Resources

Smartphone sensor–enabled health measurement, as part of medical device technologies, is rapidly progressing from theory to practice, therefore utilizing comprehensive health datasets to train and validate artificial intelligence (AI) models for digital health applications.There is a critical gap in the reach of medical devices in low–resource settings where supply of basic health technologies like pulse oximeters, hemoglobinometers, and patient monitors do not meet clinical demand, while many companies prioritize wellness products for high–income populations. A strong need exists to strengthen the innovation ecosystem to allow AI researchers to externalize algorithms more easily to deliver public health products faster, specifically for solutions intended for use by health care providers in low–resource clinical settings.The goal of this guide is to provide insight and ideas to merge the innovative ecosystem of wellness products and medical device AI technology to suit all populations and deliver basic health technology to those who need it. The intended audiences for this toolkit are organizations working to develop AI tools for public health, as well as groups investing in the development of these tools for low–resource settings.

Data and evidence–based public health planning can deliver targeted interventions. PATH is utilizing geographic information system mapping technology to overlay demographic and health indicator data to develop a health atlas along with crafting the City Health Plan to promote urban health development.We are implementing a multipronged strategy for a rabies–free city—including policy oversight—city–level micro–planning, health professional training, community engagement, focused prevention measures for at–risk populations, enhanced surveillance, and efficient resource management.PATH is supporting the organization of special outreach camps for sanitation and mining workers and their families to implement active case finding for tuberculosis.

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.