Category

European Union

18 February 2021

European Medicines Agency Issues Updated Good Clinical Practice Q&A

On February 17, 2021 the European Medicines Agency (EMA) published an updated version of its good clinical practice questions and answers (GCP Q&A).  The updated section relates to access to patient medical records by GCP inspectors from European Economic Area (EEA) Member States.  It … Read More

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21 January 2021

A Digital Europe – Digital Health and other Recent EU Data Initiatives

Taking a step into the digital age, the European Commission announced that the 2020s shall become the EU’s Digital Decade.  The EU’s digitalization, including in the area of health, is one of the Commission’s key priorities and covers a wide range of actions and related initiatives.

Building on prior initiatives, … Read More

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21 December 2020

European Union Implements Changes to Export Control Rules

The EU Dual-Use Regulation regulates exports outside the EU, transfers inside the EU, transit through the EU and the brokering of certain sensitive goods, services, software and technology (referred to as “items”) that are considered “dual-use.” Dual-use items have both military and civil applications. The EU has updated its export … Read More

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18 December 2020

Schrems II Concerns Regarding U.S. National Security Surveillance Do Not Apply to Most Companies Transferring Personal Data to the U.S. Under Standard Contractual Clauses

The thesis articulated in the article linked here is that (1) nearly all companies relying on standard contractual clauses for data transfers to the US under the EU General Data Protection Regulation are not electronic communications service providers for purposes of FISA 702 (i.e., only companies in the business of … Read More

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13 November 2020

European Commission Proposes Revised Standard Contractual Clauses

The European Commission (EC), on 12 November 2020, published a draft decision implementing revised Standard Contractual Clauses (draft SCCs) – (the EC’s Draft). The EC’s Draft was published following the Court of Justice of the European Union’s (CJEU) decision in Data Protection Commissioner v Facebook Ireland Ltd and Maximillian SchremsRead More

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11 November 2020

European Data Protection Board Issues Schrems II Recommendations

Following the Court of Justice of the European Union’s (“CJEU”) decision in Data Protection Commissioner v Facebook Ireland Ltd and Maximillian Schrems on 16 July 2020 (“Schrems II”), the European Data Protection Board, tasked with overseeing compliance with the GDPR (“EDPB”), on 11 November 2020 issued its anticipated … Read More

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22 October 2020

SEC Lifts Moratorium on Registration of UK-Based Managers

Recent communications from the U.S. Securities and Exchange Commission (SEC) indicate that the SEC is again considering registration of advisers located in the UK. The SEC had delayed approving UK and European Union (EU) investment managers’ applications for registration since the adoption of the EU’s General Data Protection Regulation (GDPR), … Read More

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07 October 2020

European Court of Justice Applies Free Movement Rules of E-Commerce Directive to Advertising by Mail-Order Pharmacy

In its judgment from October 1, the European Court of Justice (ECJ) ruled that an EU Member State cannot restrict a mail-order pharmacy, established in another Member State, from using paid referencing on search engines and price-comparison websites to promote its service, unless the Member State clearly establishes that the … Read More

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02 October 2020

European Commission to Issue New Standard Contractual Clauses by End of 2020

In the wake of the recent Court of Justice of the European Union’s decision in Schrems II, the European Parliament’s Committee on Civil Liberties, Justice and Home Affairs met in early September to discuss the long-awaited revision of Standard Contractual Clauses (SCCs). During the meeting, Commissioner for … Read More

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