Secondary uses of patients' data in the European health data space: A UK-German comparison

The European Union's (EU) proposed European Health Data Space (EHDS) involves unprecedented integration of patient data across European national boundaries. Part of this Proposal is for patients' direct benefit: to facilitate their healthcare in another EU state if they travel for work or leisure. The second dimension of the Proposal, however, has proved more controversial: to make health data available for "secondary uses" such as medical research and developing health-related algorithms. Much of this controversy revolves around the degree of control patients should have over these secondary uses of their information. To address this tension, we compare two jurisdictions with differing legal approaches to the secondary use of health data: Germany and the United Kingdom. As the EU enters trilogue negotiations, it appears unlikely that patients' informational control can be implemented to the extent of creating an "opt-in" system for secondary uses of health data. However, our analysis suggests that the requirements of both legal cultures could be satisfied by an EHDS system with "opt-outs" from secondary uses of health data. We thus advocate for the consistent availability of "opt-outs" across the EHDS, and call for further research into the creation of accessible opt-outs for patients across the EU.