AI-Guided Precision Medicine: A European Biotechnology Thematic Network Association Perspective on Multi-Omics, Digital Sensors, Medical Assessment, and Ethical-Regulatory Challenges
Luca Ferrari, Muhammad Imran, Beatrice Della Frera, Ahmad Jainul Abidin, Tommaso Beccari, Nuriye Gokce, Štefánia Hrončeková, Hilal Akalin, Satya Prakash, Ed Judge, Dominika Vešelényiová, Martin Koller, Kosi Gramatikoff, Oscar Vicente, Izabela Radecka, Robert S. Marks, Ratnesh Lal, Michel Salzet, Kisung Ko, Michele Maffia, Isabelle Fournier, Lejla Pojskic, Qun Sun, Lembit Nei, Reynir Arngrimsson, Gary Henehan, Irina Nakashidze, Dijana Plaseska-Karanfilska, Karla Santacruz-Gomez, Dana Tapaloaga, Andreas Janecke, Ivana Márová, Ariola Bacu, Alexander Kilchevsky, Anita Slavica, Jose Carlos Lorenzo Feijoo, Andrés Izquierdo Romero, Bajram Berisha, Mark Nuijten, Nikolai Zhelev, Mario Petrov Milkov, Svetlana Fotkova Georgieva, Luis Izquierdo Lopez, Juraj Krajcovic, Saharuddin Bin Mohamad, Fideline Tchuenbou-Magaia, Donald K. Martin, Isabel Belo, Fabrizio Bruschi, A. Baki Yildirim, Recep Eroz, Victor Revin, Anargyros N. Moulas, M. Sait Dundar, Paolo Bartolini, Helal Ragab Moussa, Amin Hejazi, Attya Bhatti, Alma Kokhmetova, Viktor Nedovic, Alla Salmina, Majeti Narasimha Vara Prasad, Alena Mikhalenka, Serghei Sprincean, Adam Mechler, Munis Dundar, Matteo BertelliAbstract
Artificial intelligence (AI) is increasingly integrated with genomics, multi-omics, pharmacogenomics, liquid biopsy, and digital biosensing, yet the data infrastructure, governance practices, and evidence standards remain uneven. This European Biotechnology Thematic Network Association (EBTNA) position paper includes peer-reviewed studies, regulatory reviews, and official policy surveys up to October 2026, to gauge clinical maturity and set out priorities for a responsible implementation across Europe. The review aims to identify critical gaps in governance and workforce readiness and then propose concrete lines of action. Across the World Health Organization (WHO) European Region, only 8% of Member States have a health-specific AI strategy, 24% provide in-service AI training for the health workforce, and fewer than 10% have drafted liability standards for AI in health. At the same time, the Food and Drug Administration (FDA) has authorized 903 AI-enabled medical devices as of August 2024, and 97.1% were cleared through the 510(k) pathway, for which clinical-data requirements depend on intended use and technological characteristics. Therefore, the EBTNA proposes seven lines of action whose responsible integration should link technical performance to clinical utility, equity, transparency, and continuous oversight. The European biomedical community should push for active governance to develop AI-driven precision medicine. This position paper explains the scientific rationale, provides the regulatory analysis, and lays out strategic proposals for transition.