Our Managing Partner, Ioanna Michalopoulou, recently spoke at the 6th Panhellenic Congress of the Hellenic Association of Medical Geneticists in Athens, joining the round table on Innovation & AI.
The congress serves as a premier forum for scientists and healthcare professionals to explore modern developments in human genetics, focusing on how new technologies and research are reshaping clinical practice, diagnostics, and patient care.
During her session, Ioanna addressed the complex regulatory framework and legal considerations surrounding the use of AI in genetics.
Key insights from her presentation included:
▪️Overlapping regulations: navigating the AI Act, MDR/IVDR, and GDPR involves overlapping obligations, and harmonised standards are not expected until Q4 2026.
▪️Data sensitivity: genetics requires a highly specific regulatory approach. Genetic data is immutable, predictive of future health conditions, and carries significant risks of genetic discrimination.
▪️Dataset bias & compliance: currently, 86-91% of participants in genome-wide association studies are of European ancestry. Because Article 10 of the AI Act mandates dataset representativeness, this lack of diversity presents a direct non-compliance risk for developers.
