Determining the future of health| MEDICUS 2024 Issue 4

Determining the future of health
By Dr Khoo Yoong Khean, Assistant Professor, Centre of Regulatory Excellence

Celebrating ten years of regulatory excellence with a special scientific symposium // Credit: Courtesy of CoRE

In today’s rapidly evolving healthcare, where transformations are driven by advancements in artificial intelligence (AI), precision medicine and strategies for healthy ageing, regulatory frameworks play a pivotal role in shaping safe and equitable health services. Celebrating its 10th anniversary, Duke-NUS’ Centre of Regulatory Excellence (CoRE) discussed pioneering regulatory approaches that could define the future of global healthcare at its two-day scientific conference from in October.

Distinguished guests, including Dr Janil Puthucheary, lauded CoRE’s decade of substantial contributions to regulatory science, both locally and internationally. Speaking on the first day of the conference, the Senior Minister of State with the Ministries of Digital Development and Information, and Health noted that over the last ten years, the Centre has become an important player in the healthcare landscape, making “significant strides in advancing regulatory science, not only in Singapore but also across Asean and the Asia-Pacific”.

“As we celebrate these achievements, we must also anticipate the challenges on the horizon,” he said, adding, “Singapore’s healthcare landscape is undergoing fundamental changes, driven by demographic shifts and evolving healthcare needs. To meet these changes, we are embracing digital health and precision medicine technologies. Such innovations can improve population health and ensure the sustainability of our healthcare system.”

He added that this necessitated a parallel shift in healthcare regulations, to keep pace with innovation while remaining committed to patient safety and welfare: “Our goal is to create a regulatory framework that acts as a catalyst for progress, not a barrier to it”

Prof John Lim delivers his opening address at the 2024 CoRE Scientific Conference as he declares the conference open // Credit: Courtesy of CoRE

“We have had an impactful first decade and I am deeply grateful for the support from our many local and global partners and collaborators. It was very fitting to celebrate our 10th anniversary with a scientific conference that led the thinking on converging health products and health services regulation in important areas such as AI in health, precision medicine and preventive health. ”
Prof John Lim

Some 200 local and international participants attended the scientific conference, titled “Regulating the Future of Health: Converging Products and Services for Access, Innovation & Sustainability”, co-organised by CoRE and the Ministry of Health. From government officials, regulators, policymakers, academics, industry to patient organisations, participants represented the full spectrum of stakeholders essential in bringing about the transformation required.

To be successful in this endeavour, real-world evidence should be regulators’ guiding star, urged Professor Mark McClellan, Director of the Duke-Margolis Institute of Health Policy, who delivered the 2024 Sir Alasdair Breckenridge Lecture.

Titled “Regulating the Future of Health”, McClellan advanced the argument that real-world evidence, essential to regulatory science, also underpins health policies, medical product development, care delivery models and healthcare finance.

Prof Mark McClellan delivered the 2024 Sir Alasdair Breckenridge lecture // Credit: Courtesy of CoRE

“What we’re seeing … is that real-world evidence is expanding beyond the domains that have traditionally been part of regulatory science and regulatory review,” he said.

This convergence must be considered in the face of the rapidly changing healthcare landscape to ensure good patient and population outcomes, he added.

Working through the biggest drivers in this rapidly changing landscape, the participants first focused on developing AI and digital health regulations. During this session’s talks, local and international speakers showcased a wide range of AI applications in health, from simple chatbots to complex voice and emotional expression analysis to improve healthcare communication. Local AI solutions, such as using AI analytics to summarise medical notes, predict early interventions and avoid time-sensitive disease complications, were evidence of how nimble the local system is in developing AI-based solutions for pressing needs.

The speakers, who included Dr Harvey Castro from Helpp.AI and Duke-NUS’ Associate Professor Liu Nan, also discussed balancing innovations in AI, patient safety and the ethical considerations of using AI, especially using AI as both a product and service—a pertinent nod to the ongoing work by the health regulations group of Singapore’s Ministry of Health, who is developing regulations on AI in healthcare with CoRE as its supporting partner.

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Panel discussion featuring (from left to right): Dr Harvey Castro, Dr Boitumelo, Ms Idamazura Idris, Asst Prof James Lee Wai Kit, and Asst Prof Liu Nan on developing AI and digital health regulation across different jurisdictions // Credit: Courtesy of CoRE

Regulation of precision medicine was the topic for the second session. Experts from the Ministry, Singapore’s National University Hospital, SingHealth and the University of Sydney discussed how precision medicine will be part of mainstream healthcare services in the future, as well as the ethical considerations in regulating these advanced technologies. The common theme that emerged from all the speakers was the necessity of trust and being able to engage with diverse communities beyond gaining consent on the use of genomic data.

Having focused on the use of AI and precision medicine on the first day of the scientific conference, participants reconvened on the second day to consider how these will contribute to countries’ efforts to close the gap between lifespan and healthspan. Bridging this gap, said Professor Silke Vogel, Deputy Director at CoRE, will be the marker of successful regulation. She emphasised that healthspan-centered actions and strategies must evolve in unison around scientific, medical and social innovation and take into consideration of how regulations can facilitate innovations and their implementation while ensuring patient safety

Prof Silke Vogel

Prof Silke Vogel opened the second day of the conference, giving participants a recap of key insights from Day 1, setting the stage for the day’s discussions // Credit: Courtesy of CoRE

This seamlessly segued into the session on regulation for disease prevention and healthy ageing. Experts, including Dr Beth Frates, President of the American College of Lifestyle Medicine, and Professor James Kingsland from the University of Central Lancashire, discussed lifestyle medicine and how this can be a primary modality to treat chronic conditions, how regulations are used in a public health context such as vaccination programmes and the deep science of how to use and regulate biological markers to design interventions to promote healthy ageing.

Dr Beth Frates (centre) in a panel discussion on disease prevention and healthy ageing, joined by experts Dr Charles Preston (left), Prof. Brian Kennedy (second from right) and Prof. Alex Cook (right) // Credit: Courtesy of CoRE

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The conference concluded with participants coming together to discuss the importance of partnership and collaboration in advancing the regulatory system to deliver better health outcomes. Central to the discussion was the need for a converged approach to regulating health products and health services, recognising that innovations in healthcare often blur traditional boundaries.

This convergence was seen as essential for ensuring comprehensive patient safety and efficacy standards, particularly as digital health solutions and hybrid treatments grow more prevalent. Additionally, participants emphasised the importance of public engagement, with insights from the Ministry of Health, the pharmaceutical and medtech industries, as well as patient organisations.

Alongside the main proceedings of the scientific conference, the co-organisers also hosted the inaugural Session for the Asia-Pacific Network of Healthcare Regulators. This in-person, closed-door session of senior health leaders from Asia-Pacific was held to strengthen collaborative ties and advance regulatory cooperation across the region. The session was a resounding success, drawing participation from representatives across 11 economies in the Asia-Pacific region. The session fostered dynamic exchanges among leaders dedicated to advancing safe and ethical practices in healthcare.

Discussions also included the potential of the Asia-Pacific network working together with the European Partnership for Supervisory Organisations in Health Services and Social Care, an active and inspiring international network committed to fostering collaboration and setting high standards in health and social care across regions.

The conference also set the stage for a regulatory advisory panel meeting, which was organised in collaboration with the Ministry. Comprising eight international experts, discussions covered key themes like digital health, evolving care models, and regulatory transformation, marking a significant step forward in shaping Singapore’s healthcare regulations.

The events culminated in the “Outcome-Based Collaboration Model Workshop”, featuring a lecture by Professor Christopher Hodges OBE from the University of Oxford on 17 October.

The workshop highlighted the importance of committing to cooperate on the basis of trust to achieve positive outcomes for all stakeholders. Hodges emphasised the need to “ask what outcomes would you like to achieve instead of asking for evidence”.

Prof Christopher Hodges

Lecture by Prof Christopher Hodges (right) from the University of Oxford at the Outcome-Based Collaboration Model Workshop.// Credit: Courtesy of CoRE

Happy graduates from the Graduate Certificate in Health Products Regulation programme share a group photo with Duke-NUS Dean Professor Thomas Coffman, Dr Lim and Prof Silke // Credit: Courtesy of CoRE

Following his session on using behavioural science to foster collaboration, participants had the chance to apply what they had just learnt during a practical workshop on open culture frameworks and problem-solving strategies.

The week of celebratory events also included the graduation ceremony for the 2023/24 cohort of graduates from the highly regarded Graduate Certificate in Health Products Regulation programme, which took place on 14 October.

Professor Kenneth Mak, Director-General of Health, delivered the welcome speech, in which he focused on the impact the graduates will make on healthcare systems in Singapore and the region. He also noted the “diversity of backgrounds among the graduates, ranging from regulatory affairs, product development and manufacturing to research and academia”, which was gratifying to see.

Reflecting on the Centre’s accomplishments and its role in shaping the future of health products and services regulation, Professor John Lim, Executive Director of CoRE, noted:

“We have had an impactful first decade and I am deeply grateful for the support from our many local and global partners and collaborators. It was very fitting to celebrate our 10th anniversary with a scientific conference that led the thinking on converging health products and health services regulation in important areas such as AI in health, precision medicine and preventive health.

“It is important for national health systems to have tighter coordination across products and services regulation.”

The anniversary events, abundant in robust discussions on collaborative regulatory practices, set out a progressive agenda for the next decade.

As CoRE continues to influence global health policy, its commitment to fostering partnerships and integrating innovative solutions across healthcare systems promises to enhance patient safety and foster sustainable health innovations.