What we do

HealthAI will support establishing and strengthening in-country, government-led regulatory mechanisms to accelerate the standards-based validation of AI technologies for use in health systems and services. HealthAI will contribute its expertise to these regulatory mechanisms, support the implementation of existing auditing tools, and provide guidance on using data for AI solutions validation. Further, HealthAI will provide technical assistance to stakeholders with an interest in regulatory guidelines and tools.

HealthAI will facilitate knowledge sharing between regulatory agencies in different countries and with members of the global regulatory community. This will serve as a mechanism for peer-to-peer learning and identifying best practices, and ultimately enable rapid notification of adverse events arising from an AI-driven health solution. Countries will share findings from AI solution assessments and certification, allowing other countries to streamline certification of the same technology and identify AI solutions requiring refinement or reevaluation based on global standards.

HealthAI will create and maintain a global directory of registered AI-related healthcare solutions, allowing countries representatives and innovators to evaluate solution options against local health needs. HealthAI will develop general use cases as an independent, neutral resource for countries to explore potential technologies and applications relevant to their specific context. This will also surface unmet needs as insight and inspiration for technology developers. 

HealthAI will develop a Global Early Warning System (EWS) for AI medical devices registered within our Global Regulatory Network. The EWS will provide the earliest possible awareness of significant harm or potentially significant harm, on a global basis. This is especially important because of the potential for large-scale uses and possible harms that can be prevalent with software used at high volume and scale, as software, especially AI, can be prone to disproportionate ‘malfunctions’ from minor software changes.

Alongside partners like the Harvard-Charite Global Health Policy Lab, HealthAI will contribute to available global resources related to policy and legislation for Responsible AI for Health. HealthAI will provide technical guidance and insights into international trends and best practices by performing analyses of existing government regulations. Both public and private stakeholders will be able to develop effective, contextually relevant strategies, policies, and regulations for Responsible AI in health. Through diverse stakeholder and citizen engagement, HealthAI will further the democratization of AI for health policy making to cultivate trust and improve inclusiveness.