AI-Guided Precision Medicine: A European Biotechnology Thematic Network Association Perspective on Multi-Omics, Digital Sensors, Medical Assessment, and Ethical-Regulatory Challenges
Year: 2026
Type: article
Abstract: 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.
Source: The EuroBiotech Journal
Authors: 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 Bertelli
Institutions: University of Perugia, Erciyes University, Institute of Chemistry of the Slovak Academy of Sciences, Slovak Academy of Sciences, McGill University, University of Ss. Cyril and Methodius in Trnava, University of Graz, Nawi Graz, Medical University of Varna, Universitat Politècnica de València, University of Wolverhampton, Ben-Gurion University of the Negev, University of California, Santa Barbara, Université de Lille, Protéomique, Réponse Inflammatoire et Spectrométrie de Masse, Chung-Ang University Hospital, Chung-Ang University, University of Salento, University of Sarajevo, Sichuan University, Tallinn University of Technology, University of Iceland, Technological University Dublin, Batumi Shota Rustaveli State University, Macedonian Academy of Sciences and Arts, Universidad de Sonora, University of Agronomic Sciences and Veterinary Medicine of Bucharest, Innsbruck Medical University, Universität Innsbruck, University of Sassari, Brno University of Technology, University of Tirana, National Academy of Sciences of Belarus, Institute of Genetics and Cytology of the National Academy of Sciences of Belarus, University of Zagreb, Universidad de Ciego de Ávila, Universidad de las Fuerzas Armadas ESPE, Academy of Sciences of Albania, Technical University of Munich, University of Prishtina, University of Dundee, Medical University Plovdiv, University of Malaya, Institut polytechnique de Grenoble, Centre National de la Recherche Scientifique, Laboratoire des Matériaux et du Génie Physique, Université Grenoble Alpes, University of Minho, University of Pisa, Azienda Ospedaliera Universitaria Pisana, Aksaray University, National Research Mordovia State University, University of Thessaly, European Laboratory for Non-Linear Spectroscopy, University of Florence, Agricultural Biotechnology Research Institute of Iran, National University of Sciences and Technology, Institute of Plant Biology and Biotechnology, University of Belgrade, Research Center of Neurology, University of Hyderabad, Moldova State University, La Trobe University
Language: English
Subfield: Health Informatics
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7225004795