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On March 7, 2023, the Irish Data Protection Commission (“DPC”) published its annual report for 2022. The report reflects the DPC’s reputation as both an active enforcer of the General Data Protection Regulation (“GDPR”) and a contributor to policy development at national and EU levels.  The level of interaction between the DPC and the European Data Protection Board (“EDPB”) is particularly significant with more than 300 meetings reported for 2022 (averaging at more than 25 per month), many of which involved participation in the EDPB’s expert subgroups.…

Continue Reading Key Takeaways from the Irish DPC’s 2022 Annual Report

In 2022, the European Union announced the creation of Digital Partnerships with three Asian countries: Japan, South Korea and Singapore. This is in line with the EU’s Digital Compass strategy which seeks to make the European Union the most connected continent by 2030. The European Commission is expanding its connections between Europe and the rest of the world to address the digital divide and further develop a sustainable digital economy with trusted partners.

Below we set out the key points from the Digital Partnerships that the European Commission has announced with Japan, South Korea and Singapore, respectively.…

Continue Reading EU Digital Partnerships with Asia: A New Path Towards Enhanced Digital Collaboration and Opportunities

On December 14, 2022, the members of the Organization for Economic Co-operation and Development (“OECD”) (which includes various EU Member States, Mexico, Turkey, the UK and the United States) and the EU, adopted the Declaration on Government Access to Personal Data held by Private Sector Entities (“Declaration”). …

Continue Reading OECD and the EU adopt Declaration on Government Access to Personal Data

On September 16, 2022, the European Commission published its Proposal for a European Media Freedom Act (“Proposed MFA”). The Proposed MFA is broadly designed to protect media pluralism and independence in the EU. It does so by setting a common set of rules “for all EU media players,” in particular, providers of “media services.” The Proposed MFA also imposes new obligations on providers of “very large online platforms” (“VLOPs”) as defined in the EU’s Digital Services Act (“DSA”).…

Continue Reading European Commission publishes its Proposal for a European Media Freedom Act

On June 30, 2022, the European Data Protection Board published draft guidelines on certification as a tool for transfers.  These guidelines complement the EDPB’s earlier guidelines on certification and identifying certification criteria.

These guidelines and the guidelines on codes of conduct as tools for transfers appear to be part of the EDPB’s broader response to the Schrems II decision issued by the Court of Justice of the European Union (“CJEU”), which invalidated the EU-US Privacy Shield framework.  The approval of certification schemes expands the toolbox available under Art. 46 GDPR for lawfully transferring personal data outside the EEA.…

Continue Reading European Data Protection Board Publishes Guidelines on Certification as a Tool for International Personal Data Transfers

On June 23, 2022, the German Federal Office for Information Security (“Office”) published technical guidelines on security requirements for healthcare apps, including mobile apps, web apps, and background systems.  Although the technical guidelines are aimed at healthcare app developers, they contain useful guidance for developers of any app that processes or stores sensitive…

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 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

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.

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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