EU Moving Closer to an AI Act – Key Areas of Impact for Life Sciences/MedTech Companies

The European Union is moving closer to adopting the first major legislation to horizontally regulate artificial intelligence. Today, the European Parliament (Parliament) reached a provisional agreement on its internal position on the draft Artificial Intelligence Regulation (AI Act). The text will be adopted by Parliament committees in the coming weeks and by the Parliament plenary in June. The plenary adoption will trigger the next legislative step of trilogue negotiations with the European Council to agree on a final text. Once adopted, according to the text, the AI Act will become applicable 24 months after its entry into force (or 36 months according to the Council’s position), which is currently expected in the second half of 2025, at the earliest.

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New EU Cyber Law for the Financial Services Industry with Significant Impact on ICT Service Providers

The new EU Regulation on Digital Operational Resilience for the Financial Sector (DORA) recently entered into force. DORA establishes cybersecurity requirements for information and communication technology (ICT) systems supporting the business processes of financial entities and represents a paradigm shift for the ICT sector.  Critical ICT third-party service providers, who are providing services to regulated financial entities, will also be directly regulated under DORA and subject to regulatory supervision by a regulator to be established under DORA (a so-called ‘Lead Overseer’).

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FemTech Has Been Warned: UK’s ICO Indicates Closer Scrutinization of FemTech Apps

On 4 April 2023, John Edwards, the UK’s Information Commissioner, stated that the UK’s Information Commissioner’s Office (ICO) would be “going after providers of women’s health apps and auditing them, and getting them to change any practices that are non-compliant.” Speaking at the IAPP Global Privacy Summit in Washington DC, the Information Commissioner indicated that this proposed strategy forms part of the ICO’s new “agile” initiative, which will focus on “areas of vulnerability, targeting…intervention [where] that has the greatest impact”.

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UK GDPR Reform Is Back! Department of Science, Innovation and Technology Introduces New Data Protection and Digital Information Bill

On 8 March 2023, the newly created Department of Science, Innovation and Technology (“DSIT”) introduced the Data Protection and Digital Information (No. 2) Bill. The “Bill” is in substance a re-introduction of the previous Data Protection and Digital Information Bill which was withdrawn from Parliament on the same day as the new Bill was published. The Bill, which has been hailed by the UK Government as one that will “save billions” and “cut down pointless paperwork” is the UK’s latest attempt to create a more streamlined piece of data protection legislation for the UK whilst still “ensur[ing] data adequacy.” The Information Commissioner’s Office (“ICO”) also welcomed the re-introduction of the Bill, with the Commissioner stating that he would “support [the Bill’s] ambition.” While much of the Bill remains the same as its previous iteration, we set out the key provisions and notable amendments below.

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Unpacking Digital Data Laws Across Europe: Addressing the Digital Markets Act

The EU Digital Markets Act (DMA) is set to revolutionize the way in which so-called ‘Big Tech’ is regulated in the EU, shifting toward ex-ante rulemaking and away from traditional after-the-fact enforcement. The DMA imposes a stringent regulatory regime on large online platforms (so-called “gatekeepers”) and gives the European Commission (Commission) new enforcement powers, including an ability to impose severe fines and remedies for noncompliance.

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EU Publishes New NIS2 Cyber Directive Imposing Liability and Obligations on Senior Management

On 17 January 2023, the new Network and Information Systems Security Directive (“NIS2 Directive”), which is aimed at establishing a minimum level of cybersecurity standards across the EU and is set to replace its predecessor (the NIS or “NIS1 Directive), entered into force. The new NIS2 Directive aims to further harmonize and strengthen cybersecurity and resilience throughout the EU in response to a continued increase in digitization and rise in cyber (and in particular ransomware) threats – which is estimated to have reached a total cost of €5.5 trillion at the end of 2020 (double the figure of 2015) and continues to rise in the EU and globally notably due to ongoing geopolitical conflicts in Ukraine and Russia. (more…)

The Ninth Edition of The Privacy, Data Protection and Cybersecurity Law Review is Now Available

The ninth edition of The Privacy, Data Protection and Cybersecurity Law Review provides a global overview of the legal and regulatory regimes governing data privacy and security, and covers areas such as data processors’ obligations, data subject rights, data transfers and localization, best practices for minimizing cyber risk, public and private enforcement, and an outlook for future developments. Several lawyers from Sidley’s global Privacy and Cybersecurity practice have contributed to this publication. See the chapters below for a closer look at this developing area of law.

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European Commission Publishes Draft Cyber Resilience Act

On 15 September 2022, the European Commission (“Commission” or “EC”) published a draft proposal for a Cyber Resilience Act (“CRA” ). The CRA comes in response to the increasingly common occurrence of cyberattacks, with some predicting that the global cost of cyberattacks for companies will reach $10.5 trillion annually by 2025, up from $3 trillion in 2015. The CRA promises to transform the European cybersecurity landscape by harmonizing and bolstering cybersecurity rules across all technologies with “digital elements.” The Commission is currently inviting public feedback on the CRA through 18 November 2022. The CRA will then pass through the European Parliament for debate and for amendments to be proposed.

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U.S.-EU Data Transfer Framework Signals Strengthened Collaboration

*This article first appeared on Law360 on October 14, 2022

A series of coordinated announcements on Oct. 7 lifted the veil on a new trans-Atlantic data transfer mechanism.

This announcement has been hotly anticipated since a joint declaration from the U.S. and European Union governments on March 25, that there was an agreement in principle for a new EU-U.S. Data Privacy Framework.

The key document in the framework process is Executive Order No. 14086 on enhancing safeguards for U.S. signals intelligence activities, accompanied by a detailed fact sheet on the executive order.

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Spotlight on Women in Privacy – Hattie Davison

Hattie Davison, UK Government, Department for Digital, Culture, Media and Sport, Head of Data Reform Policy (more…)