1. Mr Speaker, on behalf of the Minister for Health, I beg to move, that the Bill be now read a Second time.
2. Sir, the Healthcare Services Act 2020 (“HCSA”) was passed in Parliament in January 2020. It will replace the Private Hospitals and Medical Clinics Act 1980 (“PHMCA”), which was enacted in 1980 and regulates the use of premises in which healthcare services are provided. Since 1980, the healthcare landscape in Singapore had undergone many significant changes. It’s timely in 2020 to update the regulatory framework to become services-based and premises-neutral, to ensure that our regulatory approach remains relevant and flexible.
3. The Act is being implemented progressively with licensees coming onboard HCSA in three phases. We started with laboratory, radiological, ambulance and medical transport services in Phase 1 in January 2022 and will be progressing to hospital, medical and dental services in Phase 2 in mid 2023. Lastly, we will onboard the nursing home services in Phase 3, planned for the end of 2023. This phased approach is intended to give licensees sufficient time to prepare for, and to adjust to, the new Act, and thus minimise disruption to existing healthcare services.
4. Since the implementation of HCSA in Phase 1, there have been developments which require further refinement of this legislation.
5. First, the COVID-19 pandemic has led to changes in how healthcare is delivered. For instance, new models of care such as teleconsulting and home medical services have proven to be effective and efficient. While HCSA is already a services-based framework, it needs to provide more clarity and flexibility on the requirements related to these new models of care, to continue protecting patient safety and enabling new innovations in providing care. COVID-19 also highlighted the need for HCSA to be adjusted to allow us to respond to public healthcare emergencies more nimbly. This includes instances where licence conditions must be changed immediately to address urgent patient safety or public health issues.
6. Second, we received feedback on several areas of the regulatory framework, which could be improved. This includes misleading advertisements involving non-licensable healthcare services or business names. This was a result of engagements with stakeholders to continuously review and update HCSA while preparing for its rollout across existing and new licensees.
7. And third, there was a need to align the scope of regulatory action for healthcare service advertising by licensees and non-licensees. All these have led us to further review HCSA to enhance and future-proof the legislation.
8. The proposed amendments will allow us to be nimbler in responding to the evolving healthcare landscape and enable premises-neutral care to be delivered across our healthcare settings. It will also strengthen governance to safeguard patient safety and welfare, and protect patients from misinformation, exploitation or abuse.
9. Sir, I will go through the key features of the Bill and highlight changes to existing legislation.
(B) Future-proofing HCSA for regulatory agility
10. Clause 4 will amend section 9 to introduce the regulation of four primary modes of service delivery: permanent premises, temporary premises, conveyances and remote provision. Licensees must obtain approval to provide a licensable healthcare service by any of these four modes.
11. To give some examples, permanent premises are physical, in-person, General Practitioner clinics or hospitals. Temporary premises would include ad-hoc health screenings in a community centre’s multi-purpose hall or when a doctor conducts a house call visit to a patient’s homes. Conveyances refer to the healthcare service being delivered using vehicles, like ambulances or dental screening buses. Remote provision involves the delivery of healthcare services through virtual platforms such as virtual teleconsultation.
12. A clear regulatory framework for these various service delivery modes will give providers the confidence to continue to provide and expand home care services, which are critical to enable ageing in the community, in particular for seniors who are homebound, or those at the end-of-life. Bringing medical services closer to the community and into homes and will also enhance the convenience to patients and their caregivers, and reduce caregiver burden.
13. For example, home medical providers caring for patients at the end-of-life will now be able to help maximise patients’ quality of life and fulfil their aspirations to spend their last days at home. The Mobile Inpatient Care at Home (MIC@Home) is another care model where suitable patients can choose to be managed at home and receive similar clinical care as in the hospital, and this includes regular review by the care team either by home visits, teleconsultation or remote monitoring of vital signs, and even intravenous medications if required.
14. Under this approval regime, MOH can prescribe regulatory requirements and impose approval conditions on licensees. MOH can also prescribe the service delivery modes that are not permitted for a licensable healthcare service. This provides licensees with better clarity on the requirements they must meet and allows them to determine the appropriate business model for the delivery of their healthcare services. This also increases public transparency on the nature of healthcare services being provided by each licensee, how they can access these services and how the Ministry intends to regulate the delivery of the various types of healthcare services.
15. The amendments at Clauses 6 to 9, and 12 to 15, in particular the new sections 9, 11A and 11B and the amended section 20, set out the details of the approval regime for this, including the regulatory actions that can be taken against licensees who contravene the relevant regulatory requirements or approval conditions.
16. At present, MOH issues licence conditions to impose new safety standards, such as in instances where there is a change in the regulatory technical standards due to evolving scientific developments. MOH is now required to provide licensees with a minimum period of 14 days to send in written representation in response to the intent to amend the licence conditions, if any.
17. To prepare for future emergencies, Clause 11 will amend section 14 to remove the 14-day notice period for any modification of licence condition that applies to a class of licensees, where there is immediate or imminent harm to patient safety or public health. This is so that MOH can expeditiously implement new healthcare protocols to protect public health and patient safety under exceptional circumstances.
(C) Stronger governance to protect patient safety and welfare
18. To further safeguard patient safety and welfare upfront, two other approval regimes will be introduced.
19. First, for Specified Services which involve more complex or higher risk procedures provided in a licensable healthcare service, and therefore have distinct requirements. Examples of Specified Services are liposuction, endoscopy, or radiation oncology services. In addition to the existing licensing regime for licensable healthcare services, the new section 9A will require licensees to seek approval for the provision of any Specified Service. Having an approval process enables MOH to better verify that all requisite standards are met before a licensee can provide such a service, so that patient safety and welfare are upheld before these services are delivered. This approval regime builds on the approval process that is currently available for special care services in medical clinics and specialised procedures and services in private hospitals under the PHMCA framework.
20. Second, for the appointment of a Clinical Governance Officer (or “CGO”). Clause 17 will amend section 24 to replace the existing notification regime for the appointment of a CGO with an approval framework. Under HCSA, a CGO is expected to play a crucial role in overseeing the clinical governance and technical aspects of healthcare services. By requiring licensees to seek approval for the appointment of a CGO, MOH can also ensure upfront that a competent and suitable individual is appointed, and better safeguard patient safety and welfare.
21. Besides enhancing upfront safeguards, Clause 18 also re-enacts section 28 to introduce flexibility for MOH to vary the scope of restrictions for selected individuals or groups of individuals employed or engaged in different healthcare settings, based on the anticipated risk of patient harm. Under the current HCSA, certain licensees may be prohibited from employing any individual who has committed egregious crimes involving violent acts such as rape or kidnapping, except with the approval from MOH, regardless of the duties performed by the individual. This is done to protect the safety and well-being of more vulnerable patients, as they may not be able to fend for themselves if they are harmed or abused. This is similar to the approach taken under the Early Childhood Development Centres Act 2017.
22. However, the risk of patient harm varies depending on the role undertaken or performed by these personnel and the nature of the healthcare settings they work in. Hence, Clause 18 will repeal and re-enact section 28 to provide some flexibility. The restrictions will apply to prospective employees and those engaged, but not employed, by licensees to undertake work in healthcare settings. For a start, licensees operating in the Institute of Mental Health, and all nursing homes and hospices will be required to comply with these restrictions. This is because there have been a number of cases of physical violence or abuse reported at these types of healthcare institutions. MOH will continue to monitor for any emerging trends that indicate an increased risk of patient harms in other settings, and will consider extending these restrictions to other individuals or settings in the future if needed.
23. The proposed amendments also seek to enable the public to make better informed choices about their use of healthcare services. In particular, the necessity of ensuring that consumers or patients are not misinformed or unduly influenced to inappropriately consume certain healthcare services. We are addressing this with tighter controls on advertising and naming.
24. Clause 19 will amend section 29 to prohibit licensees from using a specialty name in their names or logos – in any language – if there is no practitioner actively practising the said specialty under the auspices of that licensable healthcare services. To clarify, the specialist must be locally registered to practise the specialty in question, and can either be employed or engaged by the licensee to provide the approved licensable healthcare service under the auspices of the licensee. Specialties recognised under the Medical Registration Act or the Dental Registration Act and their associated terms are the specialty names intended to be covered by the amended section 29. For example, a clinic cannot be called “The Neurology Clinic” or “The Brain Clinic” if there is no neurologist practising in that clinic. This protects patients from being misled to thinking they are receiving specialty care where the provider is not a specialist.
25. Licensees are currently prohibited under HCSA from using the terms “Singapore” or National” in their names or logos except with the approval of the Director of Medical Services. To further prevent public misperceptions, the prohibition against using these terms under section 29 will be amended to extend to the same terms in any language, not just English. To clarify, existing licensees will be allowed to retain their current business names if it contains the terms “Singapore” or “National”, unless there are changes in the business name or licensee in future.
26. To streamline the regulatory framework for healthcare service advertising, some advertising requirements for non-licensable healthcare services will now be regulated under the HCSA regime, and the relevant provisions in the Medicines (Advertisement and Sale) Act 1955 (“MASA”) will be repealed. These requirements include the prohibition on non-HCSA licensees who claim in healthcare service advertising to “treat” any medical conditions or diseases under the new section 31A inserted by Clause 22. For example, non-HCSA licensees cannot claim that “We treat chronic diseases such as hypertension, diabetes and all cardiac conditions” or that “We are experienced in treating scoliosis”.
27. At present, there is a disparity in enforcement actions between the two Acts, with MASA having significantly lower penalties and a more limited scope of regulatory action, for example, there is no power to take down non-compliant advertisements. The new section 31C inserted by Clause 22 will impose similar penalties for comparable non-compliance in healthcare advertising regardless of whether one is an errant provider of a non-licensable healthcare services, or a HCSA licensee. This will deter non-HCSA licensees and ensure all healthcare service providers are held to the same high standards when advertising their healthcare services.
28. Lastly, many stakeholders have also raised concerns about cases of misuse of the title “Doctor” in healthcare service advertising by certain non-registered healthcare professionals. To protect consumers from being misled into thinking that such persons are registered medical or dental practitioners when they are not, the new section 31B inserted by Clause 22 will require any person who is not a registered healthcare professional to state their specific qualifications and a disclaimer that their qualification is not a medical or dental qualification should they wish to use the title of “Doctor” (or any derivative in any language) in healthcare service advertising. These restrictions will not apply to registered healthcare professionals such as nurses and pharmacists, as they are regulated under their respective Professional Acts.
29. Non-registered healthcare practitioners who are PhD holders and wish to use the title “Doctor” in advertisements of healthcare services must also state their qualification and a disclaimer that the qualification is not a medical or dental qualification, in such advertisements. However, for settings beyond healthcare service advertising, for example, the use of “Doctor” by PhD holders in academic articles, this requirement will not apply.
30. We understand that there are instances of foreign-trained doctors or dentists who have proper medical or dental qualifications, but do not have these qualifications registered with the Singapore Medical Council (“SMC”) or Singapore Dental Council (“SDC”). There are also instances of doctors and dentists who have previously registered themselves locally but have allowed the registration to lapse as they are now retired. In both these cases, should these practitioners wish to use the title “Doctor” in healthcare service advertising, the amended Act will require them to additionally include a disclaimer that they do not hold a valid practicing certificate issued by the SMC or SDC. As these doctors and dentists are not locally registered, these incremental restrictions are designed to ensure that they are treated similarly as other non-registered healthcare professionals, for parity.
(D) Redesignation of Director of Medical Services
31. The amendments at Clauses 25 and 28 pertain to the redesignation of the “Director of Medical Services” to the “Director-General of Health”. This new designation is a more accurate reflection of the job scope and responsibilities of the Director of Medical Services, which goes beyond medical services to also the control of communicable and non-communicable diseases, the setting of healthcare professional standards and development and enhancing performance of the healthcare system.
32. Mr Speaker Sir, Members will see that through this Bill, the Ministry of Health seeks to enhance and future-proof the regulation of healthcare services, to enable premises-neutral services across any healthcare setting, to put in place better governance, safeguards and clarity in the provision of healthcare services to patients, to empower patients to make more informed choices, and to enable the Ministry to address any patient safety and welfare issues expeditiously.
33. If passed, we intend to implement the Amendments in mid 2023, together with the second phase of the implementation of this Act, with two exceptions. First, the redesignation of the Director of Medical Services will be implemented within two months. Second, the restriction on individuals employed or engaged will be implemented at the end of 2023 when the screening process for the prospective employees would be operationalised.
34. With that, Mr Speaker, I beg to move.