EU Data Protection

On June 21, 2022, the Court of Justice of the EU (“CJEU”) decided that that the Passenger Name Record (“PNR”) Directive’s provisions providing for  the processing of PNR data by competent Member State authorities are compatible with the EU Charter of Fundamental Rights (“Charter”).  However, the CJEU also decided that the PNR Directive limits the way in which Member State laws transpose some of its provisions, particularly in relation to the collection of passenger information for intra-EU flights.  Its decision will require Belgium to amend its law transposing the PNR Directive, mainly in relation to the PNR data competent authorities may receive and how they can process this data.  It is likely to indirectly impact air carriers and tour operators operating in Belgium, as it will reduce the amount of data they need to share with competent authorities under such a revised legal framework.

The CJEU decision also considers, as well, Member State laws transposing (1) the Council Directive 2004/82/EC on the obligation of carriers to communicate passenger data (API Directive) and (2) Directive 2010/65/EU on reporting formalities for ships arriving in and/or departing from ports of the Member States.

The case was lodged on October 31, 2019, by the non-profit organization Ligue des Droits Humainsbefore the Belgian courts in relation to the Belgian law transposing the PNR and API Directives.  The Belgian Constitutional Court referred certain questions to the CJEU.…

Continue Reading Court of Justice of the EU Decides that the Passenger Name Record Directive is Compatible with EU Law

On June 14, 2022, representatives of the EU’s Consumer Protection Cooperation (CPC) Network, together with several national data protection authorities in the EU and the secretariat of the European Data Protection Board (“EDPB”), endorsed five key principles for fair advertising to children (see press release here).  These recommendations are based on relevant requirements…

The most significant change that GDPR made to EU data privacy law was to enhance enforcement and create a framework for increased fines for non-compliance. Four years after the GDPR started to apply, and as enforcement action picks up across the EU, the EDPB has finally issued draft guidelines on the calculation of administrative fines…

On April 28, 2022, the Court of Justice of the EU (“CJEU”) decided that consumer protection associations may bring collective claims without a mandate from the affected consumers, including for violations of the GDPR, relying on national consumer law provisions.  The words “without a mandate” refers to the fact that the organization is not representing a particular consumer or group of consumers, rather, it is representing the collective interests of those whose personal data have been processed in a manner contrary to the GDPR, without naming particular data subjects.…

Continue Reading Court of Justice of the EU Greenlights GDPR Collective Claims Without a Mandate

On May 4, 2022, the General Court of the EU handed down a decision that helps clarify the standard of proof required to demonstrate that information that does not identify someone by name constitutes “personal data” under EU data protection law.  The court also clarifies that the burden of proof falls on the entity alleging that the information is personal data.

The case concerns an online press release published by the European Anti-Fraud Office’s (“OLAF”) announcing that it had determined that a Greek scientist had committed fraud using EU funds intended to finance a research project.  Among other things, the scientist alleged that the press release contained “personal data” about her and, therefore, OLAF breached data protection law because it did not have a legal basis to disseminate her “personal data”.  She also alleged that OLAF’s press release had enabled two journalists to identify her and write each an article mentioning her by name.

The court disagreed with the position taken by the scientist, holding that the she was not able to demonstrate that the published information enabled her identification and, therefore, it had not demonstrated that the information was “personal data”.  It also decided that OLAF was not responsible for the news articles that identified the scientist by name.…

Continue Reading General Court of the EU Finds that Individual was Unable to Prove that Information Published Online Constitutes “Personal Data”

In the early hours of Friday, 13 May, the European Parliament and the Council of the EU reached provisional political agreement on a new framework EU cybersecurity law, known as “NIS2”. This new law, which will replace the existing NIS Directive (which was agreed around the same time as GDPR, see here) aims to strengthen EU-wide cybersecurity protection across a broader range of sectors, including the pharmaceutical sector, medical device manufacturing, and the food sector.…

Continue Reading Political Agreement Reached on New EU Horizontal Cybersecurity Directive

On April 23, 2022, the European Parliament and Council of the EU announced that they reached a provisional political agreement on the Digital Services Act (“DSA”) during their final trilogue meeting.  The news comes roughly one month after the provisional political agreement on the Digital Markets Act (“DMA”).

Both acts are part of the European…

Update: On May 3, 2022, the European Commission published the official version of the proposal for a European Health Data Space Regulation.  It’s open for feedback until July 14, 2022.

Original blog post: On March 3, 2022, a leaked version of the proposal for a regulation setting up the European Health Data Space was published.  The draft regulation will set up a common framework across EU Member States for the sharing and exchange of quality health data (such as electronic health records, patient registries and genomic data).  The European Commission has not yet released an official version of the proposal.  It is expected to do so on May 3.

The leaked proposal is a lengthy document (126 pages, excluding annexes) that contains within it a number of different sets of rules.  Key requirements that are likely to be of interest to organizations in the life sciences sector are that the draft regulation proposes to:

  • create new patient rights over their electronic health data, and sets out rules regarding use of electronic health data for primary care;
  • establishes a pre-market conformity assessment requirement for electronic health record systems (“EHR systems”);
  • sets out rules that apply to digital health services and wellness apps; and
  • introduces a harmonized scheme for providing access to electronic health data for secondary use.

…
Continue Reading Draft Version of the European Health Data Space Regulation

The German Conference of Independent Supervisory Authorities (“DSK”) published on March 23, 2022 a statement on scientific research and data protection (see here, in German).  The DSK published the statement in response to the German Government’s initiative on a general law on research data as part of its Open Data Strategy, announced on July 6, 2021.  The DSK also refers to the Government’s intention to introduce a law on the use of health data, including the storage of data in electronic health records.
Continue Reading German Supervisory Authorities Publish Paper on Scientific Research and Data Protection