Examining the Inclusion of Trust and Trust-Building Principles in European Union, Italian, French, and Swiss Health Data Sharing Legislations: A Framework Analysis.

Abstract

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.