Octilyon

EU Legislative Interests

Main EU Legislative Proposals or Policies Targeted by Octilyon European Health Data Space (EHDS) Regulation Target: Enable secure access and reuse of health data for healthcare delivery, research, innovation, and policymaking across the EU. Octilyon Fit: OctilyData supports EHDS goals by providing compliant data governance, access control, and cross-border data interoperability infrastructure. AI Act (Artificial Intelligence Act) Target: Establish harmonised rules for trustworthy AI, especially for high-risk applications in health. Octilyon Fit: Trinity and the Data Intelligence module of OctilyData are designed with transparency, accountability, and human oversight to comply with AI Act provisions. General Data Protection Regulation (GDPR) Target: Protect individuals’ personal data and ensure lawful data processing. Octilyon Fit: Privacy-first design principles, consent management, and automated data lineage tracking ensure GDPR compliance throughout data lifecycle. EU One Health Action Plan Against Antimicrobial Resistance (AMR) Target: Promote a holistic approach to tackling AMR through integrated data from human, animal, and environmental health. Octilyon Fit: Facilitates One Health data integration and analysis across veterinary and clinical datasets to support AMR surveillance and research. Data Governance Act (DGA) Target: Strengthen data sharing mechanisms while ensuring trust and control. Octilyon Fit: The Data Hive within OctilyData enables institution-controlled data exchange and governance, aligned with DGA frameworks. Digital Europe Programme (DEP) Target: Support the development of digital capacities, including data infrastructure and AI in health. Octilyon Fit: Strategic alignment with DEP objectives through scalable, interoperable digital health infrastructure. EU4Health Programme (2021–2027) Target: Strengthen EU health systems, improve crisis preparedness, and boost digital health innovation. Octilyon Fit: Enables digital transformation of health services, cross-border research, and real-time data insights for public health response.

Communication Activities

Outreach with EU Institutions on Policy Files Octilyon has undertaken both direct and strategic outreach to engage EU institutions on key health data and AI legislative initiatives, including: 1. Targeted Briefings and Correspondence Direct communication with policy officers at DG SANTE and DG CNECT to introduce Octilyon’s infrastructure and gather feedback on alignment with the European Health Data Space (EHDS) and AI Act. Submission of informal position notes and technical overviews related to compliance-by-design strategies under the Data Governance Act (DGA) and GDPR, demonstrating Octilyon’s platform readiness and data sovereignty safeguards. 2. Participation in EU Consultations and Stakeholder Surveys Responded to public consultations on the EHDS Regulation (2022–2024), contributing insights on federated data infrastructure, research exemptions, and the operational role of data intermediaries. Provided commentary on the draft AI Act impact assessments, specifically concerning AI use in clinical support tools and transparency mechanisms built into the Trinity AI co-pilot. 3. Engagement with EU-funded Initiatives and Working Groups Initiated contact with coordinators of Digital Europe Programme (DEP) and EU4Health projects, with the aim of aligning Octilyon’s platform as a technical partner or pilot node. Participated in exploratory workshops hosted by EU Health Policy Platform and Joint Action AMR One Health (via academic collaborators), contributing to discussions on data sharing and interoperability across sectors. 4. Institutional Introductions and Collaborative Outreach Conducted introductory outreach to Members of European Parliament (MEPs) on the ENVI and ITRE Committees, with tailored briefs highlighting Octilyon’s role in enabling compliant, cross-border health research. Established early dialogue with representatives from the European Centre for Disease Prevention and Control (ECDC) and European Medicines Agency (EMA) to explore data-driven collaboration opportunities under the One Health and AMR mandates.

Interests Represented

Promotes their own interests or the collective interests of their members

Member Of

Organisations and Networks Octilyon Is a Member of or Associated With Memberships European Institute for Innovation through Health Data (i~HD) Focus: Promoting the reuse of health data for research and care, aligned with EHDS and GDPR. Link: https://www.i-hd.eu Digital Health Society (DHS) Focus: Supporting the development and scaling of digital health across Europe, particularly in alignment with EHDS and data space strategies. Link: https://www.thedigitalhealthsociety.com HealthTech Ireland Focus: Irish medtech and health data innovation network fostering public-private collaboration. Link: https://www.healthtechireland.ie European AI Alliance (hosted by the European Commission) Focus: Contributing to policy dialogue and responsible AI frameworks under the EU AI Act. Link: https://futurium.ec.europa.eu/en/european-ai-alliance Affiliations / Contributions One Health EJP (via project-level collaboration) Focus: Joint actions on antimicrobial resistance, foodborne zoonoses, and emerging threats. Link: https://onehealthejp.eu Open DEI Health Sector Community of Practice Focus: Coordination of digital transformation and data sharing initiatives in health and care sectors across the EU. Link: https://www.opendei.eu EU Health Policy Platform (EUHPP) Focus: Engagement with public health stakeholders, including thematic networks on EHDS and cross-border digital services. Link: https://webgate.ec.europa.eu/hpf/

Organisation Members

Members and Affiliated Entities of Octilyon Octilyon is a privately held company and does not operate a membership-based structure. As such, it does not have individual or institutional members in the traditional sense. However, Octilyon collaborates with a range of affiliated entities through partnerships, pilots, and research initiatives. These include: Affiliated Entities (Selected Collaborators and Partners) Academic and research institutions in Ireland engaged in health data pilots (e.g., universities, research hospitals) Veterinary and public health clinics participating in early data integration projects National and EU-funded digital health ecosystems through platforms like the EU Health Policy Platform and Open DEI A full list of project-level partners will be published soon on Octilyon’s website

Additional Information

Octilyon is an early-stage, founder-led company focused on developing privacy-first, AI-enabled health data infrastructure for academic, clinical, and public health sectors. During the period covered: All EU policy engagement, outreach, and communications have been self-funded, primarily by the co-founders as part of Octilyon’s core business development activities. No remuneration has been provided to external representatives specifically for lobbying or EU institution engagement purposes. A portion of the engagement work has been carried out on a pro bono or voluntary basis, especially in the context of contributing to EU forums and public consultations. No EU funding has been received directly by Octilyon or via any subsidiary, affiliate, or parent entity during the reporting period. Operating with a lean early-stage structure, the company has intentionally kept its lobbying-related activities and budget minimal, focusing on alignment with EU digital health policy and participation in public interest discussions. Octilyon anticipates increased investment in policy and compliance engagement as part of its scaling and EU market integration roadmap in 2025–2026, including through prospective participation in EU-funded pilots or partnerships.