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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 image

B. Introduction to Licensable Healthcare Services, Mode of Service Deliveries and Specified Services

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.

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 be 4 modes of service delivery (MOSDs) under HCSA (Figure 2). MOH will define the allowable MOSDs for each LHS. Licensees must seek MOH’s approval for the MOSDs used to deliver each LHS.
 
Figure 2: Modes of Service Delivery under HCSA

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 can be found below.
 

III.   Specified Services Under HCSA

Under HCSA, there are Specified Services (SSes) for each licensable healthcare service (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

  • 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.

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C. Refined Roles and Responsibilities of Key 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. Please refer to Figure 3 for a summary of these roles.

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.

Figure 3: Summary of Key Roles under HCSA

KOH Personnel Diagram_caaJune2023

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D. 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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E. Licence Fees under HCSA

Under HCSA, all fees will:

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

Most licensees will have their licensing fees either retained or reduced under HCSA. However, it is still possible for some licensees to experience an increase in their HCSA fees as they may take need to hold new licences or approvals for:

  • Several MOSDs for their LHS (e.g., a Radiological Service licensee need approvals for the permanent premises and conveyance MOSDs, if they wish to provide X-ray services from a modified vehicle in addition to their brick-and-mortar premises).
  • One or more Specified Services (e.g., an outpatient dental service licensee may choose to offer the dental cone beam computed tomography SS)
  • Several related HCSA LHSes (e.g. a licensee offering the Acute Hospital Service LHS may also want to offer Ambulatory Surgical Centre and Outpatient Medical Service LHSes to complement its inpatient services).

To ensure licence fees remain affordable, “Fee Bundles” were introduced, which will lower licence fees where there are potential cost synergies in inspecting the services together. As an overview, the available fee bundles are as below:

a.     Acute Hospital Service Bundle

Acute hospital service providers will not incur any additional licence fee for the licences for Outpatient Medical Service, Clinical Laboratory Service, Radiological Service, and Ambulatory Surgical Centre Service when these services are provided on the same premises.

b.     Ambulance Bundle

Providers offering both Emergency Ambulance Service (EAS) and Medical Transport Service (MTS) will enjoy a bundled licence fee, instead of having to pay for the respective licence fees of the EAS and MTS licence.

c.     MOSD Bundle

Providers offering Outpatient Medical Service or Outpatient Dental Service, will not be charged additional MOSD approval fees for the provision of these services at temporary premises and/or remote provision if provided in conjunction with a permanent premises or conveyance.

Providers offering Assisted Reproduction Service or Outpatient Renal Dialysis Service, will not be charged additional MOSD approval fee for remote provision if provided in conjunction with a permanent premises or at temporary premises (where applicable).

d.     Specified Service Bundle

Providers who offer two or more simple or complex Specified Services respectively will be able to enjoy the bundled fee.

There will be a Gradual Fee Increase for existing PHMCA licensees who experience a considerable increase in HCSA fees, i.e. MOH will increase their fees gradually over three renewal cycles (over 6 years)*.

Please click here for more information on the licence fees, the Fee Bundles and the Gradual Fee Increase mechanism.


*Gradual fee increase will not apply to Acute and Community Hospitals, which will pay the full HCSA fee from their next renewal

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F. Who needs to hold a HCSA licence?Service providers, whether organisations or individuals, who intend to offer a Licensable Healthcare Service (LHS), will be required to obtain the relevant HCSA licence, before offering the said services. Please click here for a list of descriptions of the various LHSes under HCSA.

Individual healthcare professionals who are employed or engaged (e.g. locum, part-time work) to practice their profession by a licensed service provider do not need to hold a licence under HCSA. For example, if a doctor is employed by a hospital which is already licensed under HCSA, the doctor (i.e., the employee) is not required to hold his/her own HCSA licence, as services rendered by the doctor will fall under the oversight and governance of the hospital licensee.

However, if the same doctor decides to offer services in his/her own professional and personal capacity, such as providing home medical services or teleconsultations in his/her free time, then the doctor will be required to obtain his/her own licence under HCSA. This is because the home medical service and teleconsultations do not come under the oversight and governance of the hospital licensee.

Beyond employment contracts (whether on full-time, part-time, temporary or locum arrangements), there are service contract or agreement models as well. In such instances, the healthcare professional may be required to hold the HCSA licence. For example, a freelance dentist provides dental services to residents in several nursing homes, and treats the residents on request. Regardless of whether there is a formal contract with the nursing home, the dentist will need to hold an outpatient dental service licence with approval for temporary premises mode of delivery to continue providing these services. This is because the nursing homes, although licensed, do not have governance and oversight over the dentist’s practice and services to its residents.

Therefore, healthcare professionals, who are not employees or contract personnel of a licensed healthcare provider, are advised to check with the organisation where they are providing their professional services, to ensure the roles, responsibilities and accountabilities, including which party ought to be taking the HCSA licence, is clear.

If you need to apply for a HCSA licence, please click here for the steps.

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