Preannouncement of Procurement – VALO2 Project pilot

This is not an invitation to tender nor a procurement announcement. The information provided in this notice is preliminary and may change as preparations progress. About the Project The upcoming procurement will take place under the Value from Nordic Health Data 2 (VALO2) project, which builds on the work of the original VALO initiative. VALO2 is funded by the Nordic Council of Ministers and coordinated by the Finnish Innovation Fund Sitra. The Finnish Institute for Health and Welfare (THL) is responsible for the financial management of VALO2. The procurement is a joint undertaking by Sitra and THL. Sitra is an independent public fund operating under the Finnish Parliament. It promotes sustainable well-being, economic growth, and international cooperation. THL is an independent expert and research institute under the Finnish Ministry of Social Affairs and Health, providing reliable information for decision-making in health and welfare. VALO2 aims to advance Nordic leadership in the responsible use of health data by enabling practical cross-border cooperation and supporting the future implementation of the European Health Data Space (EHDS) regulation. Scope of the Procurement The procurement will focus on a cross-border health research pilot project using pseudonymised personal health data from at least three Nordic countries to address clearly defined scientific research questions. These questions should be relevant to healthcare, public health, situational awareness, or policy making. Purely technical pilots without a substantive research objective will not be considered sufficient. We are looking for a consortium combining expertise in cross-border health research execution with knowledge and capabilities in operating and managing remote research environments. The core objective is to demonstrate how real-world research can be conducted across national borders using Secure Processing Environments (SPE), Trusted Research Environments (TRE), or equivalent controlled data access infrastructures. Expected execution period of the pilot project is November 2025 to October 2026. Key features of the pilot: The research must be conducted in secure environments that enable remote access to data without the need to travel to another country to access the data. The data can remain in its country of origin (no need to combine datasets), but combination is also possible. The study must demonstrate real cross-border collaboration, meaning that each of the participating datasets can be remotely accessed by a researcher located in another country. For clarity this means that: a researcher in Country A accesses data in Country B, a researcher in Country B accesses data in Country C, and a researcher in Country C accesses data in Country A. OR reseacher from one country (A, B or C) accesses data from other countries SPE/TRE must be operated: independently from the research group or, if operated by an organisation which is part of the research group, the independence of the environment governance must be justified and explained. After the research in addition to the study report the consortium is expected to complete a lessons-learned report to analyze identified practical, legal, and technical barriers to cross-border research in the Nordic region. Important Information for Interested Tenderers The call for tender will be published by 31 August 2025. The submission period will be 25 calendar days. We encourage early preparation due to the limited submission timeframe. Estimated budget for the tender is 250.000 euros including VAT Expected execution period of the pilot project is November 2025 to October 2026. Recommended Preparations Before the Tender is Published Interested tenderers are encouraged to: Identify existing health research groups with access to relevant personal health data in at least three Nordic countries and have dialogue with them for extension of research study scope, to reduce data permit times. Clarify whether the research data will come from one cross-Nordic study or several studies in Nordics. Confirm existing data permits or assess the feasibility of modifying permits to comply with the pilot scope. Identify SPE/TRE environments where the data is stored and assess their compliance with the remote access and independence requirements. Plan how data is going to be accessed and/or shared, for example in a federated manner or transferred from SPE to SPE. Begin drafting a plan to adapt existing research protocols to support cross-border access objectives. Consider how to systematically document barriers and enablers for cross-border research in the final deliverables. Consider project risks and prepare contingency plans incl. resources (such as IT-service at data providers to set up the required environments and data for clinicians) to ensure project completion on time. For more information on the VALO2 project or the upcoming procurement, please contact: Sitra – The Finnish Innovation Fund Nima Jokilaakso, nima.jokilaakso@sitra.fi Markus Kalliola, markus.kalliola@sitra.fi THL – Finnish Institute for Health and Welfare Persephone.doupi@thl.fi