Weaving EU digital health policy into national healthcare practices. The making of a reimbursement standard for digital health technologies in Belgium.

ABSTRACT

Along the hopes and fears around the recent rise of Digital Health Technologies (DHT), EU and Member State (MS) policymakers have sought to find ways to translate these innovations into tangible trustworthy and reliable tools for health and care practices. While these translation-efforts have been developed across different healthcare contexts with their own histories, practices, and values, their increasing entanglement has over the years raised several implementation issues between EU and MS policy initiatives. While policymakers have struggled to understand the reasons behind this, this article proposes to 'move focus' towards a socio-technical understanding of DHT by investigating how these alignment attempts come about in practice. For this we focus on Belgium's frontrunning attempt to develop a reimbursement framework for DHT. Drawing on a document analysis of EU and Belgian policy, media, and industry publications (2016-2022), field observations, and interviews, we demonstrate how Belgian policymakers have tried to align their attempt to improve trust in DHT with existing EU efforts in this regard through the development of their 'mhealthBelgium validation pyramid'. With this, we show that rather than overcoming translation difficulties, the pyramid is in fact enacting frictions around 'trust', 'medical' devices, the 'empowered' patient, and 'valuable' data. Beyond mere technical accounts of the translation challenges at hand, this article therefore points to the way this pyramid is "locking-in" these frictions, and with this has hindered the implementation of DHT. Despite the Belgian government's announcement of a renewed reimbursement framework two years later, its emphasis on overcoming technical translation issues risks re-enacting these very same entrenched frictions.