8 February, 2018
Our local healthcare industry has adapted to meet modern competition and population needs, and in step with this, the Ministry of Health in Singapore (Ministry) is looking to stay ahead of the curve by issuing a consultation paper inviting feedback on the draft Healthcare Services Bill (HCS Bill).
The HCS Bill addresses key changes taking place in the healthcare industry, such as the growing range of medical services available in the market and the increasing use of online platforms in the provision of such services. The proposed legislation is intended to be enacted in the second half of 2018 and is set to replace the present Private Hospitals and Medical Clinics Act (Chapter 248 of Singapore) (PHMCA) in three phases. As part of the first phase, medical and dental clinics as well as clinical laboratories that are presently under the PHMCA will come under the new regime in December 2019.
This client update summarises the pivotal changes to healthcare regulations under the HCS Bill.
Shift in regulatory approach to healthcare
Currently, licensing under the PHMCA is based on the physical premises of the healthcare service provider. Under the proposed legislation, licences will be granted based on the type of healthcare service provided, with licensing conditions tailored to each type of healthcare service. The six proposed categories of healthcare services are hospital service, ambulatory care service, long-term residential care service, non-premise based service, health support service and specified service. The Ministry will also define a list of allowable point-of-care-tests (POCT) in the regulations for selected licensees to provide simple diagnostic tests without a separate laboratory or radiological service licence.
The new regulatory framework under the HCS Bill allows regulation to keep up with developments in the healthcare industry. To this end, the scope of healthcare regulation will be expanded under the HCS Bill to include allied health and nursing services, traditional medicine, and complementary and alternative medicines. While the provision of such services will not require a licence, the new regulatory framework will enable the Ministry to take a risk-based approach in determining if licences are necessary in the future. Further, medical services and practices that are prohibited in Singapore will also be listed in a regularly updated schedule to the proposed legislation.
Given the broadened scope of regulation and the Ministry’s enhanced ability to publicly indicate its reception of various healthcare services under the HCS Bill, 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
To strengthen the governance of healthcare services, Managers under the PHMCA will become Principal Officers (PO) under the HCS Bill. POs will be made mandatory for all licensees and will have the enhanced responsibility of overseeing the daily operations of the licensee and ensuring operational compliance with the HCS Bill.
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.
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 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 HCS Bill, 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 (SECs) will also be introduced as a prerequisite for selected high-risk and complex medical treatments.
Under the holistic objectives of the HCS Bill, an individual qualified to serve on a QAC will be allowed to serve on QACs in different institutions so as to encourage interdisciplinary learning.
Emphasis in coordinated care across medical service providers
The HCS Bill will introduce a secured centralised patient data bank, the National Electronic Health Record (NEHR). Information in the NEHR may only be accessed for the purpose of providing healthcare services to patients. Licensees will be required to contribute to the NEHR unless a patient specifically opts out of the system in accordance with the HCS Bill.
Access to a patient’s comprehensive medical history will put licensed healthcare providers in a better position to assess each patient’s individual needs, especially where a patient requires coordinated care across multiple healthcare service providers. With the NEHR, it is anticipated that the costs/risk of maintaining a private databank, as well as the risk of giving a medical opinion based on an incomplete picture of the patient’s medical background, will decrease significantly for healthcare service providers.
