The European Health Data Space Regulation (EHDS Regulation) has shifted the European health data agenda from policy to actionable implementation, raising critical questions for life sciences companies regarding data access and governance.
The EHDS Regulation establishes a comprehensive framework for both primary and secondary use of electronic health data. Primary use pertains to healthcare delivery, while secondary use is particularly significant for the life sciences sector, enabling access to data for research, public health, and innovation. This includes various data types such as electronic health records, clinical trial data, and information generated by medical devices, which have historically been fragmented and subject to varying national regulations.
Central to this framework are Health Data Access Bodies (HDABs), which will manage access to health data for secondary use. Rather than relying solely on direct requests to healthcare providers, HDABs will evaluate applications and facilitate secure data access, marking a shift towards controlled rather than open access. This is especially relevant for companies utilizing artificial intelligence, as the regulation recognizes scientific research as a legitimate purpose for secondary data use, linking it closely with existing regulations like the AI Act and Medical Devices Regulation.
However, the EHDS does not circumvent existing data protection laws, particularly the General Data Protection Regulation (GDPR). It adds specific governance measures, including data minimization and transparency obligations. The regulation also delineates prohibited uses of health data, ensuring that it cannot be employed for discriminatory practices or harmful product development. As the implementation timeline progresses, life sciences companies are urged to prepare by mapping data assets and aligning their governance structures with the EHDS to optimize their research and innovation strategies.