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TEHDAS analysis: Health data needs dedicated EU regulation

The unique specificities of health data compared to data in many other sectors require specific EU legislation to regulate its cross-border use and exchange.

The first TEHDAS output examines why governing the secondary use of health data is a specific case in data governance in the European Union and cannot be governed only by horizontal legislation, such as the proposed Data Governance Act. The secondary use of health data means using health data, such as patient records, for purposes other than the primary reason for which they were originally collected. The secondary use can include research, decision-making, and innovation.

The document defines and analyses several elements that make health data different to many other types of data. These elements include the rights of individuals, protection and promotion of public health, sensitivity of health data, data security, interoperability of data, and data use in research and in the private sector. For instance, an individual’s health data has a significant impact not only on the person generating health data but also on public health as we need such data to prevent and cure diseases more effectively in the future.

The sensitive nature of health data necessitates special safeguards and sets requirements for its use. Governing the cross-border exchange and use of health data should respect the fundamental right to the protection of personal data as stated in the General Data Protection Regulation (GDPR).

Cross-border use of health data needs a solid legal base


To promote digital transformation and widen the use of health data, the European Commission has made the creation of a European Health Data Space as a priority for 2019-2025. The proposal stems from the GDPR. There are currently no common practices for the secondary use of health data in Europe. Also, the GDPR allows member states to further define how they process health data which has led to fragmented practices.

TEHDAS works on various aspects of governance for the cross-border exchange and secondary use of health data in Europe in a dedicated work package. This first output initiates a series of documents that will form a comprehensive view of governance options and way forward for the European Health Data Space. The next document deals with governance mechanisms and will be published in early autumn.

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