European Union

On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog post, we describe the specific…

On 12 July 2024, EU lawmakers published the EU Artificial Intelligence Act (“AI Act”), a first-of-its-kind regulation aiming to harmonise rules on AI models and systems across the EU. The AI Act prohibits certain AI practices, and sets out regulations on “high-risk” AI systems, certain AI systems that pose transparency risks, and general-purpose AI (GPAI) models.Continue Reading EU Artificial Intelligence Act Published

Last month, the European Commission published a draft Implementing Regulation (“IR”) under the EU’s revised Network and Information Systems Directive (“NIS2”). The draft IR applies to entities in the digital infrastructure sector, ICT service management and digital service providers (e.g., cloud computing providers, online marketplaces, and online social networks). It sets out further detail on (i) the specific cybersecurity risk-management measures those entities must implement; and (ii) when an incident affecting those entities is considered to be “significant”. Once finalized, it will apply from October 18, 2024.

Many companies may be taken aback by the granular nature of some of the technical measures listed and the criteria to determine if an incident is significant and reportable – especially coming so close to the October deadline for Member States to start applying their national transpositions of NIS2.

The IR is open for feedback via the Commission’s Have Your Say portal until July 25.Continue Reading NIS2: Commission Publishes Long-Awaited Draft Implementing Regulation On Technical And Methodological Requirements And Significant Incidents

On May 9, 2024, the Italian data protection authority (“Garante”) published a decision identifying the safeguards that controllers must put in place when processing health data for medical research purposes, in cases where data subjects’ consent cannot be obtained for ethical or organizational reasons.

The Garante’s decision follows a recent legislative development, enacted by Law n. 56 of April 29, 2024, and effective as of May 1, 2024, which amended, among other things, Article 110 of the Italian Privacy Code.  The amendment removes the obligation to submit a research program and related data protection impact assessment (“DPIA”) for prior consultation to the Garante, in cases where it is impossible or disproportionately burdensome to contact the concerned individuals.  

We provide below an overview of the legal framework and the safeguards identified by the Garante.Continue Reading Italian Legislator and Regulator Update Rules on Processing of Health Data for Medical Research

The French Public Health Code requires that certain service providers hosting health data hold a specific “HDS” certification.  In order to obtain this certification, providers must comply with the requirements set out in the “HDS” certification standard.  On May 16, 2024, France officially published an updated version of this “HDS” certification standard.

  1. Key Changes

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In March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  Although the text has not yet been formally adopted by all the European institutions, a number of interesting points can already be highlighted.  This article focuses on the governance and enforcement of the EHDS; 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 – 5: European Health Data Space Governance, Enforcement and Timelines

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

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

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?