PUBLIC CONSULTATION ON DRAFT HEALTHCARE SERVICES BILL
The Ministry of Health (MOH) invites you to provide feedback on the draft Healthcare Services (HCS) Bill (refer to attached draft Bill). The HCS Bill will replace the current Private Hospitals and Medical Clinics Act (PHMCA).
2. This consultation exercise will take place from 5 Jan 2018 to 15 Feb 2018. You may provide your feedback at www.hcsa.sg
. Your responses will be kept confidential and used only for the purpose of formulating the new Bill. We will consolidate and publish a summary of the feedback provided as well as our responses, after the close of the consultation exercise.
RATIONALE FOR A NEW HEALTHCARE LEGISLATION
3. The PHMCA was enacted in 1980 and last amended in 1999. It was designed to ensure patient safety through licensing of physical premises delivering healthcare, such as hospitals, medical clinics, clinical laboratories and other healthcare establishments.
4. In recent years, there have been significant changes to the healthcare landscape in Singapore. Our ageing population and increased chronic disease prevalence have led to a growing need for new care models and coordinated team-based care across healthcare settings and providers. Advancements in medicine and health technologies have given rise to new and fast changing healthcare services. Where almost all healthcare services were provided from physical “brick-and-mortar” locations in the past, there are now new services delivered wholly or partially through mobile and online channels.
5. MOH intends to replace the PHMCA with the new HCS Bill. In addition to better safeguarding the safety and well-being of patients in the changing healthcare environment while enabling the development of new and innovative services that benefit patients, it also strengthens governance and regulatory clarity for better continuity of care to patients, and addresses wider issues of patient welfare.
KEY FEATURES OF THE HCS BILL
6. The main features of the draft HCS Bill, and changes from the PHMCA, are as follows:
A) Broadened Scope Of Coverage
7. Under the HCS Bill, the regulatory scope will be broadened to include healthcare services (refer to Annex A for definition), allied health and nursing services, traditional medicine, and complementary and alternative medicine (Figure 1). Beauty and wellness services will not be included in the scope of the HCS Bill, as such services do not involve the assessment, diagnosis, prevention, alleviation or treatment of a medical condition or disorder.
8. MOH will be adopting a risk-based regulatory approach. While allied health and nursing services traditional medicine and complementary and alternative medicine are within the scope of the HCS Bill, MOH will not be licensing these services for the moment. Professionals such as physiotherapists and traditional Chinese medicine practitioners will continue to be regulated through existing Professional Acts1 to ensure patient safety.
Figure 1: Proposed scope of the HCS Bill
B) Services-Based Licensing
9. Healthcare providers will be licensed based on the type of services they provide. This is a change from the PHMCA where providers are licensed based on physical premises. The healthcare services to be licensed will be grouped into six broad categories as shown in Figure 2 (refer to Annex B for detailed definitions).
Figure 2: Services-Based Licensing Framework under the HCS Bill
10. Standards required for each licensable healthcare service will be stipulated in their respective Regulations. To allow selected licensees to provide simple diagnostic tests without the need for a separate clinical laboratory or radiological service licence, MOH will be defining a list of allowable point-of-care-tests (POCT) in the Regulations.
C) Competent Governing Bodies
11. To ensure effective governance and good leadership, clause 19 of the draft Bill requires the governing body of a healthcare service to possess the competence and skills to carry out its role. In the case of Boards that comprise different individuals, this can be met collectively by different members of the Board. Details will be promulgated in Regulations. The Third Schedule of the HCS Bill will state criteria identifying when a person is not fit to hold a licence or act as a member of a governing body of a licensee.
D) Refined Roles And Responsibilities Of Key Personnel
12. Governance and oversight of healthcare services will be strengthened with the enhanced roles for the Principal Officer (PO)2 and the appointment of a Clinical Governance Officer (CGO) for selected services, in addition to the licensee (see clause 20 of draft Bill). The roles and responsibilities of these key personnel are summarised in Figure 3. The same individual can function as the licensee, the PO and CGO for different service licenses, as long as the individual can fulfill all relevant requirements and can perform all roles adequately.
Figure 3: Roles and responsibilities of key personnel
E) Committees for Clinical Quality and Medical Ethics
13. Current PHMCA requirements for Quality Assurance Committees (QACs) for selected licensees will remain (Annex D). The QAC’s role is to monitor the quality of care within healthcare service. To enhance the quality assurance process, changes will be made to the QAC. A suitably qualified and competent individual will be designated to oversee quality assurance processes in a licensed service. The same individual will be allowed to serve as a member of two or more QACs in different institutions to facilitate cross-institutional learning.
14. A new requirement for Service Review Committees (SRCs) will be instituted for selected services or programmes that are deemed higher-risk, more complex or of greater public interest (see Annex E for list of services). The SRCs will review utilisation patterns, effectiveness, risks and benefits of these services (clause 28). Key functions of SRCs can be found in clause 29 as well as elaborated in Regulations.
15. Service Ethics Committees (SECs) will be made mandatory for selected licensees (clause 34, Annex F) to ensure that patients are treated in an ethical manner before certain complex and high-risk medical treatment can be conducted. This requirement is adapted from existing PHMCA requirements for hospitals where approval from ethics committees must be sought for similar procedures. The list of medical treatment that will require SEC referral and review will be determined based on advice from the Academy of Medicine and the National Medical Ethics Committee, and will be stipulated in the Regulations.
F) “Step-In” Safeguards For Residential Care Services
16. To protect patients against abrupt discontinuation of residential care services3, MOH will be empowered under a new provision in Part 4 of the HCS Bill to ‘step-in’ and assist in the operations of failing healthcare services where necessary. This is a transitional measure until patients can be transferred to other service providers. These powers will be exercised as a last resort after measures such as penalties, warnings, or appointment of a new management team have failed. There will be an appeal mechanism for licensees aggrieved by the step-in decision.
G) National Electronic Health Record (NEHR)
17. Licensees will be required to contribute to the National Electronic Health Record (NEHR) (refer to Annex G). The NEHR is a key enabler for better coordination and continuity of care and patient safety. As more patients have complex needs requiring coordinated care across providers, the NEHR enables their health record to follow them regardless of where they seek treatment. Their records will not be lost should a provider cease operations. The NEHR also supports better assessment and decision making among healthcare professionals through access to a patients’ medical history. In an emergency, timely access to medical records saves lives.
18. Contribution to the NEHR will be implemented in phases (refer to Annex H). Only core data set containing critical patient health information will need to be uploaded via the NEHR (clause 45 of the HCS Bill and Annex I).
19. Safeguards will be put in place to ensure that patients’ NEHR records are kept confidential. The NEHR can be accessed only for purposes of patient care, and not for other purposes including assessment for employment and insurance. Measures, including the provision of access logs to patients and regular audits on NEHR access, will be instituted to protect against illegitimate access. Penalties will be imposed for unauthorised access.
H) Options For Patients Who Do Not Wish To Participate In NEHR
20. All patients will by default have their specified health data contributed to the NEHR. This is the best way to safeguard patient safety and ensure coordination and continuity of their care.
21. Patients who do not wish for their records to be accessed via the NEHR may opt-out. They will be advised of the implications, including in emergency situations, as healthcare providers will not be able to access their past healthcare information through the NEHR. Patients who have opted out will continue to have their information uploaded to the NEHR, but with access blocked (i.e. no healthcare providers can access their NEHR record). This will allow past information to be unlocked should the patient choose to opt back in at a later point in time.
22. A small number of patients who have opted out may prefer not to have their information uploaded to the NEHR. This can be considered on a case-by-case basis. As the impact of incomplete NEHR records is irreversible, these patients will be advised on the consequences. They will have to accept that their future care could be compromised even if they choose to opt back in subsequently due to permanent gaps in their NEHR records.
I) Powers To Obtain And Publish Information
23. Existing PHMCA powers will be enhanced to enable MOH to gather data for purposes of patient safety, care and welfare, as well as public health interest (clause 66). This may include national surveillance for the prevention of public health emergencies and safety monitoring for newer services.
24. MOH will also be authorised to publish information about non-compliant licensees and unlicensed providers (clause 67). This will improve public awareness and enable patients to make better informed decisions.
J) Prohibition of unsafe practices, services and employment restrictions
25. MOH will explicitly prohibit the provision of medical practices and services that has caused or may cause harm to patients (see clause 69 and 70 of the HCS Bill). These powers are adapted from existing powers under the PHMCA. In addition to powers to direct a specific service or practice to cease, the list of specific practices and services that are prohibited will be listed in a Schedule (Annex J). This list will be reviewed with relevant experts and updated on a regular basis.
26. To ensure the safety and well-being of vulnerable patients, there will also be provisions in the regulations to impose restrictions on licensees employing staff to work in healthcare services that cater to frail or vulnerable patient groups such as long term residential care, mobile medical and the Institute of Mental Health.
K) Measures to Minimise Public Misperception
27. Existing naming restrictions under the PHMCA will be amended (clause 81) for better clarity to patients on the healthcare services provided. Licensees will be prohibited from using terms that connote a national body, such as ‘National’ or ‘Singapore’, unless explicit approval from the Director of Medical Services is obtained. Licensees will also be prohibited from using names of services that they are not licensed for4. Persons who are not licensees will be prohibited from using names that create an impression of providing licensable healthcare services. These restrictions on naming will be imposed on new business entities. Existing entities will not be affected.
28. Similar to the PHMCA, clause 82 of the HCS Bill places restrictions on the provision of licensable healthcare services together with other un-related or unlicensed services at a premise or a conveyance. Services or activities unrelated to such licensable services must be situated in a separate premise or conveyance.
29. Publicity controls will be tightened. Persons who are not licensed will be prohibited from advertising healthcare service claims (clause 83). Only authorised persons such as licensees, and their appointed agents will be allowed to advertise such claims. Allied health professionals listed in the First Schedule of the Allied Health Professions Act, registered optometrists and opticians as well as registered Traditional Chinese Medicine Practitioners will be exempted from this prohibition, as they are required to advertise within the scope of their professional activities and are subject to the regulatory controls under the Medicines (Advertisement and Sales) Act (MASA). Phase 2 and 3 HCS Bill licensees (ref para 31) and who are not currently PHMCA licensees (e.g. mobile medical) will also be exempted from this clause in the interim, until they are licensed under the HCS Bill. They will be subjected to the regulatory controls of the Medicines (Advertisement and Sales) Act and the relevant professional Acts.
L) Penalties under HCS Bill
30. The penalties for offences will be updated and aligned with comparable offences under other recently enacted legislations. Annex K contains a full list of penalties in the HCS Bill.
TRANSITION FROM CURRENT PHMCA TO NEW HCS BILL
31. MOH plans to enact the HCS Bill in the second half of 2018, following which the Act will be implemented in three phases:
(i) Phase 1 (From Dec 2019), existing PHMCA medical and dental clinics, as well as clinical laboratories will come under the new legislation.
(ii) Phase 2 (From June 2020), all PHMCA-licensed hospitals and nursing homes will come under the new legislation.
(iii) Phase 3 (From Dec 2020), new services such as Telemedicine and Sterile Pharmaceutical services etc. that have not been regulated under PHMCA will come under the new legislation.
32. Please refer to Annex L for the full list of services that will come into force at each phase. All existing PHMCA licences will be automatically converted to HCS Bill licences.
33. Your feedback on the draft HCS Bill is important to us. We look forward to receiving your feedback.
34. Thank you.
1Allied Health Professions Act and Traditional Chinese Medicine Practitioners Act
2Currently designated as Manager under the PHMCA.
3Acute hospitals, community hospitals, nursing homes, and inpatient palliative care services
4For example, a clinic will not be allowed to use the word “hospital” in its name.