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0 | I (Legislativ e acts) REGUL ATIONS REGUL ATION (EU) 2016/679 OF THE EUR OPEAN PARLIAMENT AND OF THE COUNCIL of 27 Apr il 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directiv e 95/46/EC (General Data Protection Regulation) (Text with EEA relevance) THE EUR OPEAN PARLIAMENT AND THE COUNCIL OF THE EUR OPEAN UNION, Having regar d to the Treaty on the Functioning of the European Union, and in particular Article 16 thereof, Having regar d to the proposal from the European Commission, | Passage 0 | [
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1 | After transmission of the draf t legislative act to the national parliaments, Having regar d to the opinion of the European Economic and Social Committ ee (1), Having regar d to the opinion of the Committ ee of the Regions (2), Acting in accordance with the ordinar y legislative procedure (3), Whereas: (1) The protection of natural persons in relation to the processing of personal data is a fundamental right. Article 8(1) of the Char ter of Fundamental Rights of the European Union (the ‘Char ter’) and Article 16(1) of the Treaty on the Functioning of the European Union (TFEU) | Passage 1 | [
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2 | provide that ever yone has the right to the prot ection of personal data concer ning him or her. (2) The principles of, and rules on the protection of natural persons with regard to the processing of their personal data should, whate ver their nationality or residence, respect their fundamental rights and freedoms, in particular their right to the prote ction of personal data. This Regulation is intended to contr ibute to the accompl ishment of an area of freedom, secur ity and justice and of an economic union, to economic and social progress, to the strengthening and the converg | Passage 2 | [
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3 | ence of the economies within the internal mark et, and to the well-being of natural persons. (3) Directive 95/46/EC of the European Parliament and of the Council (4) seeks to harmonise the prot ection of fundamental rights and freedoms of natural persons in respect of processing activities and to ensure the free flow of personal data between Member State s. 4.5.2016 L 119/1 Official Jour nal of the European Union EN (1)OJ C 229, 31.7.2012, p. 90. (2)OJ C 391, 18.12.2012, p. 127. (3)Position of the European Parliament of 12 March 2014 (not yet published in the Offi cial Jour | Passage 3 | [
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] |
4 | nal) and position of the Council at first reading of 8 Apr il 2016 (not yet published in the Offi cial Jour nal). Position of the European Parliament of 14 Apr il 2016. (4)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (4) The processing of personal data should be designed to serve mankind. The right to the prote ction of personal data is not an absolute right | Passage 4 | [
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5 | ; it must be considered in relation to its function in society and be balanced against other fundamental rights, in accordance with the principle of propor tionality . This Regulation respects all fundamental rights and obser ves the freedoms and principles recognised in the Char ter as enshr ined in the Treaties, in particular the respect for private and family life, home and communications, the protection of personal data, freedom of thought, conscience and religion, freedom of expression and information, freedom to conduct a business, the right to an effective remedy and to a fair trial, and cultural, religious and | Passage 5 | [
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6 | linguistic diversity . (5) The economic and social integration resulting from the functioning of the intern al mark et has led to a substantial increase in cross-border flows of personal data. The exchange of personal data between public and private actor s, including natural persons, associations and under takings across the Union has increased. National author ities in the Member State s are being called upon by Union law to cooperate and exchange personal data so as to be able to perform their duties or carry out tasks on behalf of an author ity in another Member State . (6) | Passage 6 | [
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7 | Rapid technological developments and globalisation have brought new challenges for the protection of personal data. The scale of the collection and shar ing of personal data has increased signif icantly . Techn ology allows both private companies and public author ities to mak e use of personal data on an unprecedented scale in order to pursue their activities. Natural persons increasing ly mak e personal information available publicly and globally . Technology has transf ormed both the econom y and social life, and should further facilitat e the free flow of personal data within the Union and the transfer to | Passage 7 | [
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8 | third countr ies and international orga nisations, while ensur ing a high level of the protection of personal data. (7) Those developments require a strong and more coherent data prot ection framew ork in the Union, back ed by strong enforcement, given the impor tance of creating the trust that will allow the digital econom y to develop across the internal mark et. Natural persons should have control of their own personal data. Legal and practical certainty for natural persons, economic operat ors and public author ities should be enhanced. (8) Where this Regulation provides for specific ations or restr | Passage 8 | [
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9 | ictions of its rules by Member State law, Member States may, as far as necessar y for coherence and for making the national provisions compreh ensible to the persons to whom they apply , incor porate elements of this Regulation into their national law. (9) The objectives and principles of Directive 95/46/EC remain sound, but it has not prevente d fragmentation in the implementation of data protection across the Union, legal uncer tainty or a widespread public percep tion that there are signif icant risks to the protection of natural persons, in particular with regar d to online activity . | Passage 9 | [
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10 | Differences in the level of prote ction of the rights and freedoms of natural persons, in particular the right to the prot ection of personal data, with regard to the processing of personal data in the Member States may prevent the free flow of personal data throughout the Union. Those diffe rences may theref ore constitute an obstacle to the pursuit of economic activities at the level of the Union, distor t competition and impede author ities in the disc harge of their responsibilities under Union law. Such a differ ence in levels of protection is due to the existen | Passage 10 | [
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11 | ce of differ ences in the implementation and application of Directive 95/46/EC. (10) In order to ensure a consistent and high level of prot ection of natural persons and to remo ve the obstacles to flows of personal data within the Union, the level of prot ection of the rights and freedoms of natural persons with regar d to the processing of such data should be equivalent in all Member States. Consisten t and homog enous application of the rules for the prote ction of the fundamental rights and freedoms of natural persons with regard to the processing of personal | Passage 11 | [
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12 | data should be ensured throughout the Union. Regarding the processing of personal data for compl iance with a legal oblig ation, for the performa nce of a task carried out in the public interest or in the exer cise of offici al author ity vested in the controller , Member States should be allowed to maintain or introduce national provisions to further specify the application of the rules of this Regulation. In conjunction with the general and horizontal law on data protection implementing Directive 95/46/EC, Member State s have several sector-specif ic laws in areas that need more specifi c | Passage 12 | [
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13 | provisions. This Regulation also provides a margin of manoeuvre for Member States to specify its rules, including for the processing of special categor ies of personal data (‘sensitive data’). To that exte nt, this Regulation does not excl ude Member State law that sets out the circumstances for specifi c processing situations, including determining more precisely the conditions under which the processing of personal data is lawful. 4.5.2016 L 119/2 Official Jour nal of the European Union EN (11) Effective prote ction of personal data throughout the Union requires the strengthening and setting out in detail of the rights of | Passage 13 | [
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14 | data subjects and the oblig ations of those who process and determine the processing of personal data, as well as equivalent powers for monitori ng and ensur ing compl iance with the rules for the prote ction of personal data and equivalent sanctions for infringements in the Member States. (12) Article 16(2) TFEU mandates the European Parliament and the Council to lay down the rules relating to the prot ection of natural persons with regard to the processing of personal data and the rules relating to the free movement of personal data. (13) In order to ensure a consistent level | Passage 14 | [
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15 | of protection for natural persons throughout the Union and to prevent diverg ences hamp ering the free movement of personal data within the internal mark et, a Regulation is necessar y to provide legal certainty and transparency for economic operat ors, including micro, small and medium-sized enterprises, and to provide natural persons in all Member States with the same level of lega lly enforceable rights and obligations and responsibilities for controllers and processors, to ensure consistent monitoring of the processing of personal data, and equivalent sanctions in all Member States as well as effective cooperation between the super visor y | Passage 15 | [
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16 | author ities of diffe rent Member States. The proper functioning of the internal mark et requires that the free movement of personal data within the Union is not restr icted or prohibit ed for reasons connecte d with the protection of natural persons with regard to the processing of personal data. To take account of the specific situation of micro, small and medium-sized enterprises, this Regulation includes a derog ation for organisations with fewer than 250 emplo yees with regar d to record-keeping. In addition, the Union institutions and bodies, and Member States and their super visor y author ities, | Passage 16 | [
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17 | are encourag ed to take account of the specifi c needs of micro, small and medium-sized enterpr ises in the application of this Regulation. The notion of micro, small and medium-sized enterprises should draw from Article 2 of the Annex to Commission Recommendation 2003/361/EC (1). (14) The protection afforded by this Regulation should apply to natural persons, whatever their nationality or place of residence, in relation to the processing of their personal data. This Regulation does not cover the processing of personal data which concer ns legal persons and in particular under takings established as legal persons, including the name | Passage 17 | [
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18 | and the form of the legal person and the contact details of the legal person. (15) In order to prevent creating a serious risk of circumvention, the prote ction of natural persons should be technolo gically neutral and should not depend on the techniques used. The prot ection of natural persons should apply to the processing of personal data by automat ed means, as well as to manual processing, if the personal data are contained or are intended to be contained in a filing system. Files or sets of files, as well as their cover pages, whic h are | Passage 18 | [
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19 | not structured according to specifi c criteria should not fall within the scope of this Regulation. (16) This Regulation does not apply to issues of prot ection of fundamental rights and freedoms or the free flow of personal data relat ed to activities whic h fall outside the scope of Union law, such as activities concer ning national secur ity. This Regulation does not apply to the processing of personal data by the Member States when carrying out activities in relation to the common foreign and secur ity policy of the Union. (17) Regulation (EC) No 45/2001 of the European | Passage 19 | [
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20 | Parliament and of the Council (2) applies to the processing of personal data by the Union institutions, bodies, offices and agencies. Regulation (EC) No 45/2001 and other Union legal acts applicable to such processing of personal data should be adapt ed to the principles and rules established in this Regulation and applied in the light of this Regulation. In order to provide a strong and coherent data prote ction framework in the Union, the necessar y adapta tions of Regulation (EC) No 45/2001 should follow after the adoptio n of this Regulation, in order to allow application at the same | Passage 20 | [
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21 | time as this Regulation. (18) This Regulation does not apply to the processing of personal data by a natural person in the course of a purely personal or household activity and thus with no connection to a professional or commercial activity . Personal or 4.5.2016 L 119/3 Official Jour nal of the European Union EN (1)Commission Recommendation of 6 May 2003 concer ning the definit ion of micro, small and medium‑sized enterpr ises (C(2003) 1422) (OJ L 124, 20.5.2003, p. 36). (2)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection | Passage 21 | [
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22 | of individuals with regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). household activities could include correspondence and the holding of addresses, or social netw orking and online activity under taken within the cont ext of such activities. However , this Regulation applies to controllers or processors which provide the means for processing personal data for such personal or household activities. (19) The protect ion of natural persons with regar d to the processing of personal data by compet ent author | Passage 22 | [
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23 | ities for the purposes of the prevention, investig ation, detec tion or prosecution of criminal offences or the executi on of criminal penalties, including the safeg uarding against and the prevention of threats to public secur ity and the free movement of such data, is the subject of a specific Union legal act. This Regulation should not, theref ore, apply to processing activities for those purposes. However , personal data processed by public author ities under this Regulation should, when used for those purposes, be governed by a more specific Union legal act, namely Directive (EU) 2016/680 of the European | Passage 23 | [
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24 | Parliament and of the Council (1). Member States may entr ust compet ent author ities within the meaning of Directive (EU) 2016/680 with tasks which are not necessar ily carried out for the purposes of the prevention, inve stigation, detection or prosecution of criminal offences or the executi on of criminal penalties, including the safeguarding against and prevention of threats to public secur ity, so that the processing of personal data for those other purposes, in so far as it is within the scope of Union law, falls within the scope of this Regulation. With regard to the processing of | Passage 24 | [
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25 | personal data by those compet ent author ities for purposes falling within scope of this Regulation, Member States should be able to maintain or introduce more specifi c provisions to adapt the application of the rules of this Regulation. Such provisions may determine more precisely specific requirements for the processing of personal data by those compet ent author ities for those other purposes, taking into account the constitutional, organisational and administrative structure of the respective Member State . When the processing of personal data by private bodies falls within the scope of this Regulation, this Regulation should provide for the | Passage 25 | [
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26 | possibility for Member States under specifi c conditions to restr ict by law certain oblig ations and rights when such a restr iction constitute s a necessar y and propor tionat e measure in a democratic society to safeg uard specific important interests including public secur ity and the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public secur ity. This is relevant for instance in the framework of anti-money launder ing or the activities of forensic laboratori es. (20) While this Regulation applies, | Passage 26 | [
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27 | inter alia, to the activities of cour ts and other judicial author ities, Union or Member State law could specify the processing operations and processing procedures in relation to the processing of personal data by cour ts and other judicial author ities. The compe tence of the super visor y author ities should not cover the processing of personal data when cour ts are acting in their judicial capacity , in order to safeg uard the independence of the judiciar y in the performa nce of its judicial tasks, including decision- making. It should be possible to entr ust super | Passage 27 | [
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28 | vision of such data processing operations to specific bodies within the judicial system of the Member State , which should, in particular ensure compl iance with the rules of this Regulation, enhance awar eness among members of the judiciar y of their oblig ations under this Regulation and handle compl aints in relation to such data processing operations. (21) This Regulation is without prejudice to the application of Directive 2000/31/EC of the European Parliament and of the Council (2), in particular of the liability rules of interm ediar y service providers in Articles 12 to 15 of that Directive. That | Passage 28 | [
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29 | Directive seeks to contr ibute to the proper functioning of the internal mark et by ensur ing the free movement of information society services between Member States. (22) Any processing of personal data in the context of the activities of an establishment of a controller or a processor in the Union should be carried out in accordance with this Regulation, regar dless of whether the processing itself take s place within the Union. Establishment implies the effective and real exercise of activity through stable arrang ements. The legal form of such arrang ements, whether through a branch or a subsidiar | Passage 29 | [
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30 | y with a legal personality , is not the deter mining factor in that respect. 4.5.2016 L 119/4 Official Jour nal of the European Union EN (1)Directive (EU) 2016/680 of the European Parliament and of the Council of 27 Apr il 2016 on the protection of natural persons with regar d to the processing of personal data by compet ent author ities for the purposes of prevention, investig ation, detect ion or prosecution of criminal offences or the execution of criminal penalties, and the free movement of such data and repealing Council Framewo rk Decision 2008/977/JHA (see page 89 of | Passage 30 | [
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] |
31 | this Official Jour nal). (2)Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain lega l aspects of information society services, in particular electronic commerce, in the Intern al Mark et (‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1). (23) In order to ensure that natural persons are not depr ived of the protection to which they are entitled under this Regulation, the processing of personal data of data subjects who are in the Union by a controller or a processor not established in the Union should be subject to this Regulation | Passage 31 | [
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32 | where the processing activities are related to offering goods or services to such data subjects irrespective of whether connect ed to a payment. In order to determine whether such a controller or processor is offer ing goods or services to data subjects who are in the Union, it should be ascer tained whether it is apparent that the controller or processor envisages offer ing services to data subjects in one or more Member States in the Union. Whereas the mere accessibility of the controller's, processor's or an interm ediar y's website in the Union, of an email address or of | Passage 32 | [
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33 | other contact details, or the use of a language generally used in the third countr y where the controller is established, is insufficient to ascer tain such intenti on, factors such as the use of a language or a currency general ly used in one or more Member States with the possibility of order ing goods and services in that other languag e, or the mentioning of custome rs or users who are in the Union, may make it apparent that the controller envisages offer ing goods or services to data subjects in the Union. (24) The processing of personal | Passage 33 | [
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34 | data of data subjects who are in the Union by a controller or processor not established in the Union should also be subject to this Regulation when it is related to the monitori ng of the beha viour of such data subjects in so far as their behavi our takes place within the Union. In order to determine whether a processing activity can be considered to monit or the beha viour of data subjects, it should be ascer tained whether natural persons are tracked on the intern et including potential subsequent use of personal data processing techniques which consist of | Passage 34 | [
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35 | prof iling a natural person, particularly in order to take decisions concer ning her or him or for analysing or predicting her or his personal preferences, beha viours and attitudes. (25) Where Member State law applies by virtue of public international law, this Regulation should also apply to a controller not established in the Union, such as in a Member State 's diplomatic mission or consular post. (26) The principles of data prote ction should apply to any information concer ning an identif ied or identifiable natural person. Personal data which have undergone pseudon ymisation, whic h could be attributed | Passage 35 | [
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36 | to a natural person by the use of additional information should be considered to be information on an identif iable natural person. To determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used, such as sing ling out, either by the controller or by another person to identify the natural person directly or indirectly . To ascer tain whether means are reasonably likely to be used to identify the natural person, account should be taken of all objective factors, such as the costs of and the amount of time required | Passage 36 | [
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37 | for identif ication, taking into consideration the available technology at the time of the processing and technological developments. The principles of data protection should theref ore not apply to anonymous information, namely information whic h does not relate to an identified or identif iable natural person or to personal data rendered anonym ous in such a manner that the data subject is not or no long er identifiable. This Regulation does not theref ore concer n the processing of such anony mous information, including for statistical or research purposes. (27) This Regulation does not apply to the personal data of | Passage 37 | [
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38 | deceased persons. Member States may provide for rules regar ding the processing of personal data of deceased persons. (28) The application of pseudonymisation to personal data can reduce the risks to the data subjects concer ned and help controllers and processors to meet their data-protection oblig ations. The explicit introduction of ‘pseudon y misation’ in this Regulation is not intended to preclude any other measures of data prote ction. (29) In order to creat e incentives to apply pseudonymisation when processing personal data, measures of pseudony mi sation should, whilst allowing general analysis, be possible within the same controller when | Passage 38 | [
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39 | that controller has take n technical and organisational measures necessar y to ensure, for the processing concer ned, that this Regulation is implement ed, and that additional information for attributing the personal data to a specifi c data subject is kept separately . The controller processing the personal data should indicate the author ised persons within the same controller . 4.5.2016 L 119/5 Official Jour nal of the European Union EN (30) Natural persons may be associated with online identif iers provided by their devices, applications, tools and prot ocols, such as internet protocol addresses, cookie identif iers or other | Passage 39 | [
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40 | identif iers such as radio frequency identification tags. This may leave traces which, in particular when combined with unique identifiers and other information received by the servers, may be used to creat e profiles of the natural persons and identify them. (31) Public author ities to which personal data are disclosed in accordance with a legal oblig ation for the exer cise of their official mission, such as tax and customs author ities, financial investig ation units, independent adminis trative author ities, or financial mark et author ities responsible for the regulation and super vision of secur ities mark | Passage 40 | [
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41 | ets should not be regar ded as recipients if they receive personal data whic h are necessar y to carry out a particular inquir y in the general inter est, in accordance with Union or Member State law. The requests for disclosure sent by the public author ities should alwa ys be in writing, reasoned and occasional and should not concer n the entirety of a filing system or lead to the interconnection of filing systems. The processing of personal data by those public author ities should compl y with the applicable data-protection rules according to the purposes of the | Passage 41 | [
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42 | processing. (32) Consent should be given by a clear affirmative act establishing a freely given, specifi c, informed and unambiguous indication of the data subject's agreement to the processing of personal data relating to him or her, such as by a written state ment, including by electronic means, or an oral statement. This could include ticking a box when visiting an intern et website, choosing technical settings for information society services or another statement or conduct whic h clearly indicates in this conte xt the data subject's accept ance of the proposed processing of his or her personal data. Silence, | Passage 42 | [
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43 | pre-tick ed boxes or inactivity should not theref ore constitute consent. Consent should cover all processing activities carried out for the same purpose or purposes. When the processing has multiple purposes, consent should be given for all of them. If the data subject's consent is to be given following a request by electronic means, the request must be clear , concise and not unnecessar ily disrupti ve to the use of the service for which it is provided. (33) It is often not possible to fully identify the purpose of personal data processing for scientifi c researc h purposes at | Passage 43 | [
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44 | the time of data collection. Theref ore, data subjects should be allowed to give their consent to certain areas of scientific researc h when in keeping with recognised ethical standards for scientific research. Data subjects should have the oppor tunity to give their consent only to certain areas of research or parts of research projects to the exte nt allowed by the intende d purpose. (34) Genetic data should be defined as personal data relating to the inher ited or acquired genetic charact eristics of a natural person whic h result from the analysis of a biological sample from the | Passage 44 | [
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45 | natural person in question, in particular chromosomal, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) analysis, or from the analysis of another element enabling equivalent information to be obtained. (35) Personal data concer ning health should include all data pertaining to the health status of a data subject which reveal information relating to the past, current or future physical or mental health status of the data subject. This includes information about the natural person collect ed in the course of the registration for, or the provision of, health care services as refer red to in Directive 2011/24/EU of the European Parliament | Passage 45 | [
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] |
46 | and of the Council (1) to that natural person; a number , symbol or particular assigned to a natural person to uniquely identify the natural person for health purposes; information derived from the testing or examination of a body part or bodily substance, including from genetic data and biological sam ples; and any information on, for example, a disease, disability , disease risk, medical histo ry, clinical treatment or the physiological or biomedical state of the data subject independent of its source, for example from a physician or other health profess ional, a hospital, a medical device or an in | Passage 46 | [
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47 | vitro diagnostic test. (36) The main establishment of a controller in the Union should be the place of its central administration in the Union, unless the decisions on the purposes and means of the processing of personal data are taken in another establishment of the controller in the Union, in whic h case that other establishment should be considered to be 4.5.2016 L 119/6 Official Jour nal of the European Union EN (1)Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross‑border healthcare (OJ L 88, 4.4.2011, p. | Passage 47 | [
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] |
48 | 45). the main establishment. The main establishment of a controller in the Union should be determined according to objective criteria and should imply the effective and real exercise of manag ement activities determi ning the main decisions as to the purposes and means of processing through stable arrangements. That criterion should not depend on whether the processing of personal data is carried out at that location. The presence and use of technical means and technologies for processing personal data or processing activities do not, in themselves, constitut e a main establishment and are theref ore not determining criteria for a | Passage 48 | [
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49 | main establishment. The main establishment of the processor should be the place of its central administration in the Union or, if it has no central administration in the Union, the place where the main processing activities take place in the Union. In cases involving both the controller and the processor , the compe tent lead super visor y author ity should remain the super visor y author ity of the Member State where the controller has its main establishment, but the super visor y author ity of the processor should be considered to be a super visor y author ity | Passage 49 | [
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50 | concer ned and that super visor y author ity should participate in the cooperation procedure provided for by this Regulation. In any case, the super visor y author ities of the Member State or Member States where the processor has one or more establishments should not be considered to be super visor y author ities concer ned where the draf t decision concer ns only the controller . Where the processing is carried out by a group of under takings, the main establishment of the controlling under taking should be considered to be the main establishment of the group of | Passage 50 | [
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51 | under takings, excep t where the purposes and means of processing are deter mined by another under taking. (37) A group of under takings should cover a controlling under taking and its controlled under takings, whereby the controlling under taking should be the under taking which can exer t a dominant influence over the other under takings by virtue, for example, of ownership, financial participation or the rules which govern it or the power to have personal data prote ction rules implemented. An under taking which controls the processing of personal data in under takings affiliated to it should be | Passage 51 | [
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52 | regarded, together with those under takings, as a group of under takings. (38) Children mer it specific protection with rega rd to their personal data, as they may be less aware of the risks, consequences and safeg uards concer ned and their rights in relation to the processing of personal data. Such specific protection should, in particular , apply to the use of personal data of children for the purposes of mark eting or creating personality or user profiles and the collection of personal data with regard to children when using services offered directly to a child. The consent of | Passage 52 | [
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53 | the holder of parental responsibility should not be necessar y in the context of preventive or counselling services offered directly to a child. (39) Any processing of personal data should be lawful and fair. It should be transparent to natural persons that personal data concer ning them are collect ed, used, consulte d or other wise processed and to what extent the personal data are or will be processed. The principle of transparency requires that any information and communi cation relating to the processing of those personal data be easily accessible and easy to understand, and that clear and | Passage 53 | [
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54 | plain language be used. That principle concer ns, in particular , information to the data subjects on the identity of the controller and the purposes of the processing and further information to ensure fair and transparent processing in respect of the natural persons concer ned and their right to obtain conf irmation and communication of personal data concer ning them whic h are being processed. Natural persons should be made awar e of risks, rules, safeg uards and rights in relation to the processing of personal data and how to exer cise their rights in relation to such processing. In | Passage 54 | [
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55 | particular , the specific purposes for which personal data are processed should be explicit and legitimate and determined at the time of the collection of the personal data. The personal data should be adequate, relevant and limite d to what is necessar y for the purposes for whic h they are processed. This requires, in particular , ensur ing that the period for whic h the personal data are stored is limited to a strict minimum. Personal data should be processed only if the purpose of the processing could not reasonably be fulfilled by other means. In order to ensure | Passage 55 | [
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56 | that the personal data are not kept longer than necessar y, time limits should be established by the controller for erasure or for a periodic review . Ever y reasonable step should be take n to ensure that personal data which are inaccurat e are rectified or deleted. Personal data should be processed in a manner that ensures appropr iate secur ity and conf identiality of the personal data, including for preventing unauthor ised access to or use of personal data and the equipment used for the processing. (40) In order for processing to be lawful, personal data should be | Passage 56 | [
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57 | processed on the basis of the consent of the data subject concer ned or some other legitimate basis, laid down by law, either in this Regulation or in other Union or 4.5.2016 L 119/7 Official Jour nal of the European Union EN Member State law as refer red to in this Regulation, including the necessity for compl iance with the legal oblig ation to which the controller is subject or the necessity for the performance of a contract to which the data subject is party or in order to take steps at the request of the data subject prior to | Passage 57 | [
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58 | entering into a contract. (41) Where this Regulation refers to a legal basis or a legislative measure, this does not necessar ily require a legislative act adopt ed by a parliament, without prejudice to requirements pursuant to the constitutional order of the Member State concer ned. However , such a lega l basis or legislative measure should be clear and precise and its application should be foreseeable to persons subject to it, in accordance with the case-law of the Cour t of Justice of the European Union (the ‘Cour t of Justice’) and the European Cour t of Human Rights. | Passage 58 | [
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59 | (42) Where processing is based on the data subject's consent, the controller should be able to demonstrate that the data subject has given consent to the processing operation. In particular in the context of a written declaration on another matt er, safeg uards should ensure that the data subject is awar e of the fact that and the extent to whic h consent is given. In accordance with Council Directive 93/13/EEC (1) a declaration of consent pre- formulate d by the controller should be provided in an intelligible and easily accessible form, using clear and plain languag e and it | Passage 59 | [
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60 | should not contain unfair terms. For consent to be informed, the data subject should be aware at least of the identity of the controller and the purposes of the processing for which the personal data are intende d. Consent should not be regar ded as freely given if the data subject has no genuine or free choice or is unable to refuse or withdraw consent without detr iment. (43) In order to ensure that consent is freely given, consent should not provide a valid legal ground for the processing of personal data in a specifi c case where there is | Passage 60 | [
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61 | a clear imbalance between the data subject and the controller , in particular where the controller is a public author ity and it is theref ore unlikely that consent was freely given in all the circumstances of that specifi c situation. Consent is presumed not to be freely given if it does not allow separate consent to be given to differ ent personal data processing operations despit e it being appropr iate in the individual case, or if the perf ormance of a contract, including the provision of a service, is dependent on the consent despite such consent not being | Passage 61 | [
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62 | necessar y for such performa nce. (44) Processing should be lawful where it is necessar y in the cont ext of a contract or the intention to enter into a contract. (45) Where processing is carried out in accordance with a legal oblig ation to whic h the controller is subject or where processing is necessar y for the performa nce of a task carried out in the public inter est or in the exer cise of official author ity, the processing should have a basis in Union or Member State law. This Regulation does not require a specific law | Passage 62 | [
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63 | for each individual processing. A law as a basis for several processing operations based on a legal oblig ation to whic h the controller is subject or where processing is necessar y for the perf ormance of a task carried out in the public interest or in the exer cise of an official author ity may be sufficient. It should also be for Union or Member State law to determine the purpose of processing. Further more, that law could specify the general conditions of this Regulation governing the lawfulness of personal data processing, establish specif ications for determining the controller | Passage 63 | [
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64 | , the type of personal data whic h are subject to the processing, the data subjects concer ned, the entities to which the personal data may be disclosed, the purpose limitations, the storag e period and other measures to ensure lawful and fair processing. It should also be for Union or Member State law to determine whether the controller performing a task carried out in the public interest or in the exer cise of official author ity should be a public author ity or another natural or legal person governed by public law, or, where it is in the public | Passage 64 | [
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65 | inter est to do so, including for health purposes such as public health and social protection and the manag ement of health care services, by private law, such as a professional association. (46) The processing of personal data should also be regarded to be lawful where it is necessar y to prote ct an inter est whic h is essential for the life of the data subject or that of another natural person. Processing of personal data 4.5.2016 L 119/8 Official Jour nal of the European Union EN (1)Council Directive 93/13/EEC of 5 Apr il 1993 on unfair terms in | Passage 65 | [
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66 | consumer contracts (OJ L 95, 21.4.1993, p. 29). based on the vital inter est of another natural person should in principle take place only where the processing cannot be manifest ly based on another legal basis. Some types of processing may serve both impor tant grounds of public interest and the vital inter ests of the data subject as for instance when processing is necessar y for humanitar ian purposes, including for monitori ng epidemics and their spread or in situations of humanitar ian emerg encies, in particular in situations of natural and man-made disasters. (47) The legitimate inter ests | Passage 66 | [
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67 | of a controller , including those of a controller to which the personal data may be disclosed, or of a third party, may provide a legal basis for processing, provided that the interests or the fundamental rights and freedoms of the data subject are not overriding, taking into consideration the reasonable expectations of data subjects based on their relationship with the controller . Such legitimate interest could exist for example where there is a relevant and appropr iate relationship between the data subject and the controller in situations such as where the data subject is a client or in the | Passage 67 | [
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68 | service of the controller . At any rate the existen ce of a legitimate interest would need careful assessment including whether a data subject can reasonably expect at the time and in the cont ext of the collection of the personal data that processing for that purpose may take place. The inter ests and fundamental rights of the data subject could in particular override the inter est of the data controller where personal data are processed in circumstances where data subjects do not reasonably expect further processing. Given that it is for the legislator to provide by law for the | Passage 68 | [
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69 | legal basis for public author ities to process personal data, that legal basis should not apply to the processing by public author ities in the performa nce of their tasks. The processing of personal data strictly necessar y for the purposes of preventing fraud also constitutes a legitimate interest of the data controller concer ned. The processing of personal data for direct mark eting purposes may be regarded as carried out for a legitimate inter est. (48) Controllers that are part of a group of under takings or institutions affiliated to a central body may have a legitimate inter est | Passage 69 | [
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70 | in transmitting personal data within the group of under takings for internal administrative purposes, including the processing of clients' or employees' personal data. The general principles for the transfe r of personal data, within a group of under takings, to an under taking locat ed in a third countr y remain unaffect ed. (49) The processing of personal data to the extent strictly necessar y and propor tionate for the purposes of ensur ing netw ork and information secur ity, i.e. the ability of a network or an information syste m to resist, at a given level of conf idence, | Passage 70 | [
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71 | accidental events or unlawful or malicious actions that compromise the availabi lity, authenticity , integrity and confidentiality of store d or transmitte d personal data, and the secur ity of the related services offered by, or accessible via, those netw orks and systems, by public author ities, by comput er emerge ncy response teams (CERT s), comput er secur ity incident response teams (CSIRT s), by providers of electronic communications netw orks and services and by providers of secur ity technologies and services, constitutes a legitimat e interest of the data controller concer ned. This could, for exam ple, include | Passage 71 | [
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72 | preventing unauthor ised access to electronic communications netw orks and malicious code distr ibution and stoppi ng ‘denial of service ’ attacks and damage to comput er and electronic communication systems. (50) The processing of personal data for purposes other than those for which the personal data were initially collect ed should be allowed only where the processing is compatible with the purposes for which the personal data were initially collect ed. In such a case, no lega l basis separate from that whic h allowed the collection of the personal data is required. If the processing is necessar y | Passage 72 | [
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73 | for the performa nce of a task carried out in the public interest or in the exer cise of official author ity vested in the controller , Union or Member State law may determine and specify the tasks and purposes for whic h the further processing should be regar ded as compati ble and lawful. Further processing for archiv ing purposes in the public inter est, scientific or histor ical researc h purposes or statistical purposes should be considered to be compati ble lawful processing operations. The legal basis provided by Union or Member State law for the processing of | Passage 73 | [
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74 | personal data may also provide a lega l basis for further processing. In order to ascer tain whether a purpose of further processing is compati ble with the purpose for whic h the personal data are initially collect ed, the controller , after having met all the requirements for the lawfulness of the original processing, should take into account, inter alia: any link between those purposes and the purposes of the intende d further processing; the context in whic h the personal data have been collected, in particular the reasonable expectations of data subjects based on their relationship with the | Passage 74 | [
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75 | controller as to their 4.5.2016 L 119/9 Official Jour nal of the European Union EN further use; the nature of the personal data; the consequences of the intended further processing for data subjects; and the existen ce of appropr iate safeguards in both the original and intended further processing operations. Where the data subject has given consent or the processing is based on Union or Member State law which constitut es a necessar y and propor tionate measure in a democratic society to safeguard, in particular , impor tant objectives of general public interest, the controller should be allowed to | Passage 75 | [
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76 | further process the personal data irrespective of the compatibility of the purposes. In any case, the application of the principles set out in this Regulation and in particular the information of the data subject on those other purposes and on his or her rights including the right to object, should be ensured. Indicating possible criminal acts or threats to public secur ity by the controller and transmitting the relevant personal data in individual cases or in several cases relating to the same criminal act or threats to public secur ity to a compet ent author ity should be regarded as | Passage 76 | [
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77 | being in the legitimate interest pursued by the controller . However , such transmission in the legitimate interest of the controller or further processing of personal data should be prohibit ed if the processing is not compat ible with a legal, profess ional or other binding oblig ation of secrecy . (51) Personal data whic h are, by their nature, particularly sensitive in relation to fundamental rights and freedoms mer it specific protection as the context of their processing could creat e signif icant risks to the fundamental rights and freedoms. Those personal data should include personal data revealing racial | Passage 77 | [
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78 | or ethnic origin, whereby the use of the term ‘racial origin’ in this Regulation does not imply an acceptance by the Union of theor ies which attempt to determine the existence of separate human races. The processing of photog raphs should not systemati cally be considered to be processing of special cate gories of personal data as they are covered by the definit ion of biometr ic data only when processed through a specifi c technical means allowing the unique identif ication or authentication of a natural person. Such personal data should not be processed, unless processing is allowed | Passage 78 | [
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79 | in specific cases set out in this Regulation, taking into account that Member States law may lay down specific provisions on data protection in order to adapt the application of the rules of this Regulation for compl iance with a legal oblig ation or for the performa nce of a task carried out in the public interest or in the exercise of official author ity vested in the controller . In addition to the specific requirements for such processing, the general principles and other rules of this Regulation should apply , in particular as regar ds the conditions for lawful | Passage 79 | [
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80 | processing. Derog ations from the general prohibition for processing such special catego ries of personal data should be explicitly provided, inter alia, where the data subject gives his or her explicit consent or in respect of specific needs in particular where the processing is carried out in the course of legitimate activities by certain associations or foundations the purpose of whic h is to permit the exercise of fundamental freedoms. (52) Derog ating from the prohibition on processing special categor ies of personal data should also be allowed when provided for in Union or Member State law and subject to | Passage 80 | [
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81 | suitable safeg uards, so as to protect personal data and other fundamental rights, where it is in the public inter est to do so, in particular processing personal data in the field of emplo yment law, social protect ion law including pensions and for health secur ity, monitoring and alert purposes, the prevention or control of communicable diseases and other serious threats to health. Such a deroga tion may be made for health purposes, including public health and the manag ement of health-care services, especially in order to ensure the quality and cost-eff ectiveness of the procedures used for settling | Passage 81 | [
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82 | claims for benefits and services in the health insurance system , or for archiving purposes in the public inter est, scientifi c or histor ical research purposes or statistical purposes. A derog ation should also allow the processing of such personal data where necessar y for the establishment, exercise or defe nce of legal claims, whether in cour t proceedings or in an administrative or out-of-cour t procedure. (53) Special cate gories of personal data whic h mer it higher prote ction should be processed for health-related purposes only where necessar y to achieve those purposes for the benefit of | Passage 82 | [
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83 | natural persons and society as a whole, in particular in the context of the management of health or social care services and syste ms, including processing by the management and central national health author ities of such data for the purpose of quality control, manag ement information and the general national and local super vision of the health or social care system , and ensur ing continuity of health or social care and cross-border healthcare or health secur ity, monitori ng and alert purposes, or for archiving purposes in the public inter est, scientific or histo rical researc h purposes | Passage 83 | [
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84 | or statistical purposes, based on Union or Member State law whic h has to meet an objective of public interest, as well as for studies conduct ed in the public interest in the area of public health. Theref ore, this Regulation should provide for harmonised conditions for the processing of special categor ies of personal data concer ning health, in respect of specific needs, in particular where the processing of such data is carried out for certain health-relat ed purposes 4.5.2016 L 119/10 Official Jour nal of the European Union EN by persons subject to a legal oblig ation of | Passage 84 | [
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85 | professional secrecy . Union or Member State law should provide for specific and suitable measures so as to prote ct the fundamental rights and the personal data of natural persons. Member State s should be allowed to maintain or introduce further conditions, including limitations, with rega rd to the processing of genetic data, biometr ic data or data concer ning health. However , this should not ham per the free flow of personal data within the Union when those conditions apply to cross-border processing of such data. (54) The processing of special catego ries of personal data may be necessar | Passage 85 | [
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86 | y for reasons of public interest in the areas of public health without consent of the data subject. Such processing should be subject to suitable and specifi c measures so as to prot ect the rights and freedoms of natural persons. In that context, ‘public health’ should be interpreted as defined in Regulation (EC) No 1338/2008 of the European Parliament and of the Council (1), namely all elements related to health, namely health status, including morbidity and disability , the determinants having an effect on that health status, health care needs, resources allocated to health care, the provision of, and | Passage 86 | [
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87 | universal access to, health care as well as health care expenditure and financing, and the causes of mor tality . Such processing of data concer ning health for reasons of public inter est should not result in personal data being processed for other purposes by third parties such as emplo yers or insurance and banking companies. (55) Moreo ver, the processing of personal data by official author ities for the purpose of achieving the aims, laid down by constitutional law or by intern ational public law, of officially recognised religious associations, is carried out on grounds of public interest. (56) | Passage 87 | [
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88 | Where in the course of electoral activities, the operation of the democratic system in a Member State requires that political parties compile personal data on people's political opinions, the processing of such data may be permitted for reasons of public interest, provided that appropr iate safeg uards are established. (57) If the personal data processed by a controller do not permit the controller to identify a natural person, the data controller should not be oblig ed to acquire additional information in order to identify the data subject for the sole purpose of compl ying with any provision of this Regulation. | Passage 88 | [
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89 | However , the controller should not refuse to take additional information provided by the data subject in order to suppor t the exer cise of his or her rights. Identification should include the digital identif ication of a data subject, for example through authentication mech anism such as the same credentials, used by the data subject to log-in to the on-line service offered by the data controller . (58) The principle of transparency requires that any information addressed to the public or to the data subject be concise, easily accessible and easy to understand, and that clear and plain language | Passage 89 | [
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90 | and, additionally , where appropr iate, visualisation be used. Such information could be provided in electronic form, for examp le, when addressed to the public, through a website. This is of particular relevance in situations where the prolife ration of actors and the technological complexity of practice make it difficult for the data subject to kno w and understand whether , by whom and for what purpose personal data relating to him or her are being collect ed, such as in the case of online adver tising. Given that children mer it specifi c protection, any information and communication, where | Passage 90 | [
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91 | processing is addressed to a child, should be in such a clear and plain language that the child can easily understand. (59) Modalities should be provided for facilitating the exercise of the data subject's rights under this Regulation, including mech anisms to request and, if applicable, obtain, free of charge, in particular , access to and rectification or erasure of personal data and the exercise of the right to object. The controller should also provide means for requests to be made electronically , especially where personal data are processed by electronic means. The controller should be oblig ed to respond | Passage 91 | [
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92 | to requests from the data subject without undue dela y and at the latest within one month and to give reasons where the controller does not intend to compl y with any such requests. 4.5.2016 L 119/11 Official Jour nal of the European Union EN (1)Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work (OJ L 354, 31.12.2008, p. 70). (60) The principles of fair and transparent processing require that the data subject be informed of the existen ce of the | Passage 92 | [
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93 | processing operation and its purposes. The controller should provide the data subject with any further information necessar y to ensure fair and transparent processing taking into account the specific circumstances and cont ext in whic h the personal data are processed. Further more, the data subject should be informed of the existen ce of profiling and the consequences of such prof iling. Where the personal data are collect ed from the data subject, the data subject should also be informed whether he or she is oblig ed to provide the personal data and of the consequences, where he or she | Passage 93 | [
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94 | does not provide such data. That information may be provided in combination with standardised icons in order to give in an easily visible, intelligible and clearly legible manner , a meaningful overview of the intende d processing. Where the icons are presented electronically , they should be machi ne-readable. (61) The information in relation to the processing of personal data relating to the data subject should be given to him or her at the time of collection from the data subject, or, where the personal data are obtained from another source, within a reasonable period, depending on the circumstances of | Passage 94 | [
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95 | the case. Where personal data can be legitimate ly disclosed to another recipient, the data subject should be informed when the personal data are first disclosed to the recipient. Where the controller intends to process the personal data for a purpose other than that for whic h they were collected, the controller should provide the data subject prior to that further processing with information on that other purpose and other necessar y information. Where the origin of the personal data cannot be provided to the data subject because various sources have been used, general information should be provided. (62) However | Passage 95 | [
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96 | , it is not necessar y to imp ose the oblig ation to provide information where the data subject already possesses the information, where the recording or disclosure of the personal data is expressly laid down by law or where the provision of information to the data subject proves to be imp ossible or would involve a dispropor tionate effort. The latter could in particular be the case where processing is carried out for archiving purposes in the public interest, scientific or histo rical research purposes or statistical purposes. In that regard, the number of data subjects, the age | Passage 96 | [
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97 | of the data and any appropr iate safeg uards adopt ed should be take n into consideration. (63) A data subject should have the right of access to personal data whic h have been collect ed concer ning him or her, and to exercise that right easily and at reasonable inter vals, in order to be awar e of, and verify, the lawfulness of the processing. This includes the right for data subjects to have access to data concer ning their health, for examp le the data in their medical records containing information such as diagnoses, examination results, assessments by | Passage 97 | [
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98 | treating physicians and any treatment or inter ventions provided. Ever y data subject should theref ore have the right to kno w and obtain communication in particular with regar d to the purposes for whic h the personal data are processed, where possible the period for whic h the personal data are processed, the recipients of the personal data, the logic involved in any autom atic personal data processing and, at least when based on profiling, the consequences of such processing. Where possible, the controller should be able to provide remot e access to a secure system which would provide | Passage 98 | [
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99 | the data subject with direct access to his or her personal data. That right should not adversely affect the rights or freedoms of others, including trade secrets or intellectual proper ty and in particular the copyright protecting the software. However , the result of those considerations should not be a refusal to provide all information to the data subject. Where the controller processes a large quantity of information concer ning the data subject, the controller should be able to request that, before the information is delivered, the data subject specify the information or processing activities to whic h the request | Passage 99 | [
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