Public Preferences for Digital Health Data Sharing: Discrete Choice Experiment Study in 12 European Countries.

BACKGROUND: With new technologies, health data can be collected in a variety of different clinical, research, and public health contexts, and then can be used for a range of new purposes. Establishing the public's views about digital health data sharing is essential for policy makers to develop effective harmonization initiatives for digital health data governance at the European level. OBJECTIVE: This study investigated public preferences for digital health data sharing. METHODS: A discrete choice experiment survey was administered to a sample of European residents in 12 European countries (Austria, Denmark, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) from August 2020 to August 2021. Respondents answered whether hypothetical situations of data sharing were acceptable for them. Each hypothetical scenario was defined by 5 attributes ("data collector," "data user," "reason for data use," "information on data sharing and consent," and "availability of review process"), which had 3 to 4 attribute levels each. A latent class model was run across the whole data set and separately for different European regions (Northern, Central, and Southern Europe). Attribute relative importance was calculated for each latent class's pooled and regional data sets. RESULTS: A total of 5015 completed surveys were analyzed. In general, the most important attribute for respondents was the availability of information and consent during health data sharing. In the latent class model, 4 classes of preference patterns were identified. While respondents in 2 classes strongly expressed their preferences for data sharing with opposing positions, respondents in the other 2 classes preferred not to share their data, but attribute levels of the situation could have had an impact on their preferences. Respondents generally found the following to be the most acceptable: a national authority or academic research project as the data user; being informed and asked to consent; and a review process for data transfer and use, or transfer only. On the other hand, collection of their data by a technological company and data use for commercial communication were the least acceptable. There was preference heterogeneity across Europe and within European regions. CONCLUSIONS: This study showed the importance of transparency in data use and oversight of health-related data sharing for European respondents. Regional and intraregional preference heterogeneity for "data collector," "data user," "reason," "type of consent," and "review" calls for governance solutions that would grant data subjects the ability to control their digital health data being shared within different contexts. These results suggest that the use of data without consent will demand weighty and exceptional reasons. An interactive and dynamic informed consent model combined with oversight mechanisms may be a solution for policy initiatives aiming to harmonize health data use across Europe.

Post-identifiability in changing sociotechnological genomic data environments.

Data practices in biomedical research often rely on standards that build on normative assumptions regarding privacy and involve 'ethics work.' In an increasingly datafied research environment, identifiability gains a new temporal and spatial dimension, especially in regard to genomic data. In this paper, we analyze how genomic identifiability is considered as a specific data issue in a recent controversial case: publication of the genome sequence of the HeLa cell line. Considering developments in the sociotechnological and data environment, such as big data, biomedical, recreational, and research uses of genomics, our analysis highlights what it means to be (re-)identifiable in the postgenomic era. By showing how the risk of genomic identifiability is not a specificity of the HeLa controversy, but rather a systematic data issue, we argue that a new conceptualization is needed. With the notion of post-identifiability as a sociotechnological situation, we show how past assumptions and ideas about future possibilities come together in the case of genomic identifiability. We conclude by discussing how kinship, temporality, and openness are subject to renewed negotiations along with the changing understandings and expectations of identifiability and status of genomic data.

A proposal for an international Code of Conduct for data sharing in genomics.

As genomic research becomes commonplace across the world, there is an increased need to coordinate practices among researchers, especially with regard to data sharing. One such way is an international code of conduct. In September 2020, an expert panel consisting of representatives from various fields convened to discuss a draft proposal formed via a synthesis of existing professional codes and other recommendations. This article presents an overview and analysis of the main issues related to international genomic research that were discussed by the expert panel, and the results of the discussion and follow up responses by the experts. As a result, the article presents as an annex a proposal for an international code of conduct for data sharing in genomics that is meant to establish best practices.

Biobanking and risk assessment: a comprehensive typology of risks for an adaptive risk governance.

Biobanks act as the custodians for the access to and responsible use of human biological samples and related data that have been generously donated by individuals to serve the public interest and scientific advances in the health research realm. Risk assessment has become a daily practice for biobanks and has been discussed from different perspectives. This paper aims to provide a literature review on risk assessment in order to put together a comprehensive typology of diverse risks biobanks could potentially face. Methodologically set as a typology, the conceptual approach used in this paper is based on the interdisciplinary analysis of scientific literature, the relevant ethical and legal instruments and practices in biobanking to identify how risks are assessed, considered and mitigated. Through an interdisciplinary mapping exercise, we have produced a typology of potential risks in biobanking, taking into consideration the perspectives of different stakeholders, such as institutional actors and publics, including participants and representative organizations. With this approach, we have identified the following risk types: economic, infrastructural, institutional, research community risks and participant's risks. The paper concludes by highlighting the necessity of an adaptive risk governance as an integral part of good governance in biobanking. In this regard, it contributes to sustainability in biobanking by assisting in the design of relevant risk management practices, where they are not already in place or require an update. The typology is intended to be useful from the early stages of establishing such a complex and multileveled biomedical infrastructure as well as to provide a catalogue of risks for improving the risk management practices already in place.

Chapter 6. French and Chinese regulatory approaches to end-of-life and euthanasia.

For patients in critical or terminal situations, the approach to death is a situation that raises many ethical and legal issues of importance. Health professionals and families of the person at the end-of-life are obviously at the forefront of the concerns generated by these situations, all wishing to act in the best interest of the patient. Some States have regulated the various situations encountered on the ground in order to provide stakeholders with clear and appropriate procedures to ensure human dignity in practice by elaborating the rules of an end-of-life ethics aimed at supporting health professionals involved in carrying out certain acts while setting limits in respect of the persons concerned. What are the alternatives? Is euthanasia tolerable? What role for health professionals? And for the family? The content of the regulations differs according to countries, to cultural sensitivities and ethical and legal traditions, like the political will to regulate this topic. The regulatory experience of countries like France and China can be useful to other countries and serve as a basis for discussing the topic. Therefore, we analyze the current French framework and the situation in China in order to highlight main elements of ethical discussions, adopted positions and rules, eventual joint considerations, remaining issues and challenges in a comparative approach.

The impact of the EU general data protection regulation on scientific research.

The use of personal data is critical to ensure quality and reliability in scientific research. The new Regulation [European Union (EU)] 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data [general data protection regulation (GDPR)], repealing Directive 95/46/EC, strengthens and harmonises the rules for protecting individuals' privacy rights and freedoms within and, under certain conditions, outside the EU territory. This new and historic legal milestone both prolongs and updates the EU acquis of the previous Data Protection Directive 95/46/EC. The GDPR fixes both general rules applying to any kind of personal data processing and specific rules applying to the processing of special categories of personal data such as health data taking place in the context of scientific research, this including clinical and translational research areas. This article aims to provide an overview of the new rules to consider where scientific projects include the processing of personal health data, genetic data or biometric data and other kinds of sensitive information whose use is strictly regulated by the GDPR in order to give the main key facts to researchers to adapt their practices and ensure compliance to the EU law to be enforced in May 2018.

[The foundation of research ethics in community law]. / Les fondements de l'éthique de la recherche en droit communautaire.

The creation of the European Community by the Treaty of Rome in 1957 marked the beginning of the efforts to coordinate and harmonize national policies in many strategic sectors with high economic value, among them several aspects of scientific research. The European Union Law, formerly known as European Community law, now includes a range of ethical principles that apply to research projects developed with the financial support of the European Union. Which were the steps in the integration of the ethics of sciences in the context of the Union? This article aims to study first, what were, and what are the legal bases of the integration of the ethical dimension of researches in life sciences by the European Union and, secondly, the institutional organisation that has been set up in order to discuss the development of common ethical norms, especially bioethics one, and in order to apply these rules which respect national particularities. In this regard, we analyse the relevant legal texts providing a foundation for the creation of a European bio-law and we give an overview of the European institutions' activity in the field of bioethics by looking particularly the health research field.