1 Introduction

This report on Special Study 2 is one of three ‘deep dive’ studies for the final evaluation of the Kuunika Project in Malawi. The study focuses on the governance, regulatory and policy aspects of the initiative.

The Kuunika Project: Data for Action is funded by the Bill & Melinda Gates Foundation (BMGF). It commenced in 2016 and was implemented in partnership with the Government of Malawi (GoM). The Kuunika Project aimed to establish a strong base of high-quality, routinely-available data and a culture of data use in the health sector, using the HIV/AIDS programme as a first use case. There was a particular focus on addressing the range of technological innovations, knowledge translation, and health system strengthening needs of the Ministry of Health (MoH) in Malawi.

BMGF contracted Mott MacDonald to provide independent evaluation services to the Kuunika Project over the course of programme implementation (2016-2021). These evaluation services have included baseline, midline and endline evaluations. This Special Study (2) is one of three ‘deep dive’ special studies being conducted as part of Mott MacDonald’s final, endline evaluation.

Special Study 2 aims to surface the governance, regulatory and policy achievements, challenges and barriers associated with the Kuunika initiative. In particular, the study focuses on Kuunika’s efforts to upgrade the electronic medical records (EMRs) system for HIV patients in Malawi and establish a central database and Demographic Data Exchange (DDE). The study also intends to make recommendations for:

● GoM for next steps to enable progress with the EMRs/DDE in the future ● BMGF for similar programmes elsewhere ● Global health donors involved in establishing regulatory frameworks for personal medical data exchange.

This Special Study Report begins with an overview of the Kuunika Project and the ‘essentials’ of the governance components. This, in turn, provides the context for the specific questions underpinning this study enquiry. The wider context of digital health governance in Malawi and a review of global standard in digital health governance are summarised in Chapters 3 and 4 respectively. Chapter 5 of this report describes the study methodology, including data collection methods, the analytical framework and efforts made to mitigate methodological limitations. Chapter 6 presents a synthesis of evidence-based findings from the study enquiry – these findings are presented systematically against each of the study questions. The final chapter of this report (Chapter 7) presents a summary of lessons arising from the study findings, along with our conclusion and recommendations for key stakeholders.

The annexes to this report provide more detailed background information and presentations of evidence from the enquiry process.