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 data protection, data security and cybercrime matters in various sectors, and in particular in the pharmaceutical and information technology sector. Kristof has been specializing in this area for over fifteen years and covers the entire spectrum of…

Kristof Van Quathem advises clients on data protection, data security and cybercrime matters in various sectors, and in particular in the pharmaceutical and information technology sector. Kristof has been specializing in this area for over fifteen years and covers the entire spectrum of advising clients on government affairs strategies concerning the lawmaking, to compliance advice on the adopted laws regulations and guidelines, and the representation of clients in non-contentious and contentious matters before data protection authorities.

Photo of Anna Oberschelp de Meneses Anna Oberschelp de Meneses

Anna Sophia Oberschelp de Meneses is an associate in the Data Privacy and Cybersecurity Practice Group.  Anna is a qualified Portuguese lawyer, but is both a native Portuguese and German speaker.  Anna advises companies on European data protection law and helps clients coordinate…

Anna Sophia Oberschelp de Meneses is an associate in the Data Privacy and Cybersecurity Practice Group.  Anna is a qualified Portuguese lawyer, but is both a native Portuguese and German speaker.  Anna advises companies on European data protection law and helps clients coordinate international data protection law projects.  She has obtained a certificate for “corporate data protection officer” by the German Association for Data Protection and Data Security (“Gesellschaft für Datenschutz und Datensicherheit e.V.”). She is also Certified Information Privacy Professional Europe (CIPPE/EU) by the International Association of Privacy Professionals (IAPP).  Anna also advises companies in the field of EU consumer law and has been closely tracking the developments in this area.  Her extensive language skills allow her to monitor developments and help clients tackle EU Data Privacy, Cybersecurity and Consumer Law issues in various EU and ROW jurisdictions.