Fiske Amelia, Degelsegger-Márquez Alexander, Marsteurer Brigitte, Prainsack Barbara
Institute of History and Ethics in Medicine, School of Medicine, Technical University of Munich, Munich, Germany.
Austrian National Public Health Institute (GÖG), Vienna, Austria.
Biosocieties. 2022 Apr 12:1-25. doi: 10.1057/s41292-022-00276-6.
It has become a trope to speak of the increasing value of health data in our societies. Such rhetoric is highly performative: it creates expectations, channels and justifies investments in data technologies and infrastructures, and portrays deliberations on political and legal issues as obstacles to the flow of data. Yet, important epistemic and political questions remain unexamined, such as how the value of data is created, what data journeys are envisioned by policies and regulation, and for whom data types are (intended to be) valuable. Drawing on two empirical cases, (a) interviews with physicians on the topic of digital selfcare, and (b) expectations of stakeholders on the use of Real-World Data in clinical trials, as well as existing literature, we propose a typology of what health data help us to do. This typology is intended to foster reflection about the different roles and values that data use unfolds. We conclude by discussing how regulation can better accommodate practices of valuation in the health data domain, with a particular focus on identifying regulatory challenges and opportunities for EU-level policy makers, and how Covid-19 has shed light on new aspects of each case.
在我们的社会中，谈论健康数据的价值日益增加已成为一种陈词滥调。这种言辞极具表现力：它创造了期望，为数据技术和基础设施的投资提供了渠道并证明其合理性，还将关于政治和法律问题的讨论描绘为数据流动的障碍。然而，一些重要的认识论和政治问题仍未得到审视，比如数据价值是如何产生的，政策和法规所设想的数据流程是怎样的，以及数据类型对谁（有意）具有价值。基于两个实证案例，（a）就数字自我护理主题对医生进行的访谈，以及（b）利益相关者对临床试验中真实世界数据使用的期望，再结合现有文献，我们提出了一种关于健康数据能帮助我们做什么的类型学。这种类型学旨在促进对数据使用所展现的不同角色和价值的反思。我们通过讨论监管如何能更好地适应健康数据领域的估值实践来得出结论，特别关注为欧盟层面的政策制定者识别监管挑战和机遇，以及新冠疫情如何揭示了每个案例的新方面。
