Debated in Parliament on 6 Mar 2023.
Order for Second Reading read.
Minister for Health.
Mr Speaker, Sir, on behalf of the Minister for Health, I beg to move, "That the Bill be now read a Second time".
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 and it was 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.
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 adjust to, the new Act, and thus minimise disruption to existing healthcare services.
Since the implementation of HCSA in Phase 1, there have been developments which require further refinement of this legislation.
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.
Second, we received feedback on several areas of the regulatory framework, which could be improved. This includes misleading advertisements including 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.
And third, there was a need to align the scope of regulatory action for healthcare advertising by licensees and non-licensees. All these have led us to further review HCSA to enhance and future-proof the legislation.
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.
Sir, I will go through the key features of the Bill and highlight changes to existing legislation.
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.
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 multipurpose hall or when a doctor conducts a house call visit to a patient's home. 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.
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 will also enhance the convenience to patients and their caregivers and reduce caregiver burden.
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 medication if required.
Under this approval regime, the Ministry of Health (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.
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.
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.
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.
To further safeguard patient safety and welfare upfront, two other approval regimes will be introduced.
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.
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.
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.
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 harm in other settings and will consider extending these restrictions to other individuals or settings in the future if needed.
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.
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 service. 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 "The Brain Clinic" if there is no neurologist practising in that clinic. This protects patients from being misled into thinking they are receiving specialty care where the provider is not a specialist.
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.
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".
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 service advertising regardless of whether one is an errant provider of a non-licensable healthcare service, 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.
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.
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.
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.
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.
Mr Speaker, Sir, Members will see that through this Bill, MOH 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.
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 end of 2023 when the screening process for the prospective employees would be operationalised. With that, Mr Speaker, I beg to move.
Question proposed.
Mr Louis Ng
Sir, this Bill will allow for more informed decision making on healthcare services by requiring greater transparency in the advertising of services. This Bill also introduces an approval framework for licences to providers of healthcare services which will strengthen and refine the regulation of healthcare services.
I thank MOH for conducting a public consultation to prepare for this Bill. MOH's report of the public consultation shows that the feedback was constructive and that the Bill we see today contains changes made due to the public consultation. I hope MOH will continue this good practice of consulting the public before making changes to the law.
I have clarifications in three areas.
My first area for clarification is on the regulation of telemedicine. The Bill will require entities providing telemedicine services to be licensed and regulated. How will MOH regulate the risks posed by telemedicine? COVID-19 has accelerated the use of telemedicine. MOH has also facilitated it through its Licensing Experiment and Adaptation Programme as well as the Voluntary Listing of Direct Telemedicine Service Providers.
Certain risks and concerns may be more prominent in telemedicine than in conventional medicine. The lack of in-person and physical examination may be more likely to prompt instances and claims of misdiagnosis. The online nature of doctor-patient interactions and the relative ease of recording these interactions may also increase the risk of breaches in doctor-patient confidentiality. That is not to mention the role of hackers, fraudsters, phishers and other cybersecurity threats that may see value in gaining access to the vulnerable and personal moments of doctor-patient consultations.
Can Minister provide details and examples on how it will leverage this licensing regime to regulate telemedicine? Will these regulations compel changes to ethical and professional codes?
My second clarification is on the removal of the 14-day notice requirement for modifications of a licence condition. Section 14 will be amended to clarify that a licence condition can be modified without the 14-day notice period if it is necessary to prevent or mitigate immediate or imminent harm to patient safety.
An example provided by MOH of a situation that may require quick changes to licensing conditions is COVID-19. The stakeholder consultations on the amendments raised concerns about frequent updates in healthcare protocols that are understandably disruptive. To help licensees better understand the exceptional situations where licensing conditions may be changed without the required notice, can the Minister provide more examples of such situations?
In MOH's reply to the public consultation responses, MOH said that it will review and see how to improve its communications with licensees during these special circumstances. Can the Senior Minister of State provide details on its review? What steps will it take to improve communications? Will these communication methods be stress-tested ahead of time and not implemented only when the exceptional situations occur?
The section 14 exception for notice is specific only to a situation where there may be harm to patient safety. However, crises in a healthcare setting can also pose harm to healthcare workers. Has the Ministry considered if there are any situations where licensing conditions may need to be changed without notice because of harm to healthcare workers?
My third and last area of clarification is on healthcare advertising controls. The new section 31B will restrict the use of the title "Doctor" in the advertising of a healthcare service. Where the title is used to describe someone who is not a medical practitioner or dentist, the advertisement must provide appropriate disclaimers, such as by stating that the title is not a medical or dental qualification.
But there are other ways for advertisements to mislead consumers without using the word "Doctor". For instance, the advertisements could feature people wearing scrubs, using stethoscopes, operating medical machinery and examining medication.
Further, it is possible that written disclaimers will be insufficient, particularly if the disclaimer is verbose or if the advertisement is cleverly designed. Some consumers, such as those who do not speak English, may also fail to understand the disclaimers. They will see the word "Doctor" but not benefit from the disclaimer.
After all, is there really an honest reason for a healthcare advertisement to invoke the title "Doctor" without actually referring to a medical doctor or dentist? It is healthcare; let us not let advertisers get too creative. Notwithstanding these clarifications, I support the Bill.
Assoc Prof Jamus Lim.
Mr Speaker, the proposed amendments to the Healthcare Services Act is part of a multi-year rollout of reforms to healthcare services that aims to bring healthcare governance into the 21st century. As healthcare services as well as their mode of delivery have advanced, it has become necessary to refine regulation in the sector.
The Bill being debated today implements additional enhancements based on feedback from in-consultation with stakeholders since phase one was rolled out, while also accommodating recent changes to the face of healthcare services delivery especially over the past few years. All these are unobjectionable and for this reason, the Workers' Party supports the Bill.
The first part of my speech will sketch out some residual concerns. The second part, briefly asks about the future of healthcare services provision and what it may be for non-doctor medical professionals.
Clauses 2 and 3 of the Bill as well as sections 3 and 8 of the original Act, refine the definition of service facilities so as to weave in the possibility of remote healthcare provisions such as via the Internet or telephone.
Telecare, telehealth or telemedicine have suddenly come into their own, due to the enforced isolation practises, necessitated by the pandemic. Given the confusing jumble of possible terms in this emerging field, it is natural to ask if the language in the legislation is sufficiently encompassing, or if in this case, excessively accommodating.
After all, how does defining service delivery mode to include and I quote, "(a) at permanent premises and (b) at any premises other than permanent premises" lend guidance as to the sort of location that a licensable healthcare service may be provided from? I can guess that the motivation behind why clause 2(f)(b) was inserted but it still strikes me as so universal as to lend no additional constraints at all.
Related to this issue of location is the fact that the Healthcare Services Act is not extraterritorial in nature. I understand why imposing our domestic service delivery standards on other jurisdictions is essentially untenable, but given how it is not only possible, but increasingly likely that the healthcare services value chain becomes ever more internationalised. Think of the proverbial radiographer based in Bangalore for that matter and AI system with service located in Iceland, coded by programmers in India and consulted by scientists in Israel. What sort of regulatory mechanisms are in place to protect patients in Singapore from potential safety failures by foreign providers?
The new section 31 of the Bill deals with advertising. Much of this is commonsensical. Section A prohibits marketing of the treatment of a medical condition by unlicensed healthcare service providers and section B restricts the use of the term "Doctor" in healthcare advertising. The concern here is whether these restrictions would rule out otherwise legitimate medical providers. Non-western healthcare providers naturally come to mind.
I understand that practitioners of Traditional Chinese Medicine, or TCM, do fall within the domain of specified persons, but this still raises two separate issues. First, as far as I am aware, ayurvedic, siddha and jammu practices are not included in this list. Does this Bill then preclude their ability to advertise their services? Is the reason why these groups are not included as specified persons because they do not have official oversight boards? If so, is this sufficient justification for the exclusion, given how they simply lack the critical mass to justify a societal body?
Second, the qualifications require for different accreditation bodies are actually disparate. More specifically, each group often may impose different standards of rigour, insofar as qualification benchmarks are concern. This applies not only to this Bill, but also what a suitably qualified individual means in the original act.
Local midwives, for instance, do not appear to distinguish between different levels, compared to as many as five in jurisdictions, such as the United States. Qualifications within nursing, likewise, have only recently become more differentiated. Advanced practice nurses, senior nurses who possess advanced training and can take on some roles in diagnosis and treatment, date back to only 2006, and currently, only 57 are licensed to prescribe medicine.
Singapore only recognises two categories of TCM practitioners, and for one of these, acupuncture registration is currently only open to qualify registered doctors and dentists. Compare these to the wide range of degrees, sub-specialisations and levels that exist already for doctors.
This naturally begs the question of whether the rigour associated with classifying these different tiers or medical practices are equivalent. And if not, what does this mean for their credibility when it comes to advertising?
To be clear, I am not suggesting that these other traditional medical practices be accorded the same sort of recognition as modern medicine, or that their advertising should not be regulated in some form. Still, it remains unclear to me why non-TCM groups should be prohibited from marketing their offerings.
Conversely, I am left wondering if the qualifications embodied in advertising by the different types of medical professionals are truly comparable. Perhaps a compromise would be to require an additional disclaimer, applicable to non-western medical practices, be included in all advertising efforts from this group.
This notion of differing tiers of medical practitioners as well as the stress in section 31 be about the use of the term "doctor" sparks a more general query. What steps has the Ministry undertaken to fill the niches that currently exists in our healthcare service providers? This is especially pertinent, given the lower coverage of both doctors and nurses in our population.
The latest available data, which applies to 2016, for example, indicates that Singapore has 2.3 physicians per 1,000 people, a little higher than the world average of 1.7, but substantially below the Organisation for Economic Co-operation and Development (OECD) average of 3.8.
It is also pertinent in the light of how our current slate of medical professionals are reportedly burning out, a bipartisan concern that has been raised in this House by, among others, my hon friend Ms He Ting Ru as well as the hon member who just spoke, Mr Louis Ng.
I understand that there are plans to increase the number of advanced practice nurses able to prescribe medication to 700. This is important and will provide some relief to our overworked doctors and fill in the gaps in healthcare services provision for our ageing population.
But what about the other tiers within the nursing profession? Has each tier been filled to an extent that would offer relief down the pipeline of medical professionals? What about increasing the number of recognised universities for basic medical degrees? The list of registrable medical qualifications only numbers to 100, while a few additions have been made in recent years, these are only a small handful.
It is hard to conceive of how a country, like France, with a population and medical school count, almost three times that of Australia, has only one lonely university on the list, versus Australia's eight. Similarly, I fail to understand how Japan, a country ranked first in at least one global index of health systems ranking, has only three of the country's 80 medical schools on the list.
Sir, the bottom line is that, as much as we focus on legislative refinements, the quality of our health services will ultimately be determined by ability to ensure that there is adequate supply of healthcare workers at all levels. This extends from the best doctors we are able to attract from around the world, to the invaluable community health workers that render so much of the behind-the-scenes support to every other role in-between.
Leader.
PAPERCUTS