The European Commission’s proposal to establish a European Health Data Space (“EHDS”) aims to improve access by individuals to their health data (primary use) and facilitate the re-use of health data for societal good across the European Union (secondary use).

While the draft EHDS regulation might easily get lost in an alphabet of data-related legislative proposals coming from the European Commission, businesses operating in the health and pharma sectors should carefully consider how the EHDS might affect them.

In particular, the EHDS would introduce a new regime for the compulsory licensing of health data to third parties. Taken together with the broad definition of health data under the proposal, businesses will be required to understand what health data they possess and consider what measures they need to implement to protect the intellectual property rights in the data.

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