Meet the expert of eBRAIN-Health
Prof. Dr. Nikolaus Forgó
Prof. Dr. Nikolaus Forgó, together with his research associates Klaudia Kwiatkowska and Alexandra Maria Mărginean, works on a variety of legal issues arising from ongoing technological development at the Department of Innovation and Digitalization in Law at the University of Vienna. Their work addresses questions related to technology law and intellectual property, with a special focus on data protection, artificial intelligence (AI), and copyright law.
Since its founding in 2017, the Department has participated in over 30 third-party funded projects, many of them in the healthcare and health research areas. In this context, the team provides legal expertise to project partners and supports the projects’ compliance with legal requirements stemming from EU data protection law, as well as emerging legislation in the field of AI regulation and data law.
Role within eBRAIN-Health
Prof. Dr. Nikolaus Forgó’s team is leading Work Package 2 “Ethics & Legal”, where they are responsible for developing the project’s legal and ethical framework. This work involves analysing and understanding obligations arising from European and national legislation, including regulations on data protection, the secondary use of health data, artificial intelligence, and medical devices, as well as corresponding ethics guidelines.
In addition, the team supports other project partners in addressing legal and ethical compliance through the operation of a dedicated legal and ethical helpdesk, providing guidance throughout the project’s activities.
Recent Results and Key Milestones
The team has recently completed the project’s final Data Protection Impact Assessment (DPIA). This assessment is a requirement under the EU General Data Protection Regulation (GDPR), particularly when the planned personal data processing might pose a high risk for the rights and freedoms of natural persons. Given that the eBRAIN-Health project involves the processing of sensitive personal data related to health, the completion of this task represents a key milestone for the project.
Furthermore, the team has contributed to preparing a conference presentation addressing the legal status of synthetic data in the European Data Strategy. This work forms part of the broader effort to develop the project’s final legal and ethical framework.
Hurdles and How They Were Overcome
As eBRAIN-Health conducts cutting-edge research using innovative technologies, such as AI and synthetic data, the development of a comprehensive legal framework presents several challenges. Many of these hurdles are linked to the evolving regulatory landscape, as some of the rules governing these technologies are still relatively new, not yet fully aligned, or pending full implementation. This creates a degree of legal uncertainty regarding which regulations will apply in the long term.
Moreover, the project involves data relating to potentially vulnerable groups, which raises ethical challenges. For this reason, particular importance is placed on ensuring stakeholder and public involvement, as well as appropriate ethical oversight, to support responsible research
Contribution to the eBRAIN-Health Research Platform
The work carried out in Work Package 2 (Ethics and legal) represents an integral part of achieving the project’s overall results, including the delivery of a distributed research platform for human brain data that complies with EU data protection law. The team supports this objective by assisting project partners in navigating the legal framework, clarifying relevant legal questions, and explaining applicable rules in a clear and accessible manner.
