The Pacing Problem in mHealth Regulation: Rethinking the ‘Intended Use’ Rule in the Governance of mHealth Apps in South Africa

Abstract

The rapid proliferation of mobile health applications (mHealth apps) is transforming healthcare delivery in South Africa, offering AI-enhanced, data-driven tools for remote monitoring, diagnosis, chronic disease management, and personalised interventions. While these technologies are often celebrated for their potential to expand access and improve outcomes, their rapid evolution presents significant regulatory, clinical, and ethical challenges. This article interrogates South Africa’s regulatory framework, with particular attention to the rule under the Medicines and Related Substances Act (MRSA), which classifies a product as a medical device based on the developer’s declared purpose. Although this principle provides conceptual clarity in distinguishing between medical and non-medical devices, it proves increasingly inadequate for wellness and fitness apps whose advanced functionalities extend beyond general wellness into clinically significant domains, yet evade oversight because they are marketed as lifestyle tools. Such functions include predictive diagnostics, symptom checking, continuous monitoring of vital signs (e.g., heart rate, blood pressure, oxygen saturation), treatment recommendations, mental health assessments, and medication reminders. Drawing on the conceptual lens of the pacing problem, which is the misalignment between the speed of technological innovation and the slower adaptation of legal frameworks, the article shows how reliance on declared intent generates oversight gaps that expose users to risks ranging from clinical inaccuracy to data misuse. In response, it proposes a functionality-driven regulatory approach that evaluates mHealth apps based on their real-world capabilities and health implications rather than their declared purposes. Such an approach would enhance regulatory agility, align innovation with safety and ethics, and ensure that mHealth technologies realise their transformative potential without compromising public health protections.