top of page
Search

AI4LUNGS at the IAPP Conference Brussels: Discussing EHDS & AI Model Training

AI4LUNGS was represented at the IAPP Conference in Brussels on the 20th November, where our legal partner, Magdalena Kogut-Czarkowska from Timelex, delivered a presentation on the European Health Data Space (EHDS) and discussed how health data re-use supports AI model training within AI4LUNGS.


Magdalena joined a panel session alongside Maria Bardaji Cruz, Privacy Compliance EMEA from Johnson & Johnson and Julia Bonder-Le Berre, Head of Global Privacy from Iron Mountain for the session “EU Health Data Transformation: The Promise of the European Health Data Space.” The discussion explored:


  • The EHDS, and how both the public and private sectors are involved in processing health data, which aims to enable safe, interoperable health data sharing across Europe while maintaining strong privacy safeguards.

  • Practical insight into how companies navigate and prepare for this new regulatory framework.

  • Best practices for leveraging health data in biomedical research while safeguarding patient privacy and protecting intellectual property


Understanding the EHDS: A New Era for Health Data in Europe


The EHDS regulation distinguishes between two key categories of health data use- Primary Use and Secondary Use:


Primary Use

Data used directly in care delivery such as treatment, prescriptions, and administrative services. The EHDS strengthens patient rights by introducing:

  • Patients benefit from enhanced rights to access, control, and share their EHD in addition to existing GDPR rights

  • Wellness apps which transmit EHD to medical systems have to be compliant with EHDS requirements

  • Electronic health record (EHR) systems, intended for healthcare providers, must implement interoperability and compliance standards

Secondary Use

Data re-used for purposes that benefit society, including:

  • Research and innovation

  • Policy-making and patient safety

  • Public health statistics and regulatory activities

Under the EHDS, a variety of entities, likely to include the pharmaceutical companies, may qualify as data holders and must be prepared to share electronic health data with authorised researchers and authorities. This requires clear internal processes, transparent data governance, and clear mapping of available datasets.


How EHDS Connects to AI4LUNGS

During the session, Magdalena highlighted how EHDS could support data access for AI model development in European research initiatives like AI4LUNGS, which uses clinical data from Spain, Portugal, the Netherlands, Norway, and Israel to advance AI-powered diagnosis and treatment stratification for respiratory diseases, including ILDs, infectious diseases, and lung cancer.

Responsible secondary use of health data is essential for building clinically reliable, high-performing models. The EHDS Regulation aims to simplify access to such data while ensuring:

  • Strong privacy protection

  • Transparent governance

  • Fair and secure data sharing

  • Protection of intellectual property and sensitive commercial information


So… what are the challenges to this seemingly promising regulation?


The EHDS presents great opportunities, however its practical implementation remains complex. Uncertainties for companies persist around:

  • How obligations will differ across EU member state

  • Digital maturity across Europe is highly uneven

  • The exact responsibilities of data holder

  • EHDS is (yet) another incentive for digital transformation for public and private sector enterprises


However, by sharing expertise and developing best practices now, stakeholders can better prepare for the digital transformation ahead.



Stay updated on the AI4LUNGS research development and progress by following the project on X and LinkedIn, and subscribing to our newsletter for the latest insights and advancements.

bottom of page