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WHAT IS HEALTHCARE SERVICES ACT (HCSA)?


The Private Hospitals and Medical Clinics Act (PHMCA) was enacted in 1980 and last amended in 1999. It was designed to ensure patient safety through licensing of physical premises delivering healthcare, such as hospitals, medical clinics, clinical laboratories and other healthcare establishments.

In recent years, there have been significant changes to the healthcare landscape in Singapore. Our ageing population and increased chronic disease prevalence have led to a growing need for new care models and coordinated team-based care across healthcare settings and providers. Advancements in medicine and health technologies have given rise to new and fast changing healthcare services. Where almost all healthcare services were provided from physical “brick-and-mortar” locations in the past, there are now new services delivered wholly or partially through mobile and online channels.

The Ministry of Health (MOH) intends to replace the PHMCA with the new HCSA. In addition to better safeguarding the safety and well-being of patients in the changing healthcare environment while enabling the development of new and innovative services that benefit patients, it also strengthens governance and regulatory clarity for better continuity of care to patients, and addresses wider issues of patient welfare. 

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WHAT ARE THE KEY CHANGES PROPOSED IN HCSA?


A. Broadened Scope of Coverage

Under HCSA, the regulatory scope will be broadened to include healthcare services, allied health and nursing services, traditional medicine, and complementary and alternative medicine (Figure 1). Beauty and wellness services will not be 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 be adopting a risk-based regulatory approach. While allied health and nursing services traditional medicine and complementary and alternative medicine are within the scope of HCSA, MOH will not be licensing these services for the moment. Professionals such as physiotherapists and Traditional Chinese Medicine practitioners will continue to be regulated through existing Professional Acts to ensure patient safety.

Figure 1: Proposed scope of HCSA

Figure1


B. Services-Based Licensing

Healthcare providers will be licensed based on the type of services they provide. This is a change from the PHMCA where providers are licensed based on physical premises. The healthcare services to be licensed will be grouped into six broad categories as shown in Figure 2.

Figure 2: Services-Based Licensing Framework under HCSA

Phased HCSA Implementation
 

Standards required for each licensable healthcare service will be stipulated in their respective Regulations. To allow selected licensees to provide simple diagnostic tests without the need for a separate clinical laboratory or radiological service licence, MOH will be defining a list of allowable point-of-care-tests (POCT) in the Regulations.


C. Competent Governing Bodies

To ensure effective governance and good leadership, HCSA requires the governing body of a healthcare service to possess the competence and skills to carry out its role. In the case of Boards that comprise different individuals, this can be met collectively by different members of the Board. Details will be promulgated in Regulations. HCSA will state criteria identifying when a person is not fit to hold a licence or act as a member of a governing body of a licensee.


D. Refined Roles And Responsibilities Of Key Personnel

Governance and oversight of healthcare services will be strengthened with the enhanced roles for the Principal Officer (PO) and the appointment of a Clinical Governance Officer (CGO) for selected services, in addition to the licensee. The roles and responsibilities of these key personnel are summarised in Figure 3. The same individual can function as the licensee, the PO and CGO for different service licenses, as long as the individual can fulfill all relevant requirements and can perform all roles adequately.

Figure 3: Roles and responsibilities of key personnel

PERSONNEL CHANGE FROM PHMCA ROLE AND RESPONSIBILITY
Licensee No change
  • Mandatory for all licensed services
  • Accountable for the overall compliance with HCSA and the appointment of key leadership roles
Principal Officer Similar to the role of Manager under the PHMCA
  • Mandatory for all licensed services
  • Responsible for overseeing day-to-day operations of the service and ensuring operational compliance with HCSA
  • Required to have organisational authority to secure compliance e.g. CEO, COO, etc.
Clinical Governance Officer Formalisation of previously described oversight roles for certain services, by qualified specialists
  • New role
  • Only required for selected services
  • Responsible for clinical and technical oversight of more complex services that require specialised expertise e.g. Clinical Laboratory Director, Director of the Assisted Reproduction Services
  • Will be required to meet stipulated qualifications depending on the service in question. These qualifications will be specified in the relevant service regulations

E. Committees for Clinical Quality and Medical Ethics

Current PHMCA requirements for Quality Assurance Committees (QACs) for selected licensees will remain. The QAC’s role is to monitor the quality of care within healthcare service. To enhance the quality assurance process, changes will be made to the QAC. A suitably qualified and competent individual will be designated to oversee quality assurance processes in a licensed service. The same individual will be allowed to serve as a member of two or more QACs in different institutions to facilitate cross-institutional learning.

A new requirement for Service Review Committees (SRCs) will be instituted for selected services or programmes that are deemed higher-risk, more complex or of greater public interest. The SRCs will review utilisation patterns, effectiveness, risks and benefits of these services.

Service Ethics Committees (SECs) will be made mandatory for selected licensees to ensure that patients are treated in an ethical manner before certain complex and high-risk medical treatment can be conducted. This requirement is adapted from existing PHMCA requirements for hospitals where approval from ethics committees must be sought for similar procedures. The list of medical treatment that will require SEC referral and review will be determined based on advice from the Academy of Medicine and the National Medical Ethics Committee, and will be stipulated in the Regulations.


F. “Step-In” Safeguards For Residential Care Services

To protect patients against abrupt discontinuation of residential care services, MOH will be empowered under a new provision in HCSA to ‘step-in’ and assist in the operations of failing healthcare services where necessary. This is a transitional measure until patients can be transferred to other service providers. These powers will be exercised as a last resort after measures such as penalties, warnings, or appointment of a new management team have failed. There will be an appeal mechanism for licensees aggrieved by the step-in decision.


G. Powers To Obtain And Publish Information

Existing PHMCA powers will be enhanced to enable MOH to gather data for purposes of patient safety, care and welfare, as well as public health interest. This may include national surveillance for the prevention of public health emergencies and safety monitoring for newer services.

MOH will also be authorised to publish information about non-compliant licensees and unlicensed providers. This will improve public awareness and enable patients to make better informed decisions.


H. Employment Restrictions

To ensure the safety and well-being of vulnerable patients, there will also be provisions in the regulations to impose restrictions on licensees employing staff to work in healthcare services that cater to frail or vulnerable patient groups such as long term residential care, mobile medical and the Institute of Mental Health.


I. Measures to Minimise Public Misperception

Existing naming restrictions under the PHMCA will be amended for better clarity to patients on the healthcare services provided. Licensees will be prohibited from using terms that connote a national body, such as ‘National’ or ‘Singapore’, unless explicit approval from the Director of Medical Services is obtained. Licensees will also be prohibited from using names of services that they are not licensed for. Persons who are not licensees will be prohibited from using names that create an impression of providing licensable healthcare services. These restrictions on naming will be imposed on new business entities. Existing entities will not be affected.

Similar to the PHMCA, HCSA places restrictions on the provision of licensable healthcare services together with other un-related or unlicensed services at a premise or a conveyance. Services or activities unrelated to such licensable services must be situated in a separate premise or conveyance.

Publicity controls will be tightened. Persons who are not licensed will be prohibited from advertising healthcare service claims. Only authorised persons such as licensees, and their appointed agents will be allowed to advertise such claims. Allied health professionals listed in the First Schedule of the Allied Health Professions Act, registered optometrists and opticians as well as registered Traditional Chinese Medicine Practitioners will be exempted from this prohibition, as they are required to advertise within the scope of their professional activities and are subject to the regulatory controls under the Medicines (Advertisement and Sales) Act (MASA). Phase 2 and 3 HCSA licensees and those who are not currently PHMCA licensees (e.g. mobile medical) will also be exempted from this clause in the interim, until they are licensed under HCSA. They will be subjected to the regulatory controls of the Medicines (Advertisement and Sales) Act and the relevant Professional Acts.


J. Penalties under HCSA

The penalties for offences will be updated and aligned with comparable offences under other recently enacted legislations.

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