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.