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New care models for patients have emerged, and healthcare services are increasingly delivered through different modes, such as conveyance, mobile and online channels. This necessitates a shift towards a more flexible approach in the regulation of Singapore’s healthcare system. Under the Private Hospitals and Medical Clinics Act (PHMCA) and regulations, healthcare providers are licensed based on different types of premises (e.g., medical clinic, nursing home, hospital, clinical & x-ray laboratory) while under HCSA, healthcare providers will be licensed based on the healthcare services provided.

HCSA better safeguards patient safety and well-being in the changing healthcare environment, while enabling the development of new and innovative healthcare services. It also strengthens governance and regulatory clarity for better provision and continuity of care to patients. 


KEY CHANGES FROM PHMCA TO HCSA

A. Broadened Regulatory Scope

Under HCSA, the regulatory scope will be broadened to potentially include a wider scope of healthcare services, allied health services, nursing services, traditional medicine, and complementary and alternative medicine (Figure 1). Services that do not provide direct patient care, such as Beauty and wellness services, are not included in the scope of HCSA, as such services do not involve the assessment, diagnosis, prevention, alleviation or treatment of a medical condition or disorder.

MOH will adopt a risk-based regulatory approach in determining which services are licensable under HCSA. While allied health services, nursing services, traditional medicine and complementary and alternative medicine are potentially within the scope of HCSA, MOH will not be licensing these services for the moment. The practice of professionals such as physiotherapists and Traditional Chinese Medicine practitioners will continue to be regulated through the existing Professional Acts.

Figure 1: Proposed scope of HCSA 

B. Licensing Approach and Implementation

I.     Licensable Healthcare Services under HCSA

Under HCSA, healthcare providers will need to apply for approval to hold licences for the licensable healthcare services (LHS) they provide, as well as the appropriate modes of service delivery (MOSD) applicable for the LHS. This is a change from the PHMCA where providers are licensed based only on physical premises.

The introduction of Specified Services (SSes) for each LHS is another change from PHMCA to HCSA. Licensees will also need approval from the Ministry of Health prior to offering these SSes. SSes generally involve complex or higher risk procedures provided in a LHS and have distinct requirements for patient safety. The approval regime for SSes builds on the approval process that was in place for special care services in medical clinics, and specialised procedures and services in private hospitals set out under the PHMC regulations.

More information on the MOSDs and SSes are provided below. Click here to see which HCSA Phase(s) your service(s) are in.

The requirements for each LHS will be stated in their respective Service Regulations and Licence Conditions (LCs). Please click here to access the requirements for Phase 1 services.

II.   Modes of Service Delivery

To cater for new and emerging models of care that are no-longer premises based (e.g. home care, telemedicine), there will also be 4 modes of service delivery (MOSDs) under HCSA. MOH will define the allowable MOSDs for each LHS. Licensees must seek MOH’s approval for the MOSDs used to deliver each LHS.
 

4 MOSDs Diagram_caa18Mar23

 
Example:

Dr Tan wishes to set-up a physical clinic that offers both medical and dental services in Singapore. Additionally, as part of the medical services offered by that clinic, Dr Tan also wishes to offer house calls and teleconsultation by his team of doctors to cater to the needs of different groups of patients. Dr Tan would need to hold:

  • An outpatient medical service licence approved for the following MOSDs: permanent premises, temporary premises and remote delivery*; and
  • An outpatient dental service licence approved for the permanent premises MOSD.

*To reduce the cost incurred from holding multiple licences, some licensees will be eligible for licence fee bundles. For example, a licensee who applies for an outpatient medical service licence with any combination of these MOSDs (permanent premises, temporary premises or remote) will be eligible for the bundle. More information on licence fee bundles will be provided in due course.
 

III.   Specifed Services Under HCSA

Under HCSA, there are SSes for each LHS. SSes generally involve complex or higher risk procedures provided in a LHS and have distinct requirements for patient safety. SSes include some of the specialized procedures and special care services in the Second and Third Schedules of the PHMC Regulations (e.g. radiation oncology, endoscopy), sub-disciplines of service within a LHS (e.g. different laboratory disciplines and tests, radiation technology applied) and newly identified procedures or services (e.g. collaborative prescribing, liposuction, dental cone beam computed tomography).

With the introduction of HCSA, the specialised procedures and services under the Second and Third Schedule of the PHMC regulations were reviewed; and these procedures and services were either transited to a LHS (e.g. assisted reproduction), a SS (e.g. radiation oncology), or no longer classified as a service requiring approval under HCSA (e.g. organ transplant). The specialised procedures and services under the Second and Third Schedule of the PHMC regulations which are no longer classified as a service requiring approval under HCSA are reflected in Table 1 below. Nonetheless, licensees will be required to comply with licence conditions relevant to the licensable services they provide, and these will be separately issued to the licensees.

Table 1. List of Second and Third schedule services under the PHMC regulations which do not require MOH’s approval under HCSA

PHMC Regulations Second Schedule Services

PHMC Regulations Third Schedule Services

  • Blood transfusion
  • Neonatal intensive care unit
  • Organ transplant services, including transplant-related clinical services
  • Lithotripsy
  • Specialised cardiac investigation
  • Transplant-related clinical services

Licensees will also need to seek MOH’s approval prior to the commencement of these Sses under their LHS.

Example:
Dr Gopal has a medical clinic that offers both endoscopy and liposuction services. As endoscopy and liposuction are classified as Sses under Outpatient Medical Service, Dr Gopal would need to:

  • Hold an outpatient medical service licence approved for permanent premises MOSD; and
  • Seek approval from MOH to offer both endoscopy and liposuction under his outpatient medical service licence.


For more information on the allowable MOSDs and Sses for each LHS, please click here.

IV.   Licence Fees under HCSA

Under HCSA, all licence fees will:

A.      Be based on a Standard 2-Year Licence Tenure;
B.      Be based on a per-service and per-premises / conveyance basis; and
C.      Include Standard Administrative Fees.

Click here for more information on Phase 1 HCSA Licence Fees. Details on fees for Phases 2 & 3 will be released later.

V.   Delinking Inspections from Licence Renewals


In 2018, MOH introduced the de-linking of inspections from licence renewals for clinics, clinical laboratories and radiological laboratories with good compliance history, as part of efforts to reduce regulatory burden and enhance efficiency of the licensing process. To further empower licensees to take greater responsibility to comply with HCSA, we will expand delinking to all HCSA services.

What should licensees expect with the de-linking of inspections from licence renewals under HCSA?

  • There is no change to the application and renewal process for your HCSA licences.
  • You will need to renew your HCSA licence at least two months before it expires to avoid incurring late fee charges.
  • Inspections of your licensable healthcare service will also remain. However, the inspection frequency of your service will be risk-based, and may not occur during or before renewals. As part of our risk-based inspection approach, a good history of compliance may also mean less frequent inspections.
  • If you are applying for a new licence, an inspection will be conducted before the licence is issued.

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C. Refined Roles and Responsibilities of Key Officeholder Personnel

Governance and oversight of healthcare services will be strengthened with the formalisation of the Key Appointment Holder (KAH)the Principal Officer (PO) and the appointment of a Clinical Governance Officer (CGO) for selected services, in addition to the licensee.

Suitability requirements of the various roles are promulgated in Regulations, Licence Conditions and a Code of Practice. Click here for more details on the roles and responsibilities of these key personnel, and click here for the full resources on Key Officeholders.

Please click on the following links below for more information on HCSA:

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CONTACT US
For HCSA-related enquiries, write to us at HCSA_Enquiries@moh.gov.sg

Apply for and manage
 your new HCSA licence in the Healthcare Application & Licensing Portal (HALP).

If you are not an existing PHMCA or HCSA licenseeclick here to let us know if you plan to provide/are providing any of these services:

  1. Outpatient Medical Service via Remote MOSD (i.e. teleconsultations by doctors)
  2. Outpatient Medical Service via Temporary Premises MOSD  (i.e. house calls by medical or dental practitioners)

You will need to apply for the outpatient medical service with the remote and temporary premises MOSDs if you offer both teleconsultations and house calls. If you only provide telemedicine without any house calls, then you only need to apply for the remote MOSD.


For all other licensing enquiries, write to us at eLIS@moh.gov.sg