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Implementing Regulatory Sandboxes for Digital Health Innovation in Sub-Saharan Africa: Lessons from the Fintech Sector

Abstract

Health systems in most countries in Sub-Saharan Africa face challenges relating to inadequate infrastructure, insufficient funding and shortage of skilled healthcare workers. Whereas digital health innovation has been embraced in the region to address these challenges and strengthen health systems, a delicate balance between innovation and regulation for sustainable and equitable use is imperative. However, as Africa continues to digitalise her health systems to improve healthcare, issues pertaining to data governance and privacy concerns have emerged that call for frameworks that can protect the vulnerable without stifling digital innovation in healthcare. In this article, we explore how challenges related to poor data quality and data governance in digital health innovations can be addressed through regulatory sandboxes. We draw lessons and experiences from the financial sector and how they can potentially be used in designing digital health regulatory sandboxes. Through a comparative critical analysis of the journey taken in fintech sandboxing, we highlight the challenges faced and success factors in the fintech sector that can be mirrored during the implementation of digital health sandboxes. We complement these sources with qualitative interviews and insights from engaging with different stakeholders in the Fintech and digital health sectors. Our critical analysis builds on Felix Kumah-Abiwu’s extension of the Afrocentric paradigm and analyses how an Afrocentric triple helix model can enable the co-creation of regulation in digital health. We thus provide a unique empirical analysis around the opportunities, limitations and concerns of fintech regulatory sandboxes that could be used for the implementation of digital health sandboxes across Sub-Saharan Africa.

Published: 2026-03-02
Issue:Online First
Section: Articles
How to Cite
Mkalama, Benedict, and Pamela Andanda. 2026. “Implementing Regulatory Sandboxes for Digital Health Innovation in Sub-Saharan Africa: Lessons from the Fintech Sector”. Law, Technology and Humans, March. https://doi.org/10.5204/lthj.4004.

Author Biographies

University of Nairobi
Kenya Kenya

Ben Mkalama is an adjunct faculty at the University of Nairobi (Kenya) and has been a Visiting Research Fellow at the University of Warwick (United Kingdom) amongst other positions. He holds a PhD in Business Administration from the University of Nairobi. He has over thirty years unique experience that blends academia, research and industry. In addition to teaching entrepreneurship, innovations management and International Business, his current research interests are on critical studies that focus on intersectional inequalities due to digitalisation, space, financialization and environment. 

University of Witwatersrand
South Africa South Africa

Pamela Andanda is a Professor of Law at the University of the Witwatersrand, Johannesburg and a member of the Academy of Science of South Africa. She has a background in Law and bioethics. Her research focuses on research ethics and integrity, research with vulnerable groups, privacy, data protection and the intersection between intellectual property and human rights, with specific reference to access to health technologies.

Open Access Journal
ISSN 2652-4074