Health and Medical Data Compliance and Secondary Use

Special Program on Health and Medical Data Compliance and Secondary Use

April 17, 2023 – Venice, from 09:00 to 18:00

The DG Santé is establishing the foundations of the future European Health Data Space (EHDS) to enhance citizens’ control on their medical data while facilitating secondary use of data by researchers. Other regulations, such as the Artificial Intelligence Act, will complement this framework. This programme will discuss the impact of the ongoing regulatory changes to support secondary use of data in Europe and beyond. It will bring together authorities and other stakeholders to discuss this evolution. The programme is co-organized with several European research projects such as Gatekeeper, IDEA4RC, ODIN, and Trustaware.

Objectives:
  1. To identify and discuss the current and upcoming compliance challenges (and gaps) faced by medical data processing with current and upcoming regulatory obligations such as EHDS and AIA.
  2. To share good practices for processing health-related data.
  3. To explore collaboration path to build compliant by design data spaces and market places for secondary use of data.
  4. To discuss, address and propose solutions and strategies to support international medical research.

Key sessions:
  • Overview of European regulatory landscape changes
  • European Health Data Space
  • Ensuring Data Quality
  • Health Data Standards and interoperability
  • International Cooperation beyond Europe
  • Open discussions on governance, key challenges and recommendations