Resources

Nanopore–based sequencing platforms offer the potential for affordable malaria molecular surveillance in resource–limited settings to track and ultimately counteract emerging threats, such as drug resistance and diagnostic escape.With support from the Bill and Melinda Gates Foundation and building on the success of NOMADS, NOMADS 2 is continuing to strengthen and expand the use of nanopore sequencing for malaria genomic surveillance.This factsheet provides an overview of the NOMADS 2 project.

This publication was prepared by the staff of the African Union Development Agency (AUDA-NEPAD) and PATH, with technical support from the Medicines Policy and Regulatory Reforms Technical committee and other external contributions. This document is meant to be used as a training guide on regulatory systems strengthening in Africa for National Medicines Regulatory Authorities, Regional Economic Communities and all other stakeholders directly or indirectly working in, or able to influence and support regulatory systems at country, regional or continental level.

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.