MH 78:44/1
26 June 2023
IMPLEMENTATION OF REGULATIONS AND ISSUANCE OF LICENCE CONDITIONS UNDER PHASE 2 OF THE HEALTHCARE SERVICES ACT (HCSA)
This circular informs all Licensees under the Private Hospitals and Medical Clinics Act (PHMCA), Licensees under the Healthcare Services Act (HCSA), and Telemedicine and Home Medical Care Providers on the implementation of Phase 2 HCSA Regulations and the applicable licence conditions that licensees will need to comply with in the provision of the healthcare services.
2 The HCSA was enacted in January 2020 to replace the current PHMCA to better safeguard patient safety and well-being and strengthen the governance of healthcare service providers in the evolving healthcare environment, while enabling the rollout of new and innovative healthcare services. The Act is being rolled out in three phases. Phase 1 commenced on 3 January 2022, implementing the Healthcare Services (General Regulations) 2021, the Healthcare Services (Fees) Regulations 2021, the Healthcare Services (Advertisement) Regulations 2021, and the relevant service regulations for Phase 1 services. Implementation of HCSA amendments and Phase 2 Regulations
3 Following feedback from various stakeholders, MOH has reviewed and made amendments to the HCSA and its Regulations previously promulgated under Phase 1, to better support the delivery of healthcare services under a robust regulatory regime. These amendments will be implemented together with the commencement of Phase 2.
4 The amended Act and list of applicable Regulations are found in
Annex A
Licence conditions (“LCs”)
5 Phase 2 Licensees may also be issued one or more sets of LCs together with their service licences imposed under Section 13(1) of the Healthcare Services Act 20201 . The type of LCs issued will depend on the type of licensable healthcare services that the Licensee provides or intends to provide. Please refer to
Annex B for the LCs applicable to the Phase 2 licensable healthcare services you are providing and ensure that you and your personnel are familiar and comply with these LCs when providing the healthcare services. The full list of LCs can be found in
Annex C. Any breach of these LCs may result in regulatory action being taken against licensees under section 20 of the HCSA, including but not limited to:
(a) suspension or revocation of the Licensee’s licence(s);
(b) shortening the term of the Licensee’s licence(s);
(c) a direction requiring the Licensee to rectify the contravention, or prevent a recurrence of the contravention; and/or
(d) a direction requiring the Licensee to pay a financial penalty.
For avoidance of doubt, these LCs do not override a healthcare professional’s duty to make clinical decisions that are in the best interests of each patient.
6 Following further feedback from Phase 1 Licensees, MOH has also reviewed the LCs issued to Phase 1 Licensees and modified the LCs accordingly to take into account the amendments made to the Act and the regulations. Phase 1 Licensees whose LCs will be modified will be separately notified of the amendments.
7 In addition, all HCSA Licensees will be subject to the Code of Practice for Key Officeholders. A copy of the amended Act, its Regulations, the Code of Practice, and the various Licence Conditions applicable to each licensee can be found at www.HCSA.sg from 26 June 2023.
8 Please refer to www.HCSA.sg for the latest information on the transition from PHMCA to HCSA, the various HCSA regulations, and other latest updates and resources. A set of Frequently Asked Questions for each licensable healthcare service will also be uploaded in due course. Should you require further clarification, please email us at HCSA_enquiries@moh.gov.sg.
PROFESSOR KENNETH MAK
DIRECTOR-GENERAL OF HEALTH
MINISTRY OF HEALTH
The full document with the Annexes may be downloaded below:Download [.pdf 402KB]
The LCs may be downloaded below:| C.1 LICENCE CONDITIONS FOR ACUTE HOSPITAL AND OUTPATIENT MEDICAL SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE ARTIFICIAL INSEMINATION PROCEDURES | Download [.pdf 79KB] |
| C.2 LICENCE CONDITIONS FOR ACUTE HOSPITAL SERVICE AND AMBULATORY SURGICAL CENTRE SERVICE LICENSEES PROVIDING CATARACT SURGERY | Download [.pdf 140KB] |
| C.3 LICENCE CONDITIONS FOR ACUTE HOSPITAL SERVICE AND OUTPATIENT MEDICAL SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE ORGAN TRANSPLANT SERVICE | Download [.pdf 207KB] |
| C.4 LICENCE CONDITIONS FOR ACUTE HOSPITAL SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE SPECIALISED AND INTENSIVE CARE SERVICES TO NEONATES | Download [.pdf 160KB] |
| C.5 LICENCE CONDITIONS FOR ACUTE HOSPITAL SERVICE, AMBULATORY SURGICAL CENTRE SERVICE AND OUTPATIENT MEDICAL SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE PROTON BEAM THERAPY | Download [.pdf 282KB] |
| C.6 LICENCE CONDITIONS FOR ACUTE HOSPITAL SERVICE, AMBULATORY SURGICAL CENTRE SERVICE AND OUTPATIENT MEDICAL SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE RADIATION ONCOLOGY AND RADIATION THERAPY | Download [.pdf 188KB] |
| C.7 LICENCE CONDITIONS FOR ACUTE HOSPITAL SERVICE, AMBULATORY SURGICAL CENTRE SERVICE, AND/OR OUTPATIENT MEDICAL SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE TREATMENT FOR SEXUAL STERILISATION | Download [.pdf 168KB] |
| C.8 LICENCE CONDITIONS FOR ALL ACUTE HOSPITAL SERVICE, OUTPATIENT DENTAL SERVICE AND OUTPATIENT MEDICAL SERVICE LICENSEES ADMINISTRATING OR INTENDING TO ADMINSTER CELL, TISSUE AND GENE THERAPY PRODUCTS MANUFACTURED INHOUES BY HEALTHCARE INSTITUTIONS | Download [.pdf 133KB] |
| C.9 LICENCE CONDITIONS FOR ALL LICENSEES RELATING TO IMMUNITY AGAINST MEASLES AND DIPHTHERIA FOR PERSONNEL IN HEALTHCARE INSTITUTIONS | Download [.pdf 108KB] |
| C.10 LICENCE CONDITIONS FOR ASSISTED REPRODUCTION SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE PRE-IMPLANTATION GENETIC TESTING FOR (A) MONOGENIC OR SINGLE GENE DEFECTS OR (B) CHROMOSOMAL STRUCTURAL REARRANGEMENTS | Download [.pdf 201KB] |
| C.11 LICENCE CONDITIONS FOR ASSISTED REPRODUCTION SERVICE, RADIOLOGICAL SERVICE, OUTPATIENT MEDICAL SERVICE, OUTPATIENT DENTAL SERVICE, NUCLEAR MEDICAL SERVICE, AMBULATORY SURGICAL CENTRE SERVICE, COMMUNITY HOSPITAL SERVICE AND CONTINGENCY CARE SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE (1) SEDATION; OR (2) GENERAL ANAESTHESIA | Download [.pdf 353KB] |
| C.12 LICENCE CONDITIONS FOR HUMAN TISSUE BANKING SERVICE | Download [.pdf 133KB] |
| C.13 LICENCE CONDITIONS FOR HUMAN TISSUE BANKING SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE BANKING OF CARDIAC AND VASCULAR TISSUE | Download [.pdf 124KB] |
| C.14 LICENCE CONDITIONS FOR HUMAN TISSUE BANKING SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE BANKING OF HAEMATOPOIETIC STEM CELL (INCLUDING BONE MARROW) | Download [.pdf 67KB] |
| C.15 LICENCE CONDITIONS FOR HUMAN TISSUE BANKING SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE BANKING OF OCULAR TISSUE | Download [.pdf 121KB] |
| C.16 LICENCE CONDITIONS FOR HUMAN TISSUE BANKING SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE BANKING OF SKIN TISSUE | Download [.pdf 121KB] |
| C.17 LICENCE CONDITIONS FOR LICENSEES PROVIDING ASSISTED REPRODUCTION SERVICES | Download [.pdf 135KB] |
| C.18 LICENCE CONDITIONS FOR LICENSEES PROVIDING OR INTENDING TO PROVIDE BLOOD TRANSFUSION SERVICE | Download [.pdf 230KB] |
| C.19 LICENSEES PROVIDING OR INTENDING TO PROVIDE SIMPLE IN VITRO DIAGNOSTIC TESTS | Download [.pdf 107KB] |
| C.20 LICENCE CONDITIONS FOR LICENSEES PROVIDING OR INTENDING TO PROVIDE TREATMENTS TO TERMINATE PREGNANCY | Download [.pdf 247KB] |
| C.21 LICENCE CONDITIONS FOR MORTALITY AND MORBIDITY REVIEW | Download [.pdf 29KB] |
| C.22 LICENCE CONDITIONS FOR OUTPATIENT MEDICAL SERVICE AND AMBULATORY SURGICAL CENTRE SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE LIPOSUCTION | Download [.pdf 242KB] |
| C.23 LICENCE CONDITIONS FOR OUTPATIENT MEDICAL SERVICE LICENSEES PRESCRIBING AND SUPPLYING BENZODIAZEPINES AND OTHER HYPNOTICS | Download [.pdf 102KB] |
| C.24 LICENCE CONDITIONS FOR OUTPATIENT MEDICAL SERVICE LICENSEES PRESCRIBING AND SUPPLYING CODEINE COUGH PREPARATIONS | Download [.pdf 96KB] |
| C.25 LICENCE CONDITIONS FOR OUTPATIENT MEDICAL SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE ELECTROCARDIOGRAPHY STRESS TESTING | Download [.pdf 141KB] |
| C.26 LICENCE CONDITIONS FOR OUTPATIENT MEDICAL SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE ENDOSCOPY SERVICE | Download [.pdf 163KB] |
| C.27 LICENCE CONDITIONS FOR OUTPATIENT MEDICAL SERVICE, OUTPATIENT DENTAL SERVICE, OUTPATIENT RENAL DIALYSIS SERVICE, ACUTE HOSPITAL SERVICE, COMMUNITY HOSPITAL SERVICE, CONTINGENCY CARE SERVICE LICENSEES PROVIDING OR INTENDING TO PROVIDE COVID-19 VACCINATION | Download [.pdf 148KB] |
| C.28 LICENCE CONDITIONS FOR OUTPATIENT RENAL DIALYSIS SERVICE LICENSEES | Download [.pdf 184KB] |
| C.29 LICENCE CONDITIONS FOR PROVIDING OR INTENDING TO PROVIDE EMERGENCY LIFE SAVING MEASURES | Download [.pdf 165KB] |
| C.30 LICENCE CONDITIONS FOR SERIOUS REPORTABLE EVENT | Download [.pdf 333KB] |
| C.31 LICENCE CONDITIONS FOR THE PROVISION OF NUCLEAR MEDICINE SERVICES | Download [.pdf 345KB] |
| C.32 LICENCE CONDITIONS ON CASE REVIEWS BY CLINICAL ETHICS COMMITTEES | Download [.pdf 122KB] |
| C.33 LICENCE CONDITIONS ON LICENSEES PROVIDING OR INTENDING TO PROVIDE RESTRICTED SERVICES | Download [.pdf 104KB] |
| C.34 LICENCE CONDITIONS ON PEER REVIEW LEARNING | Download [.pdf 68KB] |
| C.35 LICENCE CONDITIONS ON THE PROVISION OF LUXTURNA (VORETIGENE NEPARVOVEC) AS A TREATMENT OPTION FOR PATIENTS | Download [.pdf 87KB] |
| C.36 LICENCE CONDITIONS ON THE RETENTION PERIODS OF PATIENT HEALTH RECORDS | Download [.pdf 45KB] |
| C.37 LICENCE CONDITIONS ON VACCINE COLD CHAIN FOR LICENSEES INVOLVED IN THE HANDLING, STORAGE AND/OR TRANSPORT OF VACCINES | Download [.pdf 74KB] |