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About the Healthcare Services Act (HCSA)
The Healthcare Services Act (HCSA) was promulgated on 6 January 2020 to regulate healthcare services in Singapore. The HCSA replaces the Private Hospitals and Medical Clinics Act (PHMCA) and enables a more flexible approach to regulate healthcare services beyond premises as new care models and services emerge; and provides regulatory clarity to service providers for better care provision and continuity to patients.
The HCSA allows for the regulation of a wider scope of healthcare services if needed, such as allied health services, nursing services, traditional medicine, and complementary and alternative medicine (Figure 1). However, services that do not involve direct patient care (e.g. assessment, diagnosis, prevention, treatment of a medical condition or disorder) such as beauty and wellness services, are not included under the regulatory scope of HCSA.
Figure 1: Scope of the HCSA
While HCSA enables the regulation of a wider scope of healthcare services, MOH adopts a risk-based regulatory approach to determine the types of licensable services under HCSA. Although allied health services, nursing services, traditional, complementary and alternative medicine services are potentially within the scope of HCSA, MOH will not be licensing these services at the moment. Nonetheless, the practice of professionals providing such services, such as physiotherapists and traditional Chinese medicine practitioners, will continue to be regulated through the existing Professional Acts.
The Licensable Healthcare Services under HCSA are:
Acute Hospital Service
Ambulatory Surgical Centre Service
Assisted Reproduction Service
Blood Banking Service
Clinical Laboratory Service
Community Hospital Service
Cord Blood Banking Service
Emergency Ambulance Service
Medical Transport Service
Human Tissue Banking Service
Nuclear Medicine Service
Nursing Home Service
Outpatient Dental Service
Outpatient Medical Service
Outpatient Renal Dialysis Service
Radiological Service
Introduction to Licensable Healthcare Services, Mode of Service Delivery and Specified Services
1. Licensable Healthcare Services
Under HCSA, healthcare providers need to apply for approval to hold licences for the Licensable Healthcare Services (LHS) they provide, as well as the appropriate Mode of Service Delivery (MOSD) applicable for the LHS. This is a change from the PHMCA where providers were 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 previous PHMC regulations.
2. Mode 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 Mode 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: Mode of Service Delivery under HCSA
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.
3. Specified Services
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. Licensees will need to seek MOH’s approval prior to the commencement of these SSes under their LHS. It is an offence to offer any SSes without seeking MOH’s approval.
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).
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.
With the introduction of HCSA, the specialised procedures and services under the Second and Third Schedule of the PHMC regulations were reviewed. 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 LHS 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 |
|---|---|
|
|
More information on the allowable MOSDs and SSes for each LHS [PDF, 222KB].
Refined roles and responsibilities of key personnel
Governance and oversight of healthcare services are also strengthened under HCSA 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.
Read more on the roles and responsibilities of these key personnel [PDF, 439KB].
Figure 3: Summary of key roles under HCSA
De-linking 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 LHS 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.
Licence fees
Under HCSA, all fees will:
Be based on a Standard 2-Year Licence Tenure;
Be generally based on a per-service and per-premises / conveyance basis; and
Include Standard Administrative Fees.
Most existing PHMCA licensees will have their licensing fees either retained or reduced under HCSA. However, it is still possible for some PHMCA 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. There will be a Gradual Fee Increase Mechanism for PHMCA licensees who transited to HCSA and experience a considerable increase in HCSA fees, i.e. MOH will increase their fees gradually over three renewal cycles (over 6 years).
More information on the licence fees, the Fee Bundles, and the Gradual Fee Increase Mechanism.
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.
Head over to this page for the list of descriptions of the various LHSes.
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 also service contract or agreement models. 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 Service 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.
Please click on the following links below for more information on HCSA: