Speeches
Keynote Address by Adj Prof (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, at the Inaugural Health Regulatory Conference 2026
12 October 2026
Audiences
Consumer
Healthcare professional
Industry member
Building a Future-Ready HSA
1. Minister Ong Ye Kung, and Chairman, HSA, Prof Benjamin Ong,
a. Distinguished guests, colleagues and friends,
b. Good morning, and welcome to our inaugural Health Regulatory Conference.
2. Minister, thank you for setting out the national direction for health regulation in three dimensions – going across geographical boundaries; healthcare value chain; and regulatory domains. I will now share what this means for HSA, the organisation we need to become, and the impact to our stakeholders.
The Changing Regulatory Landscape
3. Our foresight work points to a decade of rapid scientific and technological advances, care increasingly delivered in homes, communities and digital settings, and risks that extend across borders and traditional regulatory boundaries. Hence, regulation must evolve ahead of them, or else we risk lagging behind for new technologies, innovations and care models which will benefit our patients.
4. However, our patient experiences one journey, and so do our stakeholders. And what needs to be done now is that we as regulators must be able to see that whole journey as one too — and prepare for where it is heading next.
Clarion Call for Integration in Health Regulation
5. 2026 has also been an exciting year whereby HSA took our first steps towards bringing the various health regulatory functions under HSA. We are also holding our first Health Regulatory Conference. I am super excited actually not simply because regulatory functions are coming together, but because this consolidation can help us see how we can enhance the whole healthcare ecosystem and landscape and give stakeholders and our public a clearer, more coherent experience. In fact, we have just passed the HSA (Amendment) and Other Matters Bill last month, to provide us the foundation. Definitely something worth looking out for in the future, considering this is HSA’s 25th anniversary and we are transforming ourselves to be ready for the future.
6. Today, MOH oversees healthcare services, health information, human biomedical research and biosafety; HSA regulates health products; and the Secretariat of Healthcare Professional Boards supports the Boards and Councils regulating healthcare professionals. This model has served Singapore well, but complex cases increasingly challenge and cross these boundaries.
7. Let me quote an example - AI in healthcare to illustrate the challenge: safe use will require coordinated oversight of the product, care setting, professional practice and health information. The same is true when new care models or enforcement cases span several domains. Integration should make that coordination faster and clearer.
8. So did we get there in the future?
Video Segment with Fictional Illustration
Video Segment with Fictional Illustration One fictional illustration of a Portable AI Retina Reader can help us understand what HSA’s transformation had to achieve. It is what integrated regulation looks like in practice. An optometrist-inventor had an idea to bring eye care into the community. She developed a device that could capture a detailed, three-dimensional view of the retina in seconds, without dilating eye drops. Her ambition was to help optometrists detect possible problems earlier, within the community, and refer patients for further care when needed. A promising idea. But an impressive image is not yet evidence of a safe service. And a new device does not, by itself, change what a professional is qualified or authorised to do. HSA (Medical Devices) The inventor approached HSA to have the portable AI retina scanner approved for clinical use. She planned to roll it out at optician shops in the community. While HSA could help her with the device approval, she would need to check with MOH on whether she could roll out this new service. MOH (Services and Health Information) MOH advised the inventor that she needed to consider how the service could be deployed safely, the governance for its delivery, and how patients are referred for follow-up care. This was because this service would also generate health information, and hence, the care model must also set out how patient data would be captured accurately, protected and shared appropriately. MOH told the inventor to consult the Optometrists and Opticians Board (OOB) on whether the proposed screening activities would fall within the respective scopes of practice of optometrists and opticians, and what competency, training or supervision requirements might apply. The service model, professional requirements and health information flow all needed to work together. Optometrists and Opticians Board The inventor approached the OOB. OOB informed that even if HSA approved the device, the Board would need to consider whether its use for retinal screening and possible diagnosis would fall within the scope of practice of optometrists and opticians, and what competency, training and supervision requirements would be needed. Transformed HSA While there was a need to protect the safety of the patients, the inventor had to retell her story, over and over again. However, with a transformed HSA that convened around the case, HSA could see how the different questions affected one another: the device’s intended use, the training needed, the setting, the referral arrangements and the handling of patient information. The inventor received a coordinated explanation of the evidence required, the safeguards to address, and the next steps. There was still proper scrutiny. The relevant authorities still made their own decisions. HSA had organised its expertise around the problem and the stakeholder journey, rather than leaving the inventor to organise the problem around regulation. And that is HSA’s wider ambition. A clearer way into the system. Deep expertise brought in when needed. Better connections from research to clinical care, and from an individual concern to a wider safety signal. It is not a promise that every idea would succeed but a better opportunity for every good idea. The decisions remained rigorous and independent. What changed was the journey: more connected, more predictable and more global. |
HSA's Strategic Direction
9. From illustration to reality. Colleagues and friends, the device and conversations we have just seen were imagined. But the regulatory questions they raise — and the need to prepare for the future — are very real.
10. To be clear, this is an illustration of what integrated regulation could look and feel like. It is not an announcement of a specific platform, nor does it imply that any device will be approved.
11. The transition. The HSA Amendment Bill set out in Parliament last month gives us a practical starting point. MOH’s regulatory functions and manpower will transition in the coming month on 1 November, followed by the administrative and operational functions supporting the Healthcare Professional Boards and Councils by the end of 2027.
12. MOH’s role. We will continue to work very closely with MOH who will set national health policy and steward Singapore’s healthcare system — shaping how care is delivered and financed, planning for future needs, and building critical capabilities such as the healthcare workforce and digital health infrastructure.
13. HSA’s role. What HSA will bring together is this consolidation of the various regulatory functions and streamlining of the processes and workflows to better support the stakeholders and safeguard the public, aligned with MOH’s broader mission for the healthcare system.
14. What integration enables. You will have seen from the video that a holistic view across products, services, professional practice and health information will help HSA coordinate expertise and create clearer pathways to better support innovation, while detecting cross-cutting risks earlier.
15. From consolidation to outcomes. This creates the foundation for four outcomes: a connected view of the healthcare journey; earlier, proportionate responses to risk; learning across regulatory domains; and building people and partnerships that help safe innovations reach patients sooner.
A. Connecting Expertise around the Whole Journey
16. First, connecting expertise around the whole healthcare journey.
17. One technology, several regulatory questions. Back to my example of AI. For an AI-enabled diagnostic tool, product evaluation asks whether it works reliably for its intended use; service regulation examines where and how it is deployed; professional standards govern how its output informs clinical judgement; and information governance protects the data on which that judgement depends.
18. Patient safety depends on these domains working together — not in isolation.
19. HSA therefore needs two complementary strengths:
a) Horizontal integration to coordinate the right response and identify any cross-cutting risks; and
b) Vertical depth to bring rigorous regulatory science and research, clinical, legal and professional expertise to address difficult questions.
c) We must strengthen both.
B. Anticipate Change and Respond Proportionately
20. Second, move regulation upstream as healthcare moves upstream. As a future-ready regulator, regulation must move upstream too, which means we must anticipate change and respond in proportion to risk.
21. Engage before the application arrives. We cannot wait for an unfamiliar technology to appear as a completed submission. So, we should perform horizon scanning, continue our engagement with researchers, clinicians, industry and patients so that we know what is emerging, whether existing rules still fit for purpose, and where new or agile approaches are needed, for example, using regulatory sandboxes to test new models safely.
22. Learn across the lifecycle. Also, any form of approval is not the end. As products, practice and evidence evolve, our oversight will also continue to learn and respond to real world evidence. And this also means plugging into our coordinated healthcare information structure like EPIC or NEHR or TRUST to see how we can track and monitor outcomes, linking various national initiatives such as PRECISE and pharmacogenomics to better support healthcare delivery and patient health.
C. Learn across the System
23. Third, turn fragmented signals from our regulatory domains into system-wide learning.
24. See the fuller picture. A product incident, inspection finding and professional complaint may each reveal only one part of a wider problem. Broader oversight will allow us to connect these signals across regulatory domains.
a) Act earlier. In this manner, the non-compliances or lessons learnt will shape clearer guidance, targeted education and earlier engagement. The aim is to help industry; our healthcare institutions and professionals better understand regulatory requirements and strengthen governance and practice before problems arise.
b) Share information responsibly. Integration also does not mean unrestricted access. Let me also assure you that information should be shared only where appropriate, with clear controls and proper safeguards for confidentiality and data protection.
25. Use technology to support expert judgement. Besides regulating AI, we as regulators are also using AI in our work too. For example, HSA recently unveiled a tool to support the coding of medical device adverse events as well as a risk classification tool to help the industry earlier on with the device classification. Such tools can better support our regulatory workflows and help our regulatory specialists focus attention where it matters most.
D. Build People and Partnerships across the Ecosystem
26. Lastly, build the people and partnerships that make integration work.
27. Build a coordinated innovation pathway. HSA’s relationships must extend beyond our organisation.
28. For selected high-priority products, like what Minister has mentioned just now, we will bring the right partners around innovators — including start-ups — from clinical development and evidence generation through to product application, health technology assessment (HTA) and adoption. We want more clinical development in Singapore, including early-phase clinical trials, supported by early scientific, clinical and regulatory advice. If you have your clinical development here, we may even look at prioritising some of the applications and reviews downstream too.
29. Build a trusted international ecosystem. International regulatory cooperation and reliance, like the many bilaterals we have now with Australia, Africa, China, Malaysia and Saudi, the innovative pilots like the regulatory innovation corridor we have with UK MHRA, as well as the work-sharing initiatives like ACCESS with Australia, Canada, Swissmedic and UK and Project Orbis with US FDA on oncology projects or the ASEAN Joint Assessment with our ASEAN neighbours, can all help innovators use Singapore as a launchpad into priority regional and global markets, while each regulator remains accountable for its own decisions. So this will mean that you are not looking at benefiting just a 6 million population but providing access to a larger global market outside once you have launched your product here.
HSA's Future: What Stakeholders Should Experience
30. Over the coming decade, what I hope to achieve is for our stakeholders to experience a regulator that is clearer, more connected and more responsive:
a) Innovators — including start-ups — and researchers, should have a clear entry point and, for selected high-priority products, coordinated support from clinical development and early-phase trials through product application, HTA, adoption and priority global markets;
b) Healthcare professionals and institutions should have clear expectations for scope of practice, competency, accountability and clinical service and information governance — enabling safe innovation, new care models, appropriate data contribution and continuity of care;
c) Industry should find requirements easier to navigate, with coordinated guidance and clearer routes from Singapore to regional and global markets; and
d) Patients should ultimately gain timely access to beneficial innovations, with confidence in its safety and effectiveness.
31. If you don’t know how to do this – our innovation offices can then provide early advice to clarify regulatory expectations, identify how different requirements connect, and bring in the relevant partners across the ecosystem to support your journey.
32. We will also establish an Industry Advisory Council to provide a regular forum for HSA to consult the industry, test emerging issues and co-create practical solutions.
33. HSA’s future will continue to build on the scientific rigour and excellence that have earned trust over many years — now applied across a wider field of responsibility across various regulatory domains.
34. But the future regulator cannot be built by the regulator alone. Working with all of you, whether you are from start-ups, innovators, researchers, industry, healthcare institutions, professionals, our own government agencies and even including the public and patients, we will build the integrated HSA with coordinated pathways across the healthcare ecosystem around one shared purpose: safer and more timely innovations launching here and into multiple markets globally benefiting more patients.
35. Thank you everyone, and on behalf of HSA, I want to say that we value your continued insight, support and partnership to make this a success and make Singapore a shining red dot in launching many new innovations and care models safely and responsibly for our patients. Have a fruitful conference today.