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Digital Tech & Data
Today, it’s impossible to do business – or even to think about doing business – without considering the digital world. Innovative, disruptive, challenging and regulated, effective data management is essential to commercial success. It’s key to building and maintaining trust between a company, its customers and its suppliers, across all fields and sectors. Managing the…
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Creating and Implementing Corporate AI Guidelines
Join our upcoming unyer webinar on “Creating and Implementing Corporate AI Guidelines” on 17 April at 12 pm. Our unyer expert panel will be discussing regulations on AI, liability regimes, corporate governance impacts, and more. We are welcoming our external speakers, who will add the corporate inhouse view to our discussion. ○ Gabriele Scafati, Data…
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Navigating the Digital Landscape into 2025 – EU Regulatory Reforms and their Impact on the Life Sciences Industries
The current era is witnessing unprecedented technological developments and advancements. The world of health care is no exception, with several digital innovations making their way into the industry. Join us for the upcoming webinar “Navigating the Digital Landscape into 2025: EU Regulatory Reforms and their Impact on the Life Science Industries” on 28 January 2025…
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NIS 2 Directive: Spotlight on Transposition and Practical Challenges in Austria, France, Germany and Italy
Dive into the heart of European cybersecurity challenges with our webinar dedicated to the NIS2 Directive. The NIS 2 Directive, which builds on the achievements of the NIS 1 Directive, marks a paradigm shift at both national and European level. Our unyer legal experts offer a comparative overview of the new requirements, concrete challenges, and…
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unyer reception at IAPP, Brussels
unyer is pleased to invite you to a reception during the IAPP Europe Data Protection Congress 2025 in Brussels. Please register before Wednesday 12th November to confirm your participation. Location : Radisson Collection Grand Place, rue du Fossé aux Loups 47, 1000 Brussels.
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One data protection framework for a digital health platform
From impact assessments to authority audits: one compliance framework for a platform active in twelve EU states.
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Protecting a luxury brand against online counterfeits
Coordinated enforcement removed more than 9,000 counterfeit listings and recovered damages in three countries.
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unyer reception at IAPP 2026, Brussels
unyer is pleased to invite you to a reception during the IAPP Europe Data Protection Congress 2026 in Brussels. Wednesday, 18 November 2026, 7.00 p.m. CET (UTC+2) Please register before Friday 6 November to confirm your participation. Location: Radisson Collection Grand Place, Brussels
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unyer Webinar Digital Tech & Data | NIS2 Across Europe — A Cross-Border Compliance Perspective
Join our upcoming webinar “NIS2 Across Europe — A Cross-Border Compliance Perspective” Does your group operate in more than one EU country? NIS2 sets a common baseline, but operational requirements and deadlines differ from one Member State to another. Let our unyer experts and guest speakers guide you through the national rules, the main establishment…
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MyHealth@EU: How Health Data Compliance Is Changing
On 21 September 2026, the European Commission published two new regulations in the Official Journal of the European Union, defining crucial operational aspects of the European Health Data Space. Rules and regulations governing digital health are undergoing an unprecedented transformation: the European Union intends to enforce a material revision of legal compliance strategies for companies…
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Italy adapts its legal framework to the EU AI Act: new rules on damage caused by AI systems and access to evidence
On 30 September 2026, Legislative Decree No. 160/2026 (“Legislative Decree No. 160/2026”) came into effect. The decree was adopted in accordance with Article 24 of Law No. 132 of 23 September 2025, with the aim of aligning the Italian legal framework with Regulation (EU) 2024/1689 (the AI Act), which establishes the European regulatory framework for…
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Conducting health research in France? What the CNIL’s updated standards mean for you
The French data privacy commission (the “CNIL”) has updated two data processing standards for research involving personal health data in order to respond to major changes in the health research sector ie the increasing digitisation and decentralisation of research, social and environmental considerations at the heart of new methods, stricter testing requirements for health products…
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AI Act: New Perspectives for the Healthcare Sector – Current implementation status
With the adoption of Regulation (EU) 2024/1689, known as the AI Act, the European Union has established for the first time a systematic and binding framework for artificial intelligence, becoming a pioneer in the regulation of a technology which is bound to profoundly affect the economy, fundamental rights and essential services. One of the sectors…
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IT security is at a crossroads
IT security: a multidimensional challenge IT security is no longer limited to technical considerations. It now requires a comprehensive approach that integrates technical, organizational, managerial, and legal skills. This cross-functional nature requires close cooperation between different departments within the company to define clear objectives, measure risks, and implement corrective and/or preventive actions. Despite growing awareness…
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The EU Data Act
What is the EU Data Act? The EU Data Act establishes harmonised rules regarding the fair access to and use of data across digital markets. Its overarching goal is to Promote competition, innovation and the free flow of data within the EU – with particular attention to data generated by connected (IoT) products and related…
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Integrated approach to cybersecurity management: a common compliance model
1. Introduction: a complex regulatory framework Managing cybersecurity in accordance with a complex, fragmented and constantly evolving regulatory framework is one of the most complex and significant challenges today. In fact, the digitalization of production processes, the interconnection of infrastructures and the continuous proliferation of new cyber threats have led to the emergence of different…
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What the European Health Data Space Means for Pharmaceutical Companies
New Rules, New Opportunities On 5 March 2025, the European Union adopted the European Health Data Space (EHDS) through Regulation (EU) 2025/327. This marks the EU’s most ambitious attempt yet to unlock the potential of health data – while safeguarding fundamental rights. The EHDS introduces a unified legal framework for the use of electronic health data across Member States. It…
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The Digital Services Act (DSA)
What is the DSA The Digital Services Act (DSA), officially known as EU Regulation 2022/2065, represents a critical development in the European Union’s regulatory framework, introduced to address the dynamic and complex challenges of the digital age. Together with the Digital Markets Act (DMA), it forms part of the comprehensive Digital Services Package, aiming to…
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Legal implications of the Crowdstrike incident: a wake-up call for IT security
On July 19, a serious IT security incident shook the digital world. A faulty update by the renowned security company Crowdstrike for its Falcon software led to massive computer failures at companies and organizations worldwide. The effects were dramatic: airplanes were grounded, hospitals had to cancel operations and numerous companies were faced with significant operational…
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Proposed EU AI Act’s application to medical devices
The recitals of the proposal for a Regulation laying down harmonised rules on artificial intelligence (the “AI Act”) states that “By improving prediction, optimising operations and resource allocation … the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes”, in particular in the area of healthcare.[1]…
