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Navigating Compliance Considerations Under the AI Act for AI-Driven Medical Devices

20/01/2025
Artificial Intelligence (AI)

As part of our AI series, this blog post delves into the implications of the AI Act for AI-driven medical devices. It explores key topics such as the criteria for high-risk AI systems outlined in Annex I of the Act, requirements for high-risk AI system providers, and compliance responsibilities for suppliers of AI systems, tools, components, services, or processes used in or integrated into high-risk medical devices.

AI

Understanding the impact of the AI act for Law Enforcement in 7 points and 7 key takeaways

20/12/2024
Artificial Intelligence (AI)

As part of our AI series, this blog post will cover the impact of the new Act for Law Enforcement Authorities (LEAs).

Navigating the AI Act and the GDPR

Harmonising AI and data protection: Navigating the AI Act and the GDPR

19/12/2024
Artificial Intelligence (AI)

The rapid adoption of artificial intelligence (AI) systems presents transformative opportunities for organisations but also introduces complex regulatory challenges. At the heart of these challenges lies the need to balance innovation with the protection of fundamental rights, particularly in the area of data protection. This balance is illustrated by the interplay between the European Union's General Data Protection Regulation (GDPR) and the Artificial Intelligence Act (AI Act).

New product liability rules

Developers, beware the new product liability rules

19/12/2024
Cybersecurity

This week the new product liability directive entered into force. It is the first major overhaul of this almost 40-years old legal framework. In this blogpost, we provide an overview of the upcoming changes. 

Unethical AI

Unlocking Ethical AI: A Closer Look into the Fundamental Rights Impact Assessment under the AI Act

15/11/2024
Artificial Intelligence (AI)

The Fundamental Rights Impact Assessment (FRIA) is a new obligation introduced by the EU Artificial Intelligence Act (AI Act).Despite its novelty, the origins of this assessment and the logic behind its conception are found in pre-existing legislation, such as the GDPR, and human/fundamental rights impact assessments that constitute a good practice in business when onboarding new technologies or tools or creating new processes.

Impact of the AI Act on the financial services sector

Impact of the AI Act on the financial services sector

08/10/2024
Artificial Intelligence (AI)

In this next post in our series on the AI Act we will delve deeper into the implications of this new legal framework for the financial services sector. 

Minors as vulnerable participants in social research activities

Minors as vulnerable participants in social research activities

05/08/2024
Privacy & data protection

Minors are a vital part of every society and in line with the UN Convention on the Rights of the Child, should be able to express their views on all matters affecting them. This overarching principle is why many researchers working on matters directly affecting minors are eager to include them in their research activities. This blog post will focus on the legal questions surrounding their involvement in social research.

Recent CJEU judgements concerning the right to compensation under Art. 82 GDPR – a state of affairs in ten focus points

Recent CJEU judgements concerning the right to compensation under Art. 82 GDPR – a state of affairs in ten focus points

05/08/2024
Privacy & data protection

On June 20th 2024, the Court of Justice of the European Union (CJEU) addressed the right to compensation under Article 82 of the of the General Data Protection Regulation (GDPR) in two new cases. That article provides for a right to compensation for the data subject of material and non-material damage resulting from an infringement of the GDPR.

AI-Act

The EU’s newly published Artificial Intelligence Act – an overview in 6 questions

30/07/2024
Artificial Intelligence (AI)

After three years of legislative work, the EU Artificial Intelligence Act (‘AI Act’) was finally published in the Official Journal on July 12, 2024, becoming the world’s first comprehensive artificial intelligence (AI) regulation.

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