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The Volkov Law Group

Episode 382 — AI Legal Compliance and Governance

The Volkov Law Group on

Given the real and significant potential benefits of AI, companies have to be careful in the rush to implement AI technology. Starting with a clear use case, companies have to weigh the potential benefits of AI technology and...more

Morrison & Foerster LLP

NIS 2: Strengthening Europe’s Cyber Defenses

Morrison & Foerster LLP on

European cybersecurity risk management and reporting obligations have received a substantial facelift. The Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the EU (“NIS 2”) became effective...more

A&O Shearman

Council position on EU pharma package adopted

A&O Shearman on

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

Latham & Watkins LLP

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

Latham & Watkins LLP on

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

A&O Shearman

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

A&O Shearman on

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

Ropes & Gray LLP

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

Ropes & Gray LLP on

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

McDermott Will & Schulte

Key Features of the New EU Product Liability Directive: Increased Potential for Litigation in the Technology, Pharmaceutical and...

McDermott Will & Schulte on

On October 10, 2024, the Council of the European Union adopted the new EU Directive on Liability for Defective Products (New PLD), repealing Directive 85/374/EEC (PLD), adopted in 1985....more

American Conference Institute (ACI)

U.S. Implications of the EU AI Act

American Conference Institute (ACI) on

The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

Latham & Watkins LLP

MHRA Releases No-Deal Brexit Guidance for Life Sciences Companies

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The guidance provides helpful clarity on key regulatory changes impacting life sciences companies in the event of a no-deal Brexit. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a...more

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