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

Soil organic carbon significantly increases when perennial biomass plantations are reverted back to annual arable crops

Funding: This research was supported by funding from the Rural Developing Program (measure 16.01) of the Emilia Romagna region that financed the “FarmCO2Sink” EIP-AGRI operational group (grant number 5015651). Acknowledgments: The authors thank Mike Martin for his support in the modification of the ECOSSE source code.Peer reviewedPublisher PD

The devil is in the details: an analysis of patient rights in Swiss cancer registries

Cancer registries are an important part of the public health infrastructure, since they allow to monitor the temporal trends of this illness as well as facilitate epidemiological research. In order to effectively set up such registries, it is necessary to create a system of data collection that permits to record health-related information from patients who are diagnosed with cancer. Given the sensitive nature of such data, it is debated whether their recording should be based on consent or whether alternative arrangements are possible (eg, opt-out systems where information is automatically collected but patients can later withdraw). In the recent reform of the Swiss cancer registration legislation, the lawmaker set out to implement rules about the recording of data in cancer registries that would allegedly go beyond a consent-based model, in order to balance accurate registration with respect of patient rights. However, by analysing the operational norms of the new legislation and comparing them with those of other systems, it emerges that the Swiss rules de facto closely resemble a system of registration based on informed consent-in partial contradiction with the objective pursued by the lawmaker. In this paper, we show how the details of a policy are crucial to determine its true nature and we highlight some critical elements-from an ethical standpoint-of the recently reformed Swiss policy on cancer registration

Systemic Fairness for Sharing Health Data: Perspectives From Swiss Stakeholders

Introduction:; Health research is gradually embracing a more collectivist approach, fueled by a new movement of open science, data sharing and collaborative partnerships. However, the existence of systemic contradictions hinders the sharing of health data and such collectivist endeavor. Therefore, this qualitative study explores these systemic barriers to a fair sharing of health data from the perspectives of Swiss stakeholders.; Methods:; Purposive and snowball sampling were used to recruit 48 experts active in the Swiss healthcare domain, from the research/policy-making field and those having a high position in a health data enterprise (e.g., health register, hospital IT data infrastructure or a national health data initiative). Semi-structured interviews were then conducted, audio-recorded, verbatim transcribed with identifying information removed to guarantee the anonymity of participants. A theoretical thematic analysis was then carried out to identify themes and subthemes related to the topic of systemic fairness for sharing health data.; Results:; Two themes related to the topic of systemic fairness for sharing health data were identified, namely (i) the hypercompetitive environment and (ii) the legal uncertainty blocking data sharing. The theme, hypercompetitive environment was further divided into two subthemes, (i) systemic contradictions to fair data sharing and the (ii) need of fair systemic attribution mechanisms.; Discussion:; From the perspectives of Swiss stakeholders, hypercompetition in the Swiss academic system is hindering the sharing of health data for secondary research purposes, with the downside effect of influencing researchers to embrace individualism for career opportunities, thereby opposing the data sharing movement. In addition, there was a perceived sense of legal uncertainty from legislations governing the sharing of health data, which adds unreasonable burdens on individual researchers, who are often unequipped to deal with such facets of their data sharing activities

Megatrends in Healthcare: Review for the Swiss National Science Foundation’s National Research Programme 74 (NRP74) “Smarter Health Care”.

Objectives: In this paper, we present a review of some relevant megatrends in healthcare conducted as part of the Swiss National Science Foundation’s National Research Programme 74 (NRP74) “Smarter Health Care.” Our aim is to stimulate discussions about long-term tendencies underlying the current and future development of the healthcare system. Methods: Our team—a multidisciplinary panel of researchers involved in the NRP74—went through an iterative process of internal consultations followed by a rapid literature review with the goal of reaching group consensus concerning the most relevant megatrends in healthcare. Results: Five megatrends were identified, namely: 1) Socio-demographic shifts. 2) Broadening meaning of “health.” 3) Empowered patients and service users. 4) Digitalization in healthcare. 5) Emergence of new models of care. The main features of each megatrend are presented, drawing often on the situation in Switzerland as a paradigmatic example and adding reflections on the potential influence of the COVID19 pandemic on them. Conclusion: Considering the long-term megatrends affecting the evolution of healthcare is important—amongst other things–to understand and contextualise the relevance and implications of innovative health services research results

Moisture content estimation and senescence phenotyping of novel Miscanthus hybrids combining UAV-based remote sensing and machine learning

Miscanthus is a leading perennial biomass crop that can produce high yields on marginal lands. Moisture content is a highly relevant biomass quality trait with multiple impacts on efficiencies of harvest, transport, and storage. The dynamics of moisture content during senescence and overwinter ripening are determined by genotype × environment interactions. In this paper, unmanned aerial vehicle (UAV)-based remote sensing was used for high-throughput plant phenotyping (HTPP) of the moisture content dynamics during autumn and winter senescence of 14 contrasting hybrid types (progeny of M. sinensis x M. sinensis [M. sin x M. sin, eight types] and M. sinensis x M. sacchariflorus [M. sin x M. sac, six types]). The time series of moisture content was estimated using machine learning (ML) models and a range of vegetation indices (VIs) derived from UAV-based remote sensing. The most important VIs for moisture content estimation were selected by the recursive feature elimination (RFE) algorithm and were BNDVI, GDVI, and PSRI. The ML model transferability was high only when the moisture content was above 30%. The best ML model accuracy was achieved by combining VIs and categorical variables (5.6% of RMSE). This model was used for phenotyping senescence dynamics and identifying the stay-green (SG) trait of Miscanthus hybrids using the generalized additive model (GAM). Combining ML and GAM modeling, applied to time series of moisture content values estimated from VIs derived from multiple UAV flights, proved to be a powerful tool for HTPP

Site impacts nutrient translocation efficiency in intraspecies and interspecies miscanthus hybrids on marginal lands

Miscanthus, a C4 perennial rhizomatous grass, is capable of growing in varied climates and soil types in Europe, including on marginal lands. It can produce high yields with low nutrient inputs when harvested after complete senescence. Senescence induction and rate depend on complex genetic, environmental, and management interactions. To explore these interactions, we analysed four miscanthus hybrids (two novel seed-based hybrids, GRC 3 [Miscanthus sinensis × sinensis] and GRC 14 [M. sacchariflorus × sinensis]; GRC 15, a novel M. sacchariflorus × sinensis clone; and GRC 9, a standard Miscanthus × giganteus clone) in Italy, Croatia, Germany and the UK. Over all trial locations and hybrids, the average aboveground biomass of the 3-year-old stands in August 2020 was 15 t DM ha−1 with nutrient contents of 7.6 mg N g−1 and 14.6 mg K g−1. As expected, delaying the harvest until spring reduced overall yield and nutrient contents (12 t DM ha−1, 3.3 mg N g−1, and 5.5 mg K g−1). At lower latitudes, the late-ripening M. sacchariflorus × sinensis GRC 14 and GRC 15 combined high yields with low nutrient contents. At the most elevated latitude location (UK), the early-ripening M. sinensis × sinensis combined high biomass yields with low nutrient offtakes. The clonal Miscanthus × giganteus with intermediate flowering and senescence attained similar low nutrient contents by spring harvest at all four locations. Seasonal changes in yield and nutrient levels analysed in this study provide: (1) a first step towards recommending hybrids for specific locations and end uses in Europe; (2) crucial data for determination of harvest time and practical steps in the valorization of biomass; and (3) key sustainability data for life cycle assessments. Identification of trade-offs resulting from genetic × environment × management interactions is critical for increasing sustainable biomass supply from miscanthus grown on marginal lands

Spring emergence and canopy development strategies in miscanthus hybrids in Mediterranean, continental and maritime European climates

Abstract Due to its versatility and storability, biomass is an important resource for renewable materials and energy. Miscanthus hybrids combine high yield potential, low input demand, tolerance of certain marginal land types and several ecosystem benefits. To date, miscanthus breeding has focussed on increasing yield potential by maximising radiation interception through: (1) selection for early emergence, (2) increasing the growth rate to reach canopy closure as fast as possible, and (3) delayed flowering and senescence. The objective of this study is to compare early season re‐growth in miscanthus hybrids cultivated across Europe. Determination of differences in early canopy development on end‐of‐year yield traits is required to provide information for breeding decisions to improve future crop performance. For this purpose, a trial was planted with four miscanthus hybrids (two novel seed‐based hybrids M. sinensis × sinensis [M sin × sin] and M. sacchariflorus × sinensis [M sac × sin], a novel rhizome‐based M sac × sin and a standard Miscanthus × giganteus [M × g] clone) in the UK, Germany, Croatia and Italy, and was monitored in the third and fourth growing season. We determined differences between the hybrids in base temperature, frost sensitivity and emergence strategy. M × g and M sac × sin mainly emerged from belowground plant organs, producing fewer but thicker shoots at the beginning of the growing season but these shoots were susceptible to air frosts (determined by recording 0°C 2 m above ground surface). By contrast, M sin × sin emerged 10 days earlier, avoiding damage by late spring frosts and producing a high number of thinner shoots from aboveground shoots. Therefore, we recommend cultivating M sac × sin at locations with low risk and M sin × sin at locations with higher risk of late spring frosts. Selecting miscanthus hybrids that produce shoots throughout the vegetation period is an effective strategy to limit the risk of late frost damage and avoid reduction in yield from a shortened growing season