The rapid evolution of artificial intelligence (AI) in health care presents both opportunities and challenges. As AI technology becomes increasingly sophisticated and its applications diversify, the need for a collaborative approach among countries, regulators, and industry partners has never been more urgent. This perspective is gaining momentum globally, particularly in light of recent discussions at the AI Regulatory and International Symposium (AIRIS) held in Incheon, South Korea in 2025.
Building on the groundwork laid during the inaugural AIRIS in Seoul in 2024, this symposium showcased a commitment to establishing safe, ethical, and equitable frameworks for AI’s role in health care. Under the guiding principle articulated by WHO’s Director-General Dr. Tedros Adhanom Ghebreyesus—“As AI becomes more sophisticated and its health applications expand, so must our efforts to make them safe, effective, ethical, and equitable”—the stakeholders gathered aimed to address pressing regulatory and ethical issues related to AI in health.
Global Collaboration: A Necessity
The Outcome Statement from AIRIS 2025 encapsulates the essence of advancing AI in health through collaboration. It emphasizes a lifecycle-based regulatory approach that encompasses all stages of medical product development, from clinical trials to post-market surveillance. This model acknowledges that AI systems must be assessed thoroughly to ensure not just efficacy, but also safety and ethical deployment.
In today’s intricate global landscape, risk-proportionate regulation becomes particularly salient. Stakeholders highlighted the need for regulations tailored to various national contexts and health system requirements. This adaptive approach ensures that regulations are relevant and applicable, addressing local needs without stifling innovation.
Moreover, the symposium underscored the necessity for stronger international collaboration. Amid increasing disparities in AI capabilities among countries, creating a cohesive global AI ecosystem is paramount. Collaboration can help close the existing gaps, fostering trust and ensuring that AI applications do not perpetuate inequities in health access or outcomes.
Transparent and Inclusive Governance
The call for transparency and equity in AI governance was a central theme at AIRIS 2025. With AI’s potential to transform health care delivery, it is crucial to ensure that these technologies are not only effective but are also designed and implemented in a manner that is inclusive. This means involving diverse stakeholders—patients, healthcare providers, and communities—in the development process to identify needs and potential barriers to access.
The assurance of ethical AI in health goes beyond technical efficacy. Ethical considerations involve assessing the implications of AI technologies on vulnerable populations, ensuring that all groups benefit equitably from advancements. As AI solutions become widespread, maintaining a focus on inclusivity can help prevent widening the health disparities that already exist.
Sustained Global Governance through AIRIS
AIRIS has established itself as a pivotal platform for dialogue among regulators, international organizations, and technical partners. The commitment of WHO and the MFDS to co-host AIRIS in the coming years signals an understanding of the continually evolving nature of healthcare technology and the importance of adaptive governance mechanisms.
This sustained engagement will encourage the sharing of best practices, data, and regulatory strategies that can benefit countries at varying stages of AI integration in health. Regular interactions can lead to better policies that keep pace with technological advancements, mitigating risks while promoting innovative practices.
The Future of AI in Health: Key Areas of Focus
Looking ahead, several key areas require continued focus in the global dialogue around AI and health:
Lifecycle Regulatory Frameworks: Emphasizing a comprehensive approach to AI regulation will ensure that all aspects of its deployment—development, trials, and market use—are subjected to rigorous scrutiny.
Customization of Regulations: The one-size-fits-all approach to regulation can hinder innovation. Tailored regulations that consider local circumstances and challenges will ultimately foster more effective health solutions.
International Standards and Best Practices: Developing harmonized regulations and best practices across borders can create a more predictable environment for AI advancements in health, benefiting innovators and patients alike.
Transparency Mechanisms: Establishing standards for AI interpretability and accountability will help build trust among stakeholders. Patients and providers deserve to understand how AI systems make decisions that impact health outcomes.
- Education and Training: To foster a responsible AI ecosystem, ongoing education for regulators, health professionals, and the public can promote informed decision-making and responsible use of AI technologies.
Conclusion
The collaborative approach emphasized at AIRIS 2025 represents a significant stride towards fostering safe and equitable AI in health. With the ongoing evolution of technology and the corresponding regulatory landscape, stakeholders must remain committed to transparent governance, international collaboration, and inclusive practices. By harnessing the power of AI with a focus on ethics and equity, countries and regulators can pave the way for health systems that are not only efficient but also just and accessible to all.
This comprehensive and equitable approach to AI in healthcare has the potential to redefine patient experiences and outcomes in a positive manner, ensuring that the benefits of technological advancements are realized by every segment of society. In doing so, the global community can build a healthier, more equitable future for all.
