Pre-conference: The European Health Data Space Regulation: implications for researchers and policymakers on accessing and using health data (EHDS)

Tuesday 11 November, 09:00 – 12:30 Helsinki time
(ending with network lunch at 12:30)


Organised by

Health Data Agency (BE) and Luxembourg National Data Service (LNDS)

Abstract

The European Health Data Space (EHDS) will bring about a major change in the way health and healthcare related data will be shared, accessed and processed for secondary use. This transformation will significantly affect the everyday work of researchers and policy-makers. By facilitating access to health data, the EHDS aims to optimize the use of health data to improve healthcare, foster innovation, and support evidence-based policymaking.

This pre-conference will support health data users in navigating the EHDS user journey, drawing on the EHDS regulation and TEHDAS2 recommendations, which provide concrete guidelines, technical specifications, and input for the accompanying implementing acts.

This so-called user journey starts from a data discovery phase. This means searching for and finding the right type of data by browsing a metadata catalogue and understanding the description and content of a metadata record. Following the data discovery and directly from the catalogue, the data user can decide to apply for data or data access. Aggregated, statistical or non-individual level data can be requested using a data request form. For access to anonymized, pseudonymized or individual level data, a data access application should be submitted to a Health Data Access Body. If a permit for data access is granted, the requested data is prepared and made available in a secure processing environment. The data user can then perform their analysis, followed by the publication of the results.

The pre-conference combines a research, policy making and implementation perspective with interactive discussion, and it is organized by experts from Finland, Belgium and Luxembourg from scientific institutions and health data access bodies.  

Main messages

  • The EHDS regulation will have a major impact on the way health data will be shared and accessed for secondary use (research, policy making, innovation).
  • This workshop will describe the main phases involved in a typical situation in which data is used. This so-called user journey starts from data discovery, followed by data request, data processing to reporting of results. For each phase, the challenges and opportunities will be discussed, including useful insights and good practices.

Short course outline

  • Introduction to the EHDS regulation, major principles of the framework and TEHDAS2 joint action
  • Overall description of the user journey

  • Detailed description of the different phases in a user journey
    • Data discovery:
      • how to discover data in the metadata catalogue
      • how to interpret the metadata record from a user perspective
    • Data request versus data access application: forms and procedures
    • Data preparation: how basic principles of anonymization, pseudonymization and minimization should be considered in case of a data access application
    • Data provision and data use in a secure processing environment
      • How can data be accessed and processed within a secure processing environment?
      • Which challenges can a user expect and which rules to respect?
    • Results output: EHDS expectations regarding the obligatory publication of results and transparency of results

Programme

Detailed programme will follow

Registration

The registration fee is EUR 80. Networking lunch and refreshments are included.