How Pharma Can Prepare For Incoming EU Health Data Sharing Rules

The Council of the EU has formally adopted the European Health Data Space regulation, meaning that it will soon enter into force in the EU. Experts explain what this means for the pharmaceutical industry.

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Key Takeaways
  • The rules for sharing of data for secondary uses under the European Health Data Space (EHDS) regulation will apply from 2029, but companies should start preparing for the new regulatory requirements now.
  • A senior policy officer from EUCOPE explains the benefits of the EHDS and encourages companies to engage in public consultations on the implementation of the framework.
  • A lawyer outlines actionable steps for companies to take in preparation of the EHDS, such as checking what data they own that could fall under the new framework.

The European Health Data Space (EHDS) regulation was formally adopted by the Council of the EU on 21 January and is expected to enter into force in the coming weeks....

The secondary use provisions for health data will become applicable from 2029, meaning that companies have a few years to adapt to the new requirements.

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