Engagement, Collaboration & the Way Forward

Why engagement matters

AI in health affects developers, regulators, manufacturers, health technology assessors, procurement teams, and frontline clinicians. WHO recommends accessible platforms for engagement during innovation and deployment roadmaps — streamlining oversight while accelerating beneficial advances.

Dialogue is especially important because AI technology evolves faster than static rulebooks. Regulators and developers benefit from ongoing conversation across development, deployment, post-market surveillance, and iteration.

Regulator as partner

WHO describes an engagement mindset: bilateral communication so regulators understand emerging technology and developers understand evolving requirements. Where appropriate, co-regulation can involve developers in designing practical processes — while regulators remain independent and prioritise public safety.

Countries with limited prior experience can adopt adaptable, modular, scalable regulatory models matched to national priorities. Case studies in the WHO document (e.g. Singapore HSA interactions) show how early classification and access routes can enable responsible trials.

Practical engagement for Hong Kong professionals

Healthcare professionals can participate in AI literacy by:

• feeding real-world use constraints into institutional AI governance committees;
• reporting adverse events or near-misses involving AI tools through hospital risk systems;
• collaborating with the Department of Health / MDD on listed devices and with professional colleges on practice guidance; and
• supporting multidisciplinary review (clinical, informatics, legal, ethics) before workflow integration.

Way forward

The WG-RC recommends stakeholders continue examining the 18 considerations summarised in Table 5 and engage through bodies such as IMDRF and ICMRA for regulatory convergence. The AI landscape will require updates as large language models and generative AI mature — shared learning is part of responsible practice.

Source: WHO — Regulatory considerations on artificial intelligence for health (2023)