Zavattaro Federica, von Wyl Viktor, Gille Felix
Digital Society Initiative, University of Zürich, Switzerland.
Institute for Implementation Science in Health Care, University of Zürich, Switzerland.
Milbank Q. 2024 Dec;102(4):973-1003. doi: 10.1111/1468-0009.12722. Epub 2024 Dec 4.
Policy Points First, policymakers can strengthen the inherent trust-building effect of legislations on citizens by incorporating trust-building principles within health data-sharing legislations in a recognizable and comprehensive manner to explicitly signal public trust to policy implementers as one of the policy outcomes to be achieved in the implementation phase. Second, policymakers can use the proposed "public trust in health data sharing" framework as an initial guide to incorporate trust-building principles within health data-sharing legislations.
Public trust is critical to both system legitimacy and the successful implementation of data-driven health initiatives. Legislations are an essential instrument for building public trust, as they can have a dual effect on trust: a passive effect by reinforcing the public perception of an active regulatory system that upholds the rule of law and an active effect as a tool for policymakers to signal trust-building actions to be undertaken during the implementation phase. However, there is limited evidence on the extent to which health data-sharing legislations contain references to trust and trust-building principles for their practical implementation.
By applying an evidence-based "public trust in health data sharing" framework, 36 legislations from the European Union (EU), Italy, France, and Switzerland on health data sharing were analyzed to assess 1) how the term "trust" is embedded in legislations, and 2) the presence and quality of trust-building principles within the selected legislations.
Nine legislations incorporated references to "trust," mainly within the explanatory memorandum and preambles of EU legislations. The most prevalent trust-building principles were "agencies of accountability" (72%) and data "security" (70%). In contrast, the principles "public information" (14%) and "time" (6%) were the least presented. Moreover, the qualitative analysis showed that the majority of the trust-building principles were implicit in the legal text, with Swiss legislations having the highest number of explicit references.
The limited and implicit use of "trust" and trust-building principles in EU, Italian, French, and Swiss legislation emphasizes the opportunity to raise policymakers' awareness of these principles. The proposed framework provides an initial guide for policymakers to incorporate trust-building principles within health data-sharing legislations in a recognizable and comprehensive manner. This ensures that policy implementers at various stages of the policy process can implement trust-building actions, contributing to public trust building in both European and national health data-sharing initiatives.
政策要点 首先，政策制定者可以通过以可识别且全面的方式将信任建立原则纳入健康数据共享立法中，来加强立法对公民固有的信任建立效果，从而向政策实施者明确表明公众信任是实施阶段要实现的政策成果之一。其次，政策制定者可以将提议的“公众对健康数据共享的信任”框架作为初步指南，将信任建立原则纳入健康数据共享立法中。
公众信任对于系统合法性以及数据驱动的健康倡议的成功实施至关重要。立法是建立公众信任的重要工具，因为它们对信任可能产生双重影响：一种被动影响是通过强化公众对维护法治的积极监管系统的认知，另一种积极影响是作为政策制定者在实施阶段表明将采取的信任建立行动的工具。然而，关于健康数据共享立法在实际实施中提及信任和信任建立原则的程度的证据有限。
通过应用基于证据的“公众对健康数据共享的信任”框架，对来自欧盟（EU）、意大利、法国和瑞士的36项关于健康数据共享的立法进行分析，以评估：1）“信任”一词在立法中的体现方式；2）所选立法中信任建立原则的存在情况和质量。
9项立法提及了“信任”，主要在欧盟立法的解释性备忘录和序言中。最普遍的信任建立原则是“问责机构”（72%）和数据“安全”（70%）。相比之下，“公众信息”（14%）和“时间”（6%）原则提及最少。此外，定性分析表明，大多数信任建立原则在法律文本中是隐含的，瑞士立法中明确提及的数量最多。
欧盟、意大利、法国和瑞士立法中对“信任”和信任建立原则的使用有限且隐含，这凸显了提高政策制定者对这些原则认识的机会。提议的框架为政策制定者以可识别且全面的方式将信任建立原则纳入健康数据共享立法提供了初步指南。这确保了政策过程各阶段的政策实施者能够实施信任建立行动，有助于在欧洲和国家健康数据共享倡议中建立公众信任。
