The integration of biotechnology, software, and artificial intelligence is redefining the development of advanced solutions for diagnosis, patient stratifica on, and precision medicine. However, the effective transla on of these innovations into the European clinical environment requires going beyond analytical performance or the experimental validation of biomarkers. It also requires the ability to design robust, interoperable, and regulatorily aligned systems capable of integrating into complex and highly standardized healthcare ecosystems.
This round table will examine how to build biotech solutions powered by soware and AI under an interoperability-by-design approach, incorporating from the earliest stages aspects such as data architecture, semantic standardization, traceability, algorithmic governance, and regulatory compliance. In the European context, frameworks such as the European Health Data Space (EHDS), the AI Act, and the regulations applicable to medical devices and in vitro diagnostics (MDR/IVDR) are shaping a new paradigm in which evidence generation, data quality, and the capacity for technical and semantic integra on are inseparable from clinical value and market viability.
As a practical case, the presentation will address the use of AI in digital histopathology for biomarker iden fica on, an area of par cular relevance due to its poten al in precision oncology and its high methodological complexity. The combina on of digital imaging, computational analysis, and correla on with molecular and clinical data makes it possible to move toward more reproducible and scalable models of ssue characteriza on. However, its effective implementation depends on the harmonization of formats, pre-analytical and analytical quality, clinical validation, and interoperability with pathology systems, electronic health records, and biomedical data platforms. Innovation in AI-based biotechnology cannot be understood solely as an algorithmic challenge. Interoperability is no longer an IT project; it is strategic infrastructure for enabling European biotech to scale with AI.
1. RAQUEL NARANJO_Businnes strategist_ARTIKODE_Basque Country 2. Jorge Fernández _Hospital Clinic_CHIEF INNOVATION OFFICER -International speaker_Barcelona 3. Marta Montilla_Project Lead and sr regulatory consultant_CMG MEDDEV SL_España 4. Gloria Hernandez_ Chief CNCps_Spain
