European Union (EU)

On 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare sector from cyber threats. The publication of the Action Plan follows a number of high-profile incidents in recent years where healthcare providers across the European Union have been the target of cyber attacks.

Whilst the Action Plan primarily focuses on healthcare providers including hospitals, clinics, care homes, rehabilitation centres and others, the plan identifies interdependence between those providers and the healthcare industry. Therefore, some of the measures proposed address risks affecting the broader healthcare supply chain and ecosystem, and will potentially have implications for pharmaceutical and biotechnology industry players as well as medical device manufacturers.

The action that will be of most significance for industry is the plan for Member States to request that entities subject to the NIS2 Directive, including healthcare organisations, must report on ransom payments when reporting significant incidents to the competent authority under the NIS2 Directive (section 3.3, p.14). The Action Plan rationalizes this proposal by stating that the collection of further data is needed to understand the effectiveness of measures taken against ransomware attacks, and noting that such reporting would support the effective investigation of incidents. Reporting of ransomware payments is not required by the NIS2 Directive, so this would represent a significant change for in-scope entities. While this is titled a ‘national action’ to be implemented by Q4 2025, it is not immediately clear from the Action Plan if the proposal would take the form of a new EU law that imposes the obligation on Member States or otherwise.Continue Reading European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers

On 2 December 2024, the European Data Protection Board (“EDPB”) adopted its draft guidelines on Article 48 GDPR (the “Draft Guidelines”). The Draft Guidelines are intended to provide guidance on the GDPR requirements applicable to private companies in the EU that receive requests or binding demands for personal data from public authorities (e.g., law enforcement or national security agencies, as well as other regulators) located outside the EU.

The Draft Guidelines focus in particular on Article 48 GDPR, which states that a binding demand from a non-EU public authority “requiring a controller or processor to transfer or disclose personal data may only be recognised or enforceable in any manner if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or a Member State, without prejudice to other grounds for transfer pursuant to this Chapter.”

As an initial matter, the EDPB addresses the question of whether Article 48 operates as a blocking statute—i.e., a prohibition on disclosure of personal data subject to the GDPR to non-EU public authorities in the absence of an international agreement (e.g., a mutual legal assistance treaty) that permits that disclosure. The Draft Guidelines state that, even in the absence of such an international agreement, companies can in principle disclose personal data in response to such demands, provided that they (a) have a valid legal basis for doing so under Article 6 GDPR, and (b) can validly transfer the personal data outside the EU in accordance with Chapter V GDPR (e.g., on the basis of an EU adequacy decision, “appropriate safeguards”, or one of the derogations set out in Article 49 GDPR). The Draft Guidelines nonetheless make clear that, absent such an international agreement, any demand from a non-EU public authority will not be recognized as a binding demand by, or enforceable in, EU courts.

The Draft Guidelines also provide guidance on the Article 6 legal bases and Chapter V transfer grounds that might apply where a private entity receives a request or demand for personal data from a non-EU public authority. This guidance is broadly consistent with the EDPB’s analysis in its 2019 joint opinion with the EDPS on the CLOUD Act. Of particular note:Continue Reading EDPB adopts draft guidelines on requirements when responding to requests from non-EU public authorities

On May 30, 2024, the Court of Justice of the EU (“CJEU”) handed down its rulings in several cases (C-665/22, Joined Cases C‑664/22 and C‑666/22, C‑663/22, and Joined Cases C‑662/22 and C‑667/22) concerning the compatibility with EU law of certain Italian measures imposing obligations on providers of online platforms and search engines.  In doing so, the CJEU upheld the so-called “country-of-origin” principle, established in the EU’s e-Commerce Directive and based on the EU Treaties principle of free movement of services.  The country-of-origin principle gives the Member State where an online service provider is established exclusive authority (“competence”) to regulate access to, and exercise of, the provider’s services and prevents other Member States from imposing additional requirements.

We provide below an overview of Court’s key findings.

Background

The cases originate from proceedings brought by several online intermediation and search engine service providers (collectively, “providers”) against the Italian regulator for communications (“AGCOM”).  The providers, which are not established in Italy, challenged measures adopted by AGCOM designed to ensure the “adequate and effective enforcement” of the EU Platform-to-Business Regulation (“P2B Regulation”).  Among other things, those measures required the providers, depending on the case, to: (1) enter their business into a national register; (2) provide detailed information, including information about the company’s economic situation, ownership structure, and organization; and (3) pay a financial contribution to the regulator for the purposes of supporting its supervision activities. 

The Country-of-Origin Principle

In its rulings, the Court notes that the e-Commerce Directive’s country-of-origin principle relieves online service providers of having to comply with multiple Member State requirements falling within the so-called “coordinated field” (as defined in Article 2(h)-(i) of e-Commerce Directive), that is, requirements concerning access to the service (such as qualifications, authorizations or notifications), and the provision of the service (such as the provider’s behavior, the quality or content of services). 

Member States other than where the service provider is established cannot restrict the freedom to provide such online services for reasons falling within the coordinated field, unless certain conditions are met.  In particular, measures may be taken when it is necessary for reasons of public policy, protection of public health, public security, or the protection of consumers, among other conditions (Article 3(4) of e-Commerce Directive).Continue Reading CJEU Upholds Country-of-Origin Principle for Online Service Providers in the EU

On May 20, 2024, a proposal for a law on artificial intelligence (“AI”) was laid before the Italian Senate.

The proposed law sets out (1) general principles for the development and use of AI systems and models; (2) sectorial provisions, particularly in the healthcare sector and for scientific research for healthcare; (3) rules on the national strategy on AI and governance, including designating the national competent authorities in accordance with the EU AI Act; and (4) amendments to copyright law. 

We provide below an overview of the proposal’s key provisions.

Objectives and General Principles

The proposed law aims to promote a “fair, transparent and responsible” use of AI, following a human-centered approach, and to monitor potential economic and social risks, as well as risks to fundamental rights.  The law will sit alongside and complement the EU AI Act (for more information on the EU AI Act, see our blogpost here).  (Article 1)

The proposed law sets out general principles, based on the principles developed by the Commission’s High-level expert group on artificial intelligence, pursuing three broad objectives:

  1. Fair algorithmic processing. Research, testing, development, implementation and application of AI systems must respect individuals’ fundamental rights and freedoms, and the principles of transparency, proportionality, security, protection of personal data and confidentiality, accuracy, non-discrimination, gender equality and inclusion.
  2. Protection of data. The development of AI systems and models must be based on data and processes that are proportionate to the sectors in which they’re intended to be used, and ensure that data is accurate, reliable, secure, qualitative, appropriate and transparent.  Cybersecurity throughout the systems’ lifecycle must be ensured and specific security measures adopted.
  3. Digital sustainability. The development and implementation of AI systems and models must ensure human autonomy and decision-making, prevention of harm, transparency and explainability.  (Article 3)

Continue Reading Italy Proposes New Artificial Intelligence Law

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 holders; 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.

1: Health data holder

The term “health data holder” includes, among others, any natural or legal person developing products or services intended for health, developing or manufacturing wellness applications, or performing research in relation to healthcare, who:

  • in relation to personal electronic health data: in its capacity of a data controller has the right or obligation to process the health data, including for research and innovation purposes; or
  • in relation to non-personal electronic health data: has the ability to make the data available through control of the technical design of a product and related services.  These terms appear to be taken from the Data Act, but they are not defined under the EHDS.

In practice, this means that, for example, hospitals, as data controllers, are data holders of their electronic health records.  Similarly, pharmaceutical companies are data holders of clinical trial data and biobanks.  Medical device companies may be data holders of non-personal data generated by their devices, if they have access to that data and an ability to produce it.  However, medical device companies would not qualify as a data holder where they merely process personal electronic health data on behalf of a hospital.

Individual researchers and micro enterprises are not data holders, unless EU Member States decide differently for their territory.

2: Data sets covered by EHDS

The EHDS sets out a long list of covered electronic health data that should be made available for secondary use under the EHDS.  It includes, among others:

  • electronic health records;
  • human genetic data;
  • biobanks;
  • data from wellness applications;
  • clinical trial data – though according to the recitals, this only applies when the trial has ended;
  • medical device data;
  • data from registries; and
  • data from research cohorts and surveys, after the first publication of the results – a qualifier that does not seem to apply for clinical trial data.

Continue Reading EHDS Series – 2: The European Health Data Space from the Health Data Holder’s Perspective

In December 2023, the Dutch SA fined a credit card company €150,000 for failure to perform a proper data protection impact assessment (“DPIA”) in accordance with Art. 35 GDPR for its “identification and verification process”.

First, the Dutch SA decided that the company was required to perform a DPIA because…

Continue Reading Dutch SA Sanctions Credit Card Company for Failure to Perform Data Protection Impact Assessment

Yesterday, the European Commission, Council and Parliament announced that they had reached an agreement on the text of the Cyber Resilience Act (“CRA”). As a result, the CRA now looks set to finish its journey through the EU legislative process early next year. As we explained in our prior…

Continue Reading The EU’s Cyber Resilience Act Has Now Been Agreed

On July 10, 2023, the European Commission adopted its adequacy decision on the EU-U.S. Data Privacy Framework (“DPF”). The decision, which took effect on the day of its adoption, concludes that the United States ensures an adequate level of protection for personal data transferred from the EEA to companies certified to the DPF. This blog post summarizes the key findings of the decision, what organizations wishing to certify to the DPF need to do and the process for certifying, as well as the impact on other transfer mechanisms such as the standard contractual clauses (“SCCs”), and on transfers from the UK and Switzerland.

Background

The Commission’s adoption of the adequacy decision follows three key recent developments:

  1. the endorsement of the draft decision by a committee of EU Member State representatives;
  2. the designation by the U.S. Department of Justice of the European Union and Iceland, Liechtenstein, and Norway (which together with the EU form the EEA) as “qualifying states,” for the purposes of President Biden’s Executive Order 14086 on Enhancing Safeguards for U.S. Signals Intelligence Activities (“EO 14086”). This designation enables EU data subjects to submit complaints concerning alleged violations of U.S. law governing signals intelligence activities to the redress mechanism set forth in the Executive Order and implementing regulations (see our previous blog post here); and
  3. updates to the U.S. Intelligence Community’s policies and procedures to implement the safeguards established under EO 14086, announced by the U.S. Office of Director of National Intelligence on July 3, 2023.

The final adequacy decision, which largely corresponds to the Commission’s draft decision (see our prior blog post here), concludes “the United States … ensures a level of protection for personal data transferred from the Union to certified organisations in the United States under the EU-U.S. Data Privacy Framework that is essentially equivalent to the one guaranteed by [the GDPR]” (para. 201).

Key Findings of the Decision

In reaching the final decision, the Commission confirms a few key points:Continue Reading European Commission Adopts Adequacy Decision on the EU-U.S. Data Privacy Framework

On 11 May 2023, members of the European Parliament’s internal market (IMCO) and civil liberties (LIBE) committees agreed their final text on the EU’s proposed AI Act. After MEPs formalize their position through a plenary vote (expected this summer), the AI Act will enter the last stage of the legislative…

Continue Reading EU Parliament’s AI Act Proposals Introduce New Obligations for Foundation Models and Generative AI