Summary 

DISARM is a European Union-funded Innovation Action under the Horizon Europe Programm, aiming to address critical gaps in hereditary ovarian cancer risk assessment and early detection. The project combines multifactorial risk stratification, large-scale clinical studies, innovative liquid biopsy technologies, and AI-enabled digital tools to improve prevention, early diagnosis, and decision-making in routine healthcare. DISARM is implemented over 48 months (September 2025–August 2029) by a multidisciplinary consortium of 28 partners from 12 countries, integrating clinical research, digital health, artificial intelligence, social sciences, and policy, with the ultimate objective of enabling the uptake of validated, affordable, and trustworthy solutions across European healthcare systems.

Our role 

Timelex acts as the legal advisor within the DISARM consortium, leading the cross-cutting work on the legal, ethical, and regulatory framework of the project. In this capacity, Timelex ensures that all project activities and outputs comply with applicable EU and national legal requirements, including data protection (GDPR), research ethics, governance of clinical studies, and the regulatory framework for high-risk AI systems under the EU AI Act. Timelex supports the design of legally and ethically compliant study protocols, drafts key legal documents such as informed consent templates, data protection policies, the Data Protection Impact Assessment, and the joint controllership agreement, and provides guidance on trustworthy and lawful AI development. Through continuous legal oversight and targeted training activities, Timelex contributes to risk mitigation, regulatory alignment, and the long-term sustainability and lawful deployment of DISARM solutions.