The recent surge of AI innovation has led to the rapid development of AI-driven health solutions with immense potential to improve the health and well-being of individuals and communities around the world, by accelerating drug discovery and development, increasing access to care, delivering personlized care, optimizing care delivery, and providing support to an overstretched health workforce. In order to build trust in AI systems, as well as further accelerate innovation and equitable access to these technologies, a regulatory ecosystem with effective guardrails and safety brakes need to be in place to safeguard individuals and communities.

AI technologies bring a unique set of risks and challenges, such as unethical data collection, cybersecurity threats and amplifying biases, that must be addressed. Without effective and robust regulatory and enforcement systems in place, AI health solutions could have access to sensitive personal information, compromising privacy, health security, and undermining collaboration. This results in biases, mistrust, inaccuracies, and ineffectiveness in health systems. The lack of governance mechanisms also contributes to the slow adoption of AI solutions within health systems. Governments are hesitant to approve technologies without evidence of safety and efficacy; technology developers do not have clear pathways to certification or regulatory approval; and private sector companies are left to develop ethical frameworks without a governmental mandate to protect the public good.

Therefore, strong, responsive governance frameworks and regulatory mechanisms are required to establish AI systems’ safety and effectiveness by putting Responsible AI standards into actual practice. The use of regulatory sandboxes for safe innovation, promotion of open AI models and the use of AI in compliance tech present interesting options to explore as one establish a regulatory ecosystem for AI in health. A robust ecosystem will help mitigate risks, ensure AI’s foundation remains firmly rooted in ethical principles and respect for human rights, as well as build trust for long-term acceptability and success of AI-enabled progress in the health sector.