Tag: GDPR
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.
4. February 2021
The President of the Personal Data Protection Office in Poland (UODO) imposed a fine on the Medical University of Silesia in the amount of PLN 25.000 (approx. EUR 5.600). The university had suffered a data breach of which it should have notified the supervisory authority and the data subjects according to Articles 33, 34 GDPR, but failed to do so.
First indications of the data breach reached UODO in early June 2020. It was related to exams held at the end of May 2020 by videoconference on an e-learning platform. These were also being recorded. Before the exam, students were identified by their IDs or student cards, so a large amount of their personal data was documented on the recordings. After the exam was completed, the recordings were made available on the platform. However, not only the examinees had access to the platform, but also a wider group of people, about which the students had not been informed. In addition, using a direct link, any extern person could access the recordings and therefore the data of the examinees. Many students, fearing that the video would be deleted to cover up the incident, secured the file or took photographs of the computer screens to protect evidence. Eventually, the chancellor (being the decision-making unit) expressed the position that the incident of 200 people viewing the IDs of some 100-150 other people cannot be considered a personal data breach.
The controller, who was requested to clarify the situation by UODO, did not dispute the data breach. In fact, the virtual room of the platform is only available to the exam group and only those people have access to the recordings. The violation occurred because one of the employees did not close access to the virtual room after the exam. Though, the controller stated that no notification was required. In his opinion the risk to the rights or freedoms of the data subjects was low. Moreover, after the incident, the system was modified to prevent students from downloading the exam files. The controller also indicated that he identified the individuals who had done so and informed them about their criminal liability for disseminating the data.
Despite several letters from UODO, the university still omitted to report the data breach and notify the data subjects. Therefore, administrative proceedings were initiated. UODO found that the controller failed to comply with his obligations to notify both the supervisory authority and affected data subjects as well as improperly assessed the risk involved.
When imposing the fine, the President of UODO took into account the duration of the infringement (several months), the intentional action of the controller and his unsatisfactory cooperation with the supervisory authority. The fine will serve not only a repressive but also a preventive function, as it shows that the obligations arisen in connection with data breaches cannot be ignored. All the more so because an inappropriate approach to the obligations imposed by the GDPR may lead to negative consequences for those affected by the breaches.
28. January 2021
On January 18th, 2021, the European Data Protection Board (EDPB) published their draft Guidelines 01/2021 on Examples regarding Data Breach Notification.
These Guidelines are supposed to give further support to Controllers alongside the initial Guidelines on Personal Data Breach Notification under the GDPR, adopted by the Article 29 Working Party in February 2018. These new Guidelines are meant to consider different types of situations that the Supervisory Authorities have come across in the last two and a half years since the implementation of the GDPR.
The EDPB’s intention is to assist Controllers in deciding how to handle data breaches, namely by identifying the factors that they must consider when conducting risk assessments to determine whether a breach must be reported to relevant Supervisory Authorities as well as if a notification to the affected Data Subjects is necessary.
The draft Guidelines present examples of common data breach scenarios, including:
• ransomware attacks, where a malicious code encrypts the personal data and the attacker subsequently asks the controller for a ransom in exchange for the decryption code
• data exfiltration attacks, which exploit vulnerabilities in online services offered by the controller and typically aim at copying, exfiltrating and abusing personal data for malicious purposes
• human errors resulting in data breaches that are fairly common and can be both intentional and unintentional
• lost or stolen devices and paper documents
• “mispostal” scenarios, that arise from human error without malicious intent
• social engineering, such as identity theft and email exfiltration
The draft Guidelines further emphasize key elements of data breach management and response that organizations should consider, namely:
• proactively identifying system vulnerabilities in order to prevent data breaches from happening in the first place
• assessing whether a breach is likely to result in a risk to the rights and freedoms of the Data Subject, the timing of this assessment and the importance of Controllers not delaying a notification because of unclear circumstances
• implementing plans, procedures and guidelines indicating how to handle data breaches that have clear reporting lines and persons responsible for the recovery process
• organizing regular trainings for employees to raise awareness on data breach management, and the latest developments in the area
• documenting breaches in each and every case, irrespective of the risk they pose
The Guidelines will be open for public consultation until March 2nd, 2021, during which the EDPB will gather feedback on the draft.
Clubhouse is a new social networking app by the US company Alpha Exploration Co. available for iOS devices. Registered users can open rooms for others to talk about various topics. Participation is possible both as a speaker and as a mere listener. These rooms can be available for the public or as closed groups. The moderators speak live in the rooms and the listeners can then join the virtual room. Participants are initially muted and can be unmuted by the moderators to talk. In addition, the moderators can also mute the participants or exclude them from the respective room. As of now, new users need to be invited by other users, the popularity of these invitations started to rise in autumn 2020 when US celebrities started to use the app. With increasing popularity also in the EU, Clubhouse has come under criticism from a data protection perspective.
As mentioned Clubhouse can only be used upon an invitation. To use the option to invite friends, users must share their address book with Clubhouse. In this way, Alpha Exploration can collect personal data from contacts who have not previously consented to the processing of their data and who do not use the app. Not only Alpha Exploration, but also users may be acting unlawfully when they give the app access to their contacts. The user may also be responsible for the data processing associated with the sharing of address books. Therefore, it is not only the responsibility of Alpha Exploration, but also of the user to ensure that consent has been obtained from the contacts whose personal data is being processed. From a data protection perspective, it is advisable not to grant the Clubhouse app access to this data unless the consent of the respective data subjects has been obtained and ideally documented. Currently, this data is transferred to US servers without the consent of the data subjects in the said address books. Furthermore, it is not apparent in what form and for what purposes the collected contact and account information of third parties is processed in the USA.
Under Clubouse’s Terms of Service, and in many cases according to several national laws, users are prohibited from recording or otherwise storing conversations without the consent of all parties involved. Nevertheless, the same Terms of Service include the sentence “By using the service, you consent to having your audio temporarily recorded when you speak in a room.” According to Clubhouse’s Privacy Policy, these recordings are used to punish violations of the Terms of Service, the Community Guidelines and legal regulations. The data is said to be deleted when the room in question is closed without any violations having been reported. Again, consent to data processing should be treated as the general rule. This consent must be so-called informed consent. In view of the fact that the scope and purpose of the storage are not apparent and are vaguely formulated, there are doubts about this. Checking one’s own platform for legal violations is in principle, if not a legal obligation in individual cases, at least a so-called legitimate interest (Art. 6 (1) (f) GDPR) of the platform operator. As long as recordings are limited to this, they are compliant with the GDPR. The platform operator who records the conversations is primarily responsible for this data processing. However, users who use Clubhouse for conversations with third parties may be jointly responsible, even though they do not record themselves. This is unlikely to play a major role in the private sphere, but all the more so if the use is in a business context.
It is suspected that Clubhouse creates shadow profiles in its own network. These are profiles for people who appear in the address books of Clubhouse users but are not themselves registered with Clubhouse. For this reason, Clubhouse considers numbers like “Mobile-Box” to be well-connected potential users. So far, there is no easy way to object to Clubhouse’s creation of shadow profiles that include name, number, and potential contacts.
Clubhouse’s Terms of Use and Privacy Policy do not mention the GDPR. There is also no address for data protection information requests in the EU. However, this is mandatory, as personal data of EU citizens is also processed. In addition, according to Art. 14 GDPR, EU data subjects must be informed about how their data is processed. This information must be provided to data subjects before their personal data is processed. That is, before the data subject is invited via Clubhouse and personal data is thereby stored on Alpha Exploration’s servers. This information does not take place. There must be a simple opt-out option, it is questionable whether one exists. According to the GDPR, companies that process data of European citizens must also designate responsible persons for this in Europe. So far, it is not apparent that Clubhouse even has such data controllers in Europe.
The german “Verbraucherzentrale Bundesverband” (“VZBV”), the german federate Consumer Organisation, has issued a written warning (in German) to Alpha Exploration, complaining that Clubhouse is operated without the required imprint and that the terms of use and privacy policy are only available in English, not in German as required. The warning includes a penalty-based cease-and-desist declaration relating to Alpha Exploration’s claim of the right to extensive use of the uploaded contact information. Official responses from European data protection authorities regarding Clubhouse are currently not available. The main data protection authority in this case is the Irish Data Protection Commissioner.
So far, it appears that Clubhouse’s data protection is based solely on the CCPA and not the GDPR. Business use of Clubhouse within the scope of the GDPR should be done with extreme caution, if at all.
4. January 2021
Almost fit to be called a Christmas miracle, the European Union (EU) and the United Kingdom (UK) came to an agreement on December 24th, 2020. The Trade Agreement, called in full length “EU-UK Trade and Cooperation Agreement“, is set out to define new rules from the date of the UK Exit from the EU, January 1st, 2021.
President of the European Commission, Ursula von der Leyen, claimed it was a deal worth fighting for, “because we now have a fair and balanced agreement with the UK, which will protect our European interests, ensure fair competition, and provide much needed predictability for our fishing communities. Finally, we can leave Brexit behind us and look to the future. Europe is now moving on.”
In light of Data Protection however, the new Trade Deal has not given much certainty of what is to come next.
Both sides are aware that an adequacy decision by the EU Commission is very important with regard to data protection and cross-border data flows. Accordingly, the EU has agreed to allow a period of four months, extendable by a further two months, during which data can be transferred between EU Member States and the UK without additional safeguards. This period was granted to give the Commission enough time to make an adequacy decision. Accordingly, data transfers can continue as before until possibly mid-2021. However, this arrangement is only valid if the UK does not change its data protection laws in the meantime.
With regard to direct marketing, the situation has not changed either: for individuals, active consent must be given unless there was a prior contractual relationship and the advertising relates to similar products as the prior contract. Furthermore, the advertising must also be precisely recognisable as such, and the possibility of revoking consent must be given in every advertising mail.
However, much else has yet to be clarified. Questions such as the competence of the UK Data Protection Authority, the Information Commissioner’s Office (ICO), as well as the fate of its ongoing investigations, have not yet been answered. As of now, companies with their original EU Headquarters in the UK will have to designate a new Lead Supervisory Authority (Art. 56 GDPR) for their business in the EU.
The upcoming months will determine if questions with high relevance to businesses’ day to day practice will be able to be answered reassuringly.
16. December 2020
The Administrative Court of Stockholm announced on November 23rd, 2020, that it had rejected Google LLC’s appeal against the decision of the Swedish Data Protection Authority (Datainspektionen) determining Google’s violations of the GDPR. Google as a search engine operator had not fulfilled its obligations regarding the right to be forgotten (RTBF). However, the court reduced the fine from a total of SEK 75 million (approx. € 7,344,000) to SEK 52 million (approx. € 5,091,000).
Background to the case was the Swedish DPA’s audit in 2017 concerning Google’s handling of requests on delisting, which means removal of certain results from a search engine. The DPA concluded the inspection by ordering Google to delist certain individuals’ names due to inaccuracy, irrelevance and superfluous information. In 2018 the DPA initiated a follow-up audit because of indications that Google had not fully complied with the previously issued order. It resulted in issuing an administrative fine of SEK 75 million in March 2020.
The DPA raised attention to the fact that the GDPR increases the obligations of data controllers and data processors as well as strengthens the rights of individuals, which include the right to have their search result delisted. Though, Google has not been fully complying with its obligations, as it has not properly removed two of the search result listings that the DPA had ordered to delete. In one case Google has done a too narrow interpretation of what web addresses to remove, in the other case Google has failed to remove it without undue delay.
Moreover, the DPA criticized Google’s procedure of managing delisting requests and found it to be undermining data subjects’ rights. Following the removal of a search result listing, Google notifies the website to which the link is directed. The delisting request form, directed to the data subject raising the request, states that information on the removed web addresses can be provided to the webmaster. This information has to be seen as misleading since the data subject is made to understand that its consent to the notification is required in order to process the request. Therefore, such practice might result in individuals refraining from exercising their right to request delisting, which violates Art. 5 (1) lit. a) GDPR. What’s more, in the opinion of the DPA the delisting notifications to the webmasters are not covered by legal obligations according to Art. 6 (1) lit. c), 17 (2) GDPR, nor legitimate interests pursuant to Art. 6 (1) lit. f) GDPR. Also, Google’s routine of regularly sending information to webmasters constitutes processing of personal data being incompatible with the purpose for which the data was originally collected. This practice infringes Art. 5 (1) lit. b), 6 (4) GDPR.
Google appealed the decision of the DPA. Though, the Swedish Administrative Court of Stockholm reaffirmed the DPA’s opinion and confirmed Google’s violations of the GDPR.
The court stated that the process concerning delisting requests must facilitate for the individual to exercise its rights. That means, any process that restricts the individuals’ rights may violate Art. 15 through 22 GDPR. The court also specified why the personal data had been processed beyond their original purpose. Since the notifications are only sent after Google has removed a search result, the purpose of the processing has already expired when the notification is sent. Thus, the notification cannot be considered effective in achieving the purpose specified by Google.
Google shall now delist specific search results and cease to inform webmasters of requests. Also, Google must adapt its data subject rights procedure within eight weeks after the court’s judgment has gained legal force.
8. December 2020
The Belgian Data Protection Authority (DPA) signed a Cooperation Agreement on November 26, 2020, with DNS Belgium, the organization behind the management of the “.be” country-code domain name. The background is to allow DNS Belgium to suspend “.be” websites that are infringing the GDPR. The Agreement builds up a two-tier cooperation system, which aims at identifying infringements and suspending the websites if no action is taken.
The first step is a cooperative investigation, for which DNS Belgium has to support the Belgian DPA by providing all information necessary for the investigation.
The second step is the “Notice and Action” procedure, during which, if the Belgian DPA’s Investigation Service considers a data processing activity conducted via a website with a “.be” domain name to infringe one of the data protection principles under the GDPR, and the responsible data controller or data processor does not comply with the DPA’s order to suspend, limit, freeze or end the data processing activity, the Investigation Service is authorized to send a “Notice and Action” notification to DNS Belgium. Once DNS Belgium receives the “Notice and Action” notification, they will proceed to inform the website owner about the infringement and re-direct the relevant domain name to a warning page of the Belgian DPA.
The website owner can take remedial measures within 14 days to remedy the infringement, upon which he can indicate it to the Belgian DPA. If the Belgian DPA does not contest the measures taken, the relevant domain name will be restored. However, if the infringement is not remediated during the 14-day period, the website will continuously to be re-directed to the Belgian DPA’s warning page for a period of six months. After this time the website will be cancelled and placed in quarantine for 40 days before becoming available for registration once again.
Due to the heavy penalty in cases of a controller not taking any action to remedy the infringement, this action by the Belgian DPA is only possible in cases of infringements that cause very serious harm and are committed by natural or legal persons who deliberately infringe the law, or continue a data processing activity despite a prior order by the Investigation Service of the Belgian DPA to suspend, limit, freeze or end the processing activity.
It is to note that the Inspector General of the Belgian DPA can provide extra time to a website owner to comply with the relevant data protection requirements at the Inspector General’s discretion. However, this will depend on a case by case basis and on the cooperation of the website owner.
26. November 2020
On November 19th, the European Data Protection Board (EDPB) met for its 42nd plenary session. During the session, the EDPB presented two new Standard Contractual Clauses (SCCs) drafts, which have been developed after the Schrems II decision to give more legal certainty to data transfers, as well as extended the public consultation period on transfer mechanisms until the 21st of December 2020.
The drafts presented by the EDPB include one set of SCCs for contracts between controllers and processors, and another one for data transfers outside the EU.
The first are completely new, and have been developed by the Commission in accordance with Art. 28 (7) GDPR and Art. 29 (7) of Regulation 2018/1725. This set of SCCs is intended for EU-wide application, and the Commission drafted them with the aim to ensure full harmonisation and legal certainty across the EU for contracts between controllers and processors.
The second set of drafts is a new take on the SCCs as transfer mechanisms according to Art. 46 (2) (c) GDPR. These SCCs will replace the existing SCCs for international transfers that were adopted on the basis of Directive 95/46 and needed to be updated to bring them in line with GDPR requirements, as well as with the CJEU’s ‘Schrems II’ ruling, and to better reflect the widespread use of new and more complex processing operations often involving multiple data importers and exporters.
The Commission requested a joint opinion from the EDPB and the EDPS on the implementation on both sets of SCCs.
During the plenary, the Members of the Board also decided to extend the deadline for the public consultation on the recommendations on measures that supplement transfer tools to ensure compliance with EU level of protection of personal data from, originally, 30th November 2020 until 21st December 2020.
The EDPB further adopted a statement on the future ePrivacy Regulation and the future role of supervisory authorities and the EDPB in this context during the plenary. The EDPB underlines that many of the provisions of the future ePrivacy Regulation relate to the processing of personal data and that many provisions of the GDPR and the ePrivacy Regulation are closely intertwined. The most efficient way to have consistent interpretation and enforcement of both sets of rules would therefore be fulfilled if the enforcement of those parts of the ePrivacy Regulation and the GDPR would be entrusted to the same authority. The EDPB further underlined the necessity to adopt the new Regulation as soon as possible.
20. November 2020
During its 41st plenary session, the European Data Protection Board (EDPB) adopted by a two-thirds majority of its members its first dispute resolution decision under Art. 65 GDPR regarding Twitter International Company. The binding decision aims to resolve a dispute arisen from a draft decision by the Irish supervisory authority, being the lead supervisory authority in that case, and subsequent relevant and reasoned objections raised by several authorities concerned.
The Irish supervisory authority prepared a draft decision following an own-initiative investigation into Twitter International Company, after the company had notified the Irish supervisory authority of a personal data breach on January 8th, 2019. According to Art. 60 (3) GDPR, the Irish supervisory authority submitted its draft decision to the other authorities concerned in May 2020, which had the opportunity to express their objections within a period of four weeks afterwards. They referred to, inter alia, violations of the GDPR identified by the lead supervisory authority, the role of Twitter International Company as the sole data controller, and the quantification of the proposed fine.
Due to the fact that the lead supervisory authority rejected the objections and/or considered them not to be “relevant and reasoned”, it submitted the matter to the EDPB pursuant to Art. 60 (4) GDPR, thus initiating the dispute resolution procedure.
Thereupon, the completeness of the file was evaluated, that led to the institution of legal proceedings stated in Art. 65 GDPR on September 8th, 2020. In accordance with Art. 65 (3) GDPR and in conjunction with Art. 11.4 of the EDPB Rules of Procedure, the default time period of one month was extended by a further month on account of the complexity of the subject-matter.
On November 9th, 2020, the EDPB adopted its binding decision and will shortly notify it to the Irish supervisory authority, which, on the other hand, will issue a final decision. It will be addressed to the data controller without undue delay and at the latest by one month after the EDPB has notified its decision. In compliance with the requirements of Art. 65 (6) GDPR, the lead supervisory authority shall inform the EDPB of the date when its final decision is notified respectively to the controller. After that, the EDPB decision will be published on its website.
12. November 2020
In recent days, social networks in Poland have teemed with posts containing private addresses and telephone numbers of judges of the Constitutional Tribunal, politicians and activists openly supporting the abortion sentence. In conjunction with the publication of the above on Twitter, the President of the Personal Data Protection Office (UODO) took immediate steps to protect the personal data and privacy of these persons.
Background to this was the judgement of the Constitutional Tribunal repealing the provisions allowing abortion in cases of, for example, serious genetic defects or severe impairment of the human fetus. This provoked resistance from a part of Polish society and led to a street revolution of “liberal” men and women. Unfortunately, the agitation turned into invectives, destruction of property, public disorder and personal arguments. As a result, personal data of people supporting the prohibition of abortion have been shared thousands of times on all social media too. For this reason, numerous protesters appeared at the indicated houses, covered the walls of the surrounding buildings with vulgar inscriptions, and the addressees began to receive packages, e.g. with a set of hangers.
On October 29th, 2020 the President of the UODO responded to the case:
Publishing private addresses and contact details of pro-life activists, politicians and judges by users of the Twitter social network is an action leading to the disclosure of a wide sphere of privacy, and thus posing threats to health and life, such as possible acts of violence and aggression directed against these people and their family members.
The announcement stated that the President of the UODO requested an immediate procedure by the Irish supervisory authority, which is responsible for the processing of personal data via Twitter. Pointing out the enormous scale of threats, he indicated the need to verify the response time to reported irregularities and the possibility of introducing automated solutions to prevent the rapid furtherance of such content by other portal users. He also notified the law enforcement authorities that Twitter users had committed a crime consisting in the processing of personal data without a legal basis. The lawfulness had neither been guaranteed by consent according to Art. 6 (1) lit. a GDPR nor legitimate interests pursuant to Art. 6 (1) lit. f GDPR or any other legal basis. Thus, the processing has to be seen as illegitimate as also stated by the President of the UODO. The law enforcement authorities will be obliged to examine and document both the scope of personal data disclosed in a way that violates the principles of personal data protection and to determine the group of entities responsible for unlawful data processing. The President of the UODO also applied to the Minister of Justice – Public Prosecutor General for placing this case under special supervision due to the escalation of conflict and aggression, which pose a high risk of violating the life interests of both people whose data is published on social media and their family members.
In conclusion, the President of the UODO added:
The intensification of actions of all competent authorities in this matter is necessary due to the unprecedented nature of the violations and the alarming announcements of disclosing the data of more people, as well as the deepening wave of aggression.
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