In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS generally, see our first post in this series.

The final text of the EHDS was adopted by the European Parliament on 24 April 2024 and is expected to be formally adopted by the European Council in the coming months.

Continue Reading EHDS Series – 4: The European Health Data Space’s Implications for “Wellness Applications” and Medical Devices

On April 22, 2024, the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) issued a statement on the application of the AI Act in the medicinal product lifecycle. The EFPIA statement highlights that AI applications are likely to play an increasing role in the development and manufacture of medicines.  As drug development is already governed by a longstanding and detailed EU regulatory framework, EFPIA stresses that care should be taken to ensure that any rules on the use of AI are fit-for-purpose, adequately tailored, risk-based, and do not duplicate existing rules.  The statement sets forth five “considerations”:

Continue Reading EFPIA Issues Statement on Application of the AI Act in the Medicinal Product Lifecycle

With the 2024 election rapidly approaching, the Biden Administration must race to finalize proposed agency actions as early as mid-May to avoid facing possible nullification if the Republican Party controls both chambers of Congress and the White House next year.  This post summarizes the Congressional Review Act (“CRA”) which will apply to a number of U.S. federal rulemakings, including those related to privacy and cybersecurity.

Continue Reading Congressional Review Act Threat Looms Over Biden Administration Rulemakings

In six months’ time, on 17 October 2024, Member State laws that transpose the EU’s revised Network and Information Systems Directive (“NIS2”) will start to apply.  As described in more detail in our earlier blog post (here), NIS2 significantly expands the categories of organizations that fall within scope of EU cybersecurity legislation. This new, cross-sector law imposes additional and more granular security and incident reporting rules, enhanced governance requirements that apply to organizations’ “management bodies,” and creates a stricter enforcement regime.

Continue Reading NIS2 implementation enters the final stretch – six months to deadline

In recent months, the European Court of Justice (“CJEU”) issued five judgments providing some clarity on the scope of individuals’ rights to claim compensation for “material and non-material damage” under Article 82 of the GDPR. These rulings will inform companies’ exposure to compensation claims, particularly in the context of the EU’s Collective Redress Directive, but open questions remain about the quantum of compensation courts will offer in these cases and we expect both the CJEU and national courts to deliver additional case-law clarifying this topic in the coming year (for more information on recent CJEU cases related to compensation, see our previous blog posts here and here).

  • In VB v Natsionalna agentsia za prihodite (C-340/21), the CJEU concluded that individuals may have suffered “non-material damage”—and therefore be able to claim compensation—if they can demonstrate that they feared future misuse of personal data that was compromised in a personal data breach.  
  • In VX v Gemeinde Ummendorf (C-456/22), the CJEU found that there is no de minimis threshold for damage, below which individuals cannot claim for compensation.
  • In BL v MediaMarktSaturn (C-687-21), the CJEU restated its existing case-law, and expanded upon its analysis in VB by clarifying that alleged harms cannot be “purely hypothetical”.
  • In Kočner v Europol (C-755/21), the CJEU awarded non-material damages of €2000 for the publication in newspapers of transcripts of “intimate” text messages.
  • In GP v Juris GmbH (C-741/21), the CJEU found that where one processing activity infringes multiple provisions of the GDPR, this should not allow claimants to “double-count” the harm they suffered.

We provide further detail on each case below.

Continue Reading Rounding up Five Recent CJEU Cases on GDPR Compensation

Earlier this month, lawmakers released a discussion draft of a proposed federal privacy bill, the American Privacy Rights Act of 2024 (the “APRA”).  While the draft aims to introduce a comprehensive federal privacy statute for the U.S., it contains some notable provisions that could potentially affect the development and use of artificial intelligence systems.  These provisions include the following:

Continue Reading Certain Provisions in the American Privacy Rights Act of 2024 Could Potentially Affect AI

On April 2, the Enforcement Division of the California Privacy Protection Agency issued its first Enforcement Advisory, titled “Applying Data Minimization to Consumer Requests.”  The Advisory highlights certain provisions of and regulations promulgated under the California Consumer Privacy Act (“CCPA”) that “reflect the concept of data minimization” and provides two examples that illustrate how businesses may apply data minimization principles in certain scenarios.

Continue Reading California Privacy Protection Agency Issues Enforcement Advisory on Data Minimization

On January 17, 2024, the European Data Protection Board (“EDPB”) published its report on the 2023 Coordinated Enforcement Framework (“CEF”), which examines the current landscape and obstacles faced by data protection officers (“DPOs”) across the EU.  In particular, the report provides a snapshot of the findings of each supervisory authority (“SA”) on the role of DPOs, with a particular focus on (i) the challenges DPOs face and (ii) recommendations to mitigate and address these obstacles in light of the GDPR.  This blog post summarizes the key findings of the EDPB’s 2023 CEF report.

Continue Reading EDPB 2023 Coordinated Enforcement Framework on DPOs: What Are the Key Takeaways for Organizations?

On April 3, at the International Association of Privacy Professionals’ global privacy conference, California Privacy Protection Agency (“CPPA”) Executive Director Ashkan Soltani gave remarks on his agency’s priorities with respect to rulemaking and administrative enforcement of the California Consumer Privacy Act (“CCPA”).  Below we provide a few key takeaways:

Continue Reading CPPA Executive Director Remarks on Policy and Enforcement Priorities

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data users; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.

Continue Reading EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective