Tag Archives: GDPR

The European Data Protection Board’s Revised Guidelines on the Territorial Scope of GDPR Are Out (With Some Interesting Examples). Check Them Out!

One of many innovations introduced by GDPR is its territorial scope.

In fact, the two main criteria defining the territorial scope of the GDPR – the establishment criterion (Art. 3.1 of GDPR) and the targeting criterion (Art. 3.2 of GDPR) – have been drafted in such a way to avoid easy way outs when it comes to the protection of individuals and their personal data.

Last November, the European Data Protection Board (“EDPB”) published a revised version of its Guidelines 3/2018 on the territorial scope of the GDPR, which provide some interesting remarks and examples on both the establishment and the targeting criteria. We will concentrate on a selection of a few of them.

THE ESTABLISHMENT CRITERION

EDPB suggests a threefold approach in determining whether or not certain processing of personal data falls within the scope of the GDPR on the basis of the establishment criterion.

1) Is there an establishment in the EU?

This is, of course, an answer that must be given having regard to the effective and real exercise of activities through stable arrangements, rather than to other formal circumstances, such as the legal form of a certain entity.

It is worth noting that, on the issue, the EDPB made sure to remind – by making reference to the Weltimmo case – that the threshold to be applied in determining whether or not an arrangement can be deemed as stable can be quite low, for example, when it comes to the provision of online services. Even a single employee may be sufficient to constituting a stable arrangement, if that employee acts with a sufficient degree of stability.

2) Is processing carried out in the context of the activities of the establishment?

The EDPB points out two factors that must be taken into consideration: (i) the relationship between a controller or processor outside the EU and its local establishment in the Union; and (ii) revenue raising in the EU.

3) There is no need that the processing takes place in the EU!

The place of processing is irrelevant, if processing takes place in the context of the activities of the establishment. So is the geographical location of the data subjects in question.

In addition to the threefold approach, the EDPB offers some hints on how the application of the establishment criterion me be affected by the relationship between the controller and the processor. To such regard, the first thing to note is that the relationship between a controller and a processor does not per se trigger the application of GDPR to both. Furthermore, it is more likely that the establishment within the EU of the controller will lead to the application of GDPR to the processor located abroad than vice versa. In fact, on one hand, when a controller subject to GDPR chooses a processor located outside the EU, the processor located outside the EU will become indirectly subject to the obligations imposed by GDPR by virtue of contractual arrangements under Art. 28 of GDPR. On the other hand, unless other factors are at play, the processor’s EU establishment will not per se trigger the application of GDPR to the non-EU controller, because by instructing the EU processor the non-EU controller is not carrying out any processing in the context of the activities of the processor in the EU.

THE TARGETING CRITERION

The first thing to which EDPB draws our attention to is a simple, yet important, fact. Whenever the targeting criterion leads to the application of GDPR to controllers or processors which are not EU-established, such controllers or processor will not benefit from the one-stop shop mechanism, allowing them to interact with only one Lead Supervisory Authority. That is an important factor to be taken into consideration when assessing the opportunity to establish an entity within the EU to offer services or monitor data subjects.

Having said that, the EDPB recommends a twofold approach for the targeting criterion.

1) Are data subjects “in the Union”?

Under the targeting criterion, GDPR will be applied to controllers or processors not established in the EU insofar as processing is related to the offering of goods and services to / monitoring of data subjects in the EU.

With regard to the presence of the data subject in the EU, no reference is made to any formal legal status of the data subject (e.g. residence or citizenship): it is sufficient that data subject are physically located in the EU at the moment of offering  goods or services or at the moment when their behaviors are being monitored.

Nevertheless, that will not be sufficient to extend the application of GDPR to such activities that are only inadvertently or incidentally targeting individuals in the EU. Hence, whenever processing relates to a service offered only outside the EU – which is not withdrawn by individuals entering the EU – the relevant processing will not be subject to GDPR.

2) Offering of goods or service / monitoring of data subjects’ behavior, yes or no?

The first activity triggering the application of the targeting criterion is the offering of goods or services. It is interesting to note, to such regard, how the EDPB recalls the CJEU case law on Council Regulation 44/2001 on jurisdiction. Although underlining some differences, the notion of “directing an activity” can be applied to assess the presence of a goods or services offer by non-EU controllers/processor.

The factors that the EDPB lists, considering them a good indication, especially in combination with one another, of an offer in the UE of goods and services, are taken from the Pammer case and they include:

  • The EU or at least one Member State is designated by name with reference to the good or service offered;
  • The data controller or processor pays a search engine operator for an internet referencing service in order to facilitate access to its site by consumers in the Union; or the controller or processor has launched marketing and advertisement campaigns directed at an EU country audience;
  • The international nature of the activity at issue, such as certain tourist activities;
  • The mention of dedicated addresses or phone numbers to be reached from an EU country;
  • The use of a top-level domain name other than that of the third country in which the controller or processor is established, for example “.de”, or the use of neutral top-level domain names such as “.eu”;
  • The description of travel instructions from one or more other EU Member States to the place where the service is provided;
  • The mention of international clientele composed of customers domiciled in various EU Member States, in particular by presentation of accounts written by such customers;
  • The use of a language or a currency other than that generally used in the trader’s country, especially a language or currency of one or more EU Member states;
  • The data controller offers the delivery of goods in EU Member States.

With reference to monitoring activities, the EDPB first reminds us that not only data subjects must be in the EU but, as a cumulative criterion, the monitored behavior must take place within the territory of the EU.

It then offers a fairly comprehensive list of examples of monitoring activities, including:

  • Behavioral advertisement;
  • Geo-localization activities, in particular for marketing purposes;
  • Online tracking through the use of cookies or other tracking techniques such as fingerprinting;
  • Personalized diet and health analytics services online;
  • CCTV;
  • Market surveys and other behavioral studies based on individual profiles;
  • Monitoring or regular reporting on an individual’s health status.

EDPB EXAMPLES SUMMARIZED

Based on the above, here’s a summary of some interesting examples (with some not-so-obvious outcomes):

WITHIN THE TERRITORIAL SCOPE OF GDPR OUTSIDE THE TERRITORIAL SCOPE OF GDPR
Case Why? Case Why?
An e-commerce website is operated by a company based in China. The personal data processing activities of the company are exclusively carried out in China. The Chinese company has established a European office in Berlin in order to lead and implement commercial prospection and marketing campaigns towards EU markets. The processing is indeed inextricably linked to the activities of the European office in Berlin relating to commercial prospection and marketing campaign towards EU market. A hotel and resort chain in South Africa offers package deals through its website, available in English, German, French and Spanish. The company does not have any office, representation or stable arrangement in the EU. Absence of any representation or stable arrangement of the hotel and resort chain within the territory of the Union.
A French company has developed a car-sharing application exclusively addressed to customers in Morocco, Algeria and Tunisia. The service is only available in those three countries but all personal data processing activities are carried out by the data controller in France. Processing of personal data is carried out in the context of the activities of an establishment of a data controller in the Union. An Australian company offers a mobile news and video content service, based on users’ preferences and interest. Users can receive daily or weekly updates. The service is offered exclusively to users located in Australia, who must provide an Australian phone number when subscribing. An Australian subscriber of the service travels to Germany on holiday and continues using the service. The service is not targeting individuals in the Union, but targets only individuals in Australia.
A start-up established in the USA, without any business presence or establishment in the EU, provides a city-mapping application for tourists. The application processes personal data concerning the location of customers using the app (the data subjects) once they start using the application in the city they visit, in order to offer targeted advertisement for places to visits, restaurant, bars and hotels. The application is available for tourists while they visit New York, San Francisco, Toronto, Paris and Rome. The US start-up, via its city mapping application, is specifically targeting individuals in the Union. A US company, without any establishment in the EU, processes personal data of its employees that were on a temporary business trip to France, Belgium and the Netherlands for human resources purposes, in particular to proceed with the reimbursement of their accommodation expenses and the payment of their daily allowance, which vary depending on the country they are in. While the processing activity is specifically connected to persons on the territory of the Union (i.e. employees who are temporarily in France, Belgium and the Netherlands) it does not relate to an offer of a service to those individuals, but rather is part of the processing necessary for the employer to fulfil its contractual obligation and human resources duties related to the individual’s employment. The processing activity does not relate to an offer of service.

Is Your Cookie Policy Right?

In a recent decision by the Court of Justice of the European Union in case C-673/17 against Planet49 GmbH, the issue of consent was analyzed on the basis of the ePrivacy Directive and the GDPR.

The case regarded a preliminary question by the German Federal Court of Justice on the validity of consent given through a pre-ticked checkbox, which the user must deselect to refuse his or her consent.

The Court analyzed the features of consent under the ePrivacy Directive (“freely given specific and informed indication of his wishes by which the data subject signifies his agreement to personal data relating to him being processed” by reference to the Data Protection Directive) and in the GDPR (“any freely given, specific, informed and unambiguous indication of the data subject’s wishes”).

The Court concluded that the user is required to “give” consent and to provide an “indication”, which “points to active, rather than passive, behavior.” Therefore, an opt-out consent is not validly given.

You may want to check if your website has a passive mechanism to accept cookies (including a mechanism whereby “continuing to browse the website means acceptance of these cookies”): under the Court’s decision described above, it is possible that such a passive consent would be regarded invalid.

This conclusion would appear to contradict the previous guideline by the Italian Data Protection Authority providing that “if the user continues browsing by accessing any other section or selecting any item on the website (e.g. by clicking a picture or a link), he or she signifies his or her consent to the use of cookies.”

Further, the Court set forth that “the information that the service provider must give to a website user includes the duration of the operation of cookies and whether or not third parties may have access to those cookies.

Takeaways from the EU Pharmaceutical Law Forum in Brussels

I really enjoyed attending and speaking at the EU Pharmaceutical Law Forum in Brussels this week. The event offered a number of insights into the legal challenges faced by the life sciences industry in an ever-evolving regulatory landscape. These are the main takeaways from the conference:

#1: Clearly, the political climate is not favorable to pharma and med-tech companies. A number of measures have been proposed at various levels that would significantly decrease the incentives to innovation that companies currently enjoy. Such proposed measures range from halving the term of protection for orphan drugs exclusivity to compulsory licensing of drug patents, from incentives to drug compounding by pharmacies to mandatory price reductions. The general public and the media continue to have a negative perception of the industry and the regulatory framework appears to be evolving in a restrictive way.

#2: Despite the uniform letter of GDPR throughout the Member States, interpretation of data protection rules continues to be very different throughout Europe. This is especially clear in the field of clinical trials, where there is a patchwork of legal solutions that makes it impossible to multinational corporations to adopt a consistent approach. The recent EDPB opinion on the legal basis for processing of data deriving from clinical trials has further shown that there has been a shift away from consent as the legal basis for the processing, but some countries (like Germany, Italy and Spain, for example) continue to find it hard to accept such a shift.

#3: EU harmonization is expected to occur in the coming years in a number of areas, such as off-label use, artificial intelligence and health technology assessment.

#4: Compliance efforts must be continued, but it is clear that formal compliance is not sufficient to shield a company from risks, especially reputational risks. Even when compliance safeguards are in place, the approach to reputational risks must be perfectionist, as pointed out by Ms. Alice Cabrio, compliance officer at Roche S.p.A.

Enjoy your weekend, and do not forget to celebrate the GDPR’s first birthday!

Italian Data Protection Legislation Is Enacted

Finally (!), the Italian government has enacted a legislative decree that amends the existing Data Protection Code in order to ensure its compliance with the GDPR. Additionally, the Italian legislator has filled the gaps that the GDPR had left to Member States.

Here are the main takeaways in the health area:

  • Processing of health data, genetic data or biometric data requires compliance with specific protection measures (“misure di garanzia”) that will be issued by the Italian Data Protection Authority bi-annually in light of guidelines of the European Committee, of technological developments and in the interest of data circulation within the European Union.
  • Under section 9.2.g) of the GDPR, personal data relating to health can be processed when processing is necessary for reasons of substantial public interest, on the basis of Union or Member State law. The Italian legislator has listed the circumstances under which such substantial public interest exists, i.e., inter alia:
    • administrative activities connected to those of diagnosis, assistance or health or social therapy;
    • obligations of the national health service and of subjects operating in the health area;
    • hygiene and safety tasks to be carried out on the workplace and for safety and health of the population, for protection of the population and to safeguard life and physical integrity;
    • management and assessment of health assistance;
    • social protection of maternity and abortion, addictions, assistance, social integrations and rights of disabled individuals.
  • Data protection rights of deceased individuals may be exercised by those who have act on the basis of an own interest, in protection of the interested person, or for family reasons that are worth of protection, unless – with respect of services of information society – the interested person has expressly prohibited through a written statement the exercise of such rights by third parties. Such statement must be unequivocal, specific, informed and free, and may also relate only to some of the rights. The prohibition must not prejudice the exercise by third parties of patrimonial rights arising from death of the interested person nor the right to judicial defense.
  • The prescription of drugs that do not require the indication of the name of the interested person will be subject to specific measures (misure di garanzia) also in order to control the correctness of the prescription, for administrative purposes and for the purpose of scientific research in public health.
  • Reuse of personal data for purposes of scientific research or for statistical purposes must be previously authorized by the Data Protection Authority, who can set forth conditions for the processing. Reuse of genetic data cannot be authorized. However, processing of personal data collected for clinical activity for the purpose of research by research hospitals (IRCCS, both private and public) is not deemed to be reuse.
  • Processing of health personal data for the purpose of scientific research in the medical, biomedical or epidemiological field without the patient consent is in any case subject to a favorable opinion by the competent ethics committee and a consultation with the Data Protection Authority.
  • Criminal sanctions continue to apply in case of illegal data processing and can be up to 6 years of imprisonment.
  • The Data Protection Authority has 90 days to indicate which of the measures contained in the general authorizations it already adopted are compatible with the GDPR. The ones which are not will cease to apply.

GDPR from Down Under: an Australian Perspective

We have interviewed Dr. Peytee Grusche, special counsel at the Australian law firm Russell Kennedy, to ask about her view on GDPR. Peytee assists clients in the areas of research and development, commercialisation of intellectual property, patent, trade mark and design registration and enforcement.

Do Australian companies care about GDPR, and why?

Yes, Australian companies do care about the GDPR if they have an establishment in the European Union (EU), if they offer goods and services in the EU, or if they monitor the behaviours of individuals in the EU.  Also, if Australian businesses are recipients of personal data, then they will be caught by the provisions of the GDPR.

Have you seen significant compliance efforts?

We have had clients request advice on their privacy policies in order to update them to include compliance with the GDPR. In particular, where AU businesses are recipients of personal data advice, on standard data protection clauses and binding corporate rules.  Also, we have received instructions for advice on compliance with GDPR in respect of direct marketing practices (mailouts, newsletters etc).

How would you compare the GDPR to Australian data protection legislation?

The GDPR and the Australian Privacy Act 1988 have much in common including the requirement to show that businesses comply with the privacy principles. However, there are some differences under the GDPR which do not appear in the Australian Privacy Act 1988 including a number of rights for individuals.

Under the GDPR, individuals have the rights to erasure, right to data portability and right to restriction of processing.  The Australian Privacy Act does not include the equivalent rights to these new rights. However, it specifies that business must take reasonable steps to destroy or de-identify personal information that is no longer needed for a permitted purpose.  Additionally, where access is given to an individual’s personal information, it must generally be given in the manner requested by the individual.

What is the preferred strategy of Australian companies who face different standards in data protection legislations around the world?

In our experience, Australian companies will try to comply by adopting  an appropriate privacy policy and/or by contractual provisions to include provisions relating to relevant countries.

Thank you, Peytee!

May 25, 2018: Did You Survive the GDPR D-Day?

Last May 25 the GDPR came into force. It was hard not to notice given the inundation of emails that everyone received, as well as the clear signs of burnout in the eyes of GDPR experts.

Here are my personal top 3 takeaways from that experience:

  • The flood of data protection emails received on May 25 showed me how my data had been disseminated all over the place and archived for a really long time. I had some recollection of only a few of those who wrote me to share their most recent privacy policy (and remind me how they deeply, deeply care about privacy!), since many may have bought, inherited or just collected my data a long time ago. It reminded me that those data subjects’ rights are an empowering tool, which I intend to use more frequently in the future.

 

  • The Law (capital “L”) showed its full might and power on May 25, something which surprised even those, like me, who work with legal requirements all day every day. Look at what companies do when you threaten a 4% fine on their worldwide turnover! (Incidentally, this reminded me why politics is important and why people who are indifferent to politics are wrong: this stuff does make a difference in our lives).

 

  • The Italian authorities (mostly the government and parliament) lost yet another opportunity to be helpful to citizens. We had been waiting for a national data protection law for months, but no such law was enacted before May 25. Until that happens, Italians are supposed to assess, for each and every provision of the Data Protection Code, whether or not it conflicts with the GDPR. How practical.

GDPR: do’s and dont’s

Seminario GDPR 03052018

Paola Sangiovanni will be speaking at a seminar on GDPR on May 3, 2018 at Gitti and Partners’ office in Brescia.

The seminar, followed by a reception, will focus on DOs and DONTs for small and medium enterprises in the field of data protection.

While Italians are still awaiting the enactment of a national data protection law that will clarify the relationship between GDPR and the previous privacy legislation, GDPR compliance efforts must nonetheless continue.

Join us in this interesting seminar to find out what should be done and what should be avoided!

2017 New Year’s Privacy Resolution: Road to Compliance with the New European Privacy Framework

Year 2017 already brought to us some exciting change. The beginning of the year is also the perfect time for appraisals of the past and resolutions for the near future. Whether we see it as a welcome enhancement of personal data rights or simply as another burdensome European set of requirements, 2016 delivered the new European General Data Protection Regulation (Regulation EU 2016/679, “GDPR”). Already 233 days passed since GDPR entered into force and 498 days are left until the new Regulation will start to apply on May 25, 2018. Roughly, one third of the time given to comply with the new regulatory framework has already gone by. Then, perhaps, the beginning of 2017 can be a good chance to ask ourselves what has already been done in the first 233 days and what still needs to be done in the future 498 days in order not to miss May 2018’s deadline.

The GDPR imposes a much more burdensome level of compliance requirements to companies acting as data controllers and data processors.

Some of them require the assessment and preparation of organizational and implementing measures that need to be put in place well in advance of May 2018.

  • Data controllers and data processors must appoint a data protection officer (“DPO”). The controller and the processor shall ensure that the DPO is involved, properly and in a timely manner, in all issues which relate to the protection of personal data. The controller and processor shall support the DPO in performing his/her tasks by providing resources necessary to carry out those tasks and access to personal data and processing operations, and to maintain his/her expert knowledge. The controller and processor shall also ensure that the DPO does not receive any instructions regarding the exercise of those tasks. Furthermore, the DPO shall not be dismissed or penalized by the controller or the processor for performing his tasks and shall directly report to the highest management level of the controller or the processor.
  • Data protection by design and by default will have to be implemented. The data controller: (i) both at the time of the determination of the means for processing and at the time of the processing itself, must “implement appropriate technical and organizational measures, such as pseudonymisation, which are designed to implement data-protection principles, such as data minimization, in an effective manner and to integrate the necessary safeguards into the processing in order to meet the requirements of [the GDPR] and protect the rights of data subjects” and (ii) “to implement appropriate technical and organizational measures for ensuring that, by default, only personal data which are necessary for each specific purpose of the processing are processed”.
  • A data protection impact assessment must be carried out. Such impact assessment must contain: a systematic description of the envisaged processing operations and the purposes of the processing, including, where applicable, the legitimate interest pursued by the controller; an assessment of the necessity and proportionality of the processing operations in relation to the purposes; an assessment of the risks to the rights and freedoms of data subjects; the measures envisaged to address the risks, including safeguards, security measures and mechanisms to ensure the protection of personal data and to demonstrate compliance with GDPR.
  • Data controllers must guarantee the effectiveness of the data subject’s right to be forgotten and right to portability. This requires an assessment of the adequacy of the technical and organizational instruments currently available and, possibly, their improvement. More specifically, data controllers must be able to fulfill: (i) in relation to the right to be forgotten, their obligation to “take reasonable steps, including technical measures, to inform controllers which are processing the personal data that the data subject has requested the erasure by such controllers of any links to, or copy or replication of, those personal data”; (ii) as regards to the right to portability, their obligation to allow the data subjects to effectively exercise their right to “receive the personal data concerning him or her, which he or she has provided to a controller, in a structured, commonly used and machine-readable format and have the right to transmit those data to another controller”.
  • Data controllers shall notify personal data breaches to the relevant supervisory authority without undue delay and, where feasible, not later than 72 hours after having become aware of it. This imposes on controllers the preparation of appropriate notification forms, as well as organizational measures to guarantee adequate resources to complete such task.
  • The mandatory content of the written contract between the data controller and the data processor requires a revision of all such contracts. They shall include, inter alia, the obligations of the processor to: process the personal data only on documented instructions from the controller, including with regard to transfers of personal data to a third country or an international organization; ensure that persons authorized to process the personal data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality; delete or return all the personal data to the controller after the end of the provision of services relating to processing, including copies; make available to the controller all information necessary to demonstrate compliance with the obligations under GDPR; allow for and contribute to audits, including inspections, conducted by the controller or another auditor mandated by the controller.
  • Information notice forms currently in use will need to be revised. In fact, information to be provided to data subjects must include, inter alia: the contact details of the DPO; the legal basis for the processing; the fact that the controller intends to transfer personal data to a third country or international organization and the existence or absence of an adequacy decision by the Commission; the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that period; the existence of the right to data portability; the existence of the right to withdraw consent at any time for processing based on consent; the existence of the right to lodge a complaint with a supervisory authority; the existence of automated decision-making, including profiling.
  • Data controllers and data processors must keep record of processing activities under their responsibility. Records to be kept by data controllers shall contain all of the following information: the name and contact details of the controller and, where applicable, the joint controller, the controller’s representative and the DPO; the purposes of the processing; a description of the categories of data subjects and of the categories of personal data; the categories of recipients to whom the personal data have been or will be disclosed including recipients in third countries or international organizations; where applicable, transfers of personal data to a third country or an international organization, including the identification of that third country or international organization and the documentation of suitable safeguards; where possible, the envisaged time limits for erasure of the different categories of data; where possible, a general description of the technical and organizational security measures. Records to be kept by data processors shall include: the name and contact details of the processor or processors and of each controller on behalf of which the processor is acting, and, where applicable, of the controller’s or the processor’s representative, and the DPO; the categories of processing carried out on behalf of each controller; where applicable, transfers of personal data to a third country or an international organization, including the identification of that third country or international organization and the documentation of suitable safeguards; where possible, a general description of the technical and organizational security measures. Data controllers and data processors shall therefore dedicate and organize resources to be able to start keeping such records.

All this may appear daunting. Nevertheless, 498 days are more than enough to take all necessary steps, if we let one of our New Year’s resolutions be to timely walk the road to compliance with the GDPR.