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- A Very Brief Introduction to the GDPR Recitals
- GDPR: Recitals
- The impact of the EU general data protection regulation on scientific research
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A Very Brief Introduction to the GDPR Recitals
Chassang Gauthier The impact of the EU general data protection regulation on scientific research ecancer 11 Gauthier Chassang. Correspondence to: Gauthier Chassang. E-mail: gauthier. The use of personal data is critical to ensure quality and reliability in scientific research. The GDPR fixes both general rules applying to any kind of personal data processing and specific rules applying to the processing of special categories of personal data such as health data taking place in the context of scientific research, this including clinical and translational research areas.
This article aims to provide an overview of the new rules to consider where scientific projects include the processing of personal health data, genetic data or biometric data and other kinds of sensitive information whose use is strictly regulated by the GDPR in order to give the main key facts to researchers to adapt their practices and ensure compliance to the EU law to be enforced in May Keywords: privacy, computer security, humans, European Union EU , translational medical research, biomedical research.
The ultimate goal of the GDPR is to create legal certainty and sustainability of the data protection measures in a technological neutral 6 approach.
Without fundamentally changing the approach to the field compared to what existed previously with the Directive of , the GDPR performs several updates and introduces some new individual rights and procedures of importance which impact scientific research activities.
Indeed, the GDPR still applies roughly to the data controllers 7 and processors 8 acting in the public and private sectors for profitable and not-profitable purposes. It will still also consider scientific research 9 activities as a specific context of personal data processing where the equilibrium between individual freedom and the freedom of research triggers particular challenges and ethical issues 10 , thus necessitating appropriate rules 11 allowing both personal data processing and sharing in the pursuit of the public interest.
The GDPR adopts a new general risk-based approach intended to facilitate the case-by-case identification of data protection issues and the related necessary data protection measures to respect.
Because personal data processing and the use of sensitive personal data 12 such as genome-based information are crucial for the advances of health research activities such as clinical research and translational research, for practicing whole genome sequencing, for research biobanking or the creation of research databases, this article describes the main news 13 or specifications of importance concerning scientific research activities that have to be considered in the coming years.
The GDPR maintains the approach of the previous Directive by fixing general principles to be observed in any context of personal data processing, including in research and for archiving purposes in the public interest, and regardless of the kind of personal data, including to the processing of data qualified as sensitive personal data. Nevertheless, the GDPR adds three new general principles of importance. The main general principles remain the same than under the previous Directive.
Indeed, according to Article 6 of the GDPR, personal data shall be processed lawfully, fairly and in a transparent 14 manner in relation to the data subject 15 ; collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes 16 ; adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed 17 ; accurate and, where necessary, kept up to date; every reasonable step must be taken to ensure that personal data that are inaccurate, having regard to the purposes for which they are processed, are erased or rectified without delay 18 ; kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed The GDPR completes the principles cited above by fixing two relatively new additional principles of general application in its Article 6 which existed under the previous Directive but which have now acquired a new dimension.
The first principle is about respect of the data integrity and of their confidentiality. This principle imposes that the data be processed in a manner that ensures appropriate security of personal data, including protection against unauthorised or unlawful processing and against accidental loss, destruction or damage 20 , using appropriate technical or organisational measures. This principle will find application not only through the enforcement of health professional rules and research ethics guidelines, such as those ensuring scientific and research integrity 21 [ 5 ], but also through technical measures, such as the use of coding techniques e.
This principle is particularly important in the research context where a potentially large amount of sensitive data are at stake and where the quality of the data is essential to ensure research results to be reliable,.
The second principle which was also existing under the previous Directive but that has been clarified and associated with detailed implementation procedures see below is the accountability principle. According to this principle, the controller shall be responsible for, and be able to demonstrate compliance with the general principles of data processing exposed above.
This will necessitate, in particular, that the controller, or where applicable its representatives in the EU, and the processors organise and maintain clear and secured records of any data processing activities performed under their responsibility in order to be able to demonstrate compliance with the GDPR.
In research, such records can constitute archives to be retained for a certain period of time according to applicable law. The GDPR explicitly details the minimal information to be preserved within such records in its Article Each controller and processor should be obliged to cooperate with the supervisory authority and make those records available, on request, so that it might serve for monitoring those processing operations.
This new principle traduces the integrated approach adopted by the EU in order to create a sustainable data protection system through the early use of adapted privacy enhancing technologies 22 [ 6 , 7 ] in the design of the processing operations and throughout the life cycle of the data. Here, the EU definitely approximates the law and the technology, two essential elements of the data protection system that shall develop together to allow legal compliance in a modern world.
The technical aspects are completed by organisational measures which allows data protection to be respected e. However, this by-design feature is completed by the default one. That obligation applies to the amount of personal data collected, the extent of their processing, the period of their storage and their accessibility. However, it should not be entirely autonomous, as it would create a risk in terms of data control and thus a loss of the protective feature of the by-default criterion.
In addition to these principles, Article 9 of the GDPR fixes general rules regarding respect for processing sensitive personal data, such as data concerning health or genetic data, and keeps the previous mechanisms based on a general prohibition 23 of processing with some important exceptions 24 , in particular, for the healthcare practice and the management of health systems 25 , public health 26 and research 27 sectors where the processing is authorised under specific conditions.
Focusing on research, according to Article 9 al. In addition, the data controller shall respect the new Article 89 1 of the GDPR requiring both sufficient and adequate technical and organisational measures ensuring data protection and, in particular, in this context, the respect of data minimisation.
Understanding the legal terminology is paramount for ensuring its proper dissemination and application by stakeholders. In the field of research, lawyers met difficulties in understanding and circumventing notions which are very scientifically based and depend on the evolution of technologies and contexts. With the GDPR, we can salute the work that has been done by the EU legislator to design several definitions of direct utility in the context of scientific research and that represent the new common benchmark for the Member States.
In particular, the GDPR introduces some new definitions of certain special categories of personal data whose processing is forbidden, by principle, but exceptionally admitted for research or archiving purposes in the public interest in the respect of Articles 9 and 89 of the GDPR. With this opening, it is hard to understand what kind of data could potentially be qualified as genetic data.
Could this be genealogical information gathered through questionnaires? Could this aims epigenetic data? To a certain extent, this creates confusions with regard to the notion of biometric data see below.
Whatever, this definition seems to be a very useful and workable basis. Regarding the condition of the data, the GDPR also adopts new definitions, those of pseudonymisation and encryption, and confirms the previous notion of anonymous data. The result of pseudonymisation is pseudonymised data which remain personal data but being protected through coding or encryption.
Throughout the GDPR, the use of pseudonymisation is promoted and shall be implemented, as far and as soon as possible, in personal data processing for scientific research purposes, as a standard data protection practice.
This Regulation does not, therefore, concern the processing of such anonymous information, including for statistical or research purposes. In addition, among the issues surrounding the rights of the data subjects, the GDPR provides a new definition of the consent term. Here, we can note that the notion has been specified regarding the unambiguous feature of the consent which does not rise doubt about the scope of the activities agreed by the data subjects and regarding the form of consent that shall be a statement or by a clear affirmative action.
The new rules regarding consent of the data subject, including in the research field, are further exposed below. Aside from these terminological advances, the GDPR innovates in the way data protection will be ensured in practice by setting up some new procedures to adhere to.
The GDPR establishes a new system using a risk-based approach. This new approach is implemented through an integrated system of data protection, both close to the data controller s and processors, and able to adapt to the diverse contexts of processing. Thus, this system relies on a couple of new procedures which are also applied in scientific research settings. The procedure of designating a data protection officer DPO by the data controller is a very structuring point.
In most of the case for research organisations, biobanks, and health database infrastructures as well as in the context of most of research projects, the DPO designation will be mandatory.
An important criterion here is the scale of the processing. Furthermore, the GDPR does not consider activities such as full genome sequencing or the use of other high throughput technologies in health and research sectors as being on a large scale despite the fact that such a process creates big data at the individual level and particular risks regarding privacy protection 37 [ 10 ].
Where a DPO has to be mandatorily designated, its designation shall be based on professional qualities and expert knowledge of data protection law and practices in the field. This will necessitate adequate educational programs with teaching in law and ethics. The DPO shall show sufficient skills to perform its tasks fixed in Article In that sense, the data controller and the processor will have to properly and timely consult the DPO in the decision-making process regarding data protection issues.
As stated in Article 38, the DPO shall have necessary means to perform its tasks independently, without receiving any instructions from the controller or processor for performing its tasks. In addition, a DPO shall not be dismissed or penalised by the controller or the processor for performing his tasks. The DPO shall directly report to the highest management level of the controller or the processor.
The DPIA is an entirely new self-assessment exercise which somewhat prolongs the requirements of most of the funding agencies requiring, as an integrated part of the ethics assessment of a research proposal, to describe how personal data will used and responsibly managed in the research e.
The DPIA serves not only to know the state of the art of data protection means in a certain context, to plan and manage the necessary enhancements to ensure compliance of the system, but also to determine if a prior consultation 38 of the supervisory authority is necessary.
Indeed, the GDPR abolishes the obligation to systematically declare any kind of personal data processing in favour of the sole declaration of the processing that is likely to result in a high risk to the rights and freedoms of data subjects. This concerns, in particular, situations where new technologies are used we can think about full genome sequencing , where special categories of data is processed on a large scale 39 presumably in biobanking and research cohorts or in the context of a systematic and extensive evaluation of personal aspects relating to natural persons which is based on automated processing, including profiling activities, on which decisions are based that produce legal effects concerning the natural person or similarly significantly affect the natural person such as for some e-health technologies.
The controller shall consult the supervisory authority prior to processing where the results from the DPIA indicate that the processing would result in a high risk in the absence of measures taken by the controller to mitigate the risk The controller shall review the DPIA, in particular, where a significant change occurred in the processing that change the nature or scope of the risk generated by the processing DPIA reports will need to be recorded and made available to the authorities in accordance with the accountability principle.
Some well-known existing methodologies [ 11 ] elaborated at national level before the adoption of the GDPR provide a good idea of the practice of the DPIA and tools. These methodologies can still be used today as they keep on complying with the GDPR. Allowing this kind of processing is crucial as the access to personal data that can be reused for different objectives constitutes an essential activity for scientific and translational research.
As a general principle stated under Article 5 of the GDPR see above , the processing of personal data for purposes other than those for which the personal data were initially collected should only be allowed where the new purpose of the processing is compatible with the purposes for which the personal data were initially collected. This presumption of compatibility with the initial purposes of the processing advanced at the time of the first collection is notably related to the specific exemption to the principle of storage minimisation, where the further processing e.
This is a good news for health registries, cohorts and research biobanking maintaining personal sensitive data available for future scientific or statistical reuses. However, this presumed compatibility is not fully automatic and must answer to several requirements such as the respect of data minimisation principle. This test is a new and very useful tool providing criteria that the controller shall use in order to ascertain whether processing for another purpose is compatible with the purpose for which the personal data are initially collected.
Where the results of the test shows that none of these elements has significantly changed in a way that would make the further processing unfair or otherwise illicit, the compatibility test is satisfied and no legal basis separated from that which allowed the initial collection of the personal data is required.
If not, the further processing will have to rely on a separate legal basis e. Indeed, as soon as a breach has been noticed, in parallel of the relevant corrective actions to immediately undertake, the processor shall notify the controller without undue delay. Then, two kinds of actions must be implemented: 1 a notification 48 of the competent supervisory authority, including through the DPO and 2 in limited cases, a communication 49 with the concerned data subjects.
Where such notification cannot be achieved within 72 h, the reasons for the delay should accompany the notification and information may be provided in phases without undue further delay. The minimal content of the notification to address to the NDPA is specified in Article 33 3 and includes notably a description of the facts, of the nature of the breach, of the categories and approximate number of both the data subjects concerned and the records affected by the breach, an analysis of the likely consequences of the breach and the measures taken or proposed by the controller to address the personal data breach and, where appropriate, to mitigate possible adverse effects.
Where the information required cannot be entirely provided at the same time, the GDPR allows providing it in several phases. In the latter case, individual communication shall be replaced by general public information about the breach or a similarly effective communication mean that would easily allow the data subjects to be aware of the facts and consequences of the breach.
Where the communication with the data subjects is to be done, it must be transparent and presents information in clear and plain language. The point of this communication with the data subjects is to provide him with both informative and useful information such as advices on the way to act. A supervisory authority, mandatorily notified in the respect of Article 33, can, having considered the likelihood of the personal data breach resulting in a high risk, require to implement such communication with the data subjects or decide that any of the exemption conditions 51 are met.
Consent has always been a central ethical element for participating in research projects involving human beings. New research practices triggered debates in Europe about the risk that the GDPR require systematic consent before each and every data processing and around the necessity to allow the practice of broad consent intended to maximise the use of personal data, including sensitive data for several different and unknown research purposes. We will successively address these questions. Regarding the fear of seeing written consent becoming a systematic obligation for processing personal data for research uses, the GDPR keeps consent as only one of the means justifying the lawfulness of the processing
That mechanism should in particular apply where a supervisory authority intends to adopt a measure intended to produce legal effects as regards processing operations which substantially affect a significant number of data subjects in several Member States. It should also apply where any supervisory authority concerned or the Commission requests that such matter should be handled in the consistency mechanism. That mechanism should be without prejudice to any measures that the Commission may take in the exercise of its powers under the Treaties. Source: EUR-lex. Enter something special:. Forgot your password? Lost your password?
Considering the following reasons the articles of the GDPR have been adopted. These are the latest and final recitals of April 27th Search for:. Skip to content Search for:. Recitals 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 Report error.
Nonetheless, confusion reigns over the actual scope of the GDPR, and many non-EU companies are unsure whether they must comply with the new Regulation and, if so, how. Yet, much of the discussion about the territorial reach of the GDPR appears to be generating more heat than light. While non-EU companies should take EU privacy laws more seriously, there is a risk of taking the fear of non-compliance too far and needlessly chilling innovation. Guidance from regulatory authorities and the Article 29 Working Party will be crucial for understanding the real risk to non-EU companies. Adoption of the GDPR — after more than four years of intense debate, negotiation, and lobbying — marked an important milestone in EU data protection laws. Whether the GDPR will truly create a consistent data protection framework in the EU remains to be seen — Member States retain the ability to derogate from certain aspects of the Regulation. In addition to broad new rights for data subjects, the GDPR imposes several specific obligations on data controllers and processors, including notice and privacy by design requirements.
General Data Protection Regulation (EU GDPR) – The official PDF of the Regulation (EU) /, All Articles of the GDPR are linked with suitable recitals.
The impact of the EU general data protection regulation on scientific research
Skip to content. The GDPR imposes obligations on organizations—regardless of their geographical location—that target or collect data on European Union citizens. However, someone unfamiliar with the regulation may find it difficult to grasp—the document contains 99 articles and recitals! As mentioned, the GDPR consists of two components : the articles and recitals. The articles constitute the legal requirements organizations must follow to demonstrate compliance.
Article Responsibility of the controller Article Data protection by design and by default Article Joint controllers Article Representatives of controllers or processors not established in the Union Article Processor Article Processing under the authority of the controller or processor Article Records of processing activities Article Cooperation with the supervisory authority Article Security of processing Article Notification of a personal data breach to the supervisory authority Article Communication of a personal data breach to the data subject Article Data protection impact assessment Article Prior consultation Article Designation of the data protection officer Article Position of the data protection officer Article Tasks of the data protection officer Article Codes of conduct Article Monitoring of approved codes of conduct Article Certification Article Certification bodies. Article General principle for transfers Article Transfers on the basis of an adequacy decision Article Transfers subject to appropriate safeguards Article Binding corporate rules Article Transfers or disclosures not authorised by Union law Article Derogations for specific situations Article International cooperation for the protection of personal data. Article Supervisory authority Article Independence Article General conditions for the members of the supervisory authority Article Rules on the establishment of the supervisory authority Article Competence Article Competence of the lead supervisory authority Article Tasks Article Powers Article Activity reports. Article Right to lodge a complaint with a supervisory authority Article Right to an effective judicial remedy against a supervisory authority Article Right to an effective judicial remedy against a controller or processor Article Representation of data subjects Article Suspension of proceedings Article Right to compensation and liability Article General conditions for imposing administrative fines Article Penalties.