility which is not functioning properly or effectively is replaced in a timely manner. [S 414/2023 wef 26/06/2023] [S 414/2023 wef 26/06/2023]
(a) the equipment is secured against unauthorised access, interference and tampering; (b) the data held in the equipment is protected from unauthorised local or remote electronic access by implementing appropriate security measures; (c) the security measures mentioned in paragraph (b) are reviewed regularly; and (d) the transmission of the data held in the equipment to any person authorised by the licensee to receive such data is done so securely.
(a) every patient of the licensee who enters into a transaction for the provision of a specified healthcare service or co‑located service makes an independent decision in relation to the transaction; (b) every advertisement relating to the licensee’s licensable service that also advertises a specified healthcare service or co‑located service is in compliance with the requirements in the Healthcare Services (Advertisement) Regulations 2021 (G.N. No. S 1033/2021) that apply to, or in relation to, an advertisement of a licensable healthcare service; (c) every advertisement that advertises a specified healthcare service or co‑located service but not the licensee’s licensable healthcare service must state that the service advertised — (i) is not licensed under the Act; but (ii) is permitted under the Act to be provided at the approved permanent premises or in the approved conveyance where the licensee’s licensable healthcare service is also provided; [S 414/2023 wef 26/06/2023] (d) the provision of the licensee’s licensable healthcare service is not adversely affected, and the privacy and safety of the licensee’s patients is not compromised, by the provision of any specified healthcare service or co‑located service; and (e) if the provision of a specified healthcare service or co‑located service is also for individuals other than the licensee’s patients — (i) there is a clear demarcation of the space used to provide the specified healthcare service or co‑located service; or (ii) where the space cannot be so demarcated — (A) there is a conspicuously displayed signage, or such other means of communication to the licensee’s patients as specified by the DirectorGeneral, stating that the specified healthcare service or co‑located service is not licensed under the Act; and [S 414/2023 wef 26/06/2023] (B) there is a written agreement between the licensee and the provider of the specified healthcare service or co‑located service (as the case may be) which stipulates clearly the respective responsibilities of the licensee and the provider in relation to the use of the approved permanent premises or approved conveyance. [S 414/2023 wef 26/06/2023]
(a) the licensee does not make such transaction a condition for the provision to the patient of a licensable healthcare service, unless otherwise allowed by any written law or the applicable professional ethical guidelines or standards; (b) the licensee does not give the patient any incentive for such transaction that is connected to the provision of a licensable healthcare service; and (c) the licensee does not give the patient any incentive for the provision of a licensable healthcare service that is connected to such transaction. [S 414/2023 wef 26/06/2023] [S 414/2023 wef 26/06/2023]
(a) from a person who holds a valid licence authorising that person to supply or sell the product; or (b) otherwise expressly permitted under any written law.
(a) the medicinal product or health product is packed and labelled appropriately; [S 414/2023 wef 26/06/2023] (aa) the label on the medicinal product or health product includes the expiry date of the product; and [S 414/2023 wef 26/06/2023] (b) the patient’s medication record contains adequate, accurate and relevant information to ensure that there is no error or confusion as to the medicinal product or health product prescribed, dispensed, administered or otherwise provided (as the case may be), and to ensure the proper and safe use of the medicinal product or health product by the patient.
(a) ensure that the erroneous prescription is properly identified and recorded; and (b) take appropriate and timely measures to correct the error and prevent a recurrence.
(a) that every medicinal product or health product is accurately prepared, dispensed and administered in accordance with a prescription that is issued by — (i) a dentist; (ii) a medical practitioner; or (iii) a collaborative prescribing practitioner in accordance with a collaborative practice agreement; and (b) the keeping and maintenance of proper and accurate records of each medicinal product or health product prepared, dispensed or administered under sub‑paragraph (a). [S 414/2023 wef 26/06/2023]
(a) immediately inform the patient of the deviation and the steps or measures to be taken to avoid or minimise patient harm; and (b) keep and maintain proper and accurate records of the deviation and when the patient was informed of the deviation under sub‑paragraph (a). [S 414/2023 wef 26/06/2023] [S 414/2023 wef 26/06/2023]
(a) in such a way that — (i) it is protected from the likelihood of contamination; and (ii) the environmental conditions under which it is stored will not adversely affect its efficacy, quality and safety; and (b) in accordance with the manufacturer’s specifications. [S 414/2023 wef 26/06/2023] [S 414/2023 wef 26/06/2023]
(a) if the expiry date is known — as soon as practicable after the expiry date of the product; and (b) in any other case — when the productshows itsfirstsign of deterioration.
(a) protected from any likelihood of contamination; (b) kept under suitable conditions (such as temperature, humidity, length of time, lighting and position of the product), so as not to affect its efficacy, quality and safety; and [S 414/2023 wef 26/06/2023] (c) delivered or transported directly to the intended destination without any diversion or deviation from the intended route. [S 414/2023 wef 26/06/2023] (d) [Deleted by S 414/2023 wef 26/06/2023]
(a) the personnel who is responsible for collecting the specimen checks and verifies the identity of the patient prior to the collection; (b) the specimen collected is the correct specimen for the type of test that is ordered by a requestor to be carried out for the patient; and [S 414/2023 wef 26/06/2023] (c) the container containing the specimen is labelled accurately and clearly with — (i) a name and reference number unique to the patient; (ii) the site from which the specimen is collected, where relevant; and (iii) where the test ordered by a requestor to be carried out for the patient requires the collection of more than one specimen, the sequence in which the specimen is collected. [S 414/2023 wef 26/06/2023] [S 414/2023 wef 26/06/2023]
(a) implement a system where all relevant specimen collection information may be traced from an identifier on the container containing the specimen; or (b) include all relevant specimen collection information on the label on the container containing the specimen. [S 414/2023 wef 26/06/2023]
“relevant specimen collection information”, in relation to a specimen, means the following information: (a) the date and time of the collection of the specimen; (b) the type of specimen; “requestor”, in relation to a patient, means the medical practitioner, dentist or collaborative prescribing practitioner who ordered a test for the patient. [S 414/2023 wef 26/06/2023]
(a) a licensee authorised to provide a clinical laboratory service; or (b) where the sample is intended to be sent for testing outside Singapore — a person who operates a clinical laboratory outside Singapore that is accredited by an accreditation body approved by the Director-General.
A licensee must ensure that every test that is carried out on a specimen from a patient provides information that is relevant for the clinical management of the patient’s health or medical condition. [S 414/2023 wef 26/06/2023]
(a) the container containing the specimen is kept safely in packaging that is appropriate for transportation; and (b) the specimen is transported in a manner that — (i) does not cause any confusion in the identification of the specimen; (ii) preserves the integrity of the specimen; and (iii) does not endanger public safety.
A licensee must ensure that every patient’s privacy is respected and every patient is treated with dignity and respect.
(a) every patient is protected from abuse or neglect by any personnel in the course of receiving care and treatment; and (b) there is in place a proper system to report any such abuse or neglect to an appropriate authority so that appropriate action may be taken against the personnel.
(a) the findings of the test are brought to the attention of the requestor without undue delay; [S 414/2023 wef 26/06/2023] (b) the requestor reviews the findings in a timely manner; [S 414/2023 wef 26/06/2023] (c) the patient is informed, without undue delay, of the findings that, in the professional opinion of the requestor, are clinically significant; [S 414/2023 wef 26/06/2023] (d) the requestor advises the patient, based on the findings and without undue delay, on the patient’s condition, prognosis and clinical management. [S 414/2023 wef 26/06/2023] [S 414/2023 wef 26/06/2023]
(a) the medical practitioner, dentist or collaborative prescribing practitioner who ordered the test for the patient; and (b) any medical practitioner, dentist or collaborative prescribing practitioner designated by the person mentioned in sub‑paragraph (a) to carry out any duty mentioned in paragraph (3)(a), (b), (c) or (d). [S 414/2023 wef 26/06/2023]
(a) name; (b) identification number or passport number; (c) gender; (d) date of birth.
(a) residential address; (b) ethnic group; (c) date and time of every consultation, referral, admission, investigation and discharge; (d) admission forms and patient registration number for the visit, consultation or admission; [S 414/2023 wef 26/06/2023] (e) medical history, referral documents and declaration forms relating to the patient’s health or medical history; [S 414/2023 wef 26/06/2023] (f) clinical findings and progress notes; (g) clinical management and care plan containing details such as medication, nursing care, treatment, diet and allied health care; (ga) the name of each medical practitioner or dentist (as the case may be) who has provided care or treatment to the patient; [S 414/2023 wef 26/06/2023] (gb) the date of and reason for each medical certificate issued to the patient; [S 414/2023 wef 26/06/2023] (gc) any consent or acknowledgment forms; [S 414/2023 wef 26/06/2023] (h) allergies and other factors requiring special consideration; (i) results of laboratory tests; (j) reports of X-rays and other investigations; (k) vaccinations; (l) consent forms; (m) discharge summary containing details such as significant findings and events of the patient’s stay, the patient’s condition on discharge and recommendations and arrangements for future care; (ma) health declaration forms; [S 414/2023 wef 26/06/2023] (mb) financial counselling forms; [S 414/2023 wef 26/06/2023] (mc) records of any adverse event that occurred in the provision of the licensable healthcare service and the actions taken by the licensee’s personnel in response to the adverse event; [S 414/2023 wef 26/06/2023] (n) date and time of death (if the patient is deceased).
(a) accurately and clearly sets out any follow‑up action identified by the licensee or any personnel as being appropriate and necessary for the patient; and (b) subject to paragraph (5), contains accurate information about whether that follow‑up action is taken, and if no follow-up action is taken, the reason for the failure to take that follow-up action.
(a) the confidentiality, integrity and security of every patient health record is maintained at all times; and (b) every personnel handling any patient health record is aware of his or her role and responsibility in maintaining the confidentiality, integrity and security of the records.
(a) implement adequate safeguards and appropriate protocols and processes to protect the patient health records against accidental or unlawful loss, modification or destruction, or unauthorised access, disclosure, copying, use or modification; (b) 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 staff involved in handling the patient health records; and (c) take reasonable care in the disposal or destruction of the patient health records so as to prevent unauthorised access to the records.
(a) inform the patient of the cessation or transfer of care (as the case may be) within a reasonable period before the cessation or transfer of care, as the case may be; (b) consult the patient about the transfer or disposal of his or her patient health record; (c) transfer the patient health record or give a detailed medical report of the patient to — (i) the licensee that is taking over the care of the patient; or (ii) the patient or his or her authorised representative, upon request by the patient or authorised representative, as the case may be.
(a) if the patient is a child — the patient’s parent, adoptive parent, step‑parent or guardian; (b) if the patient lacks capacity within the meaning of section 4 of the Mental Capacity Act 2008 — (i) a deputy appointed or deemed to be appointed for the person by the court under that Act with power in relation to the person for the purposes of these Regulations; or (ii) a donee under a lasting power of attorney registered under that Act with power in relation to the patient for the purposes of these Regulations; (c) if the patient is an adult who has capacity — a person whom the patient has authorised to act on the patient’s behalf for any matter (including legal proceedings) that requires information in his or her patient health record.
(a) if the patient is a child — the patient’s parent, adoptive parent, step‑parent or guardian; (b) if the patient is an adult who lacks capacity within the meaning of section 4 of the Mental Capacity Act 2008 — any of the following persons: (i) where there is a deputy appointed or deemed to be appointed for the patient by the court under that Act with power in relation to the patient for the purposes of these Regulations — the deputy; (ii) where there is a donee appointed under a lasting power of attorney registered under that Act with power in relation to the patient for the purposes of these Regulations — the donee; (iii) in any other case — any of the patient’s next of kin; [S 848/2023 wef 18/12/2023] (c) if the patient is an adult who has capacity — a person whom the patient has authorised to receive the bill on the patient’s behalf; (d) if the patient has died — any of the patient’s next of kin.
(a) where the licensable healthcare service is provided at approved permanent premises or using an approved conveyance — the environment surrounding and within the approved permanent premises or approved conveyance is clean and safe; [S 414/2023 wef 26/06/2023] (b) all the equipment and facilities used for the provision of the licensable healthcare service are clean and safe; [S 414/2023 wef 26/06/2023] (c) the use of all the appliances, equipment, instruments and materials for the provision of the licensable healthcare service is in compliance with the established or recommended procedures for their maintenance and use; and [S 414/2023 wef 26/06/2023] (d) appropriate infection control processes are implemented at any premises or in any conveyance used for the provision of the licensable healthcare service. [S 414/2023 wef 26/06/2023] [S 414/2023 wef 26/06/2023]
(a) a patient of the licensee; (b) a person who is referred to the licensee by another licensee for care or treatment. [S 414/2023 wef 26/06/2023]
[Deleted by S 414/2023 wef 26/06/2023]
(a) take effective measures to ensure the safe and proper use, storage and disposal of the biohazardous material or sharps; (b) establish policies and procedures to prevent any patient or personnel from contracting an infection resulting from exposure to biohazards or any sharps injury; and (c) ensure that each policy and procedure mentioned in sub‑paragraph (b) is implemented. [S 414/2023 wef 26/06/2023]
(a) any substance which contains toxins; (b) any biological waste; (c) any culture medium; (d) any contaminated blood, urine or faeces; and (e) any infected tissue or organ. [S 414/2023 wef 26/06/2023]
(a) a clinical incident impacting or endangering public health or patient safety; (b) a clinical incident indicating that there is a systemic or process failure; (c) an incident of abuse or allegation of abuse, or of a breach of privacy, of any patient; (d) any compromise of data kept by the licensee, whether in electronic form or otherwise, that directly affects the safety or welfare of patients, or the confidentiality or security of data; (e) an incident impacting the structural safety (including fire safety) of any approved permanent premises or approved conveyance or any structure, facility, equipment or device used for the provision of the licensable healthcare service which requires an individual to enter the structure, facility, equipment or device. [S 414/2023 wef 26/06/2023]
(a) to prevent or limit the occurrence of any incident mentioned in paragraph (1); (b) to minimise the harm to patients that may arise or has arisen as a result of such an incident; and (c) to prevent the recurrence of such an incident.
(a) establish an effective emergency response plan to deal with or respond to any national emergency; (b) participate in national emergency efforts; (c) participate in the planning, design and conduct of national emergency preparedness exercises; (d) develop and implement emergency infection control measures (such as isolation facilities and infection control equipment) to control and prevent the spread of any infectious disease in an epidemic or a pandemic; (e) ensure that every personnel, whose responsibility includes the handling of national emergencies, is competent in responding to any national emergency, including, but not limited to, the wearing of the Personal Protective Equipment (PPE) safely and properly; [S 414/2023 wef 26/06/2023] (f) in relation to each premises or conveyance that the licensee uses for the provision of a licensable healthcare service — (i) ensure that there is at all times, at least one week’s supply of Personal Protective Equipment (PPE) available at the premises or conveyance for each personnel deployed at the premises or conveyance; or (ii) implement processes to ensure that the licensee may, at any time, obtain at least one week’s supply of Personal Protective Equipment (PPE) for each personnel deployed at the premises or conveyance; and [S 414/2023 wef 26/06/2023] (g) ensure that each item of Personal Protective Equipment (PPE) given to the licensee’s personnel isfit for use and has not passed its expiry date, if any. [S 414/2023 wef 26/06/2023] [S 414/2023 wef 26/06/2023]
(a) N95 face masks or masks of the equivalent standard; (b) isolation gowns or gowns of the equivalent standard; (c) examination gloves or gloves of the equivalent standard. [S 414/2023 wef 26/06/2023]
(a) the business continuity plan must also establish the systems and set out the procedures necessary (including the measures specified in regulation 39(1)) for the transfer of the care of the licensee’s patients to another licensee in the event of the licensee’s death; and (b) the licensee must nominate a person to carry out the procedures mentioned in sub‑paragraph (a) in the event of the licensee’s death. [S 414/2023 wef 26/06/2023]
(a) take reasonable steps to ensure that the business continuity plan can be effectively followed if any contingency or disaster disrupts the licensee’s business of providing a licensable healthcare service; (b) periodically review the business continuity plan; and (c) implement changes, where necessary, to ensure the effectiveness of the business continuity plan.
For the purposes of section 29(3) of the Act, the prescribed terms and names are as specified in the Fifth Schedule.
(a) a licensee contravenes regulation 29(2)(a) or (3) in relation to any medicinal product or health product dispensed or administered to a patient; and (b) the contravention results in the patient suffering any harm, the licensee shall be guilty of an offence. [S 414/2023 wef 26/06/2023]
[Deleted by S 414/2023 wef 26/06/2023]
LICENSABLE HEALTHCARE SERVICES AND SPECIFIED SERVICES REQUIRING APPOINTMENT OF CLINICAL GOVERNANCE OFFICERS
Regulations 19, 20 and 23D COMMITTEES APPOINTED BY LICENSEES
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[S 848/2023 wef 18/12/2023]](/xmlViewerPage/image.do?FL_SEQ=93435&FL_NM=feb5d26598a7d96b09707c164eb9a234.JPG)
“cluster HQ” means any of the following: (a) National Healthcare Group Pte Ltd; (b) National University Health System Pte Ltd; (c) Singapore Health Services Pte Ltd; “Mortality and Morbidity QAC” means a QAC established by a licensee to identify and evaluate any case for mortality and morbidity review, and take any steps that are necessary or appropriate, in accordance with the Act and these Regulations; “Peer Review Learning QAC” means a QAC established by a licensee to review and evaluate clinical quality, safety and appropriateness of care provided by specialists employed or engaged by the licensee, and take any steps that are necessary or appropriate, in accordance with the Act and these Regulations; “Serious Reportable Event QAC” means a QAC established by a licensee to identify and evaluate any serious reportable event that occurs in the course of providing a licensable healthcare service, and take any steps that are necessary or appropriate, in accordance with the Act and these Regulations.
(a) has not experienced the onset of puberty and has been diagnosed with any medical condition that requires gonadotoxic therapy; or (b) has Klinefelter syndrome.
(a) has not experienced the onset of puberty and has been diagnosed with any medical condition that requires gonadotoxic therapy; or (b) has Klinefelter syndrome.
(a) that is manufactured by a licensee; and
(b) in respect of which use has not been accepted by a respectable body of medical opinion as conventional treatment for the medical condition.
Regulation 26(1) NON-LICENSABLE HEALTHCARE SERVICES THAT CAN BE PROVIDED IN APPROVED PERMANENT PREMISES OR APPROVED CONVEYANCES
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[S 414/2023 wef 26/06/2023]](/xmlViewerPage/image.do?FL_SEQ=93435&FL_NM=1d34901e5a98dc9bbaa91e4a6f24f55c.JPG)
Regulation 49 PROTECTED TERMS AND NAMES