Tag Archives: European Union

Unified Patent Court Could be Operational as Early as December 2017

As we discussed in a prior post, the introduction of the Unified Patent Court (UPC) will be a significant change to the European patent landscape and will have a profound effect on how life sciences companies set about their patent strategies – from filing through exploitation to enforcement. Consequently, life sciences companies should take note … Continue Reading

European Patent Litigation for Life Sciences Companies: a Silver Lining to the Brexit Cloud?

The introduction of the Unified Patent Court (UPC) is undoubtedly the most significant change to the European patent landscape since the European Patent Convention of 1973. It will have a profound effect on how life sciences companies set about their patent strategies – from filing through exploitation to enforcement. Leaving aside the inevitable delays to … Continue Reading

What Brexit Means for Data Protection

For global pharmaceutical and medical device companies handling personal data in the European Union (EU) or engaged in transatlantic data transfers, some of the many questions created by the Brexit vote include what its impact will be on the United Kingdom’s (UK) data protection laws. These questions also arise in the context of the EU’s … Continue Reading

Privacy Shield Details Have Been Revealed: Here’s What Companies Need to Know

The European Commission has published its draft adequacy decision on the EU-U.S. Privacy Shield, the proposed data transfer framework that would replace the defunct Safe Harbor program. The draft adequacy decision formally supports the view that the proposed EU-U.S. Privacy Shield will ensure an adequate level of protection for the transfer of personal data from … Continue Reading

Obama Signs Judicial Redress Act (JRA) – Another Step on the Way to Securing EU-U.S. Data Flows

President Obama signed the U.S. Judicial Redress Act (JRA) into law on 24 February 2016, giving European citizens the same right as U.S. citizens to bring actions against the U.S. government if their personal data are misused. While the JRA is not a formal prerequisite to finalizing the EU-U.S. Privacy Shield transatlantic data-sharing framework, it’s … Continue Reading

What the “EU-U.S. Privacy Shield,” the New Safe Harbor, Means for Your Business

European Union and United States authorities have announced the “EU-U.S. Privacy Shield,” a new transatlantic data transfer framework to replace Safe Harbor, which was invalidated by the European Court of Justice in October in Maximillian Schrems v. Data Protection Commissioner (C-362-14). Since this issue has clear implications for our pharmaceutical and medical device clients, we’ve … Continue Reading

Current State of “Safe Harbor 2.0” And Steps Your Business May Need to Take

Last year, the European Court of Justice issued a judgment invalidating the safe harbor framework for US-EU data sharing, creating uncertainty and a number of questions about what is, and is not, permissible when sharing data involving personal information across borders. The Safe Harbor decision has clear implications for our pharmaceutical and medical device clients, … Continue Reading

Russia to Increase Data Audits in 2016 With Data Localization Law & More News on The EU’s Safe Harbor Ruling

Russia announced its plan to increase data localization audits in 2016 pledging to conduct around 1,000 data localization compliance audits and 2,000 monitoring procedures, under Russia’s data protection authority, the Roskomnadzor. This stems from Russia’s data localization law which came into effect September 1, 2015, requiring that all companies that collect or process personal data … Continue Reading

U.S.-EU Safe Harbor Framework for Data Sharing

Exactly one month after the Court of Justice of the European Union (CJEU) released its judgment in Maximillian Schrems v Data Protection Commissioner (C-362-14), the European Union released a Communication discussing the implications of their decision on data sharing involving personal information. This topic is no stranger to the blog, as we’ve posted about it … Continue Reading

Synopsis of Safe Harbor Guidance Issued by European Union Data Protection Authorities

Data privacy issues in the European Union seem to be a reoccurring theme here on the blog, following Court of Justice of the European Union’s judgment in Maximillian Schrems v Data Protection Commissioner (C-362-14)  on October 6. We’ve posted about it here and also had a recent Reed Smith Client Alert here. Last week, European … Continue Reading

Upcoming Reed Smith Webinar on Cross-Border E-Discovery & New Ruling Regarding the US-EU Safe Harbor Framework

The Reed Smith Life Sciences Health Industry (LSHI) Group will be hosting an upcoming webinar “Cross-Border E-Discovery & New Ruling Regarding the US-EU Safe Harbor Framework” on November 24, 2015 from 9:00 a.m. PT, 12:00 p.m. ET, 5:00 p.m. GMT until 10:00 a.m. 1:00 p.m. ET, 6:00 p.m. GMT. Reed Smith presenters including London based … Continue Reading

FAQs Regarding the Safe Harbor Ruling

As you know, data privacy issues in the European Union are still fresh in the news, given the recent changes outlined in the Safe Harbor decision; we’ve written about it here, here and here. A recent Reed Smith Client Alert outlines frequently asked questions on what businesses need to know now in lieu of the … Continue Reading

Upcoming Reed Smith Webinar on European Union’s Safe Harbor Ruling

As previously discussed here and here the Court of Justice of the European Union (CJEU) handed down its judgment in Maximillian Schrems v Data Protection Commissioner (Case C-362/14)  that the Safe Harbor Decision no longer provides adequate protection for data transferred between the EU and the U.S. In light of this ruling, Reed Smith will be … Continue Reading

Court Justice of the European Union Rules Safe Harbor Decision Invalid

In a decision with significant potential ramifications for flows of personal data from the European Union to the United States, the Court of Justice of the European Union (CJEU) handed down its judgment in Maximillian Schrems v Data Protection Commissioner (Case C-362/14) that the Safe Harbor Decision no longer provides adequate protection for data transferred between … Continue Reading

Toward Class Actions for Health-Related Claims in France

The French government issued a bill on March 17 for the extension of class actions to health-related claims in France. Starting today, March 31, the text will be discussed at the French National Assembly, particularly to address the issue of compensation for personal injury within the framework of the proposed class action.… Continue Reading

French Sunshine Act’s Scope Expands with Recent French Supreme Administrative Court Decision

Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent decision by the French Supreme Administrative Court (Conseil d’Etat) that expands the scope of the French Sunshine Act. “French Supreme Administrative Court Decision Significantly Broadens the Scope of the French Sunshine Act,” written by Reed Smith attorneys Daniel Kadar and Caroline Gouraud, … Continue Reading

In-House Lawyers in France Remain without Legal Privilege

French Minister for Economic Affairs Emmanuel Macron recently introduced a bill proposing the recognition of legal privilege for in-house lawyers in France, which does not currently exist. However, this recognition was rejected by the Special Commission of the French National Assembly before the bill was passed by the lower chamber - a decision consistent with the Grand Chamber of the European Court of Justice's 2010 ruling in Akzo.… Continue Reading

Public Consultation Examines Potential Confidentiality Issues with New European Clinical Trial Regulations

Since January 21, the European Medicines Agency (EMA) has been holding a public consultation on the new European Clinical Trial Regulations (CTRs), which are intended to streamline the application process for clinical trials and increase the availability of information and results. However, the CTRs have met with some concerns regarding commercial and patient confidentiality. As … Continue Reading

EU Justice Ministers Reach Partial General Approach on Aspects of Data Protection Regulation

Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent meeting at which Justice ministers from across the European Union managed to agree on a partial general approach on several aspects of the draft Data Protection Regulation, which aims to set out a general EU framework for data protection. The ministers have … Continue Reading

EU Article 29 Data Protection Working Party Releases Guidelines Stemming from Google Spain Case

Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent set of guidelines issued by the European Union’s Article 29 Data Protection Working Party outlining how EU Data Protection Authorities (DPAs) intend to implement the judgment of the Court of Justice of the European Union in Google Spain SL and Google Inc. … Continue Reading
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