Martani Andrea, Geneviève Lester Darryl, Wangmo Tenzin, Maurer Julia, Crameri Katrin, Erard Frédéric, Spoendlin Julia, Pauli-Magnus Christiane, Pittet Valerie, Sengstag Thierry, Soldini Emiliano, Hirschel Bernard, Borisch Bettina, Kruschel Weber Cornelia, Zwahlen Marcel, Elger Bernice Simone
Institute for Biomedical Ethics, University of Basel, Basel, Switzerland.
Personalized Health Informatics Group, SIB Swiss Institute of Bioinformatics, Basel, Switzerland.
Digit Health. 2023 Apr 20;9:20552076231169826. doi: 10.1177/20552076231169826. eCollection 2023 Jan-Dec.
Ensuring that the health data infrastructure and governance permits an efficient secondary use of data for research is a policy priority for many countries. Switzerland is no exception and many initiatives have been launched to improve its health data landscape. The country now stands at an important crossroad, debating the right way forward. We aimed to explore which specific elements of data governance can facilitate - from ethico-legal and socio-cultural perspectives - the sharing and reuse of data for research purposes in Switzerland.
A modified Delphi methodology was used to collect and structure input from a panel of experts via successive rounds of mediated interaction on the topic of health data governance in Switzerland.
First, we suggested techniques to facilitate data sharing practices, especially when data are shared between researchers or from healthcare institutions to researchers. Second, we identified ways to improve the interaction between data protection law and the reuse of data for research, and the ways of implementing informed consent in this context. Third, we put forth ideas on policy changes, such as the steps necessary to improve coordination between different actors of the data landscape and to win the defensive and risk-adverse attitudes widespread when it comes to health data.
After having engaged with these topics, we highlighted the importance of focusing on non-technical aspects to improve the data-readiness of a country (e.g., attitudes of stakeholders involved) and of having a pro-active debate between the different institutional actors, ethico-legal experts and society at large.
确保健康数据基础设施和治理允许对数据进行高效的二次研究利用是许多国家的政策重点。瑞士也不例外，已经发起了许多倡议来改善其健康数据状况。该国目前正处于一个重要的十字路口，在讨论正确的前进方向。我们旨在从伦理法律和社会文化角度探讨数据治理的哪些具体要素能够促进瑞士出于研究目的的数据共享和再利用。
采用改良的德尔菲法，通过就瑞士健康数据治理主题进行的多轮中介互动，从专家小组收集并梳理意见。
首先，我们提出了促进数据共享实践的技术，尤其是当数据在研究人员之间共享或从医疗机构共享给研究人员时。其次，我们确定了改善数据保护法与研究数据再利用之间的互动方式，以及在此背景下实施知情同意的方式。第三，我们提出了政策变革的想法，例如改善数据领域不同行为者之间协调以及克服在健康数据方面普遍存在的防御性和风险厌恶态度所需的步骤。
在探讨了这些主题之后，我们强调了关注非技术方面以提高国家数据准备程度（例如，相关利益者的态度）以及在不同机构行为者、伦理法律专家和广大社会之间进行积极辩论的重要性。
