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Short abstract:

Policymakers strive to ensure trustworthiness of digital health for healthcare. Yet, regulatory standards clash with its dynamic nature. Investigating 3 regulatory experiments, this study explores Real-world Evidence as a novel governing mode, impacting medical expertise, data, and patients.

Long abstract:

Ranging from electronic health records, mhealth and sensors to more sophisticated advancements in AI, genomics, and Big Data, EU policymakers have sought to find ways to translate digital health technologies (DHT) into ‘trustworthy’ tools for healthcare. Despite several initiatives, one of its most prominent translational tensions resides around the evidence standards that are used by regulatory agencies to assess the quality and safety and reimbursement-potential of medical Digital Health Technologies. According to developers, industry, and researchers alike, the struggle for these technologies to navigate these regulatory approvals arises from the fact that these policy frameworks still rely on evidence standards that mismatch with the dynamic nature of these technologies, hindering their translation into ‘trustworthy’ tools for healthcare. This misfit ties into a far wider debate that has been incubating for years in the world of drug approvals on the move from Evidence-based Medicine towards Real-world evidence (RWE) for assessing the quality and safety, and reimbursement of biomedical innovations. By investigating three ‘regulatory experimentations’ to develop RWE as governing tools for DHT (e.g., In Silico Modeling, Digital Clinical Trials, and RWE reimbursement frameworks), this paper builds on STS, innovation-, and RRI studies to investigate the social dimensions of RWE as a new mode of governing for DHT: how does this governing technique come into being? Which type of knowledges are produced, and by whom? and how does this reconfigure our understanding of ‘medical’ expertise, -data, and patients?