News & Analysis as of August 16, 2025

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

AI in healthcare: Legal and ethical considerations in this new frontier

A&O Shearman on 7/30/2025

Can human beings cure all diseases in our lifetime? For centuries, humanity has strived to cure diseases. With the advent of Artificial Intelligence (AI), the dream of a disease-free world seems more attainable than ever...more

Council position on EU pharma package adopted

A&O Shearman on 6/16/2025

On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

Jones Day on 6/3/2025

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

The future of the robotics metaverse in the healthcare sector

A&O Shearman on 5/19/2025

On 26 February 2025, the European Economic and Social Committee (EESC) adopted an opinion addressing the integration of robotics and the metaverse in healthcare. This forward-looking document outlines the opportunities and...more

Preparing for the European Health Data Space - Opportunities and Challenges for Europe’s Digital Future

Latham & Watkins LLP on 4/18/2025

The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more

European Health Data Space Regulation sets requirements for electronic health record systems

A&O Shearman on 3/28/2025

On March 5, 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council of February 11, 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (the Regulation)...more

European Health Data Space Regulation enters into force

McDermott Will & Schulte on 3/27/2025

March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming into force. The EHDS represents a transformative initiative by the European Union...more

The Data Act: Six Months to Go — But What To Do?

Ropes & Gray LLP on 3/27/2025

Our clients are at the forefront of many of the developments covered by the report. That said, I couldn’t help thinking that the report overlooked a law that takes effect in less than six months’ time and which will have...more

Zooming in on AI - #14: Enforcement of the AI Act

A&O Shearman on 2/6/2025

The European Union Artificial Intelligence Act (AI Act) entered into force on 1 August 2024. The AI Act establishes a risk-based approach to AI, prohibiting certain practices that are deemed unacceptable, such as social...more

Council of the EU adopts the European Health Data Space Regulation

A&O Shearman on 1/29/2025

On January 21 2025, the Council of the European Union (Council) announced its decision to adopt the Regulation of the European Parliament and of the Council on the European Health Data Space (EHDS). As we have previously...more

Decoded - Technology Law Insights, V 5, Issue 8, October 2024

Spilman Thomas & Battle, PLLC on 10/25/2024

Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more

AEPD and EDPS publish report on data protection issues arising from the handling of neuro data

A&O Shearman on 7/11/2024

On 27 June 2024, the Spanish supervisory authority (‘AEPD’) and the European Data Protection Supervisor (‘EDPS’), announced the joint publication of a report addressing the data protection challenges associated with neuro...more

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Skadden, Arps, Slate, Meagher & Flom LLP on 4/4/2024

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

Spilman Thomas & Battle, PLLC on 3/8/2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

Nelson Mullins Riley & Scarborough LLP on 7/20/2023

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more

Health Data in the EU and UK – Regulatory Trends and Developments

McDermott Will & Schulte on 3/3/2023

In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on 12/2/2022

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Investing in European Healthcare - What's on the Horizon for 2022? - Regulatory and Legal Changes

McDermott Will & Schulte on 9/20/2021

Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more

International Privacy Laws and Clinical Trials

Butler Snow LLP on 9/20/2021

Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more

Update on European Data Protection Law

McDermott Will & Schulte on 2/19/2021

In mid-January 2021, the European Data Protection Board (EDPB) announced by press release that it has adopted jointly with the European Data Protection Supervisor (EDPS) written Opinions on the European Commission’s drafts...more

French Data Protection Authority Rules on Transfers of Health Data

Foley Hoag LLP - Security, Privacy and the... on 11/12/2020

The French Conseil d’Etat handed down an important decision October, 13th regarding privacy and personal data protection. This decision comes in the wake of the “Schrems II” ruling of the Court of Justice of the European...more

One For All! Collective Redress Is Coming To The EU

Morrison & Foerster LLP on 7/16/2020

The EU may soon introduce and adopt a collective redress directive that will make it possible for consumers across the EU to bring forward class action cases on various legal matters. The European collective redress system,...more

What’s Your Game Plan? Offensive or Defensive: Playing to Your Strengths [Expect Focus – October 2016]

Carlton Fields on 10/31/2016

- AXA Prevails at First Post-Jones v. Harris Excessive Fee Trial - Potential Secondary Effects of Regulatory Examinations: Evidentiary Issues and Preclusion in Parallel Litigation - On The Horizon: Global...more

Alphabet Soup and Data Security

Bilzin Sumberg on 10/19/2015

In the span of two days, mobile device users learned of two data breaches that could compromise their personal data. In one, Experian (a credit reporting agency) reported that it was hacked, potentially putting 15 million...more

10 Popular Reads Covering Latest European Union Developments

JD Supra Perspectives on 7/16/2014

Recap of popular updates covering latest developments in the European Union....more

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