The datafication of Swiss healthcare and biomedical research: ethical and legal issues and the way forward for health data governance

This Thesis presents the research conducted over the course of three years on some ethical and legal challenges related to the governance of data in the Swiss healthcare and research context. In PART 1, the background to the work conducted during the PhD is presented. Datafication – as a phenomenon – and its epistemological underpinnings are briefly outlined, to then show that they relate to the most current trends how healthcare and biomedical research are evolving. It is illustrated that the datafication of these two domains calls for the extensive collection, exchange and linkage of different data, thus exacerbating the challenges related to the governance of such processes. It is then argued that a great deal of such challenges are of an ethical and legal nature and a short overview them is provided. Effectively tackling such ethical and legal challenges requires adjusting governance at the international level, but it is also underlined that the national level should not be neglected, given the different shapes that the datafication of healthcare and biomedical research takes in single countries. Finally, the specific context of Switzerland is introduced, by first illustrating the most important initiatives that have lead healthcare and biomedical research to being increasingly datafied and by then sketching out the legal and ethical challenges that these have raised in terms of data governance. In PART 2, it is delineated which questions in relation to data governance in Switzerland this PhD investigated and how it went about answering them from a methodological point of view. It is emphasised that there were three main research questions corresponding to three modules to which the original contributions constituting this PhD belong. In Module 1, the ethical issues raised by the collection and use of data through digital health tools were investigated. In Module 2, the focus was on questioning the (un)readiness of Swiss data protection law to keep up with the challenges that datafication of healthcare and biomedical research generates. In Module 3, the challenges in terms of data governance and the evolution of the Swiss health data landscape mentioned during qualitative interviews with national stakeholders were analysed. An overview of the methodological approaches followed in the three modules is also sketched out. PART 3 contains the original manuscripts that have been written as part of the research conducted in the PhD, divided in the three modules outlined before. In PART 4, there is an overall discussion of the research conducted in the different modules of this Thesis. With respect to the use of data collected via novel digital health tools, a range of ethical issues that are relevant both in general (e.g. the risk of stigmatisation) and more specifically to Switzerland (e.g. the personalisation of health insurance premiums via data) are extensively examined. With reference to the (un)readiness of Swiss data protection law zo face the challenges of datafication in healthcare and research, it is demonstrated that Swiss law still sticks to the outdated ‘consent or anonymise’ approach, which in turns contributes to creating a divide between the law-in-the-books and the law-in-action – as exemplified by the study case of data linkage. With regard to the views of expert stakeholders on the challenges raised by the datafication of Swiss healthcare and biomedical research, it is explained how a tension persists around the issue of the control of health data in Switzerland and it is reflected on the governance changes necessary for the data landscape to evolve in an ethically acceptable fashion. In PART 5, an overview of the limitations of the research conducted in this PhD is given. PART 6 contains a brief conclusion, and PART 7 includes the appendices to some of the original manuscripts of this Thesis.