保护欧洲健康数据空间的知识产权和商业秘密

Safeguarding intellectual property andtrade secrets in the European Health DataSpace 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 thatprotects intellectual property (IP), trade secrets and commercially confidential information, whichEurope’s capacity to innovate dependson.1 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 ofconfidential informationthat drivesinnovation. 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 manufacturerscan participate in data-sharing mechanisms without risking theloss of valuable know-how or competitiveadvantage. 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 thatsupports innovation. 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 neededto assess data requests involving commerciallyconfidentialinformation; Allow health data holderstoindicate the confidentiality level and access conditions for eachdataset and its metadata, so that sensitive information is not inadvertently exposed through theEHDS catalogues; Outline best practices around existinglegal, organisational and technical safeguards,includingcontractual terms,confidentiality clauses,secure processing environments andproportionate technical controls developed in consultation withhealthdata holdersand otherrelevant entities; Ensure structured cooperation between HDABs,healthdata holders and rightsholders,sothatthose who understand a dataset’s sensitivity are actively involved throughout the access andpermitting process;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 andrightsholdersbefore deciding whether data can be shared.3Clarify thecomplaint and liability mechanisms, including suspension of data use whilst a permitis under review and transparent allocation of responsibility for misuse or data breaches. 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 whilstpreserving the incentives that make such innovation possible. DIGITALEUROPE stands ready to work closely with the European Commission, Member States and theHDAB Community of Practice to ensure thatEHDSimplementation strengthens Europe’s global leadershipinhealthcare. 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 healthdata. 3TheEHDSimplementation guidelines could build on the approach takenin the recentGuidance onvehicle data, accompanying the Data Act(C(2025) 6119 final),which explains how key obligationsapply to vehicle data and sets out sector-specific access rules for original equipment manufacturers,suppliers, aftermarket service providers and insurers. 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....................................................................................................................................6Organisational measures....................................................................................................................7Technical measures.............................................................................................................................7Collaboration between HDABs, health data holders and rights