Keynote Address at the 2025 AmChamSG Healthcare Conference by Adj Prof (Dr) Raymond Chua, CEO, HSA

Good Morning,

Dr. Hsien-Hsien Lei – CEO, AmCham Singapore

Distinguished guests, industry leaders, healthcare executives, innovators, and partners across Singapore's healthcare ecosystem,

2     Good morning and thank you for the opportunity to address this important gathering as we pioneer the future of health for SG100. It is my pleasure to be here at the 2025 AmChamSG Healthcare Conference, exploring how we can create a truly sustainable healthcare system for the next 40 years.

3     What you have just listened to is my digital twin speaking to you about a scenario from the future of healthcare. Now, I would like to ask you to reimagine what the future of healthcare might look like in SG100. What possibilities do you see for transforming patient care, advancing medical innovation, and creating a truly sustainable healthcare ecosystem for the next 40 years?

Regulation: Enabler or Inhibitor?

4     As we envision this future, a fundamental question emerges: how does regulation play a part in this transformation? Will regulation be the enabler that accelerates innovation, or will it become the inhibitor that holds back progress?

5     The challenges facing Singapore on our journey to SG100 are unmistakable: an ageing population, rising healthcare costs, and the imperative to build more sustainable and resilient healthcare systems. These challenges demand bold transformation – and regulation must be the enabler, not the barrier, to this change.

6     Without innovative, progressive and adaptive regulatory frameworks, breakthrough innovations risk being delayed from reaching patients who need them most. In today's rapidly evolving healthcare landscape, regulatory excellence must become the foundation that accelerates innovation whilst maintaining the safety and quality standards that build public trust.

7     At MOH and HSA, we recognise that effective healthcare regulation spans several interconnected domains: products, services, data, and professionals. Each domain plays a crucial role in shaping Singapore's healthcare landscape. Let me share how we've been evolving our approach across the products and services front to enable the transformation needed for SG100.

Products: Evolving Through Innovation, Harmonisation and Collaboration

8     In the domain of health products, HSA's standing as a globally recognised regulatory authority is reflected in our achievements and international recognition. We are proud to be one of the first 3 regulatory authorities designated as a WHO-Listed Authority since 2023 with the highest Maturity Level 4 status since 2022. This means that medicines approved by HSA can receive earlier approvals in other countries as well, as they trust HSA's assessment. We have transformed from referencing other agencies to becoming a reference agency that other agencies can rely. This global confidence is evidenced by growing numbers of jurisdictions recognising HSA, including Australia, Brunei, Hong Kong, the Philippines, Switzerland, and the United Kingdom.

9     Through international strategic work-sharing under the ACCESS Consortium – a coalition of regulatory authorities from Australia, Canada, Singapore, Switzerland, and the United Kingdom – companies can submit a common dossier for simultaneous review across multiple jurisdictions.    This collaborative approach accelerates regulatory timelines and enables earlier access to innovative medicines for patients. In parallel, regulatory reliance frameworks for medicines and medical devices mean that companies obtaining HSA approval can now reach beyond Singapore’s 6 million residents to a combined market of over 236 million people.

10.     We also partner with the US FDA collaborating on Project Orbis, which is a pioneering international regulatory collaboration that enables the concurrent submission and review of oncology products across multiple countries, including Singapore, Australia, Canada, Switzerland, Brazil, Israel, and the UK. This regulatory partnership initiated by FDA’s Oncology Center of Excellence in 2019 has significantly accelerated patient access to innovative cancer therapies by streamlining regulatory reviews and fostering global cooperation. In Singapore, this programme has facilitated faster patient access to over 60 innovative oncology treatments. For industry, this means faster market access, reduced duplication through collaborative and shared FDA assessments.

11.     Notably, through an enhanced bilateral partnership with Malaysia’s Medical Device Authority last month, we launched a pilot Medical Device Regulatory Reliance Programme. The pilot will streamline the registration of medical devices which industry can expect a shorter review time in Malaysia and Singapore. This pilot programme exemplifies HSA’s continuous effort to create expedited pathways for faster market access that better support the MedTech industry and market growth with more efficient processes.

12.     Overall, these international and regional partnerships not only improve patient access to safe, effective, and affordable health products but also strengthen Singapore’s biomedical innovation ecosystem, accelerating growth, enhancing competitiveness, and contributing to economic growth and job creation for the industry.

Services: Enabling New Models of Care Delivery

13     In the services domain, we've made a fundamental transition from the rigid premises-based Private Hospitals and Medical Clinics Act to a modular services-based Healthcare Services Act (HCSA). This premises-neutral approach allows us to regulate healthcare services more flexibly as new care models  emerge, licensing providers based on the services they provide, rather than where they are located. To facilitate this shift, the HCSA introduced the world's first concept of Modes of Service Delivery (MOSD) where licensees must obtain approval for the applicable MOSD for each licensable healthcare service. There are four MOSD: permanent premises for traditional brick-and-mortar settings; conveyances for mobile healthcare services such as ambulances; temporary premises for ad-hoc services or house calls; and remote delivery for teleconsultations. This concept of MOSD futureproofs the regulatory regime, providing flexibility for business innovation while ensuring patient safety. 

14     Beyond the flexibility built in our legislation, our regulatory sandboxes further exemplify this adaptive approach by partnering with industry to understand new and innovative services and business models in a controlled environment. 

• Telemedicine was our first use case for sandboxing where we worked with private telemedicine providers to understand risks and different business models, co-create effective mitigations and regulatory approaches, while assuring patients that services are provided safely. The sandbox subsequently paved the way for licensing under the Healthcare Services Act. 
  

• Another example is MOH’s ongoing community pharmacist influenza vaccination regulatory sandbox which creates a safe environment for community pharmacists to administer influenza vaccinations. As part of the sandbox, we also ensured that community pharmacists are adequately trained and equipped to administer such vaccinations, while supporting patient safety and care. This sandbox would also provide us with valuable insights on the regulatory approach to adopt moving forward.  

15     Therefore, how regulations could unlock and bring in new and innovative healthcare services and care models in Singapore to benefit more Singaporeans could be exemplified through this sandbox approach, yet allowing regulators to co-create a “fit-for-purpose” regulations together with the service providers.                                                                          

Disruption and the Need for Regulatory Evolution

16     While these regulatory domains have served us well in addressing traditional healthcare challenges, the journey towards SG100 presents us with new complexities that may also disrupt how we look at regulations themselves. 

17     Take Artificial Intelligence as an example. AI holds tremendous promise to improve patient outcomes, make care more personalised and help our healthcare system operate more efficiently. But for all its potential, AI also carries real risks if left unguided – from algorithmic bias and hallucinations to data leaks and adversarial attacks that can distort or even compromise clinical decisions and erode trust in our healthcare system. 

18 That is why robust governance is of critical across the entire ecosystem of products, services, data, and professionals. It ensures that AI is deployed in a safe, transparent and effective manner, giving confidence to healthcare providers and patients. For example, HSA has established a comprehensive Regulatory Framework for AI Medical Devices through our Regulatory Guidelines published in 2019. To date, HSA has registered approximately 160 AI Medical Devices, with major technology companies including Google and Apple submitting registrations. 

19     But managing AI risks cannot stop at the product level. Responsible AI also requires looking upstream – at the quality and governance of data used to train AI - and downstream, at how AI tools are deployed and used.  This is where our other legislation, such as the Healthcare Services Act (HCSA) and various Professional Acts come in. They work in tandem to ensure that healthcare services are properly licensed and that professional codes of conduct continue to uphold patient safety and good practice, even as new technologies emerge. Beyond product-level regulations, AI tools are deployed in healthcare settings. To guide the safe and effective use of AI, MOH, HSA and Synapxe (Singapore’s national healthtech agency) jointly issued the Artificial Intelligence in Healthcare Guidelines (AIHGle, pronounced ‘agile’) in 2021. Since then, new technologies like Generative AI have emerged. We are now updating the guidelines to clarify the roles and responsibilities of stakeholders across the AI lifecycle, and to recommend essential training for users to support responsible AI adoption. In the coming months, we will engage key stakeholders to gather their feedback and ensure the revised guidelines remain practical and relevant. 

20     This example of AI illustrates a broader truth: emerging technologies are creating regulatory challenges that cut across domains and demand holistic, agile governance. Traditional medical device regulations focused on safety and efficacy of individual products. Going forward, we need frameworks that can address networked device security, AI algorithm validation, data interoperability, and system-wide resilience across multiple regulatory domains.

Right-Touch Regulation: A One-Stop Solution

21     To better support our stakeholders in navigating this complex landscape, we're working towards a Right-Touch Regulation approach towards a one-stop health regulatory hub that provides more integrated and coordinated regulatory support across all domains. Modern healthcare challenges require coordinated responses that break down traditional regulatory silos, and allows regulators to be more effective, efficient and sustainable. 

22     This integrated approach recognises that emerging technologies like AI don't fit neatly into traditional regulatory categories. A single innovation might simultaneously involve product safety, service delivery, data governance, and professional standards. Our challenge is developing regulatory capabilities that can address these multi-domain complexities in a coordinated manner, rather than requiring stakeholders to navigate multiple separate processes. More details on this will be made known later. 

Redefining Regulation and Co-Creating the future together

23     Hence, as we look ahead, we're exploring how to redefine our regulatory approach - can we move beyond traditional compliance to become active partners in fostering innovation ecosystems? We see opportunities to co-create solutions with industry in expedited pathways, reliance models, and digital innovations that drive economic value whilst strengthening Singapore's biomedical ecosystem whilst maintaining the safety and quality standards that build public trust.

24     But we cannot build this future alone. I urge all of you – the innovators, technology companies, healthcare providers, and industry leaders in our audience – to work together with us on developing new regulatory tools and approaches. Let us conduct a horizon scan to better understand and be aware of what new innovations are coming our way so that we can co-create the regulations that enable Singapore's healthcare transformation. 

A Vision for Sustainable Healthcare

25     As we work towards SG100, we're not just regulating today's healthcare system – we're enabling tomorrow's. A system where care follows patients rather than requiring patients to follow care. Where digital technologies seamlessly integrate to deliver personalised, proactive interventions. Where innovation and quality work hand in hand to ensure equitable access for all Singaporeans.

Conclusion: Partnership for the Future

26     The question isn't if healthcare will transform but whether our regulatory frameworks can enable that transformation safely and sustainably. Together, let us build a future where regulation enables innovation, partnerships multiply impact, and patients benefit from our collective efforts as we shape the future of health for Singapore.

27     Thank you, and I look forward to our continued partnership in this vital endeavour.

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