Safeguarding intellectual property and trade secrets in the European Health Data Space

Executive summary 

The objective of the European Health Data Space (EHDS) of enabling the responsible re-use of health data for research, innovation, and public health requires a governance framework that protects intellectual property (IP), trade secrets and commercially confidential information, which Europe’s capacity to innovate depends on.

The EHDS represents an unparalleled opportunity to advance research, innovation and patient care. Yet its success will depend on achieving the right balance between open data access and the protection of confidential information that drives innovation. 

The EHDS introduces obligations that could bring privately held or pre-commercial data into scope for secondary use. Their implementation must strike a careful balance between openness and the protection of legitimate proprietary interests. The EHDS will only succeed if innovators, researchers and manufacturers can participate in data-sharing mechanisms without risking the loss of valuable know-how or competitive advantage. 

With no implementing act attached to Art. 52 (IP and trade secrets), the risk of fragmentation is high, and implementation guidelines are needed to ensure a workable and harmonised EHDS framework that supports innovation.  

These implementation guidelines should: 

• Encourage Member States to establish dedicated IP and trade secret task forces within health data access bodies (HDABs), equipped with the legal, technical and industrial expertise needed to assess data requests involving commercially confidential information; 

• Allow health data holders to indicate the confidentiality level and access conditions for each dataset and its metadata, so that sensitive information is not inadvertently exposed through the EHDS catalogues; 

• Outline best practices around existing legal, organisational and technical safeguards, including contractual terms, confidentiality clauses, secure processing environments and proportionate technical controls developed in consultation with health data holders and other relevant entities; 

• Ensure structured cooperation between HDABs, health data holders and rights holders, so that those who understand a dataset’s sensitivity are actively involved throughout the access and permitting process; 

• Further delineate the scope of the categories of data in Art. 51 to avoid excessive disclosure obligations on health data holders, particularly in the case of early-stage R&D and raw medical-device data. The guidelines should require HDABs to consult data holders and rights holders before deciding whether data can be shared.3 

• Clarify the complaint and liability mechanisms, including suspension of data use whilst a permit is under review and transparent allocation of responsibility for misuse or data breaches. 

Investing resources in harmonised guidance on the key elements outlined above will be decisive for the overall success of this landmark law. A coherent and well-resourced approach will ensure that the EHDS becomes a trusted and harmonised framework, enabling data-driven research and innovation whilst preserving the incentives that make such innovation possible. 

DIGITALEUROPE stands ready to work 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.