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Is the new EU Health Data Space Regulation a turning point for EU health data access?

Surrounded by computer screens and medical personnel, a patient waits inside the Clinical Decision Unit (CDU).
Photo: Brooks Kraft LLC/Corbis via Getty Images

Nuria Pastor | Fieldfisher, Renzo Marchini | Fieldfisher

3 min read
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The regulation creates an EU health “data space” and is designed to facilitate access to and control of health data.

On January 21, 2025, the EU Council approved the EU Health Data Space Regulation (the EHDSR). This will come into force 20 days after its publication in the EU Official Journal, which is expected shortly.

The EHDSR:

  • creates an EU health “data space” and is designed to facilitate:
    • access to and control of
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