On July 12, 2019, the European Data Protection Board (“EDPB”) and the European Data Protection Supervisor (“EDPS”) issued a joint opinion on the processing of patient data and the role of the European Commission within the eHealth Digital Service Infrastructure (“eHDSI”).

Background

The eHDSI system was established in the context of the eHealth Network.  The system allows for the exchange of electronic health data of patients, in particular e-prescriptions and summaries of patient medical records, between Member States.  eHDSI enables the exchange of patient data in an encrypted format through a secure private network set up and maintained by the European Commission.

Opinion

The EDPB and the EDPS confirmed that personal data is processed in the eHDSI system for two main purposes.  First, the European Commission processes personal data of individuals with access to eHDSI’s core systems to manage their access rights.  Second, relevant stakeholders process personal data of patients for the purpose of transferring this information from one Member State to another.

The opinion focuses particularly on the processing of patient data.  It confirms that Member States act as “joint controllers” and the European Commission acts as a processor.  The opinion indicates that the European Commission has “a certain degree of involvement in the processing of personal data, also in terms of defining security and communication standards”.  However, the European Commission does not have a “decision-making power in terms of defining the purpose or the essential means relating to the processing operation.

As a basis for its assessment, the opinion relies on the Article 29 Working Party’s Opinion on the concepts of “controller” and “processor”, where it says that “while determining the purpose of the processing would in any case trigger the qualification as controller, determining the means would imply control only when the determination concerns the essential elements of the means.  In this perspective, it is well possible that the technical and organizational means are determined exclusively by the data processor.

For this reason, the EDPB and the EDPS are of the opinion that the European Commission acts as a processor in relation to patient data transferred via the eHDSI.

Photo of Kristof Van Quathem Kristof Van Quathem

Kristof Van Quathem advises clients on information technology matters and policy, with a focus on data protection, cybercrime and various EU data-related initiatives, such as the Data Act, the AI Act and EHDS.

Kristof has been specializing in this area for over twenty…

Kristof Van Quathem advises clients on information technology matters and policy, with a focus on data protection, cybercrime and various EU data-related initiatives, such as the Data Act, the AI Act and EHDS.

Kristof has been specializing in this area for over twenty years and developed particular experience in the life science and information technology sectors. He counsels clients on government affairs strategies concerning EU lawmaking and their compliance with applicable regulatory frameworks, and has represented clients in non-contentious and contentious matters before data protection authorities, national courts and the Court of the Justice of the EU.

Kristof is admitted to practice in Belgium.

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.