European Union

On 11 November 2020, the European Data Protection Board (“EDPB”) issued two draft recommendations relating to the rules on how organizations may lawfully transfer personal data from the EU to countries outside the EU (“third countries”).  These draft recommendations, which are non-final and open for public consultation until 30 November 2020, follow the EU Court of Justice (“CJEU”) decision in Case C-311/18 (“Schrems II”).  (For a more in-depth summary of the CJEU decision, please see our blog post here and our audiocast here. The EDPB also published on 24 July 2020 FAQs on the Schrems II decision here).

The two recommendations adopted by the EDPB are:

Continue Reading EDPB adopts recommendations on international data transfers following Schrems II decision

Over the past 9 months, the UK has been hammering out the shape of its future trading relationship with the EU, as well as many others, and there apparently are signs of progress in the past few days as a result of intensified talks between the two sides. Some are
Continue Reading Inside Privacy Audiocast: Episode 7 – Brexit and the Future of UK Data Privacy Law

In this edition of our regular roundup on legislative initiatives related to artificial intelligence (AI), cybersecurity, the Internet of Things (IoT), and connected and autonomous vehicles (CAVs), we focus on key developments in the European Union (EU).
Continue Reading AI, IoT, and CAV Legislative Update: EU Spotlight (Third Quarter 2020)

On July 17, 2020, the High-Level Expert Group on Artificial Intelligence set up by the European Commission (“AI HLEG”) published The Assessment List for Trustworthy Artificial Intelligence (“Assessment List”). The purpose of the Assessment List is to help companies identify the risks of AI systems they develop, deploy or procure, and implement appropriate measures to mitigate those risks.

The Assessment List is not mandatory, and there isn’t yet a self-certification scheme or other formal framework built around it that would enable companies to signal their adherence to it.  The AI HLEG notes that the Assessment List should be used flexibly; organizations can add or ignore elements as they see fit, taking into consideration the sector in which they operate. As we’ve discussed in our previous blog post here, the European Commission is currently developing policies and legislative proposals relating to trustworthy AI, and it is possible that the Assessment List may influence the Commission’s thinking on how organizations should operationalize requirements relating to this topic.
Continue Reading AI Update: EU High-Level Working Group Publishes Self Assessment for Trustworthy AI

On April 21, 2020, the Regulation on the Requirements and Reimbursement Process for Digital Health Applications (Digitale Gesundheitsanwendungen-Verordnung or „DiGAV“, available here) entered into force in Germany.  Among other provisions, the DiGAV includes specific IT security and privacy requirements.  Shortly after the law took effect, Germany’s Federal Medicines and Medical Devices Agency (“BfArM”) also released an extensive explanatory Guidance (Leitfaden, available here) to the DiGAV.

Independently, on April 15, 2020, the German Federal Office for IT Security (“BSI”) published a draft version of its guidance on “Security Requirements for Digital Health Applications” (BSI TR-03161) (available here).  The BSI is now seeking feedback from industry on this draft guidance before releasing a final version.

While the scope of application of the DiGAV and the BSI draft guidance may be limited, the documents can serve to provide useful insights and benchmarks for health applications generally.Continue Reading German Federal Agencies Publish Privacy and IT Security Requirements for Digital Health Applications

On July 24, 2019, the European Parliament published a study entitled “Blockchain and the General Data Protection Regulation: Can distributed ledgers be squared with European data protection law?”  The study explores the tension between blockchain technology and compliance with the General Data Protection Regulation (the “GDPR”), the EU’s data protection law.  The study also explores how blockchain technology can be used as a tool to assist with GDPR compliance.  Finally, it recommends the adoption of certain policies to address the tension between blockchain and the GDPR, to ensure that “innovation is not stifled and remains responsible”.  This blog post highlights some of the key findings in the study and provides a summary of the recommended policy options.
Continue Reading European Parliament Publishes Study on Blockchain and the GDPR

On June 28, 2019, the French Supervisory Authority (CNIL) announced that it will issue new guidelines on the use of cookies for direct marketing purposes.  It will issue these guidelines in two phases.

First, during July 2019, the CNIL will update its guidance issued in 2013 on cookies.  According to
Continue Reading French Supervisory Authority will issue new guidelines on cookies

On November 9, 2018, the French Supervisory Authority for Data Protection (known as the “CNIL”) announced that it issued a formal warning (available here) ordering the company Vectaury to change its consent experience for customers and purge all data collected on the basis of invalid consent previously obtained.

 
Continue Reading CNIL imposes GDPR-consent in online advertising space

On November 6, 2018, the French data protection authority (the “CNIL”) published a report that discusses some of the questions raised by the use of blockchain technology and perceived tensions between it and foundational principles found in the General Data Protection Regulation (the “GDPR”).  As we noted in an earlier blog post on this topic, some pundits have claimed that certain features of blockchain technology, such as its reliance upon a de-centralised network and an immutable ledger, pose GDPR compliance challenges.  The CNIL has attempted to address some of these concerns, at least in a tentative manner, and further guidance from EU privacy regulators can be expected in due course.

De-centralised network

The CNIL acknowledges that EU data protection principles have been designed “in a world in which data management is centralised,” and where there is a clear controller of the data (“data controller”) and defined third parties who merely process the data (“data processors”).  Applying these concepts to a de-centralised network such as blockchain, where there are a multitude of actors, leads to a “more complex definition of their role.”  In brief, EU data privacy rules are the square peg to blockchain’s round hole.

Notwithstanding this, the CNIL considers that participants on a blockchain network, who have the ability to write on the chain and send data to be validated on the network, must be considered data controllers.  This is the case, for instance, where the participant is registering personal data on the blockchain and it is related to a professional or commercial activity.  By contrast, according to the CNIL, the miners, who validate the transactions on the blockchain network, can in certain cases be acting as data processors.  As a consequence, data processing agreements would need to be in place between the data controllers and the data processors on any blockchain network.

The CNIL further considers that where there are multiple participants who decide to carry out processing activities via a blockchain network, they will most likely be considered “joint controllers,” unless they identify and designate their roles and responsibilities in advance.   Individuals who use the blockchain for personal use (i.e., individuals who access the network to buy and sell a virtual currency), however, would not be data controllers as they can rely on the “purely personal or household activity” exception.  
Continue Reading The CNIL Publishes Report On Blockchain and the GDPR

On October 23, 2018, the European Federation of Pharmaceutical Industries in cooperation with the Future of Privacy Forum and the Center for Information Policy Leadership will organize a workshop entitled, “Can GDPR Work for Health Research.”  In the first session, the workshop will discuss the implications of the General Data
Continue Reading The Implications of the GDPR on Clinical Trials in Europe