欧洲健康数据空间（EHDS）：数据重用综合指南

European Health Data Space (EHDS):A Comprehensive Guide to Data Reuse A comprehensive guide to prepare for the reuse of health dataunder the EHDS regulation PHILIP HINES, IQVIAOLIVIA LOUNSBURY, Oxford UniversityELENA SOFIA MASSACESI, Oxford UniversityJENNY GONG, Oxford UniversityLARISSA CHAN, Oxford UniversityHANNE VAN BALLEGOOIJEN, IQVIAGEORGE GARRARD, IQVIACHRIS VAN BRONCKHORST, IQVIA Table of contents Executive summary1Document aims2Background2Health data access today2EHDS — The enabler2EHDS1 versus EHDS23EHDS2 implementation timeline5How EHDS2 will work — The process6Health Data Holders (HDHs)14Key requirements for Health Data Holders14Challenges for Health Data Holders15Recommendations for Health Data Holders17Health Data Access Bodies (HDABs)18Key requirements for Health Data Access Bodies18Challenges for Health Data Access Bodies19Recommendations for Health Data Access Bodies21Health Data Users (HDUs)23Key requirements for Health Data Users23Challenges for Health Data Users24Recommendations for Health Data Users25Readiness checklist26Health Data Holders (HDHs)26Health Data Access Bodies (HDABs)26Health Data Users (HDUs)27Conclusion27How IQVIA can help?27Staying up to date29Appendix 1: Difference between primary use and secondary use29Appendix 2: The proposed governance structure31Appendix 3 Operating model of the Health Data Access Body32 Executive summary The European Health Data Space (EHDS) is an initiative by the European Union aimed at creating a unifiedframework for the secure and ethical reuse of electronic health data across the EU for research, innovation, andpolicy. The EHDS will benefit patients by providing easier access to their health records across borders and greatercontrol over their data. Healthcare providers and patients will experience improved continuity of care, whileresearchers and the pharmaceutical industry will gain access to large-scale, high-quality health data. Policymakersand regulators will have a robust foundation for monitoring public health. The EHDS distinguishes between EHDS1 for the primary use of health data (e.g., patient care) and EHDS2 for thesecondary use of health data (e.g., research, innovation, policy making), with this document specifically focusingon the latter. The operation of EHDS2 involves three key stakeholders: Health Data Holders (HDHs), which are organisationsthat control electronic health data; Health Data Access Bodies (HDABs), which are public sector bodies managingdata access for secondary use; and Health Data Users (HDUs), which are individuals or organisations grantedaccess to electronic health data for secondary purposes. In addition to discussing the requirements for eachstakeholder, this document highlights potential challenges and solutions they may face in implementing theEHDS2. Specifically: • Health data holdersshould establish an internal cross-functional EHDS group to prepare their compliance.This could include people dealing with IT, legal, data entry, depending on the organisation. This team shouldhelp prepare to catalogue electronic health data assets and to evaluate their capacity and capability for dataprovision and other EHDS2 obligations •Health data access bodieswill require significant investment and staffing to operate. The main challengesinclude successfully establishing a National Catalogue of health data, evaluating health data applications,processing the health data, setting up a ‘Secure Processing Environment’ (SPE) where the data can be accessedand analysed, and monitoring compliance and security. To succeed in their role, they need to ensure trust andcompliance through stakeholder engagement from the outset • Health data applicants and userswill need to carefully prepare their applications. This could include buildingsample analysis models and requesting pre-submission consultations with HDABs. To respect the 18-monthdeadline for publishing results, HDUs may need to plan their research accordingly and utilise the extensionexceptions, if needed The combined challenge for all EHDS2 stakeholders is to establish a health data network, which is useable andsustainable. There are examples of successful, and less successful, health data networks, although the scale ofEHDS2 is significantly larger, lessons should be learned from these past experiences. We have taken these lessonsto identify the challenges, provide you with directions on how to overcome these challenges and successfullyimplement your requirements. Should you want to discuss implementing the EHDS, emailinfo@iqvia.com, we would love to hear from you. Document aims This document offers a comprehensive guide to reusing health data under the EHDS, with practicalrecommendations for HDHs, HDUs and government bodies such as HDABs. Background Health data access today Electronic health data access across the EU is currently hindered by fragmented regulations (including GDPRimplementation), varying software and hardware (infrastructure), and limited