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New care models for patients have emerged, and healthcare services are increasingly delivered through different ways, such as mobile and online channels. This necessitates a shift towards a more flexible approach in the regulation of Singapore’s healthcare system.

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 WITHIN 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). 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 
Proposed scope of HCSA

B. Licensing Approach and Implementation

Under HCSA, healthcare providers will need to hold licences based on the services they provide. This is a change from the PHMCA where providers are licensed based only on physical premises.

Click here to see the full implementation timeline.

The requirements for each licensable healthcare service will be stated in their respective Service Regulations.

Click here for more information on HCSA Licence Fees.

C. Refined Roles And Responsibilities Of Key Officeholders 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 will be promulgated in Regulations, Licensing Terms and 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.

In addition to the above changes under HCSA, there are several other aspects of HCSA that licensees should be aware of:

(i)              Committees To Ensure Clinical Governance

(ii)            “Step-In” Safeguards For Residential Care Services

(iii)           Powers To Obtain And Publish Information

(iv)           Employment Restrictions

(v)            Measures to Minimise Public Misperception (i.e. naming restrictions, co-location with non-licensable healthcare services and advertising)

(vi)           Penalties under HCSA

Please click here for more detailed information.

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TRANSITIONING YOUR LICENCE FROM PHMCA TO HCSA

PHMCA licensees will transition over to HCSA in phases based on the service license categories under HCSA. Click here to see the full implementation timeline. If you are a PHMCA licensee, you will need to complete the following steps prior to the Phases where your HCSA service license takes effect.

Transition from PHMCA to HCSA
A. Steps to transit your licence from PHMCA to HCSA:

  1. Participate in MOH's Consultations on HCSA, which provide more information on the regulatory requirements for the services you offer.
    • Consultation details will be shared over email for Phase 2 and 3, and in the Join Our Consultations page when scheduled.
  2. Complete the Service Mapping Exercise
  3. Complete the Data Verification Exercise
  4. Access and Manage your new HCSA licence in the new Healthcare Application & Licensing Portal (HALP) @ https://halp.moh.gov.sg
    • A dedicated helpdesk is available to assist those who may face issues with HALP
    • Training will also be conducted for licensees to familiarise themselves with the system

What is Service Mapping and why Map?

  • Service mapping helps you to identify the service licences that you will need to hold under HCSA.
  • Licensees who have completed their service mapping will not be required to re-apply for these mapped HCSA licence(s) when your HCSA phase is implemented.
  • In the service mapping exercise, you will need to login to eLis to confirm the services that you are providing (existing PHMCA services and personnel information will be pre-populated).
  • Affected licensees will be notified by MOH to participate when the exercise begins for each phase of HCSA implementation.

What is Data Verification for?

  • The Data Verification exercise ensures that your HCSA licence records in HALP are complete and accurate.
  • Licensees' information in eLis will be transferred to the new licensing system (i.e. HALP) as part of the transition. However, depending on the HCSA service licences required, there may be additional information required.
  • During the exercise, you are required to:
    • Verify the licence information that has been ported over from eLis to ensure that all information has been migrated and mapped accurately, and
    • Submit additional/missing HCSA related information that was previously not available or required under PHMCA.
  • Up-to-date and accurate information will help licensees transit seamlessly at each HCSA phase.
  • If there are missing or inaccurate information, you may not have a valid licence to continue with operation when the HCSA regulations take effect for your licensable services.
  • Licensees will be notified by MOH to participate in the exercise closer to the implementation date.

Click here to see the dates of each phase. 

B. 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.
  • If you are providing a new licensable service, an inspection will be conducted before the licence is issued.
  • You will need to re-apply for your HCSA licence when it expires.
  • Inspections of your licensable services will also remain, and the inspection frequency of your service will be risk-based. As part of our risk-based inspection approach, a good history of compliance may mean less frequent inspections. This also means that you may not have an inspection of your licensable service prior to your licence renewal.

Applying for a New Licence (HCSA)

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MEASLES AND  DIPHTHERIA IMMUNITY REQUIREMENTS

Why the need for measles and diphtheria immunity requirements for workers in healthcare institutions?

  • Measles and diphtheria are serious infectious diseases.
  • Staff in healthcare settings have an important role to play in ensuring patient safety, including minimising the risks of spreading diseases to patients and other colleagues at the workplace. As such, we need to ensure high vaccination coverage or immunity among workers in healthcare.

When will the regulatory requirements come into effect?

  • For HCSA Phase 1 licensees, the requirements will be promulgated under the HCSA General Regulations as well as Licensing Conditions (LCs) from 3 January 2022.
  • For existing PHMCA licensees, the requirements will be promulgated under PHMCA Licensing Terms and Conditions (LTCs) from 3 January 2022.
  • For new non-PHMCA licensees that will only begin offering HCSA services under Phase 2 and/or 3, the immunity requirements will apply when your HCSA licences begin.

There is no difference in the immunity requirements between PHMCA Licensing Terms and Conditions (LTCs), and HCSA General Regulations and Licensing Conditions (LCs).

Who will need to adhere to the immunity requirements?

  • All the following staff and personnel below will need to meet the immunity requirements:
    • All new and existing staff of licensees, and volunteers, who regularly enter and/or work in the licensee’s premises; and
    • All personnel from outsourced partners/vendors that have contractual agreements with the licensee, whose personnel are (a) required to work in licensee’s premises, regardless of the frequency of the onsite work, and (b) do not provide services or volunteer on a one-off basis.

How do I fulfil the immunity requirements & what documentation do I need to have?

Acceptable Documentation
 MeaslesDiphtheria 
 
  • Documented proof of vaccination (completion of a course of vaccination involving 2 doses given at least 4 weeks apart); or
  • Serological evidence of immunity; or
  • Laboratory confirmation of past infection.
  • Documented proof of vaccination with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (“Tdap”) or tetanus and diphtheria toxoids (“Td”) in the last 10 years
 

For staff who are your direct employees, licensees are expected to maintain and be able to provide relevant supporting documents if requested during MOH inspections.

 

For personnel who are not your direct employees (i.e. volunteers, outsourced vendors and partners), licensees should put in place measures, to ensure that they comply with the required immunity requirement. These may include, for example, stipulating the requirements for immunity and vaccination in their contractual agreements with such partners and vendors, and ensuring that such documentation is made available to the licensee when requested.

* Note: Self-declaration is not acceptable as an individual’s proof of immunity.

It is the licensee’s responsibility to ensure and self-assess that all new and existing staff comply with these immunity requirements, documenting justifications for exemptions where appropriate. During inspections, you may be asked to provide these justifications.

Who are exempted from the immunity requirements?
Personnel who meet any one of the conditions below are permitted to be exempt from the immunity requirements:

  • Personnel who do not have direct patient interaction AND who do not work within any healthcare institution premise that provides services involving direct patient interactions;
  • Personnel who are certified as permanently medically unfit for vaccination (via memo from a medical practitioner);
  • Personnel who are employed or engaged by the licensee (e.g. volunteers), to provide a one-off service/visit (e.g. catering, event organiser, or delivery riders who drop off food/items); or
  • Personnel who are Singaporeans or Permanent Residents (PRs) who are (i) born in Singapore and (ii) before 1 Jan 1975 are exempted from the measles immunity requirement (note: this particular exemption does not apply to diphtheria).

Licensees must self-assess the applicable exemptions, and justify these when requested.

While SC/PR born in Singapore before 1975 are exempted from the measles immunity requirement, licensees may put in place additional appropriate measures based on their risk assessment to ensure that there is no risk of spreading the disease.

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CONTACT US
  • For HCSA-related enquiries, write to us at HCSA_Enquiries@moh.gov.sg
  • Click here to learn more, if you plan to provide/are providing any of these services:
    1. Emergency Ambulance
    2. Medical Transport services
    3. Health Screening
    4. Telemedicine
  • For all other licensing enquiries, write to us at eLIS@moh.gov.sg