top of page
Search

Legal Challenges in AI-Driven Healthcare: AI4LUNGS at the Privacy Symposium Conference

During the 2025 Privacy Symposium in Venice, Magdalena Kogut-Czarkowska, legal partner of AI4LUNGS from Timelex took the stage in the panel “AI for Health” , presenting “Legal Challenges in Developing AI for Healthcare.” Magdalena shared how the project is addressing the evolving regulatory landscape surrounding artificial intelligence in healthcare.





Staying Ahead of Regulation: A Proactive Strategy

In recent years, the integration of AI into clinical and health research environments has started critical legal and ethical discussions. With the introduction of key frameworks like the General Data Protection Regulation (GDPR), the European Health Data Space (EHDS), and the EU Artificial Intelligence Act (EU AI Act), projects like AI4LUNGS must navigate the approach with a proactive attitude.


Under the EU AI Act, high-risk AI systems- such as those intended for clinical decision support- are subject to strict requirements. These include:

  • Data governance

  • Transparency

  • Human oversight

  • Cybersecurity

  • Robust documentation


A key legal consideration for the project is the need to examine whether the results will qualify as AI systems and medical devices. If so, they require third-party conformity assessment.


While the scientific research exception may apply to early-stage work, any clinical use or deployment would fall within the scope of the AI Act. This is an important consideration as the AI4LUNGS platform evolves from research to potential clinical application.


How AI4LUNGS is navigating?

To reduce future compliance risks, in April 2025, led by Timelex, the consortium hosted a AI Act Workshop to start the discussion and build shared understanding of the regulation’s implications.

Furthermore, a Digital Ethics Risk Assessment (DERA@), conducted by Deloitte, was launched to evaluate the regulatory and ethical landscape from the outset.


These actions ensure that AI4LUNGS not only meets regulatory requirements but also follows high ethical standards throughout its development.


Building Trustworthy AI

By following legal and ethical assessments from the very beginning, AI4LUNGS aims to minimise the need for retrofitting later in the process. This proactive strategy supports the creation of AI tools that are not only technically robust, but also legally, ethically, and clinically trustworthy.



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


 
 
bottom of page