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European Union › Healthcare Reform

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... more +
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 -
Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

Skadden, Arps, Slate, Meagher & Flom LLP on

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

McDermott Will & Emery

Partnering with Legal at the Critical AI/Healthcare Crossroads

McDermott Will & Emery on

The intersection of AI and healthcare is outpacing the development of laws and regulations governing the technology. Even in the early days of AI transformation, this is creating uncertainty for healthcare organizations....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

A&O Shearman

The future of the robotics metaverse in the healthcare sector

A&O Shearman on

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

McDermott Will & Emery

European Health Data Space Regulation enters into force

McDermott Will & Emery on

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

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, V 2, Issue 2, January 2025

Spilman Thomas & Battle, PLLC on

Welcome to our second issue of 2025 of The Health Record -- our healthcare law insights e-newsletter. In this edition, we look at the effect of the decline of DEI on the healthcare industry, the fate of Medicaid under the...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

A&O Shearman on

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Akin Gump Strauss Hauer & Feld LLP

US Presidential Elections 2024—What is at Stake for Swiss Companies and Investors?

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The November U.S. Presidential electoral campaign is in full swing. Since President Joe Biden ended his reelection bid and Vice President Kamala Harris secured the Democratic Party nomination, polls now show a tight race...more

A&O Shearman

European Commission approves EUR1 billion of state aid to revolutionize healthcare

A&O Shearman on

The European Commission (EC ) has approved the first Important Project of Common European Interest (IPCEI) in the health sector— IPCEI Med4Cure. Under the IPCEI, six EU member states will provide up to EUR1bn of state aid...more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

Sheppard Mullin Richter & Hampton LLP on

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

Hogan Lovells

Regulation of health care centers: a limited reform on the way

Hogan Lovells on

A new bill of law has been proposed to improve the regulation of health care centers in France. While limited in scope as currently drafted, the bill contributes to the establishment of a regulatory framework applicable to...more

Hogan Lovells

La réforme de l’encadrement des centres de santé, une réglementation attendue mais dont les contours restent encore limités

Hogan Lovells on

Une nouvelle proposition de loi est en cours d’adoption, visant à améliorer l’encadrement des centres de santé en France. Ce texte participe à la construction du cadre réglementaire applicable à la mise en place de ces...more

Foley & Lardner LLP

Priorities of the 118th Congress and the Biden Administration

Foley & Lardner LLP on

As the final votes of the 2022 Midterm Elections are counted, Republicans have taken back control of the House of Representatives, while the Democrats will retain control of the Senate. Both chambers will be held by extremely...more

Butler Snow LLP

Go-Live of the EU’s Clinical Trial Information System Completes Implementation of the EU’s 2014 Clinical Trial Regulation:...

Butler Snow LLP on

From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive 2001/20/EC (CTD) which set rules for conducting...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No.72

Jones Day on

COMPETITION & STATE AID - Competition- European Commission expresses views on IAG’s (aborted) intended acquisition of Air Europa, including in light of impact of COVID-19 restrictions - On 16 December 2021, the...more

Orrick, Herrington & Sutcliffe LLP

PNRR as the new Marshall Plan for Europe and Italy

Orrick, Herrington & Sutcliffe LLP on

On April 27, 2021, the Italian Parliament, in both Chambers, Representative and Senate, approved the National Recovery and Resilience Plan. Now the Government shall submit within April 30th the Plan to the European Commission...more

Hogan Lovells

Nouvelle doctrine de la Commission de la Transparence de la Haute Autorité de santé

Hogan Lovells on

Dans la continuité de son Plan d’action pour les médicaments innovants exposé début 2020, la Haute Autorité de santé a mis à jour sa doctrine d’évaluation des médicaments. ...more

Hogan Lovells

New Doctrine of the French National Authority for Health

Hogan Lovells on

In line with its Action Plan for Innovative Medicines outlined in early 2020, the French National Authority for Health has updated its doctrine for the health technology assessment of medicines. Following its Action Plan for...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

Hogan Lovells on

Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

Hogan Lovells

European Commission publishes new documents regarding the Clinical Trials Regulation

Hogan Lovells on

Shortly after updating the related draft Questions and Answers document, the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed...more

Hogan Lovells

European Commission provides clarification regarding the implementation of the Clinical Trials Regulation

Hogan Lovells on

The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing...more

Smart & Biggar

Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

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