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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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News

New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and...

News

The EC publishes an inception impact assessment for the proposal of a European Health Data Space

The European Commission has published an inception impact assessment for a potential legislative proposal establishing a European Health Data Space. In its document, the European Commission ...

News

CJEU Advocate General reinforces the GDPR’s One Stop Shop

On 13 January 2021, the Advocate General (AG) of the Court of Justice of the European Union (CJEU) issued an important opinion in the case of Facebook Belgium v...

News

CMS finalizes “reasonable and necessary” definition, expedited breakthrough device coverage process

On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a ...

News

Five highlights from FDA’s new AI device regulation Action Plan

On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part...

News

EO prohibits U.S. persons from engaging in certain transactions involving eight Chinese apps

On 5 January 2021, President Donald Trump issued Executive Order (EO) 13971 on "Addressing the Threat Posed By Applications and Other Software Developed or Controlled By Chinese...

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New SFC requirements on electronic data storage

In response to the growing popularity in the use of external data storage for record-keeping, on 31 October 2019, the Hong Kong Securities and Futures Commission (SFC) issued a circular to...

News

The effect of the Brexit Deal on data protection

After months of arduous negotiations, the EU-UK Trade and Cooperation Agreement (the Brexit Deal) of 24 December 2020 is good news and provides a welcome degree of certainty to businesses....

News

2020 data protection greatest hits in Spain

This is the time of the year in which we look back to what has happened during the last 12 months and try to get ready for what is to come. This can be done in many ways, although one of...

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