The AI Act and European Health Data Space Proposal: Seeing ‘AI to AI’ With Each Other?

Blogpost 26/2023

Over the past few months, general-purpose artificial intelligence (AI) has emerged as a hot topic for policymakers. The ‘AI hype’ that followed the seemingly immediate success of the conversational bot ChatGPT has led to renewed calls for regulation in the EU, placing Large Language Models (LLMs) in the spotlight. Such models, which can be described as a subset of general-purpose AI that can process and generate human-like text, are increasingly being integrated into various industries. Healthcare is no exception, with potential applications ranging from clinical and operational decision-making to patient engagement. AI enthusiasts hope that LLMs will enable better communication between patients, physicians and healthcare workers, improve healthcare delivery or contribute to the advent of personal therapy bots. It remains to be seen which of these promises are feasible and realistic, but their capabilities have been and are continuing to grow exponentially, enabling them to reliably perform routine tasks for care providers like collecting information or navigating health record systems (an area of particular interest). Recent peer-reviewed studies have shown that virtual assistants and other AI-based tools can already perform many healthcare tasks better than specialist physicians, leaving experts wondering about the future of the human element in the patient experience.

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Out of Scope, Out of Mind, and Don’t Say Decentralisation: Brief Remarks on the new MiCA Regulation

Blogpost 25/2023

The views expressed on this post bind the author exclusively.

The Markets in Crypto-assets Regulation (“MiCA”), even though not yet published in the Official Journal of the European Union, is now politically agreed upon and its final text (formal revisions notwithstanding) has been adopted by the European Parliament and the Council of the European Union. The MiCA Regulation is a ground-breaking piece of legislation, as it seeks to create a comprehensive framework applicable to various aspects of crypto-assets issued and traded in the European Union.

The EU is taking the lead in the regulation of crypto-assets, as it tries to strike a middle-ground between a complete absence of rules protecting investors and consumers, and stifling prohibition, trying to make the EU an attractive but safe hub for blockchain-based activity and business. However, leading the field in regulation always implies a certain degree of risk and the new instrument is not without its shortcomings.

This post, after a brief overview of the scope and main features of the MiCA Regulation, will make some remarks on two outstanding issues: the doubtful rationale behind the scope of the Regulation, and its choice not to deal with decentralisation.Continue reading

Why the CJEU should not follow the AG Opinion on the application of ne bis in idem in the pending Volkswagen case

Blogpost 24/2023

Disclaimer: The author represents the interests of companies having suffered damages in the “Dieselgate” case. He thanks Ms Amélia Guglielmi for her research work and Prof. Maria José Azar-Baud for her valuable comments.

On 30 March 2023, Advocate General (“AG”) Campos Sánchez-Bordona delivered his Opinion in C-27/22 Volkswagen Group Italia and Volkswagen Aktiengesellschaft. This Opinion addresses the application of the ne bis in idem principle in the case of the diesel emissions scandal, better known as “Dieselgate“. According to the ne bis in idem principle, a fundamental principle of criminal law enshrined, inter alia, in Article 50 of the Charter of Fundamental Rights, “no one shall be liable to be tried or punished again in criminal proceedings for an offence for which he or she has already been finally acquitted or convicted within the Union in accordance with the law”.

The Court’s ruling is highly anticipated, both, by the authorities in the Member States which are currently prosecuting VW for offences committed on their territory in connection with the vehicles sold and used there, and by the victims – whether consumers or companies – who are seeking compensation for their losses in the context of ongoing criminal proceedings, as is the case in France, for example.Continue reading

Case C-769/22: A further step in the protection of the fundamental rights within the European Union?

Blogpost 23/2023

On 19 December 2022, the Commission brought an infringement action against Hungary regarding the adoption of Law LXXIX of 2021 (Anti-LGBTI+ law). The Hungarian legislation raises concern because it outlaws sharing information related to homosexuality or gender change with under-18s. The Commission claimed that Hungary has infringed several Union provisions, among which Article 2 TEU was expressly included. The explicit mention of the violation of the Article 2 TEU and, thus, the values of the Union is an example of the growing impact and relevance of the European rule of law crisis. Several measures adopted by Hungary and Poland are currently threatening the Union’s values on a systematic scale, affecting the Union’s very nature. Therefore, the resulting judgement could play a key role regarding the justiciability of Article 2 and the use of the infringement proceedings under art. 258 TFEU to tackle the violation of such provision. 

This blog will firstly discuss the use of the infringement proceeding as a lawful route to claim violations of Article 2 TEU, instead of following the specific procedure under Article 7 TEU, and the relation between these two Articles. After assessing that possibility, both the justiciability and the direct effect of Article 2 will be evaluated. Lastly, the blog will address the definition of the values given by the Court of Justice and its necessary character. Continue reading

‘Voluntary detection orders’ under the proposed EU Child Sexual Abuse Regulation violate EU (privacy) law

Blogpost 22/2023

On 11 May 2022, the European Commission (Commission) published its proposed Regulation laying down rules to prevent and combat child sexual abuse (Child Sexual Abuse (CSA) Regulation). The proposed CSA Regulation aims to establish a clear and harmonized legal framework to better identify, protect, and support victims of CSA, notably through a clarification of the rules and responsibilities of online service providers when it comes to online CSA. It seeks to provide legal certainty to providers as to their responsibilities to assess and mitigate risks and, where necessary, to detect, report, and remove online CSA in a manner consistent with the fundamental rights laid down in the Charter of Fundamental Rights of the European Union and existing EU law.

The proposed CSA Regulation establishes a risk assessment and risk mitigation regime complementary to the Digital Services Act, specifically targeting risks associated with online CSA. If a so-called national ‘Coordinating Authority’, which oversees the risk assessment and risk mitigation measures undertaken by providers, identifies a significant risk of online CSA on a specific service, it can request a judicial or independent administrative authority to issue a detection order. If a provider receives a detection order, it is obliged to use technologies to detect and report specific types of online CSA to a newly established ‘EU Centre’. If the company fails to comply, it can be fined up to 6% of its annual income or global turnover.Continue reading

AG Opinion on Eco Advocacy Case (C-721/21): the statement of reasons for a decision not to carry out an appropriate assessment or environmental impact assessment

Blogpost 21/2023

Disclaimer: John Condon and Juliet Stote are working with the environmental law organisation ClientEarth who is a party in the case at hand.

On 19 January 2023, Advocate General Kokott issued her Opinion in Case C-721/21 Eco Advocacy CLG before the CJEU. The Opinion is significant at least for two reasons: first, it articulates the obligations for public authorities to provide a statement of reasons when refusing to carry out an appropriate assessment under the Habitats Directive. Second, it examines the same duty with respect to an environmental impact assessment under the EIA Directive. Third, AG Kokott seeks to make an important distinction between the different types of ‘mitigation measures’, (i.e. measures to minimise or cancel the negative impacts on a site) that can be considered during the screening stage of the appropriate assessment. The purpose of an appropriate assessment is to assess the potential adverse effects of an area protected under the Habitats Directive; the ‘screening’ of an appropriate assessment aims to carry out an initial examination to determine whether the plan is likely to have significant effects on the site such that a full appropriate assessment is required.

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The Data Act: a (slippery) third way beyond personal/non-personal data dualism?

Blogpost 20/2023

In the age of highly intensive data processing, personal and non-personal data are increasingly inextricable in datasets. Impressive computational capabilities are making it possible to identify data subjects even in datasets that – until recently – we would have considered “anonymous”. However, the need to guarantee digital users’ protection goes beyond the mere issue of identification, considering that many risks to fundamental rights online can occur even without any personal data processing. At the same time, intensive data processing is becoming essential in any critical or fundamental infrastructure of our society.

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Judicial review of investigative measures under the EPPO Regulation. More to it than it seems? A recap of the Oral Hearing in G.K & Others

Blogpost 19/2023

This post discusses the public oral hearing in Case C-281/22 held by the ECJ in Luxembourg on 27 February 2023, which the author attended in person/online. The summary of the oral hearing as presented here is based on the author’s own observations and notes taken during the hearing.

The European Public Prosecutors Office (EPPO) began operating on June 1st, 2021, and its 2022 Annual Report was recently published, on 7 March 2023. The Report provides an overview of the EPPO activities during its first full year of operation and indicates that by the end of 2022 it had over 1000 opened investigations, with 28.2% of its cases having a cross border dimension.

While the report gives the new and shiny EU prosecutorial body rave reviews for its achievements during its first full year in operation, Regulation 2017/1939 on the European Public Prosecutors office (the EPPO Regulation) is currently facing its first big test before the Court of Justice in the European Union (CJEU) with the case C-281/22 G.K and Others. The central focus of the case pertains to the extent of judicial review of cross-border investigative measures within the EPPO framework, i.e. Article 31 EPPO Regulation. While this may seem like a merely technical issue, this case addresses a key question for the EPPO, namely whether the practical implementation of its legal framework allows for it to achieve its objective: conducting effective investigations of crimes against the financial interests of the EU. The outcome of the case will also affect the protection of individual rights during EPPO proceedings and particularly the right to challenge investigative measures.

With the opinion of Advocate General (AG) Capeta due on 22 June 2023 we are (hopefully) close to getting some answers. This blog post will provide a short recap of the Oral Hearing, which took place before the Grand Chamber on 27 February 2023.Continue reading

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