Tag: GDPR

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.

EDPB adopts final Recommendation 01/2020 on Supplementary Measures for Data Transfers to Third Countries

22. June 2021

On June 21st, 2021 during its 50th plenary session, the European Data Protection Board (EDPB) adopted a final version of its recommendations on the supplementary measures for data transfers.

In its recent judgment C-311/18 (Schrems II) the Court of Justice of the European Union (CJEU) has decided that, while the Standard Contractual Clauses (SCCs) are still a valid data transfer mechanism, controllers or processors, acting as exporters, are responsible for verifying, on a case-by-case basis and where appropriate, in collaboration with the importer in the third country, if the law or practice of the third country impinges on the effectiveness of the appropriate safeguards contained in the Article 46 GDPR transfer tools. In the cases where the effectiveness of appropriate safeguards is reduced due to the legal situation in the third country, exporters may need to implement additional measures that fill the gaps.

To help exporters with the complex task of assessing third countries and identifying appropriate supplementary measures where needed, the EDPB has adopted this recommendation. They highlight steps to follow, potential information sources as well as non-exhaustive examples of supplementary measures that are meant to help exporters make the right decisions for data transfers to third countries.

The recommendations advise exporters to follow the following steps in order to have a good overview of data transfers and potential supplementary measures necessary:

1. Know the data transfers that take place in your organization – being aware of where data flows is essential to identify potentially necessary supplementary measures;

2. Verify the transfer tool that each transfer relies on and its validity as well as application to the transfer;

3. Assess if a law or a practice in the third country impinges on the effectiveness of the transfer tool;

4. Identify and adopt supplementary measures that are necessary to bring the level of protection of the data transferred up to the EU standard;

5. Take formal procedural steps that may be required by the adoption of your supplementary measure, depending on the transfer tool you are relying on;

6. Re-evaluate the level of protection of the data you transfer at appropriate intervals and monitor any potential changes that may affect the transfer.

The EDPB Chair, Andrea Jelinek, stated that “the effects of Schrems II cannot be underestimated”, and that the “EDPB will continue considering the effects of the Schrems II ruling and the comments received from stakeholders in its future guidance”.

The recommendations clearly highlight the importance of exporters to understand and keep an eye on their data transfers to third countries. In Germany, the Supervisory Authorities have already started (in German) to send out questionnaires to controllers regarding their data transfers to third countries and the tools used to safeguard the transfers. Controllers in the EU should be very aware of the subject of data transfers in their companies, and prepare accordingly.

Belgian DPA approves first EU Data Protection Code of Conduct for Cloud Service Providers

21. June 2021

On May 20th, 2021, the Belgian Data Protection Authority (Belgian DPA) announced that it had approved the EU Data Protection Code of Conduct for Cloud Service Providers (EU Cloud CoC). The EU Cloud CoC is the first transnational EU code of conduct since the entry into force of the EU General Data Protection Regulation in May 2018.

The EU Cloud CoC represents a sufficient guarantee pursuant to Article 28 (1) and 28 (5) of the GDPR, as well as Recital 81 of the GDPR, which makes the adherence to the code by cloud service providers a valid way to secure potential data transfers.

In particular, the EU Cloud CoC aims to establish good data protection practices for cloud service providers, giving data subjects more security in terms of the handling of their personal data by cloud service providers. In addition, the Belgian DPA accredited SCOPE Europe as the monitoring body for the code of conduct, which will ensure that code members comply with the requirements set out by the code.

It further offers cloud service providers with practical guidance and a set of specific binding requirements (such as requirements regarding the use of sub-processors, audits, compliance with data subject rights requests, transparency, etc.), as well as objectives to help cloud service providers demonstrate compliance with Article 28 of the GDPR.

In the press release, the Chairman of the Belgian DPA stated that „the approval of the EU Cloud CoC was achieved through narrow collaboration within the European Data Protection Board and is an important step towards a harmonised interpretation and application of the GDPR in a crucial sector for the digital economy“.

New SCCs published by the EU Commission for international data transfers

10. June 2021

On June 4th 2021, the EU Commission adopted new standard contractual clauses (SCC) for international data transfers. The SCCs are model contracts that can constitute a suitable guarantee under Art. 46 of the General Data Protection Regulation (GDPR) for the transfer of personal data to third countries. Third countries are those outside the EU/European Economic Area (EEA), e.g. the USA.

The new clauses were long awaited, as the current standard contractual clauses are more than 10 years old and thus could neither take into account the requirements regarding third country transfers of the GDPR nor the significant Schrems II ruling of July 16th, 2020. Thus, third country transfers had become problematic and had not only recently been targeted by investigations by supervisory authorities, inter alia in Germany.

What is new about the SCCs now presented is above all their structure. The different types of data transfers are no longer spread over two different SCC models, but are found in one document. In this respect, they are divided into four different “modules”. This should allow for a flexible contract design. For this purpose, the appropriate module is to be selected according to the relationship of the parties. The following modules are included in the new SCCs:

Module 1: Transfer of personal data between two controllers.
Module 2: Transfer of personal data from the controller to the processor
Module 3: Transfer of personal data between two processors
Module 4: Transfer of personal data from the processor to the controller

The content of the new provisions also includes an obligation to carry out a data transfer impact assessment, i.e. the obligation to satisfy oneself that the contractual partner from the third country is in a position to fulfil its obligations under the current SCCs. Also newly included are the duty to defend against government requests that contradict the requirements of the standard protection clauses and to inform the competent supervisory authorities about the requests. The data transfer impact assessment must be documented and submitted to the supervisory authorities upon request.

The documents are the final working documents. The official publication of the SCCs in the Official Journal of the European Union took place on June 7th, 2021. From then on and within a period of 18 months until December 27th, 2022, the existing contracts with partners from third countries, in particular Microsoft or Amazon, must be supplemented with the new SCCs.

However, even if the new SCCs are used, a case-by-case assessment of the level of data protection remains unavoidable because the new clauses alone will generally not be sufficient to meet the requirements of the ECJ in the above-mentioned ruling. In such a case-by-case examination, the text of the contract and the actual level of data protection must be examined. The latter should be done by means of a questionnaire to the processor in the third country.

Accordingly, it is not enough to simply sign the new SCC, but the controller must take further action to enable secure data transfer to third countries.

Dutch data protection authority imposes fine of €525,000

Company fails to appoint an EU representative. Dutch data protection authority imposes fine of €525,000.

The Dutch Data Protection Authority (Autoriteit Persoonsgegevens) imposed a fine of €525,000 on Locatefamily.com on May 12, 2021. The company failed to comply with its obligation under Article 27 of the EU General Data Protection Regulation, which required the company to appoint a representative in the EU.

The online platform caught the attention of the authorities because it published the contact details (including telephone numbers and addresses) of individuals. In this regard, the Dutch data protection authority stated that data subjects had often not registered for the online platform. In particular, the data subjects did not know how the company had obtained their data.

After numerous complaints from individuals, the data protection authority determined that the online platform had not complied with requests to delete data. It further came to light that the company had no branches in the EU and had not appointed a representative accordingly. This made it almost impossible for data subjects to assert their rights against the company.

Article 27(2)(a) of the GDPR provides that companies not established in the EU that offer goods or services to persons in the EU or monitor the conduct of persons in the EU must designate a representative in the EU. Although exceptions to this are possible, they are narrowly defined.

An exemption may be considered if the processing of personal data is occasional and does not involve the extensive processing of sensitive personal data or the processing of personal data in connection with criminal convictions and offenses. The processing must also not, taking into account the nature, context, scope and purposes of the processing, result in a risk to the rights and freedoms of natural persons.

As no exceptional case existed in the assessment of the Dutch data protection authority, the company imposed a fine in the amount of €525,000 on Locatefamily.com. To avoid further penalties, the company was to appoint an EU representative by a certain deadline.

Portuguese DPA Orders Suspension of U.S. Data Transfers by National Institute of Statistics

29. April 2021

On April 27, 2021, the Portuguese Data Protection Authority “Comissão Nacional de Proteção de Dados” (CNPD) ordered the National Institute of Statistics (INE) to suspend any international data transfers of personal data to the U.S., as well as other countries without an adequate level of protection, within 12 hours.

The INE collects different kinds of data from Portuguese residents from 2021 Census surveys and transfers it to Cloudfare, Inc. (Cloudfare), a service provider in the U.S. that assists the surveys’ operation. EU Standard Contractual Clauses (SCCs) are in place with the U.S. service provider to legitimize the data transfers.

Due to receiving a lot of complaints, the CNPD started an investigation into the INE’s data transfers to third countries outside of the EU. In the course of the investigation, the CNDP concluded that Cloudfare is directly subject to U.S. surveillance laws, such as FISA 702, for national security purposes. These kinds of U.S. surveillance laws impose a legal obligation on companies like Cloudfare to give unrestricted access to personal data of its customers and users to U.S. public authorities without informing the data subjects.

In its decision to suspend any international data transfers of the INE, the CNPD referred to the Schrems II ruling of the Court of Justice of the European Union. Accordingly, the CNPD is if the opinion that personal data transferred to the U.S. by the INE was not afforded a level of data protection essentially equivalent to that guaranteed under EU law, as further safeguards have to be put in place to guarantee requirements that are essentially equivalent to those required under EU law by the principle of proportionality. Due to the lack of further safeguards, the surveillance by the U.S. authorities are not limited to what is strictly necessary, and therefore the SCCs alone do not offer adequate protection.

The CNPD also highlighted that, according to the Schrems II ruling, data protection authorities are obliged to suspend or prohibit data transfers, even when those transfers are based on the European Commission’s SCCs, if there are no guarantees that these can be complied with in the recipient country. As Cloudfare is also receiving a fair amount of sensitive data n relation to its services for the INE, it influenced the CNDP’s decision to suspend the transfers.

Irish DPC launches investigation into Facebook data leak

26. April 2021

On April 14th, 2021, Ireland’s Data Protection Commission (DPC) announced it launched an investigation into Facebook’s data leak reported earlier this month (please see our blog post here). The inquiry was initiated on the Irish DPC’s own volition according to section 110 of the Irish Data Protection Act. It comes after a dataset of 533 million Facebook users worldwide was made available on the internet.

The Irish DPC indicated in a statement that, “having considered the information provided by Facebook Ireland regarding this matter to date, the DPC is of the opinion that one or more provisions of the GDPR and/or the Data Protection Act 2018 may have been, and/or are being, infringed in relation to Facebook Users’ personal data”. The Irish DPC further stated that they had engaged with Facebook Ireland in relation to this reported issue, raising queries in relation to GDPR compliance, to which Facebook Ireland furnished a number of responses.

The launch of an investigation by the Irish authorities is significant due to the fact that Ireland remains home to Facebook’s European headquarters. This means the Irish DPC would act as the lead regulator within the European Union on all matters related to it. However, Ireland’s data watchdog has faced criticism from privacy advocates for being too slow with its GDPR investigations into large tech companies. In fact, the inquiry comes after the European Commission intervened to apply pressure on Ireland’s data protection commissioner.

Facebook’s statement on the inquiry has been shared through multiple media, and it has announced that Facebook is “cooperating fully with the DPC in its enquiry, which relates to features that make it easier for people to find and connect with friends on our services. These features are common to many apps and we look forward to explaining them and the protections we have put in place.”

EPRS publishes report on post-Brexit EU-UK Data Transfer Mechanisms

20. April 2021

On April 9th, 2021, the European Parliamentary Research Service (EPRS) published a report on data transfers in the private sector between the EU and the U.K. following Brexit.

The report reviews and assesses trade dealings, adequacy challenges and transfer instruments under the General Data Protection Regulation (GDPR). The report is intended to help take regulatory and business decisions, and in the Press Release the European Parliament stated that “a clear understanding of the state of play and future prospects for EU-UK transfers of personal data is indispensable”.

The report provides in-depth analysis of an adequacy decision for the UK as a viable long-term solution for data flows between the U.K. and the EU, also considering possible mechanisms for data transfer in the potential absence of an adequacy decision, such as Standard Contractual Clauses, Binding Corporate Rules, codes of conduct, and certification mechanism.

In this analysis the EPRS also sheds light on adequacy concerns such as U.K. surveillance laws and practices, shortcomings of the implementation of the GDPR, weak enforcement of data protection laws, and wavering commitment to EU data protection standards.

As part of its conclusion, the EPRS stated that the European Data Protection Board’s (‘EDPB’) opinion on the draft decision, which has just been published (please see our blogpost here), will likely scrutinise the Commission’s approach and provide recommendations on next steps.

Data protection authorities around the world are taking action against the facial recognition software Clearview AI

25. February 2021

The business model of the US company Clearview AI is coming under increasing pressure worldwide. The company collected billions of facial photos from publicly available sources, especially from social networks such as Facebook, Instagram, YouTube and similar services. Data subjects were not informed of the collection and use of their facial photos. Using the photos, Clearview AI created a comprehensive database and used it to develop an automated facial recognition system. Customers of this system are in particular law enforcement agencies and other prosecutors in the US, but companies can also make use of the system. In total, Clearview AI has around 2000 customers worldwide and a database with around 3 billion images.

After a comprehensive investigation by the New York Times in January 2020 drew attention to the company, opposition to the business practice is now also being voiced by the data protection authorities of various countries.

The Hamburg Data Protection Commissioner had already issued an order against Clearview AI in January 2021. According to the order, the company was to delete the biometric data of a Hamburg citizen who had complained to the authority about the storage. The reason given for the decision was that there was no legal basis for processing sensitive data and that the company was profiling by collecting photos over a longer period of time.

Now, several Canadian data protection authorities have also deemed Clearview AI’s actions illegal. In a statement, the Canadian Privacy Commissioner describes the activities as mass surveillance and an affront to the privacy rights of data subjects. The Canadian federal authority published a final report on the investigation into the Clearview AI case. In it, the company was found to have violated several Canadian federal reports.

It is interesting that the Canadian authorities even consider the data collection to be unlawful if Clearview AI were to obtain consents from the data subjects. They argue that already the purpose of the data processing is unlawful. They demand that Clearview AI cease its service in Canada and delete data already collected from Canadian citizens.

The pressure on Clearview AI is also growing due to the fact that the companies from which the data was collected are also opposing the procedure. In addition, the association “noyb” around the data protection activist Max Schrems is dealing with Clearview AI and various European data protection authorities have announced that they will take action against the facial recognition system.

Data Protection and Clinical Trials – Part 1

10. February 2021

In the two and a half years since the General Data Protection Regulation (GDPR) has come into effect, a lot of organizations have gotten used to the new laws and standards it has established. However, there are still a lot of unanswered questions in certain industries, one of those industries being life sciences, and more specifically clinical trials.

The GDPR and the guidance of the European Data Protection Board (EDPB) allow for a lot of speculation, due to the fact that they are unable to fully specify the reach and definitive approach to data protection in a lot of industries.

This short series aims to give an overview on the handling of clinical trials from a data protection point of view, as well as answers to important questions that come up in day to day business in the industry.

In general, clinical trials are a processing activity according to Art. 4 (2) GDPR, therefore the basic data protection obligations are to be applied to clinical trials, such as:

  • Following the basic GDPR principles laid out in Art. 5 GDPR, namely lawfulness, fairness and transparency, purpose limitation, data minimisation, data accuracy, storage limitation, integrity, confidentiality and accountability
  • Information obligations of the controller according to Art. 13, 14 GDPR
  • Data Subjects Rights according to Art. 15 to Art. 21 GDPR
  • Obligation to have a record of processing activities according to Art. 30 para. 1, 2 GDPR
  • Security Measures need to be in place, in compliance with Art. 32 GDPR
  • Data Breach Notifications to the supervisory authority as well as the data subjects according to Art. 33, 34 GDPR
  • A Data Protection Impact Assessment has to be done prior to the start of the clinical trials, according to Art. 35 GDPR

However, the first and foremost important question regarding the processing of personal data for clinical trials is:

Which legal basis is applicable to the processing?

The EDPB addressed this issue in their Opinion on the Interplay between Clinical Trials and the GDPR, and has, in a first instance, differentiated between the processing of personal data for clinical trial protocols as primary purpose of the processing, and, on the other hand, clinical trials as a secondary purpose next to, for example, patient care.

According to the EDPB’s opinion, the applicable legal basis is to be determined by the controller on a case by case basis. However, the EDPB does give their own general assessment on the legal basis applicable for the different scenarios that have crystalized in the eyes of the EDPB:

  • Primary use of the processed personal data for clinical trials
    a. Processing activities related to reliability and safety
    -> Legal obligations of the controller, Art. 6 para. 1 (c) GDPR in conjunction with Art. 9 para. 1 (i) GDPR
    b. Processing activities purely related to research activities
    -> Task carried out in the public interest, Art. 6 para. 1 (e) GDPR in conjunction with Art. 9 para. 2 (i) or (j) GDPR
    -> Legitimate interest of the controller, Art. 6 para. 1 (f) GDPR in conjunction with Art. 9 para. 2 (j) GDPR
    -> In specific circumstances, explicit consent of the data subject, Art. 6 para. 1 (a) GDPR and Art. 9 para. 2 (a) GDPR
  • Secondary use of the clinical trial data outside the clinical trial protocol for scientific purposes
    -> Explicit consent of the data subject, Art. 6 para. 1 (a) GDPR and Art. 9 para. 2 (a) GDPR

While the guidance in assessing the legal basis for the processing is helpful, the EDPB does not address any further open issues regarding clinical trials in their opinion. Nonetheless, there are further subjects that cause confusion.

However, some of these subjects will be treated in our next part of this series, where we will have a closer look at clinical trial sponsorship from outside the EEA as well as the questions revolving around controllership roles in clinical trials.

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