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MedTech Europe joins health stakeholders in urgent plea for European Health Data Space Legislative Refinement

Posted on 07.12.2023

As discussions in the EU institutions advance, MedTech Europe co-signed, together with key health stakeholder organisations, a statement on the European Health Data Space (EHDS), highlighting the priorities of the group and the need for further legislative refinement.

The statement reiterates the need for adequate resources for the implementation of the EHDS at all levels and provides recommendations for the resolution of five key challenges that will define the impact and effectiveness of the EHDS:

  1. The EHDS must set forth clear and coherent definitions to ensure legal certainty.
  2. The EHDS should clarify its interaction with other legal frameworks, such as General Data Protection Regulation (GDPR), Data Governance Act, Data Act, Database Directive, AI Act, Cyber Resilience Act, Medical Devices Regulation, In Vitro Diagnostic Medical Devices Regulation and Clinical Trials Regulation.
  3. The EHDS should specify the scope of electronic health data categories for secondary use.
  4. The EHDS should avoid excessive data localisation and international health data transfer requirements.
  5. The EHDS governance should consider the active engagement of a broad range of stakeholders.

Read the full statement here.

For more information, please contact Verena Thaler, Manager Digital Health.