保护欧洲健康数据空间的知识产权和商业秘密

Safeguarding intellectual property and Executivesummary The objective of the European Health Data Space (EHDS)of enablingthe responsible re-use ofhealth data for research, innovation,and public health requiresa governance framework that The EHDS represents an unparalleled opportunity to advance research, innovation and patient care. Yetits success will depend on achieving the right balance between open data access and the protection of The EHDS introduces obligations that could bring privately held or pre-commercial data into scope forsecondary use.2Their implementation must strike a careful balance between openness and the protectionof legitimate proprietary interests. The EHDS will only succeed if innovators, researchers and manufacturers With no implementing act attached to Art. 52(IP and trade secrets), the risk of fragmentation is high,andimplementation guidelines areneeded to ensure a workable and harmonised EHDS framework that These implementation guidelines should: EncourageMember Statestoestablishdedicated IP and trade secret task forces within healthdata access bodies (HDABs), equipped with the legal, technical and industrial expertise needed Allow health data holderstoindicate the confidentiality level and access conditions for eachdataset and its metadata, so that sensitive information is not inadvertently exposed through the 1Regulation (EU) 2025/327. 2Art.52EHDS requiresthat electronic health data protected by IP, trade secrets and regulatory dataprotection be made available‘in accordance with this Regulation,’ butit also allows HDABs to refuse Outline best practices around existinglegal, organisational and technical safeguards,includingcontractual terms,confidentiality clauses,secure processing environments and Ensure structured cooperation between HDABs,healthdata holders and rightsholders,sothatthose who understand a dataset’s sensitivity are actively involved throughout the access and Further delineate the scope of the categories of data in Art. 51to avoid excessive disclosureobligations on health data holders, particularly in the case ofearly-stage R&D and raw medical-device data. The guidelines should requireHDABstoconsult data holders andrightsholders Clarify thecomplaint and liability mechanisms, including suspension of data use whilst a permit Investing resources in harmonised guidanceon thekey elements outlined abovewill be decisive for theoverall success of this landmarklaw. A coherent and well-resourced approach will ensure that the EHDSbecomes a trusted and harmonised framework, enabling data-driven research and innovation whilst DIGITALEUROPE stands ready to work closely with the European Commission, Member States and theHDAB Community of Practice to ensure thatEHDSimplementation strengthens Europe’s global leadership This paper is endorsed by key industry partners who share DIGITALEUROPE's vision for a fair andworkable European Health Data Space that protects innovation while enabling secondary use of health Table ofcontents Executive summary.....................................................................................................................1Table of contents.........................................................................................................................3Establishing dedicated IP and trade secret task forces within HDABs..................................4Enabling health data holders to indicate confidentiality levels and access conditions........5Measures to protect IP and trade secrets in databases...........................................................6Legal measures....................................................................................................................................6 Establishingdedicated IP and trade secret task forces within Health data access bodies (HDABs) will play a central role in ensuring consistent interpretation of Art. 52EHDSacross Member States.Their credibility will depend on their ability to handle commercially Art. 57(c) tasks HDABs with balancing the rights and interests of bothhealthdata holders andhealthdatausers. This role includes taking appropriate legal, organisational and technical measures to protectIP, tradesecrets and regulatory data protection, as required by Art. 52. HDABs’ competence and resources will Member States are currently defining their HDABs’ structures, mandates and resource allocations,supported by initiatives such as TEHDAS2,4the HDAB Community of Practice and, more recently, theInnovative Health Initiativeproject ‘Safeguarding innovation in secondary use of health data in the EuropeanHealth Data Space.’5Whilstseveral Member States already operate frameworks for secondary data use,the EHDS significantly expands the scope of data and actors involved. For the first time, private health data DIGITALEUROPE calls on Member States toestablish specialised task forces within HDABsfocusedonrequests that involve innovation,IP,trade secrets,regulatory