Data protection and biomedical research in Switzerland: setting the record straight

Abstract

Ensuring the protection of privacy and the compliance with data protection rules have become central issues for researchers active in the biomedical field. Data protection law is often perceived as very complex and difficult to interpret, which can hinder the efficacious planning and implementation of new research projects. Indeed, the sophisticated legal architecture that governs data processing activities in general and biomedical research in particular might feel overwhelming for both legal practitioners and researchers.The objective of this article is to review the interaction of data protection law and biomedical research with a predominant focus on the Swiss context. In order to facilitate a better understanding of this issue, we discuss three crucial nodes that shape the interplay of law and data processing in research First, we explore the meaning of "personal" data, the requirements to classify data as "personal", "non-personal", "pseudonymised" or "anonymised" and the implications of such classifications from a legal perspective. We then consider the relationship between sector-specific data processing regulations for research and other laws on data protection. Finally, we examine the role of consent for data processing in the research field and its significance from a data protection perspective. In conclusion, this review underlines the importance of fostering reciprocal collaboration of data protection experts and biomedical researchers to facilitate the development of new projects in the future.

Evolution or Revolution? Recommendations to Improve the Swiss Health Data Framework

“…This study is part of a broader project aimed at identifying, mapping and ordering current deficiencies of the health data infrastructure and data culture in Switzerland and the possible solutions thereto (29). The project included also a systematic review (30) and the analysis of relevant legal (31,32) and ethical (33) issues. From the qualitative part of the project, an article on the conception of health data ownership has been written (34).…”

Mapping ethical issues in the use of smart home health technologies to care for older persons: a systematic review

“…It is not surprising that privacy was the most discussed ethical issue in relation to SHHTs in caregiving. The topic of privacy, especially in relation to monitoring technologies and/or health, has been widely discussed (see for example (102)(103)(104). A particularly interesting nding within this ethical concern was related to privacy and cognitive impairment.…”

Systemic Fairness for Sharing Health Data: Perspectives From Swiss Stakeholders

“…One of the contributing factors is that data protection regulations are elaborated broadly to cover many situations but they lack specificity when applied to a particular context ( 45 ). Furthermore, even if there are research exemptions or research-specific rules that are implemented within certain pieces of legislations (e.g., the GDPR at the European level) or the Swiss Federal Act on Data Protection (FADP), it is still unclear for researchers how to implement these exceptions in practice ( 46 , 47 ). These issues were reflected in our study where participants experienced difficulties in ascertaining whether their data sharing activities were operating within legally acceptable margins.…”

“…Another contributing factor to the perceived legal uncertainty is the multitude of data protection regulations present in the Swiss legal landscape and the difficulty in identifying which specific regulation would supersede the other in a particular context. In the current Swiss legislative framework, solving this legal uncertainty requires a case-by-case approach ( 46 ), but this uncertainly slows down data sharing.…”