AIRIS 2025 Unites Global Leaders to Advance Safe, Ethical AI in Healthcare

The World Health Organization (WHO) and the Republic of Korea's Ministry of Food and Drug Safety (MFDS) have concluded the AI Regulatory and International Symposium (AIRIS) 2025, a milestone global event focused on building robust regulatory frameworks for the ethical and effective use of artificial intelligence (AI) in health. Held in Incheon, Republic of Korea, this year's symposium built on the foundations laid by AIRIS 2024 in Seoul, taking global cooperation to the next level.

Under the theme "Regulation for AI, Together for Tomorrow," AIRIS 2025 convened an influential group of stakeholders, including global health regulators, AI developers, medical device manufacturers, researchers, and representatives from international organizations. The gathering aimed to develop concrete strategies to ensure that AI technologies used in health are safe, inclusive, ethical, and accountable.

AI in Health: Potential and Responsibility

The increasing use of AI in health—from diagnostic tools and predictive algorithms to personalized treatment systems—is revolutionizing healthcare delivery. However, this transformation also raises complex regulatory, ethical, and equity-related challenges.

"As AI becomes more sophisticated and its health applications expand, so must our efforts to make them safe, effective, ethical, and equitable," emphasized Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in his opening remarks.

AIRIS 2025 acknowledged the growing global demand for regulatory clarity in the face of rapidly evolving AI technologies. Participants stressed that without adequate oversight, AI tools risk deepening health inequities, reinforcing biases, or undermining patient trust—issues that must be tackled through international dialogue and action.

Key Themes and Recommendations from AIRIS 2025

The symposium served as a global regulatory forum and showcased emerging best practices, national experiences, and tools to assess AI throughout the medical product lifecycle. This included AI's use in drug development, medical imaging, diagnostics, clinical trials, patient monitoring, and post-market surveillance.

The AIRIS Incheon 2025 Outcome Statement outlines a shared roadmap for regulatory cooperation and global alignment. The key recommendations include:

1. Lifecycle-Based Regulatory Approach

Regulators emphasized the need for a comprehensive approach that spans all stages of the AI-enabled medical product lifecycle:

• Preclinical development

• Clinical trials and validation

• Manufacturing and data integrity

• Evaluation and regulatory approval

• Post-market monitoring and surveillance

This lifecycle focus ensures that AI technologies remain safe and effective even after deployment, as they continue to learn and evolve.

2. Risk-Proportionate, Context-Sensitive Regulation

Recognizing that healthcare systems vary widely, participants called for regulatory flexibility that is:

• Proportionate to the level of risk posed by the AI tool

• Tailored to national regulatory capabilities and local health needs

• Designed to encourage innovation while protecting patient safety

3. International Collaboration and Harmonization

The need for cross-border cooperation was a dominant theme. Regulatory gaps between countries can lead to inconsistencies in AI oversight and limit access to quality innovations. Participants urged:

• Harmonization of regulatory terminology, safety standards, and ethical norms

• Capacity-building support for low- and middle-income countries

• Collaborative research and shared evaluation frameworks

4. AIRIS as a Permanent Global Platform

Acknowledging AIRIS's unique role in fostering multi-stakeholder dialogue, the Outcome Statement supports its continuation as a recurring international forum. It will serve as a hub for:

• Policy coordination

• Sharing of regulatory science

• Engagement between regulators, developers, civil society, and technical partners

The WHO and MFDS jointly reaffirmed their long-term commitment to co-hosting AIRIS, ensuring that it evolves alongside the technology it helps to govern.

Promoting Ethical, Inclusive, and Transparent AI Governance

A core focus of the symposium was to promote AI governance rooted in equity, transparency, and inclusivity. Delegates emphasized that:

• Algorithmic transparency must be prioritized to ensure patient trust and explainability

• Bias detection and mitigation mechanisms should be mandatory in AI design

• Access to AI tools must be inclusive, benefiting underserved populations and low-resource settings

AIRIS 2025 also highlighted the importance of patient-centered governance, ensuring that AI technologies are not just technically sound but also aligned with public values and social norms.

Looking Ahead: Expanding Impact Through AIRIS

As AI becomes further embedded in health systems around the world, the regulatory decisions made today will shape outcomes for decades to come. The successful conclusion of AIRIS 2025 reinforces the urgency and promise of international cooperation.

With support from WHO and MFDS, the AIRIS platform will continue to evolve as a key pillar of global health governance—empowering countries to adopt AI tools that are safe, ethical, and effective, and ensuring that no population is left behind in the digital health revolution.