Healthcare Services Bill

Order for Second Reading read.

4.15 pm

The Senior Minister of State for Health (Mr Edwin Tong Chun Fai) (for the Minister for Health): Mr Deputy Speaker, on behalf of the Minister for Health, I beg to move, "That the Bill be now read a Second time."

Sir, the objectives of the Healthcare Services Bill are to safeguard the safety, welfare and continuity of care for patients. These are all matters of paramount importance. Today, premises which are used as hospitals, medical clinics, nursing homes and clinical laboratories in Singapore are licensed under the Private Hospitals and Medical Clinics Act (PHMCA). The PHMCA was enacted in 1980 and sets minimum standards for licensees' premises, personnel as well as processes to safeguard patient safety and welfare. The PHMCA was last amended in 1999 and the regulatory framework needs to be refreshed and updated to address today's rapidly-evolving healthcare landscape.

While Singapore has one of the longest life expectancies in the world, there has also been a rise in the number of unhealthy years lived because of ageing-related illnesses and chronic diseases. Hence, to provide more appropriate and accessible healthcare to our ageing population, there needs to be a shift in care models to align ourselves with one of my Ministry's "Three Beyonds" – "Beyond Hospital to Community". There will, therefore, be more vertical and also horizontal integration across traditional healthcare settings. For example, nursing homes may now be able to also provide dementia care and geriatric clinical services within one location. And that is for the better, because it puts the related and complementary services under one umbrella.

These integrated models of care are difficult to license under the present premises-based licensing framework of the PHMCA, and therefore, the licensing framework will need to be improved to accommodate such new and also evolving models of care.

Secondly, patients, especially the aged sick, may want more convenience and cost savings in their clinical care for some minor ailments or follow-ups to their chronic conditions. This may be possible today when hospitals or medical clinics provide telemedicine or mobile medical services, on top of their premises-based care. In other words, they provide premises-based care and, on top of that, also provide telemedicine or other mobile medical services. There is, therefore, a need to move beyond just regulating premises or to be premises-based in the regulation framework, to also be able to look at regulating services delivered beyond the premises, if we want to ensure the safe delivery of such services into the community or done remotely, as I have mentioned, through telemedicine.

At the same time, we also need to ensure that the welfare and well-being of vulnerable individuals or patients can be enhanced, and that the elderly and the frail patients are well looked after. This will include the assurance for the continuity of care for patients, and the introduction of additional safeguards to prevent abuse.

Finally, there are new scientific and technological advancements leading to the emergence of innovative diagnostic methods and also therapies, such as cell, tissue and gene therapy, clinical genomic testing, and proton beam therapy. There is, therefore, a need to have an enhanced governance structure to more closely monitor and also track the delivery of such newer services, including looking after the appropriateness of care and the information that is being provided to patients.

Taking into consideration the above issues with the changes that are needed in the evolving healthcare landscape that I have mentioned, it is timely that the Ministry is now introducing the Healthcare Services Bill to replace the existing PHMCA, so as to have better levers to regulate the safety and care provided by the existing, and also the evolving and newer, healthcare services providers. This Bill will, therefore, seek to achieve a few objectives.

First, to provide greater flexibility and modularity in licensing, to enable the development of new care models that centre around patient needs. Second, to better protect patient safety and welfare by strengthening licensee governance and also introducing additional safeguards. Third, to strengthen continuity of care and ensure more appropriate and robust licensee accountability.

In putting up this Bill, MOH conducted extensive public and stakeholder consultations between 2017 and 2018, and also studied developments in the local landscape, as well as the regulatory regime that exists in several overseas jurisdictions. We received a lot of useful feedback from licensees, patients and the public, and some of these ideas have been incorporated into the new regulatory regime that now finds its way into this Bill.

Some examples include the bundling of specific licences for GPs to accommodate their core work, as well as allowing licensees to co-locate with certain registered healthcare professionals to facilitate the provision of complementary healthcare services. I would like to take the opportunity here to thank all those who contributed actively throughout this process in the consultation exercises, helping with ideas, with suggestions to jointly shape and create the new healthcare services regime.

Sir, let me now go through the key features of the Healthcare Services Bill and highlight the areas of changes from the existing legislation.

First, let me start with the scope. We will clearly define the scope of the regulatory regime and the move towards a services-based licensing framework.

The scope of the Healthcare Services Bill extends to the regulation of any service by direct providers of "healthcare services" as defined in clause 3. This includes services that diagnose, assess or treat diseases or illnesses; provide nursing or rehabilitative care; or assess the health of individuals. Services that will require licensing will be set out in the First Schedule.

Licensable services are largely similar to the services already provided by the premises-based licensing regime currently under the PHMCA. In addition, however, the Bill will introduce licensing requirements for certain non-premises-based services, such as telemedicine, emergency ambulances, and new specialised services, such as cell, tissue and gene therapy and clinical genetic testing.

While the scope of the Bill is broad enough to include standalone allied health, nursing, traditional medicine and also complementary and alternative medicine services, we will not, at this stage, be licensing these services for the time being. However, my Ministry will continue to closely assess these services, particularly from the perspective of risks to patient safety and welfare. If sufficiently serious concerns arise, these services can then be licensed by including them in the First Schedule. In that case, the same regulatory regime as is now set out in the Bill would then apply.

Government entities, such as SAF medical centres and SCDF ambulances, are exempted from this Bill. They are bound by internal Government standards and rules, which are generally equivalent to or more stringent than the current licensing standards. There are also staff disciplinary frameworks to deal with errant personnel in the case of such Government services.

The Bill's scope also does not include beauty and wellness services as these services do not diagnose, assess or treat diseases or illnesses and are of minimal patient safety risk. Entities that do not provide direct patient care, such as Third Party Agents referring patients to healthcare services licensees for their care, will also not be regulated as licensees under the Bill. But this would be an area that we will review, and at the appropriate juncture, if necessary, can always include into the Bill through suitable amendments.

As we transit into the Healthcare Services Act, we will move away from the current premises-based licensing framework, which, as I have mentioned at the outset, is a lot more rigid and inflexible, confined only to one licence per premises and also limited to those in physical brick-and-mortar premises. Hence, Part 2 of the Bill introduces a services-based licensing framework which is more flexible and also more modular.

This approach will better suit the business models of providers, who would just have to take the licences based on the services that they wish to provide. For example, a provider can decide if he wants to hold a suite of service licences for a nursing home, a clinic, telemedicine and health screening.

Secondly, as we move towards regulating new services and care models, we will enhance institutional governance and institute additional safeguards to ensure patient safety and welfare. That, ultimately, is the raison d'etre behind this Bill. The strengthening starts first from our licensing regime and under clause 11 of the Bill, the Director of Medical Services, who is defined as the "Director", will be required to consider multiple factors in deciding whether to grant or to renew a licence. This includes, but is not limited to, whether the applicant is a suitable person and his ability to provide clinically, as well as ethically, appropriate patient care.

Other factors that may also be considered include the applicant's prior conduct when participating in various public schemes, such as the Community Health Assist Scheme (CHAS), MediSave or MediShield Life schemes, as well as the track record of compliance with regulatory requirements under the Bill and also under other laws relevant to the provision of healthcare services in a safe and appropriate manner.

Clause 23 also requires the key appointment holders of a licensee, such as its governing board or key management, to be suitable persons. Key appointment holders must possess the appropriate skills and competencies to carry out effective governance functions.

While the licensee is ultimately accountable for overall compliance to the Bill, clause 24 requires the licensee to appoint a suitably qualified individual as the licensee's Principal Officer – defined as the PO – or the Clinical Governance Officer (CGO), to strengthen accountability as well as clinical oversight at the different layers of its management.

However, even as powers and responsibilities are set out under the different layers of governance under the Bill, healthcare professionals will be given autonomy to exercise discretion in the execution of clinical decisions for patient care, to serve the patient's best interests and also in accordance with professional ethics and considerations. We will, therefore, introduce provisions in the regulations for due consideration to be given to the views of practising professionals for clinical care matters.

Clause 25 of the new Bill will also require certain licensees providing higher patient risk services, for example acute hospitals, to set up specific internal committees to monitor the quality as well as the ethics of the services. These specified committees include the Quality Assurance Committees, the Service Review Committees and the Clinical Ethics Committees, each dealing with different aspects of clinical, ethical and quality considerations. Procedural details for these committees will be carried in the Regulations.

Stakeholders had raised concerns on whether these governance requirements impose additional burden on smaller licensees, such as the GP clinics. This is a relevant concern, but this will not be the case, as the requirements that are set out are appropriately calibrated to the scale and also to the complexity of the licensee's operations.

In addition to setting up proper governance structures and imposing standards on key appointment holders, we also need to ensure that the employment of healthcare workers – those who work or who are employed by the licensees and who deal with patients on a day-to-day basis – are also properly managed and there is appropriate oversight. This, I would say, is especially so when catering to the vulnerable patient groups. Such patients may be at risk of abuse, particularly when they require substantially long stays at a healthcare institution.

Therefore, this Bill introduces safeguards in this area at clause 28 to impose employment restrictions on certain licensees. Let me explain that. Such licensees will be prohibited from employing any individual convicted of prescribed egregious criminal offences involving violent acts, and must provide the information of all prospective staff to the Ministry for screening with the Criminal Records Office. We understand that we should not treat all past offenders in the same way, or to assume that they are automatically recalcitrant. Employers who wish to employ past offenders of prescribed offences in the appropriate case may apply to seek the approval of the Director, who will consider each such case on its own merits. I would add that this employment restriction is not new. It is similar in nature to the approach taken under the Early Childhood Development Centres Act.

Additionally, the employment restrictions will be limited only to settings where patients are at higher risk if they require, for instance, substantially long stays or are mentally and physically vulnerable. This would include long-term residential care services like nursing homes, inpatient palliative care services, and the Institute of Mental Health.

Next, the Bill will also introduce a number of measures to ensure that patients are well-informed and are aware and not misled by errant healthcare providers.

Clause 29 will enhance naming restrictions to provide better clarity to patients on the healthcare services provided. Hence, non-licensees will not be able to use names that create a misimpression of providing licensable healthcare services when they either are not or should not be doing so. Likewise, licensees will also be prohibited from using names of services that they are not licensed to provide.

Clause 30 will disallow unrelated, unlicensed services to co-locate with or within a licensed service, unless MOH approves. The intent behind this is to prevent or, as far as possible, mitigate public misperception that such unlicensed services, such as wellness and spa services, are either endorsed or licensed, because of their close physical proximity and association with the licensed healthcare services.

Clause 31 will strengthen the advertisement controls under the Bill to prevent non-licensees from advertising licensable healthcare services. Therefore, only licensees and authorised persons appointed by a licensee will be allowed to advertise licensable healthcare services and, in doing so, will have to comply with the prescribed requirements to prevent advertisements that are false, misleading, or laudatory and lead to a consumption of unwarranted treatments; and also those that cause a mismatch of expectation between the advertisement and what the public sees.

Besides having levers to regulate the licensees, the Bill will also enhance existing powers of the Ministry, carried at clause 36, to gather data for patient safety, welfare and public interest purposes.

Clause 37 will then empower the Ministry to publish information acquired in the course of administering this Act. In this regard, we intend to publish a list of non-compliant licensees and unlicensed providers, and we hope that by making such information available to the public, we can help patients make more informed decisions.

Thirdly, we will put in place rules and powers to ensure the safety and continuity of care for patients through the introduction of "step-in" arrangements.

Part 4 of the Bill will specifically introduce provisions to achieve this by empowering MOH to directly "step-in" or appoint a "step-in" operator to take over the operations of a licensee who is in serious financial trouble, or is contravening or is not complying with the provisions of the Bill, or is otherwise carrying on its operations in a manner that is detrimental to the interests of patients or customers, but nonetheless wants to or persists in carrying on these operations. The primary purpose is to protect patients’ safety and welfare against a recalcitrant provider endangering patients and also preventing an abrupt discontinuation of residential healthcare services.

For this reason, the "step-in" provisions will only apply to a list of designated residential healthcare entities that will be prescribed in the regulations. These will include nursing homes, hospitals and inpatient palliative care centres. "Stepping-in" will also be a temporary arrangement until the service has been stabilised, and the patient's safety and welfare are no longer compromised.

I would add that "step-in" powers are not unique to this Bill. Other regulatory frameworks for essential services, such as those in the financial services or transport sector or the like, also provide similar powers. And I would argue that the case for this is perhaps even more compelling in the healthcare setting given that lives as well as the continued delivery of care to patients, whose welfare and interests are at risk, remain at stake.

The Bill will also ensure licensee accountability by broadening our range of regulatory sanctions and strengthening our regulatory toolkit.

Clause 39 provides powers to stop the provision of services that are detrimental to patients. While such powers presently exist in the PHMCA, they are limited to cases where the service endangers the health, safety and welfare of patients. Under the Bill, we will also be able to stop services that go against the rules of professional conduct and ethics. So, for instance, if a disciplinary tribunal under the Singapore Medical Council has found that a particular treatment should not be provided for specific indications as there is insufficient clinical basis or evidence, MOH can issue stop orders for all licensees to cease any provision of such treatment accordingly.

To exercise oversight and control over non-compliant licensees, we will have a wider range of regulatory actions and higher penalties for offences in the Bill. Clause 20, therefore, allows various regulatory actions to be taken against non-compliant licensees, as opposed to the PHMCA, where we could only revoke or suspend the licence. So, there is a broader range in the toolkit which allows for more flexible arrangements, given the nature of each particular situation. Penalties for offences have also been updated and aligned with comparable offences under other more recently enacted legislation.

Next, let me turn to the proposed implementation of this new regime. MOH intends to take a phased approach on the Bill, targeted to be from early 2021 through to the end of 2022 – a phased, graduated implementation of the regime under this Bill. Regulation of licensable healthcare services will be effected, therefore, in three phases, so that providers will be given sufficient time to understand the regulations and also, in some cases, to ramp up its own resources to meet the relevant regulatory requirements. The first phase will bring PHMCA laboratory licensees under the Bill’s regulatory regime. The second phase will involve medical clinics and other ambulatory care services, as well as ambulance services. In the third and final phase, hospital and long-term care services, as well as other new licensable services, will be regulated by the Bill.

MOH will assist all licensees and ensure a seamless transition to the new licensing regime. We will also continue streamlining our regulatory processes to reduce the burden on licensees as far as possible.

Sir, let me conclude by making the point that in implementing the regulatory regime under this Bill, MOH will continue to engage licensees in the same manner as it had done in coming up with the rubric under this Bill to ensure that they will have a seamless transition from the PHMCA into the regime under this Bill. We strive to enable new and innovative healthcare service models as well as the use of technology to develop within safe and reasonable boundaries.

The Healthcare Services Bill will allow my Ministry to evolve its regulatory framework in tandem with the changing needs of healthcare demands and also the changing healthcare landscape. Together, we can achieve the key objectives of protecting patient safety, welfare and also assuring continuity of care. My Ministry remains committed to ensure that healthcare in Singapore is safe, of good quality, affordable, as well as accessible.

As we continue to build on our regulatory transformation journey to enable new healthcare services and care models to support our ageing population, I would like to urge the Members of this House to give your support to the Healthcare Services Bill. Mr Deputy Speaker, I beg to move.

Question proposed.

4.37 pm

Dr Chia Shi-Lu (Tanjong Pagar): Mr Deputy Speaker, Sir, I rise in support of this Bill, which is timely, given the vast changes in the way that healthcare is organised and delivered.

As the Senior Minister of State has just elaborated, a key feature of this Bill is the change from the current fixed-type licensing framework, which is based on physical premises, to a framework which is modular, with the flexibility of customisation based on the services provided. This is a major and necessary transition, which will accommodate newer healthcare services and also healthcare delivery modes. Not only will this new licensing structure enable the Ministry to better regulate and govern our growing healthcare sector, it also facilitates innovation while offering patients better protection.

As with any major transition, the process of porting over will involve some work for current licensees. So, my first question is to ask if the Ministry would share how it will help existing medical service providers, especially the smaller players, with this conversion to the new licensing regime. Will the overall licensing revenue be increased with the enactment of the Bill? And how are we helping our licensees to meet the expected costs?

Is there also a significant difference between the regulatory costs to MOH and the licence fees and, if so, who is paying for this gap? I seek the Minister’s assurance that costs for healthcare providers will not be increased inordinately such that patients are the ones that end up paying for this shortfall. And if for some reason under the new structure, certain licensees’ fees are, in fact, reduced, would the Ministry consider measures which will encourage such savings to be passed on to patients?

In regard to co-location of services, I would like to seek clarifications over what determines whether co-location with non-licensees will be permitted. With the continuing push from healthcare to health, I think the demarcation between health and wellness services continues to be blurred. And what about beauty and aesthetic services?

Since we are talking about new paradigms in healthcare, what about digital providers? For example, if you provide a telemedicine platform, how do we regulate how these services co-exist in the digital sphere?

Next, I would also like to ask how the Ministry intends to deal with certain service entities, such as ambulances and also standalone telemedicine providers, under this new regulatory framework.

I had previously voiced my concerns about the costs and level of expertise of private ambulance providers. So, will there be stipulations regarding the construct and equipment on board medical transport and emergency ambulance vehicles? How about the training qualifications and expertise of the personnel providing such services? Will the Government regulate the range of their charges and also their fees? Users of such services, we note, are usually in a vulnerable state and are in an unfavourable position to research, compare and negotiate fees.

As for telemedicine, it is a service which can be provided from anywhere to anyone so long as there is an Internet connection. This remote medical service will attract many new providers and big IT conglomerates to this sector. How will the Ministry ensure the quality and integrity of such services so as to safeguard our patients? There are so many aspects which have to be considered and made clear. For example, under which circumstances would a medical professional be permitted to make a diagnosis and prescription remotely, and when should such face-to-face interactions be required? What about the liability risks for practitioners in telemedicine? And would inter-country services be allowed and under what sort of regulatory framework?

Another area of concern which has been brought up in the past is how this Bill would deal with Third Party Administrators (TPAs) and medical concierges, although I do note that these do not fall within the scope of this particular Bill. However, both provide some form of healthcare-related services by referring patients to designated or to preferred providers. Currently, this is discouraged under the Code of Ethics, which also limits their application, but there is presently no law which specifically regulates their use. I would like to seek clarifications regarding these services either under the current proposed framework or future frameworks.

Last, it should be remarked that one notable aspect of this Bill is what it omits, and the elephant in the room is that the setting out of the legal framework for a National Electronic Health Record system is not included in this Bill. As we strive to become a Smart Nation, a unified electronic health record is a critical step towards a truly future-ready healthcare system. The hacking of the SingHealth computer system has understandably led to a pause in this regard, but it should not inflict a mortal blow to our efforts to have a robust and comprehensive digital health record system which will have many benefits for all Singaporeans, both in sickness and in health.

On this note, would the Minister share an update on the measures MOH will implement to ensure that licensees protect health information in medical records?

Going digital and implementing the National Electronic Health Records will enhance continuity of care for patients and boost productivity, but patients understandably are also more concerned about their data privacy and their data protection. In the past, one had to physically break into a clinic or hospital to steal patient data. Today, these crimes can be conducted far, far away from their targeted victims and many more patients’ data can be obtained in one fell swoop.

At the macro level, how then are we fortifying our digital defences to keep up with and keep out fast-evolving cyber attacks on our databases? On the ground, how is MOH working with individual licensees to boost their cybersecurity? What kind of technical assistance, funding and resources are available to help them set up secure systems and maintain their digital systems? I look forward to these clarifications and I support the Bill.

4.44 pm

Prof Fatimah Lateef (Marine Parade): Mr Deputy Speaker, this Bill was first enacted in 1980 and amended in 1999. Thus, it is, indeed, time to review and update to ensure patient safety through licensure, provision of more safeguards and, of course, keeping abreast of the new healthcare landscape and modalities we have today. Moreover, there are a variety of new services since then on offer and things have changed, for example, medical transportation, video conferencing, tele-conferencing and even tissue and bone banking. The migration from a premises-based to a service-based model makes sense because we are trying to integrate a lot of our healthcare services. I have a few clarifications.

Firstly, for cord blood and stem cells, how will these products be tagged? As it will usually be identified or linked to an individual, will it be under the name of the mother or the baby or the fetus?

Secondly, under Part 2, licensing of healthcare services, clause 9, it is stated and I quote, "it is an offence for a licencee to provide a licensable healthcare service at any premises other than licensed premises, or using any conveyance other than a licensed conveyance". Can the Minister comment and elaborate on the offering of House Visits services by GP and Family Practitioner colleagues, for example, as well as home care services by hospice doctors and nurses? In that same context, are there any requirements for locum healthcare services staff who move from premises to premises offering services and taking care of patients with consultations?

Thirdly, pertaining to telemedicine, can the Minister also clarify with some details? Does this apply to only within Singapore? How about when our medical staff are consulted on the regional and international platforms? At Singapore General Hospital, for example, we provide Maritime Medical Advice or Radio Medical Advice to ships in the waters around Singapore and even as far as the coverage of parts of the Pacific and Indian Oceans. Please advise on the definition and coverage of these services as well.

Fourthly, on clause 26, pertaining to the Clinical Ethics Committee (CEC), can we understand a bit more on this and also the component members and how many members will the CEC have? What are their other terms of reference? Also, will there be any difference in the components and also job scope as compared to the Ethics Committee that our institutions already have today?

Fifth, how fast can the "step in order" or the "expedited step in order" be approved and obtained in the event that it is required?

Sixth, can the Minister also explain with some details of the Quality Assurance Committee? How is it going to work? What are the main objectives and desired goals and how will they function?

Seventh, with the move from premises-based to service-based licencing, many are concerned with the rise in the costs they have to pay. What will be the framework or formula for this conversion and can the Minister ensure that the hike will be within reasonable limits? This is especially so with the current economic climate, as we update this Bill to execution.

Eighth, pertaining to the process of mapping services at the healthcare premises, how fast can the request for new services be processed? Also, will the spectrum of point of care tests permissible be reviewed from time to time to incorporate the latest and the updated?

Finally, the ninth point, on the co-location of licensed and unlicensed services within the same premises, can the guidelines be made clear and succinct? This is because I feel that this can be a potential area for abuse and also misinterpretation. Take, for example, the beauty and wellness industry. It is not within the scope of this Bill. Neither is Traditional Medicine and Complementary Medicine. But these are exactly some of the services which may potentially co-exist on the same premises as a licensed service. So, therefore, there could be some loopholes there. Notwithstanding these clarifications, Sir, I do support this Bill.

4.48 pm

Ms Sylvia Lim (Aljunied): Deputy Speaker, Sir, I note that MOH has proceeded cautiously in presenting this Bill. According to the MOH website, it started consulting on this matter in 2016 and published a draft Bill two years ago for scrutiny and feedback.

The Bill today is quite different from the draft Bill in some respects, which the Senior Minister of State explained briefly earlier.

While I agree that Government oversight of healthcare services is necessary to protect patient welfare, I have some queries and concerns about the Bill. These concerns relate to the Bill's phased coverage, price transparency, quality assurance and the National Electronic Health Records System (NEHR).

First, the Bill's phased coverage. Clause 5 states that the Bill does not apply to any healthcare service provided by the Government. And earlier, the Senior Minister of State did explain that Government-provided services included those under the Singapore Armed Forces and the Singapore Civil Defence Force. So, I take it that restructured hospitals, polyclinics and also primary care providers will be covered under the Bill. It is a question of at which phase they are included.

Again, related to the issue of coverage, I was originally a little puzzled by the First Schedule because it stated only certain specific types of healthcare services which will be required to licensable, particularly clinical support services and some specialised laboratory-type services. I was puzzled because I had previously raised concerns about the private ambulance services used by consumers and also the feedback from residents about poor quality service and also hidden charges not being feasible at the time of booking. But I believe that, if I heard the Senior Minister of State correctly, he mentioned that this would come under phase 2 of the implementation. So, I would like him to confirm that emergency ambulance services and such related conveyance services would be actually included for regulation under phase 2.

Related to that, in last year's Committee of Supply when I raised this issue, the Senior Minister of State mentioned about price transparency that the Healthcare Services Bill would include this issue in its regulation and it would mandate the publication of common fees charged, as well as give more transparency to the bill components to be paid by consumers so that they would know upfront what those costs would be. So, do I take it then that with regard to private ambulance services, this would be actually done under phase 2? If that is the case, then when would that be done? And in the meantime, would there be anything put in place to protect consumers? For example, are we still relying on the Voluntary Accreditation Scheme to try to get some standards into that industry?

Next, Sir, I move on to the important issue of quality assurance for consumers. The Bill states upfront in the explanatory statement and the Minister also mentioned earlier that one of the Bill's aims is to strengthen safeguards for the safety and welfare of patients who receive healthcare services.

Since the day I became an elected Member of Parliament nine years ago, I have, from time to time, come across families who have been devastated by unsuccessful medical procedures. Some of their family members died unexpectedly while others sustained permanent disability in their prime and have been lying in rehabilitation hospitals for years. Of course, it must be said that the cause of such tragic outcomes may not be the inadequacy of healthcare services but other causes, such as the nature of the illness itself or inherent risks of certain medical procedures. Nevertheless, healthcare is an area where there is asymmetry of knowledge, with patients placing high trust in professionals. It is critical that the public must be assured that investigations into complaints are fair to the consumer and independent of professional and institutional interests. At the same time, professionals need justice as well. And we recall the High Court's decision in July last year to reverse the conviction on an orthopaedic specialist by the Singapore Medical Council. To this end, can the Senior Minister of State elaborate on how this Bill will enhance confidence in the fairness of the quality assurance processes for all parties?

My final point, Sir, concerns the implementation of the NEHR system. I note that during the public consultation on the Bill, a lot of time was spent dealing with the issue of potential data leaks. This is understandable in view of recent incidents.

In responding to the feedback, the Ministry stated that patients concerned about the confidentiality of their medical data could possibly opt out of having their data inputed into the NEHR by healthcare service providers. Could the Ministry please update the House on the status of this opt-out option.

Sir, I look forward to the clarifications from the Ministry on the points I have raised.

Mr Deputy Speaker: Order. I propose to take a break now. I suspend the Sitting and will take the Chair again at 5.15 pm. Order. Order.

Sitting accordingly suspended

at 4.55 pm until 5.15 pm.

Sitting resumed at 5.15 pm

[Deputy Speaker (Mr Lim Biow Chuan) in the Chair]

HEALTHCARE SERVICES BILL

Debate resumed.

Mr Louis Ng Kok Kwang (Nee Soon): Sir, I stand in support of the Bill. The update is timely. In the 39 years since the Private Hospitals and Medical Clinics Act was enacted, the healthcare landscape has seen significant changes, including a shift toward digital and online services.

At the same time, Singapore faces an ageing population and an increased prevalence of chronic diseases. The demand for healthcare services is set to increase. Furthermore, there is a growing need for alternative models of care beyond face-to-face consultations or healthcare provision at physical, brick-and-mortar locations.

We cannot take for granted Singapore's high quality healthcare infrastructure. The service-based licensing model will help ensure that people in Singapore continue to have access to safe and well-regulated healthcare services, even as the services take on alternative forms.

The mandatory nationwide healthcare records database will also ensure continuity of care for patients across service providers. Sir, I have four clarifications.

First, plans to mandate the contribution of data to NEHR have been in the news as early as 2017. However, these plans were deferred in the wake of the SingHealth cyber attack in 2018, which highlighted the risks posed by weak spots in the system.

Since then, disciplinary action has been taken against top management and key individuals, the NEHR has been subject to reviews, and Minister Gan has assured this House that the Ministry is "taking many precautions" to ensure that the system is "robust before everyone is required to submit (data)".

Under the Bill, NEHR data can only be accessed for the provision of healthcare services, or with the approval of the Government. Third parties such as employers and insurance providers cannot access the data unless the patient permits.

The Ministry has also said it will implement safeguards to ensure the confidentiality of patients' NEHR records. These include the provision of access logs to patients, regular audits on NEHR access and penalties for unauthorised access. However, as with all electronic databases, the NEHR faces a risk of data breach. From a national security perspective, it would also be dire should NEHR data fall into the wrong hands. This was demonstrated by the Singhealth cyber attack. On an individual level, patients may fear having their sensitive medical information leaked since this could have repercussions on their employment prospects or social lives.

Can the Minister clarify how the use, access and transfer of patient data will be monitored by the system? Furthermore, how will the Ministry seek to prevent abuse of authority by healthcare professionals who have access to the system?

Can the Minister also share what recourse is available for a patient who suspects that there was unauthorised access to their records?

If that patient subsequently suffers perceived injustice at his or her workplace or discrimination by his or her insurer, what recourse is available then and on whom does the burden of proof fall? Who would bear the costs of any follow-up action?

Finally, would a patient be responsible for probing or proving any alleged system abuse, or will the Ministry be actively monitoring the system and taking enforcement steps against breaches identified?

Second, given the concerns with data privacy and protection, there are understandable reasons why certain patients may not want their data uploaded onto the NEHR. These patients must submit a request to the Ministry, and requests will be assessed on a case-by-case basis. Can the Minister share the criteria for assessing these requests? Would it be possible for Minister to decline a patient’s request and if so, on what grounds?

I understand that there must be a balance and must be struck between encouraging participation in the NEHR and upholding patient choice and confidentiality. Can the Minister provide assurance that the opt-out process will not be unduly difficult for patients? Can the Minister share what measures are in place to ensure that the opt-out process is relatively quick and easy for patients?

Can Minister also provide an estimate of how long the review and opt-out process might take?

Third, under the Bill, the licensing regime for healthcare service providers will transition from a premise-based to service-based one. As such, an establishment might require multiple licences depending on the services provided.

Can Minister provide some details about the projected costs for this transition? Would establishments who offer more than one type of healthcare services now have to foot higher administrative costs because they will need to hold more licences?

If there are any increase in costs, can the Minister clarify the proportion of the burden that will be borne by the end-user, the service provider, and the Ministry?

Can Minister also clarify whether there will be efforts to streamline the licence application process for establishments that might require multiple licences?

Lastly, the Bill has step-in provisions relating to residential care services such as hospitals, nursing homes and in-patient palliative care services. The step-in provisions allow the Ministry to take over the operations of providers at the risk of insolvency, or who are unable to resolve systemic patient safety or welfare concerns.

In particular, section 33 provides that the Minister has the power to issue a step-in order. Can Minister clarify how and when this power will be exercised? Will the Minister have access to a committee of industry experts who may be able to advise him on such matters?

Sir, I stand in support of the Bill. It is a necessary move to adapt our legal framework to the rapidly evolving healthcare landscape, so as to continue ensuring the well-being and care of people in Singapore. Moreover, it places us in a better position to embrace even more novel models of care.

I hope the above queries will aid in sharpening Singapore’s approach to the provision of healthcare services, thus securing Singapore’s continued leadership in healthcare globally.

5.21 pm

Mr Melvin Yong Yik Chye (Tanjong Pagar): Mr Deputy Speaker, I stand in support of the Bill, which seeks to strengthen governance in the healthcare sector amidst the rapid evolution in the industry, to ensure better patient safety and continuity of care. However, I do have a few questions and suggestions.

First, I support the proposed services-based licensing framework, as it addresses the limitations of the current Private Hospitals and Medical Clinics Act, which only regulates services provided at brick-and-mortar healthcare facilities. The introduction of Industry 4.0 and 5G telecommunications is already beginning to disrupt existing modes of healthcare delivery. New healthcare services can now be delivered entirely through mobile and online channels. The Bill’s new licensing framework is therefore timely as it will provide healthcare providers with the flexibility to "modularise" and apply for relevant licenses based on the services that they provide, rather than be confined to a physical premise.

However, while the new framework provides much needed flexibility, I am concerned with the corresponding licensing costs – how will they be impacted under the new regulatory regime? Can the Ministry provide licensees with a way to cluster and package their applications, to help them manage their licensing costs? We should bear in mind that the end-consumers would inevitably bear the brunt of any cost increase, and businesses often have an easy excuse to raise prices once regulatory costs increase. Even if the switch to the new framework will only result in an increase in licensing costs for a small number of operators, there is still a strong case to be made for the Ministry to consider absorbing the increase, as it is not uncommon to see prices increase across the industry just because someone in the market has raised their charges.

Mr Deputy Speaker, I am glad to note that the Ministry will provide ample flexibility in the Bill to help with the on-boarding of newly regulated services, such as the creation of a regulatory sandbox for telemedicine services. The sandbox will be beneficial to help us in adapting our regulations as telemedicine technologies evolve.

The introduction of 5G technology will see telemedicine and tele-surgical services become the next key growth drivers in the healthcare sector. Already, news reports out of China have emerged, claiming that doctors in the Chinese PLA General Hospital have carried out China's first 5G-based remote surgery on a patient 3,000 km away. I am sure that it is only a matter of time before such technologies are trialled here in Singapore, and having our own telemedicine regulatory sandbox will help strengthen our position as one of the leading healthcare hubs in the region.

However, new technologies will also bring about new questions pertaining to liability. Will the scope of the telemedicine regulatory sandbox be wide enough to provide a sandbox liability regime? With the introduction of artificial intelligence revolutionising how illnesses are diagnosed, will our sandbox regulations differentiate between decisions made by human doctors and those made by Artificial Intelligence? If so, who will be liable for decisions made by AI? With this sandbox, we have the opportunity to actively shape telemedicine regulations and answer the tough questions surrounding AI-related liability questions in the healthcare sector. I urge the Ministry to do so, so that we can pave the way for our businesses to remain as innovative leaders in the region.

Another opportunity for adaptive regulations under this Bill is to create a sandbox for the regulation of the entire spectrum of professions who provide Mental Healthcare Services. Industry practitioners within the mental healthcare space, such as psychologists and psychotherapists, have been providing me with feedback on their wish for the entire industry to be fully regulated as a healthcare service.

From what I can understand, only psychiatrists are fully regulated today, as they are considered doctors. But mental healthcare services span across a wide spectrum of professions, many of which lack full regulations. An example of this are psychologists. Although classified by the Ministry as allied health professionals, psychologists are yet to be regulated under the Second Schedule of the Allied Health Professionals Act which was passed in 2011. Other professions within this industry that are unregulated include counsellors and psychotherapists. The lack of regulation among the many professions within the industry is troubling, as members of the public do not know the differences between counsellors and psychologists, and may seek treatment from someone without the proper certification and expertise.

We should support the industry's call for fuller regulations. Perhaps the Ministry could consider regulating the entire industry as an allied health service under a sandbox, to be implemented in the final phase of the Act's implementation. The Labour Movement stands ready to work with the Ministry to engage mental healthcare practitioners working across the entire spectrum of the mental healthcare industry, and work towards drafting the implementation and regulatory details, and to park this under a sandbox regime to provide all parties with the necessary flexibility.

Mr Deputy Speaker, I support the Bill's proposal to strengthen governance over licensees by ensuring that they have competent and effective governing bodies. This is especially vital for medium and large corporations who are responsible for the healthcare delivery of tens and hundreds of thousands of patients every year.

However, while bigger companies will be able to easily adapt to the new governance measures, smaller players, such as our local General Practitioners (GPs) will find it much harder to comply. Under the new measures, licensees must appoint those with the appropriate skills and competencies in the areas of finance and business management. How will this new regulatory requirement affect the operations of our 1,700 GP clinics, many of whom might just be a small team of one doctor and a few clinical assistants? Will GPs be allowed to double, or even triple-hat, as the Licensee, Principal Officer and Clinical Governance Officer?

Another new area of regulation which may impact smaller players more disproportionately than larger players, is in private ambulance services. Under the Bill, private ambulance services will have to classify themselves either as Emergency Ambulance Services or Medical Transport Services and comply with the respective sets of requirements. Medical transport ambulances, for example, will not be allowed to be fitted with sirens and blinkers, while emergency ambulance services will be held to higher standards of emergency care.

While I commend the Ministry's on-going efforts to provide a voluntary accreditation scheme to facilitate a seamless transition to the new licensing framework, how will the introduction of the new regulation affect the supply of ambulance services in Singapore? Will regulations be too onerous for smaller players to invest and upgrade their existing fleet of ambulances to serve as emergency ambulances? What will happen in cases where someone calls for a medical transport service, but the patient’s condition worsens along the way and it becomes an emergency?

Finally, I would like to voice my support for the Bill's proposed safeguards to apply background checks for certain licensees, to protect vulnerable patients and those who require long-term stay. This is certainly important, as any case of patient abuse would severely damages the trust that the public has for our healthcare industry. I would like to clarify if the provisions under section 28 will apply to all professions of workers employed or hired by the licensee, or will the safeguards only apply to those directly involved in the delivery of healthcare services. Also, how will the background checks be conducted if the worker in question is a foreigner?

Mr Deputy Speaker, the healthcare sector is poised to undergo disruptions, brought about by the advent of new technologies. The proposed licensing framework and measures under the Bill are timely and will help to strengthen Singapore's position as the premier healthcare hub of the region. However, as we transit to the new framework, it is important that we ensure that we keep regulatory costs low and not overly onerous to smaller players. We should use this as an opportunity to ambitiously widen our regulatory sandbox and tackle the tough questions on liability that will inevitably arise. With that, I support the Bill.

5.35 pm

Er Dr Lee Bee Wah (Nee Soon): Mr Deputy Speaker, Sir, with the rise in demand for various healthcare services and the rapidly changing landscape in medicine, it is indeed timely that this Bill is introduced. This is especially with the growing number of elderly persons in our population which would increase the demand for certain services.

I note that the Bill would introduce a services-based licensing regime to replace the one that is premises-based licensing. Overall, I hope Minister can tell this House how these changes will impact on healthcare services in terms of operating cost, because invariably this cost may be passed on the consumers?

I would like to ask if the Ministry is reviewing all persons who are current key appointment holders in the private healthcare setting to ensure that they are qualified persons under the new Bill? Since the licensing will be services-based, should the Ministry require all licensed persons in a healthcare premise to display a photograph alongside their licence so that patients know who is who?

With the proliferation of new healthcare services, how do we ensure that patients are only treated by qualified persons? Should we educate patients to always ask to see a license? For example, if they are doing medical consultations online, or if they are being treated by someone other than a doctor or nurse such as a technician operating certain equipment. Or if they are getting their blood drawn by someone who goes clinic to clinic, whose responsibility is it to check for a valid licence – the clinic or the patient?

I would also like to ask how the Ministry views someone who, for example, holds a doctorate in liberal arts but subsequently takes up say physiotherapy but uses his title Dr so and so. This may create a mis-impression that he is a medical doctor. How do we prevent such misconceptions? In Chinese, please.

(In Mandarin): [Please refer to Vernacular Speech.] Medical Services these days are getting more and more complicated. Hence, to introduce a services-based licensing regime to replace the current premises-based one is a step towards the right direction. May I know how these changes will affect healthcare services in terms of operating costs? Because quite often, these costs will be passed on to the patients.

In addition, how can we ensure that patients know whether the medical personnel who treat them are licensed or not? Should all medical personnel display a photograph alongside their licence? If the patient is doing online consultation, or if he is not treated by a doctor or a nurse, should the patient check the person’s licence first?

I look forward to the Minister's replies. I support this Bill. Thank you.

5.36 pm

Mr Leon Perera (Non-Constituency Member): Mr Deputy Speaker, Sir, the Healthcare Services Bill seeks to accomplish a number of things. To introduce a services-based licensing regime for providers of healthcare services replacing the old premises-based licencing regime; to strengthen the safeguards for the safety and welfare of patients; to improve the governance requirements for providers of healthcare services; to enhance regulatory powers in relation to providers of healthcare services, including allowing intervention in failing providers in order to stabilise operations and ensure continued patient care.

These are all steps in the right direction. Member of Parliament Ms Sylvia Lim, my party Chair, has made a number of points about the Bill with which I agree and which I shall not repeat here. My speech will focus on what else can be done to contain healthcare inflation.

Part 57 2(R) of the Bill empowers the Minister to regulate the sector so as to require price transparency towards patients and customers. Mr Deputy Speaker, Sir, according to Mercer Marsh Benefits 2019 Medical Trends Around the World Report, based on surveys of insurers regarding types costs and frequency of medical conditions that were claimed for by company employees in 2018. Singapore's medical Trend rate, which measures medical cost inflation was 10% in 2018, 10 times the Singapore economy's estimated 2018 inflation rate of 1% at that time.

In a parliamentary reply from 2018, the Government figure for healthcare inflation measuring the growth rate of prices for healthcare related goods and services paid by patients after Government subsidies was about 1.2% between 2013 and 2016. A media report from late 2018 quoted the Life Insurance Association of Singapore (LIA), have been found that average private hospital bills were increasing by 8% a year compared to less than 3% for public hospital bills. Though I note, that the 3% figure is still far higher than general inflation.

Medical or healthcare inflation is a challenge faced by many countries around the world. It is partly driven by the increasing availability of advanced, cutting edge drugs, treatments and diagnostic techniques, which are expensive. How do we control medical inflation and curb any tendency towards over-treatment and over-prescription without shutting the door to Research and Development and innovation in the medical sphere? So, the rest of my speech will focus on ideas to answer this question. I will speak on several themes related to this question.

Firstly, I would like to speak on price transparency, which is one thrust being explored around the world. The movement towards price transparency aims to make market mechanisms work to curb healthcare inflation through market competition. In November 2018, MOH started publishing fee benchmarks for private sector professional fees, which are not mandatory caps, but which place some onus on healthcare service providers to justify their fees. And prior to this, MOH has been providing similar guidance to public hospitals since – I believe – 2017. MOH now publishes information on 222 common surgical procedures like hip replacement and colonoscopy, comprising 85% of all procedures. Details include, depending on the type of data set, the public or private setting, hospital wards type, bill size, operation fee, surgeon fee, anesthetist fee, facility, average length of stay and implant breakdown.

Data is in some cases published according to the 25th, 50th and 75th percentile. However, it is not clear what causal effect these measures have had to date – this publishing. I would like to ask, since MOH started the publication of this data, does MOH have any evidence or indications as to what the effect has been to assess the return on that investment.

At the level of theory, a few observations can be made. Not all patients would have the skills, time and inclination to study prices and make informed decisions on that basis. This problem gets compounded when that patient is faced with a medical emergency or pressing problem where familiarity with one healthcare provider or physical proximity may weigh on the decision more than any prior study of pricing.

Moreover, many patients may be confused as to the link between pricing and quality. That may not only be willing to pay more for better quality but may misunderstand higher pricing to mean higher quality. Many patients who are more broadly consumers may use price as a surrogate for quality in the absence of other information. Would the MOH consider the following further measures? Firstly, publishing data by hospital, but also with data on the outcomes for those procedures at those hospitals where relevant and where there are sufficient data points. By outcome measures, I mean for example, but not necessarily, re-admission rates, safety of care, mortality, patient experience, waiting times and so on and so forth. This will help patients make the link between price and quality.

I am aware that this needs an investment in data systems and expertise to capture data well and risk adjust to take into account the differential complexity of patients. This will take time. Doctors need to be reassured the system is fair or everyone will start to turn away or decline to treat complex or poor pre-morbid patients. But it could well be worth the investment and at the very least should be studied since what we want is value and this means price or fees as a function of outcomes.

Secondly, can MOH consider creating a simple app or website for patients to key in the counselled projected charges broken down by facility, doctor and so on, so that patients can see in simple charts the variation from norms and can such price comparisons be made a mandatory part of the financial counselling? Under pressure of time or stress a patient may not shop around when initially choosing a healthcare service provider, but this idea may give them some food for thought for considering their healthcare service provider the next time they have the same complaint.

Next, I turn to mechanisms to curb over-treatment and over-testing. There may be a natural tendency to over-prescribe, over-treat or over-test, in lieu of strong controls and pressures from customers and regulators. Earlier, I touched on how patients, as customers, may not always be in the best position, be well-incentivised or sufficiently resourced to exert pressure on healthcare providers to keep prices in check in a skillful way. Insurance coverage may also distort choices by both providers and patients.

What can regulators do? MOH's Agency of Care Effectiveness has been issuing care and drug guidance since 2017. However defining over-treatment is notoriously complex, as some cases require more extensive – and expensive – testing and treatment than others. Having said that, can we do more to monitor and publish trends relevant to curbing unnecessary treatment by focusing on specific kinds of procedures?

For example, according to the "Health at a Glance: Europe 2018" report by the OECD and European Commission, Portugal created a national commission to monitor C-section rates and indexed funding to hospitals partly to C-section rates. Italy has similar financial incentives to hospitals with lower C-section rates and publishes information on C-section rates at different hospitals.

The same report details how Denmark, Sweden, the UK and Finland have high day surgery rates for a number of common procedures. Studies have shown that day surgery can reduce the cost of surgical procedures substantially compared to in-patient surgery.

The report states: "In Sweden, one of the main factors that has contributed to the expansion of day surgery over the past few decades has been clinical leadership in the adoption of evidence-based guidelines to streamline pre- and post-operative surgical procedures and promote safe and effective use of day surgery. Nationwide collaboration and support from national authorities have helped to set up and disseminate new standards, while leaving sufficient autonomy to enable adaptation to local circumstances. The expansion of day surgery has helped achieved substantial savings...A 2016 review by the National Board of Health and Welfare showed that the costs of the 11 most common types of procedures would have been 14% higher if the share of day surgery had not increased between 2005 and 2013.”

Sir, I would like to ask if the government could consider publishing data on lower cost procedures at major healthcare service providers and perhaps even making tweaks to funding models to incentivise these lower cost approaches where relevant. This can be done initially by focusing on procedures where there is the most volume vis-à-vis potential to impact on cost.

The issue of day-surgery or outpatient surgery is a good case in point. It would seem that only medical care is covered by insurance and patients then have to pay out-of-pocket for transport, home nurse visits, perhaps some tele-monitoring and even meals. Can insurance funding models be changed such that cash is paid to cover these costs pegged to but not equal to what it would have cost to do this on an inpatient basis, so as to incentivise outpatient surgery?

Also, ambulatory or outpatient surgery centres need a formal arrangement with the hospital for transfer in case of adverse events. In terms of the regulatory regime, is there a sufficient nudge for hospitals to embrace ambulatory care for surgery?

I would also like ask if the MOH's Agency for Care Effectiveness (ACE) looks into flagging out cases that, for want of a better term, can be termed "unnecessary innovation". For example, an NPR article from 2017 in the US recounts how one pharmaceutical producer marketed a single pill that combined two over-the-counter (OTC) drugs as an innovation because it was easier to take one pill than two. A month's supply of the two inexpensive drugs cost about $40. The company billed insurance $3,252 for the new pill.

Thirdly, Mr Deputy Speaker, Sir, I will turn to the promotion of generics and biosimilars. In the Mercer Marsh study quoted earlier, it was noted that Singapore's medical inflation is partially driven up by supply-led factors such as high-cost pharmaceuticals and biologics. I ask a Parliamentary Question on the use of generics in the public healthcare system last year. The reply stated that, and I quote, "in 2017, to better guide institutions and doctors in use of generic drugs, we introduced a basket of clinically and cost-effective generic drugs, which can replace a more expensive branded equivalence. MOH and the Health Sciences Authority monitor new generic drugs that enter the local market and add them to the basket on a regular basis."

I have two suggestions. Firstly, can healthcare providers be required to include in bills information about the cost of treatment, had a generic been used? Alternatively, a simple app or website could provide information on HSA-approved generics in respect of differential pricing. Secondly, can the proportion of use of ACE-endorsed bio-equivalent, lower cost alternative drugs for key conditions and procedures, be these generics or biosimilars, also be made public, broken down by healthcare provider?

Fourthly, on waste reduction. One expert at an event in Singapore on healthcare costs said that waste in OECD countries amounts to as much as one-fifth of healthcare expenditure. I would like to discuss one example. The US FDA has long known that many drugs remain safe and potent for years longer than their published expiration dates. The FDA and the US Department of Defense created the Shelf Life Extension Program (SLEP) to test the stability of drugs in the federal government stockpiles and then extend their expiration dates where justifiable. A 2006 study of 122 drugs tested by the programme showed that two-thirds of them were stable every time a lot was tested. Each of them had their expiration dates extended on average by more than four years. But the same type of drugs in hospitals or pharmacies get thrown away when they expire.

Does our healthcare system destroy significant quantities of drugs due to expiry? If so, could we consider something like that US Shelf Life Extension Program, to use clinical data to extend the life of drugs.

5.49 pm

Ms Irene Quay Siew Ching (Nominated Member): Mr Deputy Speaker, Sir, I laud MOH's move to repeal the current PHMC Act and replace it with the upcoming Healthcare Services (HCS) Bill, which aims to transit from a premises-based licensing framework to a service-based one.

This is a progressive move which will cater to new models of healthcare delivery, in tandem with medical technology advancement, the growing needs of an ageing population and increased chronic disease concerns.

This augmented Bill will provide improved patient safety in the changing healthcare landscape through more efficient governance while allowing for new and innovative healthcare services to be deployed on online and mobile platforms.

However, I do have some questions concerning the Bill.

I understand that although Allied Health and Non-Physician Healthcare, Traditional, Complementary and Alternative medicine fall under the HCS Bill, they will not be licensed for the time being. I ask if the Minister will elaborate on the future plans and timeline as to when these aspects will be covered because it may affect healthcare professionals practising in these areas, or perhaps under what kind of circumstances will an actionable response be considered to include them in the Bill.

Furthermore, I would like to ask how MOH plans to transit healthcare institutions from the PHMC to the HCS Act. How will the existing services be mapped out and what will be the differences in standard requirements as well as the impact on healthcare institutions and professionals? How will the consequences affect licensed sites which are currently co-locating with the non-licensed services such as Traditional, Complementary and Alternative medicines or Allied Health services?

Next, I refer to part 1 of clause 5 of this Bill which states that the Bill does not apply to and is not related to any healthcare service provided by the Government. Can the Minister explain the rationale for this exclusion and how can we be assured that healthcare services not governed under this Bill will provide similar patient safety and governance standards, for example, ambulance services provided by SCDF and medical services provided by MINDEF? Would an inclusion instead enhance safety and align standards across the country with MOH providing an independent oversight as a ministry with expertise in healthcare?

Also, part 2 of clause 22 requires that the Director keep and maintain a register of licensees. May I ask if this list will be made public with their licensed scope of practice made known to patients?

Part 3 of clause 28 in the Bill imposes restrictions on licensees who employ staff to work in healthcare services which cater for the frail and vulnerable patient groups. I would like to clarify if the existing staff currently working in these premises will be screened as well or if the Bill only refers to new hires? What is to be done if the existing staff do not meet the current requirements stated in the new Bill?

I understand that the Public Sector Data Security Review Committee chaired by Senior Minister Teo Chee Hean has made five key recommendations to improve public sector data security, and these include enhancing technology and the relevant processes to protect public data, strengthening data detection and responsiveness to data incidents by building data security competencies across the public service, ensuring improved accountability and transparency, and lastly, sustainability of data security efforts.

These recommendations are targeted to be implemented fully in three years' time and I applaud the committee for the extensive review. I thank the Government for taking full responsibility and accountability for the lapses and using these lessons as opportunities to strengthen our public data security.

So, with these initiatives set in place, I seek clarification as to whether MOH has plans to introduce mandatory National Electronic Health Records (NEHR) core data contribution by licensees and if so, can the Minister provide a timeline so that private healthcare facilities may be better prepared in the eventuality that these recommendations are implemented?

At this juncture, I would like to declare my interest as the President of the Pharmaceutical Society of Singapore. I have a few queries regarding the change from premises-based to service-based licensing for pharmacy services.

How can MOH ensure that there is no overlapping scopes and standards across different regulations? Take for example, hospital outpatient pharmacies which provide dispensary and medication delivery services for walk-in patients as opposed to their own hospital patients. Although the type and the level of services provided are similar, the same pharmacy is subjected to two different Acts. Respectively, hospital patients which fall under the PHMC Act as compared to the walk-in patients which fall under the Health Product Act.

Another example is the tele-pharmacy services provided in hospitals for hospital patients versus those provided by retail pharmacies for patients in the community. Although these services are similar, they are subjected to different Acts with different licensing requirements and standards. I seek clarification as to whether the overlapping of regulatory scopes might cause confusion and inefficiency in running these different services.

Finally, I would like to ask how will the new HCS Bill impact pharmacy licensing for health screenings, telemedicine services and collaborative prescribing services in the community as they fall under the list of licensable services of this Bill. How will this impact future pharmaceutical services such as pharmacists looking into providing vaccination service in the community?

I look forward to the Minister’s response to the above-mentioned concerns. Thank you, and I support the Bill.

5.55 pm

Ms Joan Pereira (Tanjong Pagar): Deputy Speaker, Sir, the evolving healthcare landscape necessitates updates and changes to our licensing framework. Moving from the current premises-based, fixed licensing model to a services-based, flexible modular one will enable our Government to strengthen its governance over the medical sector. The refreshed structure is needed to manage new services and ensure patient safety and well-being.

Telemedicine, an emerging area, is a field that I am particularly concerned about. It is a broad field, encompassing video communications, digital storage and transmission of medical information in the form of text, data and images, remote patient monitoring, health apps on mobile devices and more.

I would like to ask the Minister if he would share more about the aspects of telemedicine the Bill is intended to regulate and the provisions included to future-proof the Bill for developments in this fast-changing field.

Since patients are not physically examined in person by the physicians, there is a higher risk of the doctors missing the detection of certain symptoms, resulting in misdiagnosis. As it is, it is already a challenge for the accurate detection of many illnesses and diseases as they manifest similar symptoms. How will the Ministry ensure the quality of diagnoses? Should something go wrong, how can patients seek help and redress?

This leads to another issue. Will doctors be held to the same standard for telemedicine? I think it is important that medical personnel and patients have a clear understanding of their responsibilities and rights for this nascent service.

I am also curious whether there will be any pre-requisites before a doctor can proceed with the provision of tele-medical communication. For example, should the doctor and patient have a pre-existing relationship, that is, the doctor had seen the patient in a face-to-face consultation at least once before?

Sir, in Mandarin.

(In Mandarin): [Please refer to Vernacular Speech.] Since patients are not physically examined in person by the physicians, there is a higher risk of the doctors missing the detection of certain symptoms, resulting in misdiagnosis. As it is, it is already a challenge for the accurate detection of many illnesses and diseases as they manifest similar symptoms. How will the Minister ensure the quality of diagnosis? Should something go wrong, how can patients seek help and redress?

This leads to another issue. Will doctors be held to the same standard for telemedicine? I think it is important that medical personnel and the patients have a clear understanding of their responsibilities and their rights for this nascent service.

I am also curious whether there will be pre-requisites before a doctor can proceed with the provision of tele-medical communication. For example, should the doctor and the patient have a pre-existing relationship, that is, the doctor had seen the patient in a face-to-face consultation at least once before?

(In English): Another concern is the prescription of medications. Will remote prescriptions be permitted and what is the Ministry’s assessment of the risks of abuse and fraud?

Since telemedicine can be practised wherever there is Internet connection, I would like to ask if this Bill will regulate cross-border consultations. Just as the Internet facilitates international trade of goods and services, will this occur in our healthcare? We can order almost everything from food to furniture, participate in courses, receive legal advice and accounting services online without taking a step out of our homes. Will telemedicine proceed similarly and what controls will the Ministry put in place to protect Singaporeans?

Next, I would like to enquire about the tightening of naming restrictions. Approval will be required for terms such as "Singapore" or "National" for new companies but existing entities do not have to make any changes to their names. In order to get around this constraint, new companies may buy out or take over existing ones with the coveted terms. This is a loophole which must be plugged. May I suggest that a certain time period, such as five to 10 years, be given to such companies to continue operating, after which the terms "Singapore" and "National" must be removed from the name, unless they receive fresh approvals from the Ministry.

With this, I conclude with my support for the Bill.

6.00 pm

Mr Murali Pillai (Bukit Batok): Mr Deputy Speaker, Sir, I support the aims of the Bill for the reasons articulated by the hon Senior Minister of State Mr Edwin Tong in his speech. I commend MOH for extensive public consultation on the Bill for two years before presenting it in Parliament.

I have five queries and I will take them in sequence. First, the scope of the definition of "healthcare services" under the Bill. Healthcare Services is defined under clause 3 quite widely and it also includes services provided not for reward. I would like to know if the intent is to also to "capture" services provided by voluntary welfare organisations (VWOs) or non-profit organisations (NPOs) running senior activity centres, eldercare centres and neighbourhood link centres.

As the hon Senior Minister of State knows, there is a wide diversity of services provided at these centres. Some focus on social well-being which is quite clearly outside the ambit of the definition. Where it gets a little more difficult is where elderly residents are offered frailty assessment, advice on physiotherapy or rehabilitation. Sometimes, this is done not just at centres but during house visits too. If the intention is to include these corporations, how many of these centres are not currently licensed under the PHMCA? What form of assistance can be given to these organisations to help them subscribe to the new licensing regime under HCS.

Next, suitability of key personnel running the licensee's business. Clause 23(1)(a) of the Bill provides that a licensee must ensure that every key appointment holder of the licensee is, in the opinion of the Director, a suitable person to act in that capacity in relation to the licensee. This is, as the hon Senior Minister of State mentioned, to ensure that high governance standards are observed. The wording in the clause however introduces a subjective test because the operative word is "the opinion of the Director". Not only that, in addition to the above requirement, under clause 23(1)(b), the licensee must also ensure that the composition of key appointment holders satisfies the skills and competencies requirements prescribed or specified in a code of practice.

In contrast, for the appointment of a Principal Officer or Clinical Governance Officer under clause 24, there is no requirement imposed to ensure that these officers are suitable in the opinion of the Director.

Clause 23(2) would allow the Director to direct a licensee to remove a key appointment holder who he is satisfied is either: (a) not suitable; or (b) does not possess the skills or competencies prescribed or specified. May I please ask why is it necessary to have a subjective test imposed under the clause? How will licensees be given notice of the Director's approach to the issue of suitability? How will appeals to the Minister on such decisions under clause 48 be determined? Would the Minister be able to revisit the issue de novo? Or should he decide based on the reasonableness of the Director’s opinion, even though he may personally disagree with it?

Next, how does the Bill assist in relation to ensuring that licensees adhere to reasonable levels of corporate governance and financial management to ensure that the entities are going concerns? Is it contemplated that the principal officer or key appointment holders take personal responsibility? This is the case in the financial services industry. The hon Senior Minister of State made reference to essential services in his speech. In the financial services industry, they have a senior manager's regime and key appointment holders have specific responsibilities. Or will it be a licensing condition imposed on the licensee?

Fourth, Exclusion of Traditional Medicine, Complementary and Alternative Medicine from licensing requirements under the proposed HCS. I understand from the Senior Minister of State that the decision is made, on a risk-based assessment, not to license these practitioners at this point in time. I also note that the TCM practitioners continue to be regulated under the TCM Act. However, there are other disciplines of traditional medicine, such as homeopathy or Ayurvedic medicine, which are not currently regulated. Bringing Traditional Medicine, and Complementary and Alternative Medicine within the HCS regulatory framework may promote integration of services with mainstream medicine which may be beneficial to patients.

The hon Senior Minister of State mentioned that the industry would be monitored on a risk-based approach going forward. I suggest the enlarging of the monitoring to also include an assessment of the potential for providing integrated services to patients.

Finally, regulatory burden and costs. I understand that during the consultation phase, there were fears expressed that there could be increased regulatory burden and fees. I further understand that the Ministry will not be collecting more revenue from existing providers. Hence, this Act is meant to be revenue neutral. May I please ask whether under the HCS, the regulatory costs attributable to the Government is anticipated to go up. If so, should it not be recovered from the licensees?

Notwithstanding my queries, I support the Bill.

6.06 pm

Mr Gan Thiam Poh (Ang Mo Kio): Deputy Speaker, Sir. This Bill is timely in view of the developments and breakthroughs in the medical sector. Technological advances are accelerating changes in how our healthcare services are delivered and the types of treatments available. The updated legislative framework will enable the Ministry to better govern our healthcare sector and ensure quality of care.

I have only one concern for this Bill and this is regarding the National Electronic Health Records (NEHR).

Going forward, all healthcare institutes, including laboratories, must input patient data into the NEHR. While this will ensure continuity in terms of treatment for patients and allow medical professionals to have a holistic grasp of their health conditions, there are also potential downsides. For example, if any physician were to arrive at an erroneous conclusion and make a wrong diagnosis, this may have an impact on subsequent consultations or any follow-ups by other medical practitioners referencing the patient's medical history. The consequence of such a mistake may be serious, leading to more issues down the line.

Would the Minister share what preventive measures are in place to minimise such incidents? In addition, I am also concerned about the security of the database and potential system failure. I would like to ask the Minister for an update on measures to boost the robustness and resilience of the NEHR.

With that, I would like to conclude with my support for the Bill.

6.09 pm

Mr Christopher de Souza (Holland-Bukit Timah): Sir, this Bill introduces a new regime of regulating healthcare services in Singapore. Previously, the Private Hospitals and Medical Clinics Act was the principal act governing the regulation of clinics and hospitals in Singapore. While it worked in a time where medical services were bound by space and time, an expanded regime is necessary with the advent of telemedicine and other similar healthcare services. Instead of licensing by physical location, the licences under this Bill are based on the kind of services provided.

Even though there is increased flexibility in the kinds of services that can be packaged under a licence, clause 29 prevents the public from being misled by the name of the healthcare service provider.

Also, as evinced by the First Schedule, not all healthcare services are licensable healthcare services. How will non-licensable healthcare services be regulated? This is important to protect those who may use or need such services. In this period of transitioning from the old regime to the new regime, how will the Ministry help healthcare providers whose services straddle, for some time, the old and new regime?

While this modular service-based system provides more flexibility, compliance with regulations may become more difficult as licensees need to look through more regulations to know which are applicable to them and which are not. The exercise may also increase the time needed to scan through a code of practice to pick up and implement relevant or salient points. Given enhanced regulation, how will the Ministry help to keep the costs of running healthcare services down? This is crucial as it was reported in June 2019 that healthcare cost inflation in Singapore in 2018 was 10 times that of the economic inflation rate.

Part 3 of the Bill also sets out positions the licensee has to have, that is, the Principal Officer and Clinical Governor Officer. The requirements for these will be set out in the code of practice per clause 23(1)(b). These positions do not appear in the Private Hospitals and Medical Clinics Act. How does the new system compare with the current system? Would the Minister please explain the rationale and thinking behind the structure and change to this governance model?

Also, in the course of my work as a lawyer, which I now declare, I have worked alongside CEOs of hospitals. They have much to deal with in the day-to-day running of the hospital and regularly attend to unprecedented situations. Given their plate is already so full, I would ask MOH not to require that the CEO of the hospital be the Principal Officer or the Clinical Governor Officer, and that the CEO be able, if appropriate, to delegate the role to a suitably qualified colleague.

Also, will current licensees with leaner manpower such as general practitioners struggle to meet this criteria?

Besides changing the mode of regulation from locale to service-based, this Bill also puts in place measures to ensure the quality of care provided. One such measure are committees. There are three committees mentioned in this Bill – the quality assurance, service review committee and the clinical ethics committee. The quality assurance committee is also present under the Private Hospitals and Medical Clinics Act. Sections 11(3) to 11(5) of that Act is similar to clauses 51(3) to (5) of the Bill. It provides that the quality assurance committee is not competent nor compellable to disclose information in court or produce documents requested or produced solely for the purpose of the quality assurance committee. This appears to be a form of privilege which protects information and reports, preventing them from being used in medical negligence lawsuits for instance. The quality assurance committee needs to be able to assess the true state of affairs with candidness and transparency, this provision allows healthcare service providers to be candid with them and work together with them to ensure that healthcare attains a degree of standard. As this committee is not novel, would the Minister share with us how well these committees have worked in the past regime and what can be done to improve its function in the new regime?

Another committee is the clinical ethics committee. Clause 26 requires a case to be referred to a clinical ethics committee where a patient is recommended to go for a service in a prescribed category. To prevent committee-shopping, clauses 26(3) and (4)(b) specify that a person must not provide the proposed prescribed service if any clinical ethics committee to which the individual’s case is referred is not satisfied that it is ethically appropriate.

Besides having committees, another measure designed to protect the public in the provision of healthcare services is step-in orders. From clause 33(1), step-in orders are used to prevent a disruption in care of the patients due to financial matters such as insolvency, lack of licence after a suspension or revocation, or where the licensee carries out things against public interest or in contravention of the Act. This order by the Minister allows partial or total takeover to protect the public's interest.

As the powers are intrusive and the threat of a step-in being invoked pre-emptively can cause uncertainty for all involved, would the Minister provide some examples to illustrate the severity involved in circumstances of public interest? Essentially, what is the threshold required?

In addition to the committees and the possibility of step-in orders, the Codes of Practice provided for under clause 38 allow for greater flexibility. This is particularly valuable where technology is rapidly changing.

Sir, similar to the current Private Hospitals and Clinics Act, the Bill also provides for powers of inspection, search and seizure and other investigative power. Clause 41(6) of the Bill did not appear in the Act and requires any person present at any premise to render all necessary assistance and cooperation for entry, inspection, investigation. This is especially important where the data or information is stored electronically. This is because in such circumstances, human assistance through the provision of passwords can greatly aid the speed and ease of accessing important information, allowing for better enforcement with less resources.

In conclusion, Sir, health is important to every person. Healthcare services are often not "good to have" but necessary. As healthcare services impact us directly, a good healthcare network is an important line of defence for the people of Singapore. This Bill changes the landscape and expands the horizon of the regulation of healthcare services. No longer bound by locale, this modular system provides more flexibility to adapt to rapidly-changing technology. Besides ensuring that our regulatory regime is able to cope with and harness the benefits of technology, this Bill also puts in place measures to protect public interest in the provision of healthcare. And therefore, I support the Bill.

Deputy Speaker: Senior Minister of State Edwin Tong.

6.17 pm

Mr Edwin Tong Chun Fai: Mr Deputy Speaker, Sir, I thank Members for speaking in support of the Bill, as well as for their constructive comments and suggestions. I thank in particular Mr Perera where he says that the Bill represents steps in the right direction. I will address the various issues raised by Members.

There have been several questions on the regulatory scope and the types of services that will be licensed. Let me address these points.

The Bill seeks to be clear and transparent in the scope of "healthcare services" that can be regulated. Our primary focus as we implement the Bill is on services that provide clinical care for a condition or a disease.

Mr Murali Pillai has asked if community-led initiatives, including those provided by voluntary welfare organisations (VWOs), will be in scope and be licensed under the Bill. And I think Mr Pillai mentioned senior care centres, for instance.

These entities, including Senior Activity Centres, provide services which are predominantly social in nature and they will, to that extent, not be regulated under the Bill. But sometimes these centres also provide services that are clinical in nature. For example, they might have a doctor located within the senior centre, and if the doctor is engaged to provide clinical services in that centre, then that doctor will require a medical clinic licence, or will have to be employed by a clinic licensee.

Ms Irene Quay, Prof Fatimah Lateef, Mr Christopher de Souza and Mr Melvin Yong asked for timelines on the licensing of allied health, mental health and traditional medicine services, as well as non-doctor-led home and community based services, so that the providers would have sufficient time to prepare for regulation.

Sir, let me be clear that there will be sufficient time and notice. Indeed, the framework for any regulation, even for these services which are yet to be in scope, will be as set out in this Bill. So, they will know the parameters and the landscape and rubric of the Bill, even before it applies to them.

Second, as to when these other services will be included, MOH will be adopting a calibrated and risk-based approach to progressively license healthcare services. We do not at present have any plans to license these services but will closely monitor the landscape. If significant patient risks, for example, emerge in these services, then we can decide to license these services, but as I said at the outset, the broad framework will already be as set out in this Bill.

In addition, before we move to regulate any new services, Members can be assured that MOH will engage and consult with the relevant stakeholders on the proposed standards to ensure that they are contextualised for that particular service. So, we might have the framework set out in this Bill, but for the particular types of services and spectrum of different services, the precise way in which they will come in might have to be contextualised. And we will have a programme to engage and to consult, before they are added into scope.

Ms Quay has asked why Government entities like SCDF-owned ambulances and SAF medical centres are excluded from the Bill's scope. As I have mentioned at the outset, these entities serve critical national functions and they do themselves come under separate internal governance structures and standards. I would add that Government entities providing healthcare services are subject to stringent internal standards, and in some cases, more stringent than what is being proposed by this Bill. Let me give some examples.

The SCDF serves highly-critical cases and they hold their services to higher standards. SCDF mandates a six-monthly paramedic skills certification test and quarterly Continual Professional Education sessions to improve and also broaden the knowledge, skills and competence of their emergency medical services crew.

In contrast, the draft ambulance Regulations require Emergency Ambulance Service Crew to attend lectures, simulation, practical sessions or clinical discussions at least once every six months and paramedics are required to be re-certified every two years.

For SAF clinics, all personnel are qualified according to national requirements. Medical officers are trained to national standards, and are also Singapore Medical Council (SMC)-registered with working experience in the restructured hospitals. There are regular refresher courses for staff, as well as regular audits for the clinics.

Dr Chia Shi-Lu asked for clarifications on how this new framework might deal with Third Party Administrators (TPAs) and medical concierges. The current scope is limited to regulating providers of direct healthcare services. TPAs and concierge services are principally administrative in nature – they are agents of the principal medical providers and are not engaged in direct patient care. So, they will not be licensed under this framework.

However, MOH is monitoring the patient safety risks and studying the landscape of these services further, before deciding on the appropriate framework, if any, to regulate these entities. If the licensing of TPAs and concierge services in some form is found to be needed, an amendment to the scope of this Bill can be made at the appropriate juncture to include them, again, with the appropriate contextualisation.

In the meantime, professional guidelines, such as the SMC's Ethical Code and Ethical Guidelines (ECEG), provide guidance for medical practitioners contracting with TPAs to ensure the objectivity of the medical practitioner's clinical judgement and the provision of the required standard of care. So, for Members who are familiar with the ECEG, you will know that advertisements are prohibited, save for certain circumstances set out; and at the end of the day, the judgement of the medical practitioner – how he looks at the patient, how he treats the patient – should be unimpaired and unaffected by any TPAs. Medical practitioners are ultimately responsible for their agents, if any; and if TPAs advertise licensable healthcare services, they would be subject to clause 31 of the Bill, and can only advertise on a licensee's authorisation and must comply with all relevant advertising rules.

Ms Quay also raised an issue on possible overlaps between the different Acts, and cited an example of hospital pharmacies being subject to both the current Private Hospitals and Medical Clinics Act (PHMCA) and in future this Bill, as well as the Health Products Act (HPA).

The HPA governs the position when a pharmacy serves walk-in customers or walk-in patients. In such a situation, where the patient is not coming from the hospital where he would have had a prescription and had been seen by doctors, different standards would apply. In fact, we would expect that different standards should apply.

If a pharmacy is part of a hospital and only serves in-hospital patients, then its licence will be part of the hospital's. The hospital being the primary licensee. The pharmacy would not need a separate one. Hence, I should clarify that the scenario that Ms Quay contemplates occurs only when a hospital pharmacy also chooses to serve walk-in customers in addition to serving the hospital's patients. That being the case, the pharmacy would be expected to abide by the retail pharmacy standards set out under the HPA.

That said, I have taken on-board Ms Quay's comments about the rationalisation and MOH and HSA will continue to streamline our processes to seek to avoid duplicative work by licensees to comply with the requirements of both this Bill as well as the HPA, including for tele-pharmacy services, and will no doubt consult with Ms Quay and the Society further on this point.

So, to give an example to Ms Quay, the 2019 Singapore Standard for Supply and Delivery of Medication is a common national standard for all healthcare providers and retail pharmacies if they want to supply and deliver medications.

Dr Chia, Mr Yong and Ms Joan Pereira have asked about services that will be regulated for the first time under the Bill – in other words, not previously or hitherto regulated, but introduced for the first time under this Bill – and these include services like telemedicine and ambulance services, and asked how these services will be regulated prior to the roll-out and implementation of this Bill.

To Dr Chia and Ms Pereira's questions on telemedicine, we should view telemedicine as an extension of the practice of medicine, provided through a platform different from the traditional clinic setting. Nonetheless, this is the practice of medicine and it remains regulated by existing standards such as the ECEG. In addition, the National Telemedicine Guidelines set out specific guidelines relevant to telemedicine that registered doctors and healthcare professionals would have to abide by.

I would reiterate that the broad principle is that doctors are expected to provide the same quality and standard of care as in-person medical care. The fact that there is now, or there could be, a more convenient medium by which the care is delivered or the patient is communicated with, should not be a reason in itself to lower that standard. The doctor should clearly indicate the limitations, in an appropriate case, of the telemedicine services at the start of the consultation, and might in fact need also to refer that patient to a face-to-face consultation if he forms the view that he is unable to take proper history, to assess the patient properly and to form a sufficient judgement in order to discharge his expected standard of care.

Moving forward, we will continue to refine the telemedicine regulations, have them tested, looked at and assessed in the context of the industry as well, to make sure that they are as appropriate and as relevant to the ground practice as possible. On this score, MOH has set up the Regulatory Sandbox to work closely with telemedicine providers to co-develop service-specific regulations. This will not only ensure that we remain in tandem with the practice of telemedicine, but that also patient safety and welfare would be adequately safeguarded.

Some Members have asked about cross-border healthcare services including the use of telemedicine. Let me clarify that the Bill does not have extra-territorial powers, but if the telemedicine provider provides services, from wherever he might be, where such services are received in Singapore, then those services must be licensed under the Bill, and all foreign doctors working for the provider of those services, must be registered with SMC.

There is, of course, this question of how do you enforce and how do you deal with potentially errant providers who exist outside of Singapore. MOH will continue to improve patient engagement and education on the benefits and some of the obvious limitations of telemedicine, including consuming healthcare services provided from abroad where, as I have said, oversight and regulatory enforcement is not as readily available, so that patients will know. They can make an informed decision as to which healthcare services to use or to consume for their treatment.

Mr Melvin Yong raised questions on licencing for new healthcare services, cutting edge healthcare services like through the use of artificial intelligence (AI). MOH is of course aware of the increasing role and importance of AI in healthcare. It is nonetheless an evolving area, and we are monitoring this space closely and also engaging the relevant stakeholders – those who develop the AI, those who use the AI – to try to find the best possible guidelines and also to develop them in tandem with the industry to assure patient safety.

Mr Melvin Yong made valid suggestions on the prospect of expanding the regulatory sandbox to these cutting edges areas to explore new frontiers and to test the boundaries, and to see what works and what does not work in the safe context of the sandbox. We will do so, so that we can then introduce these regulations after they have been found to be workable and, most importantly, safe for the patients.

Moving on to the private ambulance sector, Dr Chia Shi-Lu, Ms Sylvia Lim and Mr Melvin Yong raised questions about this. As Mr Melvin Yong mentioned, it is an area that was not previously regulated. As such, progressive efforts have been made to ensure that private ambulance operators will be able to ramp up and be regulated under this Bill. The point is, if overnight, everyone is subject to this Bill, you might then find, as I think one of the Members mentioned, some questions as to whether every ambulance operator will be able to deliver the same level of services. So, we take a more gradated and calibrated approach on this. Let me just elaborate on a couple of the measures.

In 2017, we issued standards for emergency ambulance and medical transport services so that operators will have clarity on the regulatory requirements that they must meet. This process where we expect to see ambulance operators come into scope in the second phase, in fact, started some years ago so as to socialise these requirements to them, to acclimatise them to the standards that they would have to meet.

MOH recognises that private operators may require support to ramp up their capabilities and to meet these standards. Hence, a year later, in 2018, the Voluntary Accreditation Scheme (VAS), which Ms Sylvia Lim referred to in her speech, was launched to help familiarise private operators with the applicable standards for clinical governance, for personnel, and also for vehicles early, so that steps can be taken to raise the clinical service standards, and they know what the benchmark and the bar would be. Further, training schemes have also been introduced and facilitated by MOH to upskill the existing manpower to meet the new requirements for paramedics and also emergency medical technicians.

At present, more than 50% of private ambulance operators have come on-board the VAS. MOH will continue to work with other operators to prepare their vehicles, as well as skilling up their manpower. As such, ambulance services will be licensed in the second phase, as I mentioned at the opening speech, of implementation, and ambulance operators under VAS will be seamlessly ported over as licensees under the HCS Bill.

Dr Chia Shi-Lu and Ms Sylvia Lim asked questions about costs and fees of private ambulance operators. We understand and we share those concerns. MOH will be working with the VAS ambulance operators to develop and publish an appropriate range of fees charged, so that consumers can have more transparency and can better make up their minds and have informed choices of the providers to use. We intend to publish those fees before these ambulance operators are phased in under the second phase. And, in fact, we target to do so in the course of this year.

Prof Fatimah Lateef, Mr Christopher de Souza and Mr Melvin Yong have asked how the Bill impacts existing PHMCA licensees and whether its requirements to enhance governance will place an unnecessary burden on licensees.

Members will, of course, know that that is not the intention of this Bill. But at the same time, healthcare services, especially those that are newer, will need to be properly regulated. The rationale for introducing the enhanced governance requirements is to ensure that the licensees are well managed, so that they can effectively and safely serve their patients' needs.

At the same time, we recognise that the scale and complexity of licensees and the kind of services that they offer, the scale of their operations and their set-up will differ. The requirements will, therefore, be attenuated to take into account the nature of the licensee's business, so as not to unnecessarily increase regulatory burden on all of them in equal proportions.

Let me first address the queries from Mr Melvin Yong and Mr Christopher de Souza, and I think, indeed, also from one or two other Members, about the officeholders stipulated under this Bill.

The Bill requires all licensees to appoint a Principal Officer (PO), and certain licensees providing more complex and technical services must also appoint a Clinical Governance Officer (CGO). The PO is akin to the manager appointed by the licensee under the present PHMCA regime and is responsible to assist the licensee in ensuring compliance with the requirements of this Bill. The PO is required to have sufficient organisational authority and management skills to adjust operations and make decisions, while the CGO is intended to oversee the technical and clinical aspects of the service. MOH will be satisfied as long as the PO and CGO are able to discharge their duties appropriately and we will not require specific personnel, such as the CEO, to be the PO or CGO in each case. Similarly, for small GP clinics that likely do not provide any complex specialised services, one individual can fill the role of the licensee and the PO, and a separate CGO will also not be required in those cases.

Mr Murali Pillai queried on whether there are objective criteria to determine the suitability of key appointment holders. Mr Murali Pillai would have seen clause 2(3) of the Bill which sets out the factors that will be considered in deciding whether a person is suitable to be appointed as a key appointment holder, PO or CGO. It provides, what I would regard as the no-fly zones, the broader outliers. So, there is financial suitability, there is the question of whether there is a prior conviction, antecedents and so on. But, at the same time, we also do not want to be overly prescriptive in the quality of the candidate that comes forward. So, to that extent, there is an interplay between the criteria that are set up here and what the Director of Medical Services might subjectively determine as to their suitability in each case.

We also intend to provide clear guidance of instances where persons will be found to be unsuitable, so that licensees will be apprised of the applicable criteria. This can be done through regulations and, as Members know, clause 38 of the Bill also provides for a Code of Practice as regards the relevance of all licensees to these requirements. It can be published in the Code as well.

Should a licensee appeal to the Minister against any decision to reject the appointment of his key appointment holders, the PO or CGO, the Minister will consider each case based on its own facts. I think Mr Pilliai raised the point about the appeal and how the Minister will consider it. Clause 48(7) (b) of the Bill, which provides for appeals to the Minister, allows the Minister to vary, substitute the decision of the Director, as the case might be appropriate, upon the appeal.

As for Mr Murali Pillai's point on ensuring that key appointment holders are competent in corporate governance and financial management, we agree. That is the reason really to ensure there is a PO and a CGO that deal with the technical and clinical aspects of the practice. And MOH plans to include such requirements in the Code of Practice, as I have said, under clause 38 of this Bill, which will guide licensees with a bit more specificity on the levels of skill and competencies required. But as I have said, at the same time, not being overly prescriptive so that it becomes something that you just have to tick all the boxes. That is not the intention.

Mr Christopher de Souza and Prof Fatimah Lateef have asked for details on specified committees for quality assurance and clinical ethics. I believe Ms Sylvia Lim also raised questions on the quality assurance committees (QACs). Let me deal with those questions.

QACs are already an existing requirement under the current PHMCA. They provide a protected environment, as Mr Christopher de Souza said, without prejudice, for healthcare professionals to be open about an adverse event to identify the problems, learn from it, and correct errors without fear of being sued based on the materials that are discussed there or the discussions or candid sharing at those occasions. Through the learning environment that the QACs foster, proper root-cause analysis can be conducted and professionals can come up with solutions that will prevent the recurrence of such errors. That, after all, is the intention.

Over the years, QACs have served their functions well in reviewing adverse clinical events. Ms Sylvia Lim asked specifically on the functioning of the QACs – how they are performing, and whether, ultimately, they will provide proper oversight of the way in which procedures are handled or the way in which patients might then raise complaints. I think I heard Ms Sylvia Lim mentioned also the case of Prof Lim that went before the Court of three Judges a few months ago.

The QACs' function is in reviewing adverse clinical events and recommending initiatives to improve the quality and the standard of care. That is quite different, and it does not affect the other avenues available to a patient, either through SMC's disciplinary proceedings or, should the need arise, for civil compensation under the civil Courts. Those still exist and nothing in this Bill prejudices that or changes the options available to a patient. Therefore, the oversight of a case or oversight of professional misconduct or conduct of a medical practitioner still falls with the SMC and the rubric and the regime that are there still exist. The QACs exist separately and, as I have explained, for a different purpose and outcome.

The Clinical Ethics Committees (CECs) have a different role to play. They review ethically-challenging cases and ensure that ethical care and treatment are provided in the context of the facts of that case and the treatment, modality or options that have been considered. There will be a list of prescribed medical treatments that require CEC review, where the care management of patients is likely to be complex; where societal values could be either undermined or challenged; and where the values of the medical practitioners might be challenged as well.

To give some examples to Members of what we have in mind, for instance, where there is a proposed surgical separation of conjoined twins, that will be something that the CEC should review. Or, for example, in the creation of a saviour sibling to save one sibling, that should also be considered by the CEC. Those are relevant matters that fall within the rubric of both clinical as well as ethical considerations that the CEC would be well-placed to review.

Next, let me talk about the step-in mechanisms and employment restrictions which various Members have raised.

As I have mentioned at the outset, the rationale for these powers is, ultimately, to protect patients and ensure that they receive not only appropriate but also continual care, notwithstanding the performance of the healthcare service provider.

Prof Fatimah Lateef, Mr Christopher de Souza and Mr Louis Ng raised queries as to when the step-in powers could be triggered. They will be triggered when it is in the patient's interests to do so. Ultimately, of course, that is a multi-faceted and dynamic assessment of the facts in each case. We would like to, however, assure the House that the step-in powers will be activated sparingly and as a measure of last resort for the specified licensees.

Other alternative measures as may be appropriate in the circumstances – like penalties or warnings if the situation is not at a sufficiently grave stage, or the appointment of a new management team to rectify the issues – these are measures which could be considered, and within reason, before a step-in order is made. Licensees will be given an opportunity to make written representations before the step-in order is activated, unless it is an extreme case where an expedited or urgent step-in order is required.

These powers can make a real difference in protecting patient safety and ensuring the continuity of care. For example, there may be cases of certain specified service providers with financial difficulties who may find it difficult to afford to continue its services and patient care. This, in turn, translates into undermining the safety of patients and adversely affecting their welfare.

Members would know that under the existing PHMCA, MOH can only take regulatory actions, such as revoking or suspending the licence, which was not feasible given that this would interrupt continuity of care for the resident patients.

Under the Bill, step-in powers will now enable MOH to intervene in the operations instead to address the problems and improve continuity of care for patients. MOH will also "step-out" once the service is stabilised and patient safety is assured.

On Mr Melvin Yong and Ms Irene Quay's queries regarding the restriction on employment of certain individuals in long-stay settings, the mandated background checks are to be conducted by licensees on all prospective staff, and existing employees will not be affected. The objective of the check is to prevent individuals who have committed egregious crimes – it might be causing hurt, grievous hurt, or more serious crimes like rape – from being employed and potentially harming vulnerable patients in these settings.

For foreigners – and I think some Members asked about the efficacy of this regime for foreigners – the background check really would have to be on a best-efforts basis, as and when information arises and can be determined.

Dr Chia Shi-Lu, Mr Louis Ng and Mr Gan Thiam Poh have asked for an update on the measures, including cybersecurity measures, to assist licensees in protecting health information in their electronic medical records. And Ms Irene Quay also asked when MOH would be mandating contribution of patient health information to the National Electronic Health Record (NEHR). I think one of the Members calls it the "elephant in the room" that is actually not in the Bill. And, indeed, it is not in the Bill. Let me, however, take some time to just assure Members and address some of these concerns, nonetheless.

First, clause 27 of the Bill requires licensees to implement measures to protect their medical records and ensure that the records are accurate and remain up-to-date. As MOH encourages more licensees to digitalise their medical records, we will also be working closely with the licensees to study further ways to safeguard the collection, storage, access, use and, of course, sharing of health information.

This will no doubt include developing cybersecurity guidelines specific and customised to the various healthcare services and exploring efforts to better support smaller healthcare providers as they take steps to improve their cyber and data security positions. We will be engaging the licensees on this effort and will be releasing more details on this in the first half of 2020.

As for NEHR, Dr Chia Shi-Lu asked if this would represent a mortal blow to NEHR. It does not. But, nonetheless, MOH will want to ensure that all necessary safeguards are in place to handle the evolving cybersecurity threats and also ensure that where various cybersecurity reviews for the NEHR have been commissioned, the appropriate enhancements would be made to the system.

As such, as has been announced previously, the mandatory contribution to the NEHR has been deferred until all the enhancements have been completed, and we are satisfied that the system is assessed to be sufficiently robust. MOH will make further announcements on this at the appropriate juncture.

Next, let me turn to queries raised by Prof Fatimah Lateef and Ms Irene Quay on the co-location between licensed and unlicensed services.

As I explained at the opening speech, the prohibition on the co-location is to prevent parties from being misled into consuming the unlicensed services under the impression that it is part and parcel or adjunct to the licensed services. This is no different from the current position under the present PHMCA.

However, where the services are complementary to each other between the licensed and the unlicensed services, some examples I mentioned earlier, this concern is mitigated. And in these circumstances, we will be prepared to make an exception for certain healthcare professionals to co-locate with licensees. So, for example, a physiotherapist can co-locate with an orthopaedic clinic, so that more holistic services can be provided, such as in that case. In other circumstances, we will review on a case-by-case basis.

The Bill also contains other measures which will assist patients in making informed decisions when selecting healthcare services.

So, Ms Irene Quay cited the register of licensees in clause 22 of the Bill. This register will be accessible by the public, making it easy to check, for them to determine if a provider is, in fact, licensed by the MOH or not.

Er Dr Lee Bee Wah and Mr Melvin Yong asked how we can prevent patients from being misled by unqualified providers into thinking that they are qualified when they are not and then go and seek their services.

First of all, the licensee is responsible for ensuring that their personnel, all their personnel are appropriately qualified and competent. If a licensee permits unqualified personnel to provide healthcare services, MOH could investigate and take the appropriate regulatory actions.

Second, clause 31 plays a part by limiting advertising of licensable healthcare services to licensees only and, as I mentioned at the start, to persons acting on the authority of a licensee.

Third, clause 37 allows MOH to publish information to ensure patient welfare, or for public interest, and this includes publishing a list of unlicensed providers.

That said, ultimately, public education will play an important role to prevent or reduce and, as far as possible, remove all of such mis-impressions. MOH has and will be enhancing efforts, as we implement the Bill, for public education. When in doubt, I would advise patients to check on the registers maintained by the professional boards, such as SMC.

Mr Melvin Yong raised a query on the regulation of mental health professionals. Professional associations, such as the Singapore Psychological Society and the Singapore Association for Counselling, provide advice on trained professionals in their respective fields. So, the scenario that Mr Yong is trying to avoid – where there is doubt as to whether someone is a counsellor or not, whether he is a psychologist or not – the associations can provide further avenues for assistance.

Ms Joan Pereira and Prof Fatimah Lateef have given useful comments on other Bill requirements, such as naming restrictions and point-of-care tests. We will consider these in implementing the Bill. And I would add to Ms Joan Pereira's point that should an entity today already be using one of these otherwise prohibited names, if the licensee does not change, the ownership does not change, and it is simply carried over into the new Bill, we will be prepared to allow them to continue using the name. But, of course, that will have to be revisited if they either sell the business or change the ownership in a material way.

Next, let me turn to healthcare costs which several Members, including Dr Chia Shi-Lu, Mr Leon Perera, Er Dr Lee Bee Wah and Mr Christopher de Souza, have raised. Concerns regarding the impact of the Bill on healthcare costs and, of course, passing on of these costs to the patients were raised, and I think those were valid concerns. Let me address them.

Let me start by saying that no single measure can really tackle the issue of healthcare affordability and I have taken on board Mr Perera's various suggestions. I will address them in a moment.

For now, let me just very quickly outline the various initiatives that have been done to keep healthcare costs low and sustainable for all Singaporeans. As I had mentioned, we adopt a multi-tiered approach – multi-tiered, multi-pronged, and I would say also multi-faceted approach – to controlling costs, with the basic assurance that no Singaporean would be denied access to basic healthcare due to financial difficulties. That is the assurance that would be given. The multi-tiered approach that we take will include enhancing the 3Ms – which we have done at various stages and which we will continue to do – MediSave, MediShield Life and MediFund; and also extending significant subsidies, including the CHAS scheme.

Looking ahead, we are also enhancing the role of insurance in long-term care, such as with the launch of CareShield Life from mid-2020.

We have also put in place other measures to curb the increase in healthcare costs. These include requirements under Integrated Shield Plan insurers for new rider plans. We have also developed and published fee benchmarks, as Mr Perera himself noted, for private sector professional fees for common surgical procedures.

Finally, the Agency for Care Effectiveness also publishes guidances on clinically and cost-effective patient care. Mr Perera no doubt has cited a number of different studies. I think, at various juncture he mentioned studies from various places, data published from various sources, some experts speaking at a conference, delivering a paper and some results from programmes and studies somewhere. I am not prepared at this stage to agree to the conclusion of these studies because they need to be contextualised. We need to look at the details, we need to look at who studied it and what the assumptions might be. If Mr Perera would be happy to share these studies and the other details that he had mentioned in his speech with us, we can do a more careful study and look at the options open in terms of adopting some of these measures in Singapore.

But where I think we are on common ground between Mr Perera and the Bill, is the need to ensure that we promote price transparency. As Mr Perera mentioned at the outset, indeed, that is specifically provided for in the Regulations. The Bill supports this by seeking to improve price transparency, such as requiring licensees to display common charges; by mandating financial counselling and itemisation of bills for certain settings, such as procedures conducted by hospitals or specialist clinics; and also establishing the Service Review Committee to monitor utilisation and clinical outcomes of certain high-cost and more complex services, such as proton beam therapy, for example, to ensure that not just is the care provided appropriate but it is also cost-effective, to take into account and to assuage Mr Perera's concern that not all high cost procedures are necessarily good quality procedures and, perhaps, not all good quality procedures are also at the same cost-effective level.

So, all these factors, they operate dynamically and they all have to be taken to account, depending on the nature of the service that has to be delivered and, of course, the patient's safety and the requirements of each individual patient as well.

Mr Deputy Speaker: Senior Minister of State Edwin Tong, are you likely to wrap up within the next five minutes?

Mr Edwin Tong Chun Fai: Yes, I am. May I continue?

Mr Deputy Speaker: Order.

Debate resumed.

Mr Deputy Speaker: Senior Minister of State Edwin Tong.

6.57 pm

Mr Edwin Tong Chun Fai: Thank you, Sir. Sir, the point that Members raised about cost and that it be not transferred, ultimately, to patients is a point that we are indeed concerned about. To give one example, to reduce the administrative workload for all existing providers as we implement the Bill, MOH conducted extensive stakeholder engagements – part of what we did in that two years leading up to the preparation of this Bill – to understand and do a deep dive of their licensing needs and map these, as far as possible, to the new Bill licences and the requirements in this new regime.

On Dr Chia Shi-Lu and Mr Christopher de Souza’s query on how we will help providers, specifically the smaller ones, transition from the current PHMCA to the future HCS Bill, let me assure the House that MOH will support and guide all licensees to ensure a seamless transition to the new licensing regime.

This will be done at each implementation phase, where PHMCA licences will be swapped out for equivalent licences under this Bill, without the need for existing licensees to file any applications or pay additional fees.

MOH will continue to provide clear instructions and appropriate channels for stakeholders to ask questions, clarify their doubts or come and seek assistance from us on the transition to the new regime.

Various Members – Dr Chia Shi-Lu, Prof Fatimah Lateef, Mr Christopher de Souza, Ms Irene Quay, Mr Murali Pillai, Mr Melvin Yong and also Dr Lee Bee Wah – have asked how this Bill impacts operating costs and in particular whether licensees will pay more fees as a result of the new landscape. Again, let me assure the House, and I think one of the Members said, and I echo that, that this is not intended as a revenue generating mechanism. It is necessary because of the measures that I have set out at the opening speech, that the new regulatory landscape is necessary to deal with evolving changes to the healthcare landscape. MOH would not, under this new regime, overall be collecting more licensing fees on an aggregate basis, compared to the position today.

The general principle is that licence fees are pegged at a level commensurate with the cost of manpower and resources incurred from the expected inspections and the audits to be done. MOH has and will continue to streamline our licensing processes to keep our regulatory costs down, as well as reduce excessive regulatory burden on licensees.

In fact, based on our preliminary assessment as we map the services across to the new HCS Bill requirements, based on our assessment, more than 95% of existing providers today will see either no change or a decrease in the amount of fees that they will have to pay. So, there is really no reason or basis for providers to pass on any of these costs to patients. The remaining providers who will see an increase are mainly providers who will be providing new licensable services regulated under this Bill.

For existing providers facing higher fees, MOH will put in mitigation measures to support the transition and this would include implementing the increase gradually over three licensing renewal cycles. So, we will space out as far as possible the increase, spread it out over three renewal cycles.

Sir, let me conclude. The Bill introduces a regulatory regime that is sufficiently nimble and flexible to protect patient safety and welfare, but at the same time, take on board the rapidly evolving changes to the healthcare landscape. At the same time, it will accommodate new healthcare services, new care models and also nurture innovation. This will ensure that healthcare services provided in Singapore will be able to address the existing and also the future needs of our population.

Sir, I beg to move.

7.01 pm

Mr Deputy Speaker: Well done, Senior Minister of State, you have kept it within five minutes.

Question put, and agreed to.

Bill accordingly read a Second time and committed to a Committee of the whole House.

The House immediately resolved itself into a Committee on the Bill. – [Mr Edwin Tong Chun Fai].

Bill considered in Committee; reported without amendment; read a Third time and passed.