Article 35 GDPR

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Article 35 - Data protection impact assessment
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Chapter 10: Delegated and implementing acts

Legal Text[edit | edit source]


Article 35 - Data protection impact assessment

1. Where a type of processing in particular using new technologies, and taking into account the nature, scope, context and purposes of the processing, is likely to result in a high risk to the rights and freedoms of natural persons, the controller shall, prior to the processing, carry out an assessment of the impact of the envisaged processing operations on the protection of personal data. A single assessment may address a set of similar processing operations that present similar high risks.

2. The controller shall seek the advice of the data protection officer, where designated, when carrying out a data protection impact assessment.

3. A data protection impact assessment referred to in paragraph 1 shall in particular be required in the case of:

(a) a systematic and extensive evaluation of personal aspects relating to natural persons which is based on automated processing, including profiling, and on which decisions are based that produce legal effects concerning the natural person or similarly significantly affect the natural person;
(b) processing on a large scale of special categories of data referred to in Article 9(1), or of personal data relating to criminal convictions and offences referred to in Article 10; or
(c) a systematic monitoring of a publicly accessible area on a large scale.

4. The supervisory authority shall establish and make public a list of the kind of processing operations which are subject to the requirement for a data protection impact assessment pursuant to paragraph 1. The supervisory authority shall communicate those lists to the Board referred to in Article 68.

5. The supervisory authority may also establish and make public a list of the kind of processing operations for which no data protection impact assessment is required. The supervisory authority shall communicate those lists to the Board.

6. Prior to the adoption of the lists referred to in paragraphs 4 and 5, the competent supervisory authority shall apply the consistency mechanism referred to in Article 63 where such lists involve processing activities which are related to the offering of goods or services to data subjects or to the monitoring of their behaviour in several Member States, or may substantially affect the free movement of personal data within the Union.

7. The assessment shall contain at least:

(a) a systematic description of the envisaged processing operations and the purposes of the processing, including, where applicable, the legitimate interest pursued by the controller;
(b) an assessment of the necessity and proportionality of the processing operations in relation to the purposes;
(c) an assessment of the risks to the rights and freedoms of data subjects referred to in paragraph 1; and
(d) the measures envisaged to address the risks, including safeguards, security measures and mechanisms to ensure the protection of personal data and to demonstrate compliance with this Regulation taking into account the rights and legitimate interests of data subjects and other persons concerned.

8. Compliance with approved codes of conduct referred to in Article 40 by the relevant controllers or processors shall be taken into due account in assessing the impact of the processing operations performed by such controllers or processors, in particular for the purposes of a data protection impact assessment.

9. Where appropriate, the controller shall seek the views of data subjects or their representatives on the intended processing, without prejudice to the protection of commercial or public interests or the security of processing operations.

10. Where processing pursuant to point (c) or (e) of Article 6(1) has a legal basis in Union law or in the law of the Member State to which the controller is subject, that law regulates the specific processing operation or set of operations in question, and a data protection impact assessment has already been carried out as part of a general impact assessment in the context of the adoption of that legal basis, paragraphs 1 to 7 shall not apply unless Member States deem it to be necessary to carry out such an assessment prior to processing activities.

11. Where necessary, the controller shall carry out a review to assess if processing is performed in accordance with the data protection impact assessment at least when there is a change of the risk represented by processing operations.

Relevant Recitals[edit | edit source]

Recital 75: Risks to the Rights and Freedoms of Natural Persons
The risk to the rights and freedoms of natural persons, of varying likelihood and severity, may result from personal data processing which could lead to physical, material or non-material damage, in particular: where the processing may give rise to discrimination, identity theft or fraud, financial loss, damage to the reputation, loss of confidentiality of personal data protected by professional secrecy, unauthorised reversal of pseudonymisation, or any other significant economic or social disadvantage; where data subjects might be deprived of their rights and freedoms or prevented from exercising control over their personal data; where personal data are processed which reveal racial or ethnic origin, political opinions, religion or philosophical beliefs, trade union membership, and the processing of genetic data, data concerning health or data concerning sex life or criminal convictions and offences or related security measures; where personal aspects are evaluated, in particular analysing or predicting aspects concerning performance at work, economic situation, health, personal preferences or interests, reliability or behaviour, location or movements, in order to create or use personal profiles; where personal data of vulnerable natural persons, in particular of children, are processed; or where processing involves a large amount of personal data and affects a large number of data subjects.

Recital 84: Data Protection Impact Assessment
In order to enhance compliance with this Regulation where processing operations are likely to result in a high risk to the rights and freedoms of natural persons, the controller should be responsible for the carrying-out of a data protection impact assessment to evaluate, in particular, the origin, nature, particularity and severity of that risk. The outcome of the assessment should be taken into account when determining the appropriate measures to be taken in order to demonstrate that the processing of personal data complies with this Regulation. Where a data-protection impact assessment indicates that processing operations involve a high risk which the controller cannot mitigate by appropriate measures in terms of available technology and costs of implementation, a consultation of the supervisory authority should take place prior to the processing.

Recital 89: Abolishment of Indiscriminate General Notification
Directive 95/46/EC provided for a general obligation to notify the processing of personal data to the supervisory authorities. While that obligation produces administrative and financial burdens, it did not in all cases contribute to improving the protection of personal data. Such indiscriminate general notification obligations should therefore be abolished, and replaced by effective procedures and mechanisms which focus instead on those types of processing operations which are likely to result in a high risk to the rights and freedoms of natural persons by virtue of their nature, scope, context and purposes. Such types of processing operations may be those which in, particular, involve using new technologies, or are of a new kind and where no data protection impact assessment has been carried out before by the controller, or where they become necessary in the light of the time that has elapsed since the initial processing.

Recital 90: Impact Assessment Modalities and Scope
In such cases, a data protection impact assessment should be carried out by the controller prior to the processing in order to assess the particular likelihood and severity of the high risk, taking into account the nature, scope, context and purposes of the processing and the sources of the risk. That impact assessment should include, in particular, the measures, safeguards and mechanisms envisaged for mitigating that risk, ensuring the protection of personal data and demonstrating compliance with this Regulation.

Recital 91: Conditions Necessitating an Impact Assessment
This should in particular apply to large-scale processing operations which aim to process a considerable amount of personal data at regional, national or supranational level and which could affect a large number of data subjects and which are likely to result in a high risk, for example, on account of their sensitivity, where in accordance with the achieved state of technological knowledge a new technology is used on a large scale as well as to other processing operations which result in a high risk to the rights and freedoms of data subjects, in particular where those operations render it more difficult for data subjects to exercise their rights. A data protection impact assessment should also be made where personal data are processed for taking decisions regarding specific natural persons following any systematic and extensive evaluation of personal aspects relating to natural persons based on profiling those data or following the processing of special categories of personal data, biometric data, or data on criminal convictions and offences or related security measures. A data protection impact assessment is equally required for monitoring publicly accessible areas on a large scale, especially when using optic-electronic devices or for any other operations where the competent supervisory authority considers that the processing is likely to result in a high risk to the rights and freedoms of data subjects, in particular because they prevent data subjects from exercising a right or using a service or a contract, or because they are carried out systematically on a large scale. The processing of personal data should not be considered to be on a large scale if the processing concerns personal data from patients or clients by an individual physician, other health care professional or lawyer. In such cases, a data protection impact assessment should not be mandatory.

Recital 92: Broader Data Protection Impact Assessments
There are circumstances under which it may be reasonable and economical for the subject of a data protection impact assessment to be broader than a single project, for example where public authorities or bodies intend to establish a common application or processing platform or where several controllers plan to introduce a common application or processing environment across an industry sector or segment or for a widely used horizontal activity.

Recital 93: Data Protection Impact at Public Authorties and Bodies
In the context of the adoption of the Member State law on which the performance of the tasks of the public authority or public body is based and which regulates the specific processing operation or set of operations in question, Member States may deem it necessary to carry out such assessment prior to the processing activities.

Commentary[edit | edit source]

Article 35 requires the controller to carry out a Data Protection Impact Assessment (DPIA) when a certain processing operation (or a set of operations with similar characteristics) presents a high risk to the rights and freedoms of natural persons. The DPIA is one of the most innovative elements in the GDPR related to the accountability principle (see Articles 5(2) and 24 GDPR). This provision regulates the cases in which a DPIA is mandatory, what its minimum content is, and other procedural aspects related to carrying out the analysis it entails.

EDPB Guidelines: on this Article, please see Data Protection Impact Assessments High-Risk Processing

(1) Mandatory DPIA[edit | edit source]

The DPIA is an analysis document that takes into account the nature, scope, context and purposes of the processing, evaluates its potential risks, and considers any remedy which can minimise or reduce such risks. It is the controller’s responsibility to perform a DPIA. Processors and device manufacturers are therefore not responsible for carrying out this analysis.[1] However, under Article 28(3)(f) GDPR, the processor shall assist the controller by providing any information available to them. The Data Protection Officer (DPO) must also be involved in the drafting of the DPIA under Article 35(2) GDPR and Article 39(1)(c) GDPR, and their advice should be recorded by the controller. Data subjects can also be involved in the preparation of the document, as stipulated by Article 35(9) GDPR.

Controllers must carry out a DPIA only if the processing “is likely to result in a high risk to the rights and freedoms of natural persons”. Accordingly, the Article 29 Working Party (WP29) considers that a DPIA is not required[2] when: (i) the processing is not "likely to result in a high risk to the rights and freedoms of natural persons"; (ii) the nature, scope, context and purposes of the processing are very similar to the processing for which a DPIA has been carried out;[3] (iii) the processing operations have been checked by a Data Protection Authority (DPA) before May 2018 and the specific conditions have not changed;[4] a processing operation pursuant to Article 6(1)(c) or (e) has a legal basis in EU or Member State law, where the law regulates the specific processing operation, and a DPIA has already been carried out as part of the establishment of that legal basis (Article 35(10) GDPR);[5] the processing is included on an optional list (established by a DPA) of processing operations for which no DPIA is required (Article 35(5) GDPR).[6] The DPIA must take place before the processing begins. If the processing began before the GDPR came into force there is logically no possibility of a prior impact assessment.[7] However, DPIAs should be seen as a continuous process rather than as a one-time exercise.[8] For these reasons, it would be advisable to carry out a new DPIA in such circumstances.

(2) Involvement of the Data Protection Officer[edit | edit source]

Where an obligation to carry out a DPIA exists, the designated DPO has to be involved in the procedure, and the controller should consult them for their advice.[9] The DPO involvement should be documented in writing in order to demonstrate that the advice has been sought. Although the controller is not obliged to follow the DPO’s opinion it should motivate and document its reasons if it chooses not to.[10]

(3) Likely to Result in a High Risk[edit | edit source]

Article 35(3) GDPR provides a list of “inherently” risky processing operations which always require a previous DPIA. This is the case when processing involves (a) a systematic and extensive evaluation of personal aspects relating to natural persons which is based on automated processing, including profiling, and on which decisions are based that produce legal effects concerning the natural person or similarly significantly affect the natural person; (b) processing on a large scale of special categories of data referred to in Article 9(1) GDPR, or of personal data relating to criminal convictions and offences referred to in Article 10 GDPR; or (c) a systematic monitoring of a publicly accessible area on a large scale. The use of the phrase "in particular" in this provision means that the above-mentioned circumstances, however, do not constitute an exhaustive list and a DPIA may also be required for other types of processing which are not mentioned in it.[11] Based on this argument, the WP29 has developed a list of criteria for assessing the high risk involved in certain types of processing, including, among others, the existence of assessment or scoring operations, the presence of automated decision-making, systematic monitoring, the use of particular categories of data, the existence of large-scale data processing, matching operations between different databases, personal data relating to vulnerable individuals, the use of new technologies, and finally, the fact that the processing may inhibit the data subject from either exercising their rights, or using a particular service. In the WP29’s view, regardless of the mitigating measures which a controller may adopt, as more of these criteria are met, it will be more likely that the processing will present a high risk for data subjects’ rights and freedoms, and thus require a DPIA. However, "in some cases, a data controller can consider that a processing meeting only one of these criteria requires a DPIA". Conversely, a processing operation may correspond to the aforementioned cases and still be considered by the controller not to be “likely to result in a high risk”. In such cases "the controller should justify and document the reasons for not carrying out a DPIA". However, according to the WP29, in most cases, the meeting of two criteria would suffice to justify a DPIA requirement.[12]

(4)(5) Specifications through DPAs[edit | edit source]

As previously mentioned, every DPA shall establish a list of processing operations for which a DPIA is always required ("positive" list) under Article 35(1) GDPR. At the same time, the DPAs may draft a list of processing operations which do not require a DPIA ("negative" list).[13] In both cases, the national DPAs are obliged to communicate the lists to the EDPB according to Article 68 GDPR. The lists are available online on the EDPB's website.[14]

(6) Consistency Mechanism is Required in Certain Cases[edit | edit source]

Where the lists referred to in paragraphs 4 and 5 involve processing activities which on the one hand are related to the offering of goods or services to data subjects or to the monitoring of their behaviour in several Member States, or on the other hand may substantially affect the free movement of personal data within the Union, the competent DPA shall communicate them to the EDPB and apply the consistency mechanism referred to in Article 63 GDPR.

(7) DPIA Minimum Requirements[edit | edit source]

Article 35(7) GDPR sets out a list of minimum requirements which shall be dealt with in the DPIA. To begin with, under Article 35(7)(a) GDPR, the assessment must provide a systematic description of the envisaged processing operations and its purposes. In practice, this first step includes the description of the data flow and the systematic indication of the legal basis of the processing, including any legitimate interests pursued by the controller. In accordance with Article 35(7)(b) GDPR, the assessment will then have to ponder and explain the necessity and proportionality of each processing with regard to each purpose pursued. The controller shall explain for which reason a processing, or a set of processing activities, is necessary to pursue a specific purpose. In doing so, it also has to justify why other less intrusive processing is not suitable for the purpose.

Article 35(7)(c) GDPR requires the controller to include an assessment of the risks to the data subjects’ rights and freedoms. A “risk” is a scenario describing an event and its consequences, estimated in terms of severity and likelihood.[15] Risks can exist both within the controller's organization (e.g. employees, trainees, consultants) as well as externally (e.g. hackers, suppliers), and do not have to be caused exclusively by humans (e.g. harmful computer code, animals, fire, natural disasters). An individual risk is calculated by comparing the potential damage with the probability of its occurrence.[16] It is generally possible to distinguish between “implied risk” and “residual risk”. The former refers to the probability of detrimental consequences if no preventive measures are taken by the controller. The latter , on the contrary, is related to the negative impacts which may still occur despite the fact that certain mitigation measures may have been adopted.[17]

Under Article 35(7)(d) GDPR, the DPIA must include the appropriate measures the controller has adopted to mitigate potential risks. These measures may be technical or organisational in nature, including legal safeguards arising from contracts or other legal sources. The controller shall then apply these measures to the previously identified risks and verify the extent to which they contribute to risk reduction. This makes it possible to calculate the aforementioned 'residual risk'.[18] The DPIA must be documented, otherwise the controller would not be able to "systematically describe" the envisaged processing (Article 35(7)(a) GDPR) or share the assessment with the data protection authority under Article 36 GDPR. In general, the written form is the only way to provide proof of compliance. The GDPR does not explicitly require the publication of the assessment. However, in the interest of transparency towards data subjects, the essential parts of the DPIA can and should be published, or at least made available to the interested parties.[19]

Finally, Article 35(7) GDPR does not provide specific guidance on the structure, content and methodology the DPIA should follow. Nevertheless, in order to facilitate the controller's task, some DPAs have provided DPIA templates.Article 35 requires the controller to carry out a Data Protection Impact Assessment (DPIA) when a certain processing operation (or a set of operations with similar characteristics) presents a high risk to the rights and freedoms of natural persons. The DPIA is one of the most innovative elements in the GDPR related to the accountability principle (see [20] Although there is no obligation to use any of these models, they may serve as useful methodological or content related guides.

(8) Codes of Conducts[edit | edit source]

Compliance with approved codes of conduct referred to in Article 40 GDPR shall be taken into due account in assessing the impact of the processing operations performed by the relevant controllers or processors, in particular for the purposes of a DPIA. Although adhering to an approved code of conduct does not automatically guarantee sufficient risk reduction for processing activities in specific cases, it does, however, make it significantly easier to conduct a DPIA and demonstrate compliance with GDPR.[21]

(9) Data Subjects Involvement in the Drafting of the DPIA[edit | edit source]

Under Article 35(9) GDPR, the controller, “where appropriate” may “seek the views of data subjects or their representatives on the intended processing”.[22] This will be instrumental in order to increase the transparency of the processing and the involvement of (potential) data subjects in the assessment of of the processing. Whether this is an obligatory or voluntary step is not entirely clear. Some authors focus on one part of the text ('where appropriate') and conclude that it is merely an option.[23] This view, however, does not seem conclusive. The case, in fact, provides that 'where appropriate' the controller 'shall' seek the data subject's advice. Unlike ‘may’ or ‘can’, ‘shall’ implies an obligation Accordingly, the controller must give precise reasons as to whether the consultation is appropriate or not. The same effort seems to be required in case the controller does involve the data subjects, but then decides to override their input.

(10) National Exemptions[edit | edit source]

There is no obligation to conduct a DPIA when the processing relies on Article 6(1)(c) or (e) GDPR as a legal basis, which in turn is based on European or Member State law for which the lawmaker has already conducted a general impact assessment (see also Recital 93 GDPR). In this regard, the lawmaker can effectively shift the DPIA to the law-making process, in order to reduce the resulting bureaucracy for public institutions relying on these laws to carry out their processing activities.[24] However, the lawmaker is not obliged to do so, and can still require controllers to carry out their own DPIA despite having already conducted one during the law-making process.

(11) Review of Processing and Updates[edit | edit source]

Article 35(11) GDPR requires the controller to reassess if the processing is performed in accordance with the DPIA. However, the fact that the DPIA may need to be updated once the processing has actually started is not a valid reason for postponing or not carrying out a DPIA. Carrying out a DPIA is an continual ongoing process and not a one-time exercise, especially where a processing operation and the risks it might imply are dynamic and subject to ongoing change.[25]

Decisions[edit | edit source]

→ You can find all related decisions in Category:Article 35 GDPR

References[edit | edit source]

  1. Hansen, in Wolff, Brink, BeckOK Datenschutzrecht, Article 35 GDPR, margin number 10 (C.H. Beck 2021, 39th ed.).
  2. WP29, ‘Guidelines on Data Protection Impact Assessment (DPIA) and determining whether processing is “likely to result in a high risk” for the purposes of Regulation 2016/679’, 17/EN WP248 rev.01, 4 October 2017, pp. 12-13 (available here).
  3. In such cases, the controller may use the results of a DPIA already carried out for similar processing (Article 35(1), last sentence GDPR).
  4. "Commission decisions adopted and authorisations by supervisory authorities based on Directive 95/46/EC remain in force until amended, replaced or repealed" (Recital 171).
  5. Except if Member state law states it to be necessary to carry out a DPIA prior processing activities.
  6. Such a list may contain processing activities that comply with the conditions specified by this authority, in particular through guidelines, specific decisions or authorisations, compliance rules, etc. (e.g. in France, authorisations, exemptions, simplified rules, compliance packs…). In such cases, and subject to re-assessment by the competent supervisory authority, a DPIA is not required, but only if the processing falls strictly within the scope of the relevant procedure mentioned in the list and continues to comply fully with all the relevant requirements of the GDPR.
  7. Hansen, in Wolff, Brink, BeckOK Datenschutzrecht, Article 35 GDPR, margin number 19 (C.H. Beck 2021, 39th edition).
  8. Kosta, in Kuner, Bygrave, Docksey, The EU General Data Protection Regulation (GDPR): A Commentary, Article 35 GDPR, p. 675 (Oxford University Press 2020).
  9. Jandt, in Kühling, Buchner, DS-GVO BDSG, Article 35 GDPR, margin number 18 (C.H. Beck 2020, 3rd Edition).
  10. Hansen, in Wolff, Brink, BeckOK Datenschutzrecht, Article 35 GDPR, margin number 23 (C.H. Beck 2021, 39th edition).
  11. Karg, in Simitis, Hornung, Spieker gen. Döhmann, Datenschutzrecht, Article 35 GDPR, margin number 36 (C.H. Beck 2019).
  12. WP29, ‘Guidelines on Data Protection Impact Assessment (DPIA) and determining whether processing is “likely to result in a high risk” for the purposes of Regulation 2016/679’, 17/EN WP248 rev.01, 4 October 2017, pp. 9-12 (available here).
  13. Where a supervisory authority draws up such a negative list, attention must be paid to the detailed description of the processing operations so that the controller does not run the risk of misunderstanding the entries and thus refrains from carrying out the data protection impact assessment and possibly also taking the necessary remedial measures despite a likely high risk. See, Hansen, in BeckOK DatenschutzR, Article 35 GDPR, margin number 36 (Beck 2020, 36th ed.) (accessed 25 February 2022).
  14. Available here: https://edpb.europa.eu/our-work-tools/consistency-findings/register-for-decisions_el?f%5B0%5D=register_decisions_topic%3A138
  15. WP29, ‘Guidelines on Data Protection Impact Assessment (DPIA) and determining whether processing is “likely to result in a high risk” for the purposes of Regulation 2016/679’, 17/EN WP248 rev.01, 4 October 2017, p. 6 (available here).
  16. Schwendemann, in Sydow, Europäische Datenschutzgrundverordnung, Article 35 GDPR, margin number 27 (C.H. Beck 2018, 2nd Edition.
  17. Under Article 35(8) GDPR, compliance with approved codes of conduct referred to in Article 40 GDPR by the relevant controllers or processors “shall be taken into due account in assessing the impact of the processing operations performed by such controllers or processors, in particular for the purposes of a data protection impact assessment.
  18. Hansen, in Wolff, Brink, BeckOK Datenschutzrecht, Article 35 GDPR, margin number 49 (C.H. Beck 2021, 39th edition).
  19. WP29, ‘Guidelines on Data Protection Impact Assessment (DPIA) and determining whether processing is “likely to result in a high risk” for the purposes of Regulation 2016/679’, 17/EN WP248 rev.01, 4 October 2017, p. 18 (available here).
  20. The French DPA (CNIL) provides specific guidance as well as a software for carrying out an impact assessment (here). The Belgian DPA (APD/GBA) provides a recommendation on data protection impact assessment (here). The Spanish DPA (AEPD) has also published similar guidance on its website (here).
  21. Hansen, in Wolff, Brink, BeckOK Datenschutzrecht, Article 35 GDPR, margin number 59 (C.H. Beck 2021, 39th edition).
  22. These can be, for example, works and staff councils, trade unions, consumer protection associations or civil society groups. Unless there is an obligation to participate due to other legal norms, it is left to the controller to take care of the data subjects' views. See, Hansen, in Wolff, Brink, BeckOK Datenschutzrecht, Article 35 GDPR, margin number 61 (C.H. Beck 2021, 39th edition).
  23. Baumgartner in Ehman, Selmayr, Datenschutz-Grundverordnung, Article 35 GDPR, margin numbers 70-71 (C.H. Beck 2018, 2nd Edition).
  24. Karg, in Simitis, Hornung, Spieker gen. Döhmann, Datenschutzrecht, Article 35 GDPR, margin number 58 (C.H. Beck 2019).
  25. WP29, ‘Guidelines on Data Protection Impact Assessment (DPIA) and determining whether processing is “likely to result in a high risk” for the purposes of Regulation 2016/679’, 17/EN WP248 rev.01, 4 October 2017, p. 14 (available here).