On May 3, 2021, the European Commission (the “Commission”) opened a further public consultation (“Consultation”) on the European Health Data Space (“EHDS”).

This follows a consultation earlier in the year, on the Commission’s “Inception Impact Assessment” in relation to the EHDS.  (For further information on the earlier consultation and an overview of the EHDS, please see our blog post available here).

The Consultation aims to get feedback from a wide range of stakeholders (i.e., members of the public, healthcare professionals, public health authorities, data protection authorities, and industry organisations) on their experiences with the collection, access, use and re-use of health data.  The consultation consists of a questionnaire structured in three sections focusing on:

  1. the use of health data for healthcare provision, research and innovation, policy making, and regulatory decision-making;
  2. the development and use of digital health services and products; and
  3. the development and use of artificial intelligence systems in healthcare.

Feedback is to be used to help in designing the legal framework for the EHDS.

The consultation is open until July 26, 2021, with the Commission’s adoption of the EHDS planned for the fourth quarter of 2021.

The team at Covington will continue to monitor any developments in this area.

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Anna Sophia Oberschelp de Meneses advises on EU data protection, cybersecurity, and consumer law. Her practice covers the full range of Europe’s digital regulatory framework, including GDPR, ePrivacy, NIS2, the Cyber Resilience Act, the AI Act, the Digital Services Act, the Data Act…

Anna Sophia Oberschelp de Meneses advises on EU data protection, cybersecurity, and consumer law. Her practice covers the full range of Europe’s digital regulatory framework, including GDPR, ePrivacy, NIS2, the Cyber Resilience Act, the AI Act, the Digital Services Act, the Data Act, the European Health Data Space, and EU consumer protection law, including product safety, product liability, and consumer rights legislation. She focuses on the operational side of compliance — helping clients design policies and processes, draft documentation, and build the internal frameworks needed to meet regulatory requirements in practice.

She also advises on contentious matters, drawing on experience managing investigations before national regulators and proceedings before national courts and the Court of Justice of the European Union. She works closely with Covington’s disputes teams on matters at the intersection of regulatory compliance and litigation.

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