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.

Tags: consultation, GDPR, Health data
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Photo of Daniel Pavin Daniel Pavin

Daniel Pavin advises clients on a wide range of transactions involving intellectual property, technology and data.

He has extensive experience advising pharmaceutical, biotechnology, medical device and technology companies in connection with licensing, collaborations and other strategic agreements. He also advises clients in connection…

Daniel Pavin advises clients on a wide range of transactions involving intellectual property, technology and data.

He has extensive experience advising pharmaceutical, biotechnology, medical device and technology companies in connection with licensing, collaborations and other strategic agreements. He also advises clients in connection with investments, fundraisings and M&A.

Daniel has a particular focus on digital transformation in the life sciences and healthcare sectors, including digital health transactions, and data-driven and AI drug discovery and development projects.

Daniel is one of the leaders of Covington’s global, multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and exploitation of digital health products and services.

Chambers UK notes, “Daniel Pavin has very strong legal and commercial acumen.” “Daniel Pavin is very knowledgeable about life sciences and the data and digital areas. He sits where tech and life sciences come together.” “He is incredibly knowledgeable. He is very inclusive and happy to draw colleagues into conversations.”

Prior to his legal career, Daniel worked as a computer programmer, developing microscope image processing software. He is the co-inventor of a patented invention in the field of social network analytics.

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Photo of Anna Sophia Oberschelp de Meneses Anna Sophia Oberschelp de Meneses

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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