EU Commission Launches Cybersecurity Action Plan for Hospitals and Healthcare Providers
On January 15, 2025 the EU Commission published an action plan with an aim to support cybersecurity in hospitals and healthcare providers in the EU (the Action Plan). The Action Plan is another response by the EU to the increasing cybersecurity threats facing all industries, including the health sector. The Commission notes that this risk has increased due to, amongst other factors, the increased digitisation of healthcare, which has allowed attack surfaces to grow. It also comes following a number of high-profile incidents which have impacted healthcare providers in the EU. The Action Plan is intended to build on the new EU cybersecurity legislation, such as the NIS Directive 2 (NISD2) and the Cyber Resilience Act, and feed into the full deployment of the European Health Data Space Regulation which was adopted on January 21, 2025. See our blog post here.
Data Privacy and Cybersecurity Outlook for 2025: What Financial Services Firms Need To Know
Last year saw many developments across the worldwide data privacy and cybersecurity landscape, including in the EU/UK, and this momentum shows no sign of slowing in 2025. The EU General Data Protection Regulation (GDPR) enters its seventh year in May 2025. New cybersecurity and operational resilience legislation and related guidance are coming into force to regulate new and challenging technologies, several of which will affect financial services firms.
European Health Data Space Regulation Adopted: What’s Next for Life Sciences Companies?
On January 21, 2025, the European Health Data Space Regulation (EHDS) was formally adopted by the Council of the European Union. This marks the near-final step in the adoption process, and will enter into force in the coming weeks. Importantly for life sciences companies (pharma, biotech, and medtech), the EHDS’ so-called secondary use provisions will become applicable in 2029, leaving companies four years to consider, adapt to, and implement these wide-ranging requirements.
Looking Ahead to 2025 in EU Cybersecurity Developments
As 2024 draws to a close, we look ahead to notable upcoming cyber developments in the new year. From the adoption of new cyber laws to the initiation of infringement proceedings by the European Commission against a number of EU Member States for alleged failures to adequately implement the EU Network and Information Systems Security 2 Directive, the EU continues to emphasize cybersecurity in a rapidly evolving legal and technological environment. There are no signs of this momentum slowing down in 2025.
EU AI Act: Are You Prepared for the “AI Literacy” Principle?
The EU AI Act is the world’s first horizontal and standalone law governing the commercialization and use of AI, and a landmark piece of legislation for the EU. Among the various provisions of the EU AI Act, the “AI literacy” principle is an often overlooked but key obligation which requires organizations to ensure that staff who are involved in the operation and use of AI have the necessary skills, knowledge and understanding to adequately assess AI-related risks and opportunities (e.g., through training and hiring staff with the appropriate background and skillset). This obligation – which applies from February 2, 2025 – is one of the few obligations under the EU AI Act that applies to all AI systems i.e., irrespective of the level of risk that the AI system presents. Indeed, by introducing AI literacy as one of the first provisions of the AI Act (Article 4), the EU legislators appear to underscore the significance of this requirement.
Top Trends in the European Digital Health/AI Market
Digital health AI technologies are transforming the advancement of drug development and healthcare delivery at an unprecedented speed, backed by governments facilitating the momentum to improve healthcare for their growing populations. Sidley’s European life sciences lawyers Josefine Sommer, Eva von Mühlenen, and Francesca Blythe share a timely take on the top 5 life sciences industry trends being shaped by pioneering digital technologies. We are delighted to present a series of insightful interviews with leaders from a diverse digital health ecosystem giving their perspectives from Roche, Origen Genetics, FemTech Insights, Verge, Steto, and Clario.
Advisor to the CJEU Confirms GDPR Fines For Subsidiary Infringements Should Reflect Group Turnover
On 12 September 2024, Advocate General Medina issued their Opinion in Case C-383/23 in which they confirmed that supervisory data protection authorities must, when calculating the fine for a GDPR infringement committed by a subsidiary, take into account the total annual turnover of the entire group—a concept known as parental liability.
Asia-Pacific Regulations Keep Pace With Rapid Evolution of Artificial Intelligence Technology
Regulation of artificial intelligence (AI) technology in the Asia-Pacific region (APAC) is developing rapidly, with at least 16 jurisdictions having some form of AI guidance or regulation. Some countries are implementing AI-specific laws and regulation, while others take a more “soft” law approach in reliance on nonbinding principles and standards. While regulatory approaches in the region differ, policy drivers feature common principles including responsible use, data security, end-user protection, and human autonomy.
DORA – ESAs Publish Draft Technical Standards on ICT Subcontracting
On 26 July 2024, the European Supervisory Authorities (EBA, EIOPA and ESMA, collectively, the “ESAs”) published their joint final report on the draft Regulatory Technical Standards (“RTS”) specifying the elements that a financial entity should determine and assess when subcontracting ICT services supporting critical or important functions under Article 30(5) of the Digital Operational Resilience Act (“DORA”). The RTS are intended to assist with the enhancement of the digital operational resilience of the financial services sector by improving in-scope entities’ ICT risk management, specifically with respect to the issue of ICT subcontracting.
EU Governments Sign-off Proposed Reforms to GDPR Procedural Rules and Council Reaches Common Member States’ Position
On 24 May 2024, the Council of the European Union (the “Council”) released new details of a proposed reform of the General Data Protection Regulation’s (“GDPR”) procedural rules, which representatives of EU national governments approved on 29 May 2024. On 13 June 2024, the Council issued a press release detailing its agreed common Member States’ position that maintains the general thrust of the original proposed reforms, but which seeks to: (i) introduce clearer timelines; (ii) improve efficiency of cooperation; and (iii) provide an early resolution mechanism.