Tag: European Commission

The Commission’s Proposal for the European Health Data Space raises data protection concerns

21. July 2022

On May 3, 2022, the European Commission (EC) published its proposal for the creation of the European Health Data Space (EHDS). This proposal, if adopted, would foresee the creation of an EU-wide infrastructure that allows to link health data sets for practitioners, researchers, and industry. In its communication, the EC points at the necessity for promoting “the free, cross-border flows of personal data” with the aim of creating an “internal market for personal health data and digital health products and services”.

Doctors in Germany, by way of an example, would then be able to access the medical file of a Spanish patient that is currently undergoing medical treatment in Germany. In this context, it might be worthy to note that not all Member States are maintaining electronic records of patients having the consequence that this proposal would require certain member states to take steps towards digitalization. With regard to researchers and industry, the underlying incentive of this proposal is to enable them to draw from health data available to create new solutions and to push forward innovation.

Nevertheless, health data are sensitive data within the meaning of the GDPR, which means that access to such data is only exceptionally possible. This begs the question whether and how access to personal health data that this proposal is intending to enable, can be reconciled with the GDPR. Recently, the European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) issued a joint opinion on this new legislative initiative expressing several concerns in relation to the proposal from a data protection perspective.

If one takes the example of health data processed while accessing healthcare, then the legal ground of art. 9 (2) (h) GDPR, namely that of medical diagnosis or provision of health, would be applicable. Further processing for any other purpose, however, would then require the data subject’s consent.

In the words of EDPB Chair Andrea Jelinek: “The EU Health Data Space will involve the processing of large quantities of data which are of a highly sensitive nature. Therefore, it is of the utmost importance that the rights of the European Economic Area’s (EEA) individuals are by no means undermined by this Proposal. The description of the rights in the Proposal is not consistent with the GDPR and there is a substantial risk of legal uncertainty for individuals who may not be able to distinguish between the two types of rights. We strongly urge the Commission to clarify the interplay of the different rights between the Proposal and the GDPR.”

Diving into the details of the joint opinion, the EDPB and EDPS strongly recommends making secondary use of personal data steaming from wellness applications, such as wellness and behavioral data, be subject to the prior consent of the data subject, in case these data, contrary to EDPB and EDPS’ recommendation, are not excluded from the scope of this proposal altogether.

That would not only be in line with the GDPR, but would also make possible to differentiate between health data generated by wellness applications, on the one hand, and health data generated by medical devices, on the other hand.

The fundamental difference between both data lies in the different degrees of quality and the fact that wellness applications do also process, for instance, food practices which therefore allows to draw conclusions from data subjects’ daily activities, habits, and practices.

EU: Commission publishes Q&A on SCCs

30. May 2022

On 25 May 2022, the European Commission published guidance outlining questions and answers (‘Q&A’) on the two sets of Standard Contractual Clauses (‘SCCs’), on controllers and processors (‘the Controller-Processor SCCs’) and third-country data transfers (‘the Data Transfer SCCs’) respectively, as adopted by the European Commission on 4 June 2021. The Q&A are intended to provide practical guidance on the use of the SCCs. They are based on feedback from various stakeholders on their experiences using the new SCCs in the months following their adoption. 

Specifically, 44 questions are addressed, including those related to contracting, amendments, the relationship to other contract clauses, and the operation of the so-called docking clause.  In addition, the Q&A contains a specific section dedicated to each set of SCCs. Notably, in the section on the Data Transfer SCCs, the Commission addresses the scope of data transfers for which the Data Transfer SCCs may be used, highlighting that they may not be used for data transfers to controllers or processors whose processing operations are directly subject to the General Data Protection Regulation (Regulation (EU) 2016/679) (‘GDPR’) by virtue of Article 3 of the GDPR. Further to this point, the Q&A highlights that the Commission is in the process of developing an additional set of SCCs for this scenario, which will consider the requirements that already apply directly to those controllers and processors under the GDPR. 

In addition, the Q&A includes a section with questions on the obligations of data importers and exporters, specifically addressing the SCC liability scheme. Specifically, the Q&A states that other provisions in the broader (commercial) contract (e.g., specific rules for allocation of liability, caps on liability between the parties) may not contradict or undermine liability schemes of the SCCs. 

Additionally, with respect to the Court of Justice of the European Union’s judgment in Data Protection Commissioner v. Facebook Ireland Limited, Maximillian Schrems (C-311/18) (‘the Schrems II Case’), the Q&A includes a set of questions on local laws and government access aimed at clarifying contracting parties’ obligations under Clause 14 of the Data Transfer SCCs. 

In this regard, the Q&A highlights that Clause 14 of the Data Transfer SCCs should not be read in isolation but used together with the European Data Protection Board’s Recommendations 01/2020 on measures that supplement transfer tools. 

European Commission and United States agree in principle on Trans-Atlantic Data Privacy Framework

29. March 2022

On March 25th, 2022, the United States and the European Commission have committed to a new Trans-Atlantic Data Privacy Framework that aims at taking the place of the previous Privacy Shield framework.

The White House stated that the Trans-Atlantic Data Privacy Framework “will foster trans-Atlantic data flows and address the concerns raised by the Court of Justice of the European Union when it struck down in 2020 the Commission’s adequacy decision underlying the EU-US Privacy Shield framework”.

According to the joint statement of the US and the European Commission, “under the Trans-Atlantic Data Privacy Framework, the United States is to put in place new safeguards to ensure that signals surveillance activities are necessary and proportionate in the pursuit of defined national security objectives, establish a two-level independent redress mechanism with binding authority to direct remedial measures, and enhance rigorous and layered oversight of signals intelligence activities to ensure compliance with limitations on surveillance activities”.

This new Trans-Atlantic Data Privacy Framework has been a strenuous work in the making and reflects more than a year of detailed negotiations between the US and EU led by Secretary of Commerce Gina Raimondo and Commissioner for Justice Didier Reynders.

It is hoped that this new framework will provide a durable basis for the data flows between the EU and the US, and underscores the shared commitment to privacy, data protection, the rule of law, and the collective security.

Like the Privacy Shield before, this new framework will represent a self-certification with the US Department of Commerce. Therefore, it will be crucial for data exporters in the EU to ensure that their data importers are certified under the new framework.

The establishment of a new “Data Protection Review Court” will be the responsible department in cases of the new two-tier redress system that will allow EU citizens to raise complaints in cases of access of their data by US intelligence authorities, aiming at investigating and resolving the complaints.

The US’ commitments will be concluded by an Executive Order, which will form the basis of the adequacy decision by the European Commission to put the new framework in place. While this represents a quicker solution to reach the goal, it also means that Executive Orders can be easily repealed by the next government of the US. Therefore, it remains to be seen if this new framework, so far only agreed upon in principle, will bring the much hoped closure on the topic of trans-Atlantic data flows that is intended to bring.

European Commission adopts South Korea Adequacy Decision

30. December 2021

On December 17th, 2021, the European Commission (Commission) announced in a statement it had adopted an adequacy decision for the transfer of personal data from the European Union (EU) to the Republic of Korea (South Korea) under the General Data Protection Regulation (GDPR).

An adequacy decision is one of the instruments available under the GDPR to transfer personal data from the EU to third countries that ensure a comparable level of protection for personal data as the EU. It is a Commission decision under which personal data can flow freely and securely from the EU to the third country in question without any further conditions or authorizations being required. In other words, the transfer of data to the third country in question can be handled in the same way as the transfer of data within the EU.

This adequacy decision allows for the free flow of personal data between the EU and South Korea without the need for any further authorization or transfer instrument, and it also applies to the transfer of personal data between public sector bodies. It complements the Free Trade Agreement (FTA) between the EU and South Korea, which entered into force in July 2011. The trade agreement has led to a significant increase in bilateral trade in goods and services and, inevitably, in the exchange of personal data.

Unlike the adequacy decision regarding the United Kingdom, this adequacy decision is not time-limited.

The Commission’s statement reads:

The adequacy decision will complement the EU – Republic of Korea Free Trade Agreement with respect to personal data flows. As such, it shows that, in the digital era, promoting high privacy and personal data protection standards and facilitating international trade can go hand in hand.

In South Korea, the processing of personal data is governed by the Personal Information Portection Act (PIPA), which provides similar principles, safeguards, individual rights and obligations as the ones under EU law.

An important step in the adequacy talks was the reform of PIPA, which took effect in August 2020 and strengthened the investigative and enforcement powers of the Personal Information Protection Commission (PIPC), the independent data protection authority of South Korea. As part of the adequacy talks, both sides also agreed on several additional safeguards that will improve the protection of personal data processed in South Korea, such as transparency and onward transfers.

These safeguards provide stronger protections, for example, South Korean data importers will be required to inform Europeans about the processing of their data, and onward transfers to third countries must ensure that the data continue to enjoy the same level of protection. These regulations are binding and can be enforced by the PIPC and South Korean courts.

The Commission has also published a Q&A on the adequacy decision.

European Commission pursues legal action against Belgium over independence of Data Protection Autority

16. November 2021

In its October Infringements Package, the European Commission has stated it is pursuing legal actions against Belgium over concerns its Data Protection Authority (DPA) is not operating independently, as it should under the General Data Protection Regulation (GDPR).

The Commission stated that it “considers that Belgium violates Article 52 of the GDPR, which states that the data protection supervisory authority shall perform its tasks and exercise its powers independently. The independence of data protection authorities requires that their members are free from any external influence or incompatible occupation.”

According to the European Commission, however, some members of the Belgian DPA cannot be regarded as free from external influence, as they either report to a management committee depending on the Belgian government, they have taken part in governmental projects on COVID-19 contact tracing, or they are members of the Information Security Committee.

On June 9th, 2021, the Commission sent a letter of formal notice to Belgium, giving the member state two months to take corrective measures. Belgium’s response to the Commission’s letter did not address the issues raised and the members concerned have so far remained in their posts. The European Commission is now giving Belgium two months to take relevant action. If this fails, the Commission may decide to refer the case to the Court of Justice of the European Union.

European Commission Adopts UK Adequacy Decisions

5. July 2021

On June 28, 2021, the European Commission adopted two adequacy decisions for the United Kingdom, one under the General Data Protection Regulation (GDPR) and another under the Law Enforcement Directive.

This means that organizations in the EU can continue to transfer personal data to organizations in the UK without restriction and fear of repercussions. Thus, there is no need to rely upon data transfer mechanisms, such as the EU Standard Contractual Clauses, to ensure an adequate level of protection while transferring personal data, which represents a relief as the bridging mechanism of the interim period decided on after Brexit set out to expire by the end of June 2021.

The European Commission found the U.K.’s data protection system has continued to incorporate to the same rules that were applicable when it was an EU member state, as it had “fully incorporated” the principles, rights and obligations of the GDPR and Law Enforcement Directive into its post-Brexit legal system.

The Commission also noted the U.K. system provides strong safeguards in regards to how it handles personal data access by public authorities, particularly for issues of national security.

In regards to criticism of potential changes in the UK’s legal system concerning personal data, Věra Jourová, Vice-President for Values and Transparency stated that: „We have listened very carefully to the concerns expressed by the Parliament, the Members States and the European Data Protection Board, in particular on the possibility of future divergence from our standards in the UK’s privacy framework. We are talking here about a fundamental right of EU citizens that we have a duty to protect. This is why we have significant safeguards and if anything changes on the UK side, we will intervene.“

The Commission highlighted that the collection of data by UK intelligence authorities is legally subject to prior authorization by an independent judicial body and that any access to data needs to be necessary and proportionate to the purpose pursued. Individuals also have the ability to seek redress in the UK Investigatory Powers Tribunal.

European Commission publishes draft UK adequacy decisions

25. February 2021

On February 19th, 2021, the European Commission (EC) has published the draft of two adequacy decisions for the transfer of personal data to the United Kingdom (UK), one under the General Data Protection Regulation (GDPR) and the second for the Law Enforcement Directive. If approved, the decisions would confer adequacy status on the UK and ensure that personal data from the EU can continue to flow freely to the UK. In the EC’s announcement launching the process to adopt the newly drafted adequacy decisions Didier Reynders, Commissioner for Justice, is quoted:

We have thoroughly checked the privacy system that applies in the UK after it has left the EU. Now European Data Protection Authorities will thoroughly examine the draft texts. EU citizens’ fundamental right to data protection must never be compromised when personal data travel across the Channel. The adequacy decisions, once adopted, would ensure just that.

In the GDPR, this adequacy decision is based on Art. 45 GDPR. Article 45(3) GDPR empowers the EU Commission to adopt an implementing act to determine that a non-EU country ensures an “adequate level of protection”. This means a level of protection for personal data that is substantially equivalent to the level of protection within the EU. Once it has been determined that a non-EU country provides an “adequate level of protection”, transfers of personal data from the EU to that non-EU country can take place without further requirements. In the UK, the processing of personal data is governed by the “UK GDPR” and the Data Protection Act 2018, which are based on the EU GDPR. The UK is and has committed to remain part of the European Convention on Human Rights and “Convention 108” of the Council of Europe. “Convention 108” is a binding treaty under international law to protect individuals from abuses in the electronic processing of personal data, and in particular provides for restrictions on cross-border data flows where data is to be transferred to states where no comparable protection exists.

The GDPR adequacy decision draft addresses several areas of concern. One of these is the power of intelligence services in the UK. In this respect, the draft focuses on legal bases, restrictions and safeguards for the collection of information for national security purposes. It also details the oversight structure over the intelligence services and the remedies available to those affected. Another aspect discussed is the limitation of data subjects’ rights in the context of UK immigration law. The EC concludes that interference with individuals’ fundamental rights is limited to what is strictly necessary to achieve a legitimate purpose and that there is effective legal protection against such interference. As the UK GDPR is based on the GDPR and therefore the UK privacy laws should provide an adequate level of protection for data subjects, the main risks for EU data subjects do not lie in the current status of these laws but in possible changes of these laws in the future. For this reason, the EU Commission has built a fixed period of validity into the draft adequacy decision. If adopted, this decision would be valid for a period of four years and the adequacy finding could be extended for a further four years if the level of protection in the UK remains adequate. However, this extension would not be automatic, but subject to a thorough review. This draft marks the first time that the EU has imposed a time limit on an adequacy decision. Other adequacy decisions are subject to monitoring and regular review but are not time-limited by default.

The UK government welcomed the EC’s draft in a statement, while also calling on the EU to “swiftly complete” the process for adopting and formalizing the adequacy decisions, as the “bridging mechanism” will only remain in force until June 30th. Under the EU-UK Trade and Cooperation Agreement, the EU and UK agreed on a transition period of up to six months from January 1st, 2021, during which the UK is treated as an adequate jurisdiction (please see our blog post). The draft adequacy decisions address the flow of data from the EU to the UK. The flow of data from the UK to the EU is governed by UK legislation that has applied since 1 January 2021. The UK has decided that the EU ensures an adequate level of protection and that data can therefore flow freely from the UK to the EU.

Next, the non-binding opinion of the European Data Protection Board is sought (Art. 70 GDPR). After hearing the opinion of the European Data Protection Board, the representatives of the member states must then confirm the draft in the so-called comitology procedure. This procedure is used when the EC is given the power to implement legal acts that lay down conditions for the uniform application of a law. A series of procedures ensure that EU countries have a say in the implementing act. After the comitology procedure, the EC is free to adopt the drafts.

EU offers new alliance with the USA on data protection

4. December 2020

The European Commission and the High Representative of the Union for Foreign Affairs and Security Policy outlined a new EU-US agenda for global change, which was published on December 2nd, 2020. It constitutes a proposal for a new, forward-looking transatlantic cooperation covering a variety of matters, including data protection.

The draft plan states the following guiding principles:

  • Advance of global common goods, providing a solid base for stronger multilateral action and institutions that will support all like-minded partners to join.
  • Pursuing common interests and leverage collective strength to deliver results on strategic priorities.
  • Looking for solutions that respect common values of fairness, openness and competition – including where there are bilateral differences.

As said in the draft plan, it is a “once-in-a-generation” opportunity to forge a new global alliance. It includes an appeal for the EU and US to bury the hatchet on persistent sources of transatlantic tension and join forces to shape the digital regulatory environment. The proposal aims to create a shared approach to enforcing data protection law and combatting cybersecurity threats, which could also include possible restrictive measures against attributed attackers from third countries. Moreover, a transatlantic agreement concerning Artificial Intelligence forms a part of the recommendation. The purpose is setting a blueprint for regional and global standards. The EU also wants to openly discuss diverging views on data governance and facilitate free data flow with trust on the basis of high safeguards. Furthermore, the creation of a specific dialogue with the US on the responsibility of online platforms and Big Tech is included in the proposal as well as the development of a common approach to protecting critical technologies.

The draft plan is expected to be submitted for endorsement by the European Council at a meeting on December 10-11th, 2020. It suggests an EU-US Summit in the first half of 2021 as the moment to launch the new transatlantic agenda.

European Commission issues draft on Standard Contractual Clauses

18. November 2020

A day after the European Data Protection Board (EDPB) issued its recommendations on supplementary measures, on November 12th the European Commission issued a draft on implementing new Standard Contractual Clauses (SCCs) for data transfers to non-EU countries (third countries). The draft is open for feedback until December 10th, 2020, and includes a 12-month transition period during which companies are to implement the new SCCs. These SCCs are supposed to assist controllers and processors in transferring personal data from an EU-country to a third-country, implementing measures that guarantee GDPR-standards and regarding the Court of Justice of the European Union’s (CJEU) “Schrems II” ruling.

The Annex includes modular clauses suitable for four different scenarios of data transfer. These scenarios are: (1) Controller-to-controller-transfer; (2) Controller-to-processor-transfer; (3) Processor-processor-transfer; (4) Processor-to-controller-transfer. Newly implemented in these SCCs are the latter two scenarios. Since the clauses in the Annex are modular, they can be mixed and matched into a contract fitting the situation at hand. Furthermore, more than two parties can adhere to the SCC and the modular approach even allows for additional parties to accede later on.

The potential of government access to personal data is distinctly addressed, since this was a main issue following the “Schrems II” ruling. Potential concerns are met by implementing clauses that address how the data importer must react when laws of the third country impinge on his ability to comply with the contract, especially the SCCs, and how he must react in case of government interference.  Said measures include notifying the data exporter and the data subject of any government interference, such as legally binding requests of access to personal data, and, if possible, sharing further information on these requests on a regular basis, documenting them and challenging them legally. Termination clauses have been added, in case the data importer cannot comply further, e.g. because of changes in the third country’s law.

Further clauses regard matters such as data security, transparency, accuracy and onwards transfer of personal data, which represent issues that have all been tackled in the older SCCs, but are to be updated now.

Advocate General’s opinion on “Schrems II” is delayed

11. December 2019

The Court of Justice of the European Union (CJEU) Advocate General’s opinion in the case C-311/18 (‘Facebook Ireland and Schrems’) will be released on December 19, 2019. Originally, the CJEU announced that the opinion of the Advocate General in this case, Henrik Saugmandsgaard Øe, would be released on December 12, 2019. The CJEU did not provide a reason for this delay.

The prominent case deals with the complaint to the Irish Data Protection Commission (DPC) by privacy activist and lawyer Maximilian Schrems and the transfer of his personal data from Facebook Ireland Ltd. to Facebook Inc. in the U.S. under the European Commission’s controller-to-processor Standard Contractual Clauses (SCCs).

Perhaps, the most consequential question that the High Court of Ireland set before the CJEU is whether the transfers of personal data from the EU to the U.S. under the SCCs violate the rights of the individuals under Articles 7 and/or 8 of the Charter of Fundamental Rights of the European Union (Question No. 4). The decision of the CJEU in “Schrems II” will also have ramifications on the parallel case T-738/16 (‘La Quadrature du net and others’). The latter case poses the question whether the EU-U.S. Privacy Shield for data transfers from the EU to the U.S. protects the rights of EU individuals sufficiently. If it does not, the European Commission would face a “Safe Harbor”-déjà vu after approving of the new Privacy Shield in its adequacy decision from 2016.

The CJEU is not bound to the opinion of the Advocate General (AG), but in some cases, the AG’s opinion may be a weighty indicator of the CJEU’s final ruling. The final decision by the Court is expected in early 2020.

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