HealthData@EU Pilot - Deliverable 7.2 Report based on use cases, on general conditions of data sharing and usage security measures for data use including de-identification, onsite use in a secure environment and secure transfer

This deliverable from Work Package 7 of the HealthData@EU pilot project outlines the data provision process from data holders to users, focusing on five use cases conducted over the project's 27-month duration. It begins with key insights from the literature on data use and security before addressing the use cases in detail.

After a brief introduction to each use case, the document details the security measures and procedures applied at different stages of data provision. These include data collection and transfer, processing and linkage, user access, and conditions of data sharing, such as onsite and offsite use, third-party involvement, incidental findings, and pricing models. Security aspects like de-identification, secure environments, and secure data transfer are also covered.

A separate section presents broader considerations that apply to all steps of the process while maintaining the use case perspective. These include data valorization, technical security measures, and data protection.

The document is structured as follows:

• An overview of organizational and technical approaches to data security and privacy, covering key steps in the secondary use of health data (collection, storage, access, and use).

• A summary of the use cases in the HealthData@EU pilot project and the participating entities.

• A detailed analysis of security measures used by the participants, including standard procedures and specific challenges faced in the pilot.

• A comparison of practices across different nodes and their alignment with the proposed EHDS regulation.

• Final conclusions at both EU and national levels.