HealthData@EU Pilot - Deliverable 7.1 Common data access application form

The HealthData@EU Pilot Deliverable 7.1 focuses on developing a common European data access application form, a key step in enabling the secure and harmonized cross-border secondary use of electronic health data under the European Health Data Space (EHDS) framework.

This deliverable introduces two distinct forms:

1. Data Request Form – for accessing anonymous aggregated data, which can be used freely without additional security measures.
2. Data Access Application Form – for anonymous or pseudonymized personal-level data, requiring a structured approval process, often including ethical review and secure processing environments for data analysis.

Development and Methodology

The design of these forms was guided by the EHDS Regulation proposal (May 2022) and aligned with GDPR and other relevant EU regulations. It was informed by best practices from multiple EU Member States with established health data access frameworks (e.g., Denmark, Finland, France, Norway). Key considerations included:

• Ensuring structured and standardized information collection for easier processing and translation.
• Balancing completeness (for thorough assessment) with usability (to minimize burden on applicants and data access bodies).
• Supporting partial automation in application processing.

The development process involved multiple consultations, workshops, and expert reviews across legal, technical, and research domains. The deliverable provides detailed insights into the current landscape of health data access across partner countries, identifies challenges in harmonization, and offers technical and policy recommendations for implementing a unified EHDS data access system.

This work was led by Findata (Finnish Social and Health Data Permit Authority) and carried out between February and December 2023.