Balancing Innovation and Confidentiality: Protecting IP and Trade Secrets in the European Health Data Space

The European Health Data Space (EHDS) aims to enable the responsible secondary use of health data to foster research, innovation, and public health improvements across Europe. This ambitious initiative presents an unparalleled opportunity to enhance patient care and accelerate scientific progress. Yet, its success hinges on establishing a governance framework that carefully balances open data access with the protection of intellectual property (IP), trade secrets, and commercially confidential information.

DIGITALEUROPE, representing key industry stakeholders, stresses that Europe’s capacity to innovate depends on safeguarding these proprietary interests. The EHDS introduces obligations that could bring privately held or pre-commercial data within scope for secondary use. Without adequate protections, innovators, researchers, and manufacturers risk losing valuable know-how or competitive advantage, which could undermine their willingness to participate in data-sharing mechanisms.

A significant concern is the absence of an implementing act attached to Article 52 of the EHDS regulation, which addresses IP and trade secrets. This gap raises the risk of fragmented application across Member States, potentially weakening the harmonisation and effectiveness of the EHDS framework. DIGITALEUROPE advocates for the development of clear implementation guidelines to ensure a workable and consistent approach that supports innovation.

To this end, the organisation recommends that Member States establish dedicated IP and trade secret task forces within health data access bodies (HDABs). These task forces should be staffed with legal, technical, and industrial experts capable of assessing data requests involving commercially confidential information.

Additionally, health data holders should be empowered to specify the confidentiality level and access conditions for each dataset and its metadata. This measure would help prevent inadvertent exposure of sensitive information through EHDS catalogues.

DIGITALEUROPE also calls for outlining best practices around existing safeguards, including contractual terms, confidentiality clauses, secure processing environments, and proportionate technical controls. These safeguards should be developed in consultation with health data holders and other relevant entities to reflect practical realities.

Structured cooperation between HDABs, health data holders, and rights holders is essential. Those who understand a dataset’s sensitivity must be actively involved throughout the access and permitting process to ensure appropriate protections.

The organisation further urges clarification of the scope of data categories under Article 51 to avoid excessive disclosure obligations, particularly concerning early-stage research and development and raw medical-device data. Guidelines should mandate that HDABs consult data holders and rights holders before deciding on data sharing.

Clear complaint and liability mechanisms are also necessary. These should include provisions for suspending data use while a permit is under review and transparent allocation of responsibility in cases of misuse or data breaches.

DIGITALEUROPE underscores that investing resources in harmonised guidance on these key elements will be decisive for the EHDS’s overall success. A coherent and well-resourced approach will help establish the EHDS as a trusted, harmonised framework that enables data-driven research and innovation while preserving the incentives that drive such innovation.

The organisation stands ready to collaborate closely with the European Commission, Member States, and the HDAB Community of Practice to ensure that EHDS implementation strengthens Europe’s global leadership in healthcare.

This position paper is endorsed by key industry partners who share DIGITALEUROPE’s vision for a fair and workable European Health Data Space that protects innovation while enabling the secondary use of health data.