European Union

Subscribe to European Union

On December 28, 2022, the Spanish Data Protection Authority (“AEPD”) published a statement on the interplay between its recently approved Spanish code of conduct for the pharmaceutical industry and the European Federation of Pharmaceutical Industries and Associations’ (“EFPIA”) proposal for an EU code of conduct on clinical trials and pharmacovigilance.  The statement relates specifically to the legal basis for processing personal data in the context of clinical trials.…

Continue Reading The Spanish AEPD Publishes Statement on the Interplay Between its Code of Conduct for the Pharmaceutical Industry and the Potential EU Code of Conduct on Clinical Trials

On December 13, 2022, the European Commission released its draft adequacy decision on the EU-U.S. Data Privacy Framework (“EU-U.S. DPF”), which, once formally adopted, would recognize that the United States ensures an adequate level of protection for personal data transferred from the EU to organizations certified under the EU-U.S. DPF.  The draft decision follows the issuance of Executive Order 14086 on Enhancing Safeguards for U.S. Signals Intelligence Activities (“EO 14086”) by President Biden on October 7, 2022 (see our previous blog post here), and the political agreement reached between the EU and the U.S. in March 2022 (see our previous blog post here).

As many had expected, the draft adequacy decision assesses the limitations and safeguards relating to the collection and subsequent use of personal data transferred to controllers and processors in the United States by U.S. public authorities.  In particular, the draft decision assesses whether the conditions under which the U.S. government may access data transferred to the United States fulfill the “essential equivalence” test pursuant to Article 45(1) of the GDPR, as interpreted by the Court of Justice of the European Union (“CJEU”) in Schrems II (see our previous blog post here). …

Continue Reading European Commission Releases Draft Adequacy Decision on the EU-U.S. Data Privacy Framework

On October 7, 2022, President Biden signed an Executive Order directing the steps that the United States will take to implement its commitments under the new EU-U.S. Data Privacy Framework.  The framework was announced by the U.S. and the EU Commission in March 2022, after reaching a political agreement in principle (see our blog post…

On September 28, 2022, the European Commission published its long-promised proposal for an AI Liability Directive.  The draft Directive is intended to complement the EU AI Act, which the EU’s institutions are still negotiating.  In parallel, the European Commission also published its proposal to update the EU’s 1985 Product Liability Directive.  If adopted, the proposals will change the liability rules for software and AI systems in the EU.

The draft AI Liability Directive establishes rules applicable to non-contractual, fault-based civil claims involving AI systems.  Specifically, the proposal establishes rules that would govern the preservation and disclosure of evidence in cases involving high-risk AI, as well as rules on the burden of proof and corresponding rebuttable presumptions.  If adopted as proposed, the draft AI Liability Directive will apply to damages that occur two years or more after the Directive enters into force; five years after its entry into force, the Commission will consider the need for rules on no-fault liability for AI claims.

As for the draft Directive on Liability of Defective Products, if adopted, EU Member States will have one year from its entry into force to implement it in their national laws.  The draft Directive would apply to products placed on the market one year after it enters into force.…

Continue Reading European Commission Publishes Directive on the Liability of Artificial Intelligence Systems

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 October 4, 2022, the EU adopted the Digital Services Act (“DSA”), which imposes new rules on providers of intermediary services (e.g., cloud services, file-sharing services, search engines, social networks and online marketplaces).  The DSA will enter into force on November 16, 2022 — although it will only fully apply as of February 17, 2024. …

Continue Reading EU Adopts Digital Services Act

The EU is in the process of adopting the Digital Markets Act and the Digital Services Act.  Both acts include rules applying to online-targeted advertising, commonly understood as the conveyance of messages over the Internet directed at a particular group of people who are perceived to be interested in the message in order to advance commercial or other interests.  This blog post provides an overview of the existing and soon to be adopted EU data related rules applying to online-targeted advertising.  It does not cover rules relating to ranking systems.…

Continue Reading EU Rules on Online Targeted Advertising

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…