On 6 January 2020, the HCS Bill was passed by Parliament. It is the outcome of extensive consultation two years in the making, with public consultation on the draft HCS Bill undertaken from 5 January 2018 to 15 February 2018, followed by its First Reading in Parliament on 4 November 2019.
The HCSA is set to replace the current PHMCA. It is a timely and much welcomed change from the current healthcare licensing regime under the PHMCA, which was enacted in 1980 and last amended in 1999. Since then, advancements in medicine and health technologies have drastically transformed the nature of healthcare services. Key changes include the growing range of medical services in the market and the increasing use of online platforms in the provision of such services.
The HCSA seeks to address such changes by:
(a) introducing a services-based licensing regime for providers of healthcare services, replacing the premises-based licensing regime under the PHMCA
(b) strengthening the safeguards for the safety and welfare of patients who receive healthcare services
(c) improving the governance requirements for providers of healthcare services, including the requirements for the board of directors and key management personnel of these providers; and
(d) enhancing the 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.
To give service providers time to meet new regulatory requirements, the HCSA is intended to be enacted in three phases, from early 2021 to the end of 2022. The new provisions will first apply to current PHMCA laboratory licensees (Phase 1), followed by current PHMCA clinic licensees and ambulance services (Phase 2), and lastly current PHMCA hospital licensees and other newly regulated services (Phase 3).
Key Changes Under the HCSA
From Premises-Based Licensing to Services-Based Licensing
Currently, licensing under the PHMCA is based on the physical premises of the healthcare provider. Under the HCSA, healthcare providers will be licensed based on the type of healthcare service they provide instead, with licensing conditions tailored to each type of healthcare service. The healthcare services to be licensed will be grouped into six broad categories: clinical support services; ambulatory care services; hospital services; long-term care services; non-premises based services; and specified services. Across the six-broad categories, healthcare providers can choose to take up to 25 different licenses based on the suite of services that they wish to provide. This can range from basic hospital services to nursing home care to non-premise based services like telemedicine and ambulance services.
The standards required for each licensable healthcare service will be stipulated in their respective regulations. The HCSA also covers non-premise based services for the first time. This means that these industries will now have to comply with regulations that will spell out standards regarding training and capability. The Ministry of Health (“Ministry”) will also define a list of allowable point-of-care-tests in the regulations for selected licensees, to provide simple diagnostic tests without a separate laboratory or radiological service licence. Shook Lin & Bok LLP Client Update | Healthcare 2
Broadened Scope of Coverage
Advancements in medicine and health technologies have drastically transformed the nature of healthcare services in Singapore.
To keep up with such developments, as a recap of our earlier update published in February 2018 (accessible here), the scope of healthcare regulation will be broadened under the HCSA to include allied health and nursing services, traditional medicine, and complementary and alternative medicines. These services will now fall within the scope of the HCSA, although they do not require a licence at the moment. Instead, the Ministry will adopt a risk-based approach in determining if licences are necessary for the provision of these services in the future. Professionals engaged in these services, such as physiotherapists and Traditional Chinese Medicine practitioners, will continue to be regulated through their existing professional Acts. The HCSA will not affect the operation of these professional Acts1.
1 This includes the Applied Health Professions Act, Dental Registration Act, Medical Registration Act, Nurses and Midwives Act, Optometrists and Opticians Act, Pharmacists Registration Act, and the Traditional Chinese Medicine Practitioners Act (section 6 of the HSC Bill).
Beauty and wellness services are excluded from the scope of the HCSA since such services do not involve the assessment, diagnosis, prevention, alleviation or treatment of a medical condition or disorder.
In addition, in a bid to improve public awareness, the HCSA also gives the Ministry wide powers to publish any information regarded as expedient or necessary in the public interest, ranging from regularly updated lists of licenses that have been suspended or revoked to convictions or censures of any person under the Act.
Given the broadened scope of regulation and the Ministry’s enhanced ability to publicly indicate its reception of various healthcare services under the new HCSA, investors will be better able to project the regulatory potential of new medical innovations that they are seeking to introduce into Singapore’s healthcare landscape.
Enhanced Governance and Oversight of Healthcare Service Providers
(a) Enhanced Role and Responsibilities of Key Personnel
To strengthen the governance of healthcare services, Managers under the PHMCA will become Principal Officers (“PO”) under the HCSA. POs will be made mandatory for all licensees and have the enhanced responsibility of overseeing the daily operations of the licensee and ensuring operational compliance with the HCSA.
Selected licensees that provide more complex healthcare services such as assisted reproduction services and clinical genetic and genomic services, will also be required to appoint a Clinical Governance Officer (“CGO”) in addition to a PO. CGOs will be responsible for clinical and technical oversight of such selected healthcare services. Given the specialised expertise of CGOs, the qualifications of CGOs will be tailored to each selected licence.
The new legislation will allow individuals who qualify as licensee, PO, and CGO to serve all three roles for different services concurrently, so long as such individual is able to perform all roles adequately.
(b) Committees for Clinical Quality and Medical Ethics
In addition to the current Quality Assurance Committees (“QACs”), healthcare services that are of greater public interest or that have been deemed higher-risk, such as the Proton Beam Therapy, will also be subject to the newly instituted Service Review Committees (“SRCs”). As part of the enhanced oversight of healthcare services under the HCSA, SRCs will identify the benefits and risks of such services to patients, make recommendations to the licensee in relation to compliance with prescribed service requirements and code of practice, as well as monitor the implementation of such recommendations. Referral and review from the newly instituted Service Ethics Committees will also be introduced as a prerequisite for selected high-risk and complex medical treatments.
Under the holistic objectives of the HCSA, an individual qualified to serve on a QAC will be allowed to serve on QACs in different institutions so as to encourage cross-institutional learning. Shook Lin & Bok LLP Client Update | Healthcare 3
(c) Ministry’s “Step-In” Powers
The HCSA also contains new provisions to safeguard patients against abrupt discontinuation of residential care services by empowering the Ministry to “step-in” and assist in the operations of failing healthcare services where necessary. The Ministry has stated that this power is intended to be exercised as a measure of last resort, with an appeal mechanism for licensees aggrieved by the step-in decision.
(d) Enhanced Powers to Obtain and Publish Information
Data and information gathering powers will be increased under the HCSA, to allow the Ministry to better monitor patient safety and public health interest. The HCSA also empowers the Ministry to publish information about non-compliant licensees and unlicensed providers to better allow for patients to make informed choices.
(e) Restrictions on Naming, Advertising and Co-location
In step with the Ministry’s efforts to minimise public misperception and better help patients make informed choices, the HCSA will provide for tighter restrictions on naming and advertising. New business entities will be prohibited from using terms that connote a national body (eg “National” or “Singapore”), and are also prohibited from using names of services that they are not licensed for. Existing entities will not be affected.
The HCSA also places stricter rules for collation of healthcare services in the same space, with restrictions on the provision of licensable healthcare services together with other un-related or unlicensed services at a premise or conveyance.
(f) Employment Restrictions
New restrictions on staff employment in healthcare services have been introduced to better ensure patient safety. This includes background checks for employees working with vulnerable patient groups like nursing homes or the Institute of Mental Health, and ensures that staff who are known to have caused harm in one institution will not be able to work in another institution.
National Electronic Health Record (NEHR) not implemented
As mentioned in our previous update, the draft HCS Bill sought to introduce the NEHR, a secured centralised patient data bank that operates on an opt-out basis. The intent behind the NEHR was to give healthcare providers a comprehensive picture of patients’ medical backgrounds, allowing them to better assess each patient’s individual needs, especially where it involves coordinated care across multiple healthcare service providers.
Although the NEHR was tabled at the First Reading of the HSC Bill on 4 November 2019, it was removed from the HSC Bill’s Second Reading and consequently not passed by Parliament on 6 January 2020, due to public concerns over personal data protection.
In response, the Ministry has stated that mandatory contribution to the NEHR will be deferred to a later date where the Ministry determines that all the enhancements to the NEHR have been completed and is satisfied that the system is sufficiently robust to safeguard the personal data of patients.