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European Union › Data Privacy › Medical Devices

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 -
A&O Shearman

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

A&O Shearman on

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

Hogan Lovells

Life Sciences Law Update Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain...

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Pharma: Reform of the EU Pharmaceutical Legislation; German Medical Research Act enacted fostering R&D also including confidentiality of drug prices; France adopts standard CTA clauses; UK easing clinical trials; Devices:...more

Gardner Law

AI Regulation and Legal Trends in the U.S and Abroad

Gardner Law on

The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more

A&O Shearman

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

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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

Hogan Lovells

Life Sciences Law Update - Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain...

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Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 118

Jones Day on

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

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 117

Jones Day on

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

Morgan Lewis

EU High Court Allows GDPR Claims in Business Litigation, Expands Scope of ‘Health Data’ Impacting Life Sciences and Consumer...

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The Court of Justice of the European Union (CJEU), the EU’s highest court, recently announced its significant Lindenapotheke decision, permitting companies to use the General Data Protection Regulation in business-to-business...more

Spilman Thomas & Battle, PLLC

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

Spilman Thomas & Battle, PLLC on

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

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

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FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Alston & Bird

Why the New EU-U.S. Data Privacy Framework May Be Good News for Life Sciences Companies in the U.S.

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BACKGROUND - U.S.-based life sciences companies can be subject to the European Union (‘EU’) General Data Protection Regulation (‘GDPR’), even if they do not have any subsidiary, affiliate or other physical presence in the...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 103

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This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. ...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 99

Jones Day on

This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. This COVID-19 Update...more

McDermott Will & Schulte

Special Report: Developments in UK Life Sciences – Spring Update 2022

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MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more

Jones Day

Covid-19 Key EU Developments, Policy & Regulatory Update No. 77

Jones Day on

COMPETITION & STATE AID - State Aid- European Commission publishes Annual Single Market Report 2022 - On 22 February 2022, the European Commission published the Annual Single Market Report 2022, which sets out, in...more

Latham & Watkins LLP

EU-UK Trade and Cooperation Agreement: Implications for Life Sciences Companies

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The agreement provides guidance across several areas for the life sciences sector, though gaps remain. The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more

Morgan Lewis

Life Sciences International Review - Q2 2019

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EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Value-based purchasing

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

Morgan Lewis

International Life Sciences Data Transfers After Schrems

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With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more

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