Resources

The emergence of new AI-assisted health tools has been exponential—rapidly changing and disrupting how health services are delivered. Although these innovations promise to enhance access to preventive, diagnostic, curative, rehabilitative, and palliative care, there are consequential risks to an individual’s safety and privacy if these innovations are not appropriately regulated.To mitigate potential risks, many national and international regulatory agencies have developed initiatives to control this fast-moving and continuously evolving innovation. The quantity and similarities among these initiatives can often be confusing for the developers of AI-assisted health tools, governments, and other partners. As such, PATH developed an overview of the current regulatory landscape for medical devices incorporating AI—key actors, regulatory approaches and steps, best practices, etcetera, are covered. The overview also provides high-level guidance for AI-assisted health tool developers, governments, and global health donors as they navigate and strengthen regulatory ecosystems. This work is a foundational step toward ensuring all partners have a shared understanding of the current state of regulations, and how improvements can be made amid an ambiguous and constantly changing environment.

For health care providers to make a correct diagnosis, they must be equipped with the right tools, including access to pulse oximetry. These devices are essential for alerting health workers to hypoxemia and the need for urgent treatment, including referral to higher-level facilities and access to oxygen, which can be lifesaving.Lacking these important devices and depending on clinical signs alone, frontline health care providers may be less likely to identify all patients who have hypoxemia and require immediate medical attention. When danger signs are overlooked or not adequately addressed, lives are at risk.This primer is a summary of resources to help decision-makers, implementers, and advocates understand the planning, policies, and technologies involved in pulse oximetry scale-up.

Between 2019 and 2024, the Tools for Integrated Management of Childhood Illness (TIMCI) initiative worked in collaboration with the governments of India, Kenya, Senegal, and Tanzania to improve access to critical tools (pulse oximetry and clinical decision support algorithms) that help health care providers identify and appropriately manage children who are severely ill.This work included large-scale, multi-country, mixed-method evaluation conducted to address evidence gaps and inform national and international decision-making on scale-up of these devices: a pragmatic cluster randomized controlled trial in India and Tanzania, quasi-experimental pre-post studies in Kenya and Senegal, and complementary sub-studies.This technical brief summarizes cross-country results, interpretations, as well as key takeaways from the TIMCI studies.

PATH is moving from a siloed, disease-specific approach to person-centric approaches by establishing integrated care models. We actively assist state governments in integrating maternal and child health, non-communicable, mental health, tuberculosis, and elderly care services, and establishing model adolescent-friendly facilities at the urban primary health care level.

In collaboration with national and state–level partners, PATH is adopting the One Health approach with a focus on human and animal health, working towards establishing city–level governance structures and enhancing disease surveillance systems at urban facilities, including community–based surveillance.This will improve epidemic preparedness, monitoring, and rapid response capabilities for emerging health threats like climate change and antimicrobial resistance.