Article 35 GDPR: Difference between revisions

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=== (1) Mandatory DPIA ===
=== (1) Mandatory DPIA ===
The DPIA is an analysis document that takes into account the nature, scope, context and purposes of the processing, evaluates its potential risks and consider any remedy which can minimise or reduce such risks. The minimum content of the DPIA is described in detail in paragraph 7 below. (see below).  
The DPIA is an analysis document that takes into account the nature, scope, context and purposes of the processing, evaluates its potential risks and consider any remedy which can minimise or reduce such risks.<ref>The minimum content of the DPIA is described in detail in paragraph 7 below.</ref> The party required to prepare the DPIA is the controller. Processors and device manufacturers are therefore not responsible for preparing the analysis.<ref>''Hansen,'' in BeckOK DatenschutzR, Article 35 GDPR, margin number 10 (Beck 2020, 36th ed.) (accessed 25 February 2022).</ref> 


The party required to prepare the DPIA is the controller. Processors and device manufacturers are therefore not responsible for preparing the analysis.<ref>''Hansen,'' in BeckOK DatenschutzR, Article 35 GDPR, margin number 10 (Beck 2020, 36th ed.) (accessed 25 February 2022).</ref> The GDPR does not require a DPIA to be carried out for every processing operation which may result in risks for the rights and freedoms of natural persons. 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''” (pfor a detailed analysis of which treatments are “''likely to result in high risks''”please refer to the commentary on paragraph 3).
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''”.<ref>For a detailed analysis of which processing operations are “''likely to result in high risks'', please refer to the commentary on paragraph 3.</ref> Therefore, WP29 considers that a DPIA is not required<ref>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 , 4 October 2017, p. 12-13.</ref> 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 DPIA have been carried out;<ref>In such cases, the controller may use the results of a DPIA already carried out for similar processing (Article 35(1), last sentence GDPR).</ref> (iii) the processing operations have been checked by a supervisory authority before May 2018 in specific conditions that have not changed;<ref>"''Commission decisions adopted and authorisations by supervisory authorities based on Directive 95/46/EC remain in force until amended, replaced or repealed''" (Recital 171).</ref> a processing operation, pursuant to point (c) or (e) of article 6(1), has a legal basis in EU or Member State law, where the law regulates the specific processing operation and where a DPIA has already been carried out as part of the establishment of that legal basis (Article 35(10) GDPR);<ref>Except if Member state law states it to be necessary to carry out a DPIA prior processing activities.</ref> the processing is included on the optional list (established by the supervisory authority) of processing operations for which no DPIA is required (Article 35(5) GDPR).<ref>Such a list may contain processing activities that comply with the conditions specified by this authority, in particular through guidelines, specific decisions or authorizations, compliance rules, etc. (e.g. in France, authorizations, 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.</ref>


Article 35(1) clearly indicates that the DPIA must take place before the processing begins. According to some scholars, this means that for processing that began before the GDPR came into force, there is no possibility of an impact assessment in advance.<ref>''Hansen,'' in BeckOK DatenschutzR, Article 35 GDPR, margin number 19 (Beck 2020, 36th ed.) (accessed 25 February 2022).</ref> Others, however, remark that DPIAs should be seen as a continuous process rather than as a one-time exercise.<ref>''Kosta'', in Kuner et al., The EU General Data Protection Regulation (GDPR), Article 35 GDPR, p. 675 (Oxford University Press 2020).</ref> For these reasons, it would be advisable to carry out a new DPIA also in such circumstances.
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.<ref>''Hansen,'' in BeckOK DatenschutzR, Article 35 GDPR, margin number 19 (Beck 2020, 36th ed.) (accessed 25 February 2022).</ref> However DPIAs should be seen as a continuous process rather than as a one-time exercise.<ref>''Kosta'', in Kuner et al., The EU General Data Protection Regulation (GDPR), Article 35 GDPR, p. 675 (Oxford University Press 2020).</ref> For these reasons, it would be advisable to carry out a new DPIA in such circumstances.
=== (2) Involvement of the Data Protection Officer ===
=== (2) Involvement of the Data Protection Officer ===
Where an obligation to carry out the DPIA exists, the Data Protection Officer has to be involved in the procedure. The controller has to consult the designated DPO for their advice. This advice can be of rather limited and general nature and the controller is not obliged to follow the DPO’s opinion. Moreover, the DPIA cannot be delegated to the DPO, but rather requires a mere advisory function is this regard.<ref>''Jandt'', in Kühling, Buchner, DS-GVO BDSG, Article 35 GDPR, margin number 18 (Beck 2020, 3rd ed.) (accessed 19 August 2021).</ref>
Where an obligation to carry out the DPIA exists, the Data Protection Officer (DPO) has to be involved in the procedure. The controller has to consult the designated DPO for their advice.<ref>''Jandt'', in Kühling, Buchner, DS-GVO BDSG, Article 35 GDPR, margin number 18 (Beck 2020, 3rd ed.) (accessed 19 August 2021).</ref> The DPO involvement should be documented in writing in order to demonstrate that the advice has been sought. The controller is not obliged to follow the DPO’s opinion. In this case, the controller should motivate and document its reasons.<ref>''Hansen,'' in BeckOK DatenschutzR, Article 35 GDPR, margin number 23 (Beck 2020, 36th ed.) (accessed 25 February 2022).</ref>  


=== (3) Likely to Result in a High Risk ===
=== (3) Likely to Result in a High Risk ===
Article 35(3) provides enumerates 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 GDPR|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 above-mentioned circumstances, however, do not constitute an exclusive list. It follows that a DPIA may be required also for different types of processing which are not mentioned in the list.<ref>''Karg'', in Simitis, Hornung, Spieker, Datenschutzrecht, Article 35 GDPR, margin number 36 (Beck 2019, 1st ed.) (accessed 19 August 2021).</ref>
Article 35(3) provides enumerates 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 GDPR|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 above-mentioned circumstances, however, do not constitute an exclusive list. It follows that a DPIA may be required also for different types of processing which are not mentioned in the list.<ref>''Karg'', in Simitis, Hornung, Spieker, Datenschutzrecht, Article 35 GDPR, margin number 36 (Beck 2019, 1st ed.) (accessed 19 August 2021).</ref>


The use of the phrase "in particular" means that the list provided by Article 35(3) GDPR is not exhaustive. On the basis of this argument, the WP29 has developed a list of criteria for assessing the high risk of a certain type 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 exercising his or her rights or using a certain service.<ref>The reader is invited to consult, 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 , 4 October 2017, pp. 9-10.</ref>
The use of the phrase "''in particular''" means that the list provided by Article 35(3) GDPR is not exhaustive. On the basis of this argument, the WP29 has developed a list of criteria for assessing the high risk of a certain type 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 exercising his or her rights or using a certain service.<ref>The reader is invited to consult, 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 , 4 October 2017, pp. 9-10.</ref>


In most cases, "''a data controller can consider that a processing meeting two criteria would require a DPIA to be carried out. In general, the WP29 considers that the more criteria are met by the processing, the more likely it is to present a high risk to the rights and freedoms of data subjects, and therefore to require a DPIA, regardless of the measures which the controller envisages to adopt''".<ref>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 , 4 October 2017, p. 10.</ref>
In most cases, a data controller can consider that a processing meeting two criteria would require a DPIA to be carried out. In general, the WP29 considers that the more criteria are met by the processing, the more likely it is to present a high risk to the rights and freedoms of data subjects, and therefore to require a DPIA, regardless of the measures which the controller envisages to adopt. 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 above mentioned 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''".<ref>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 , 4 October 2017, p. 11-12.</ref>


=== (4), (5) Specifications through DPAs ===
=== (4)(5) Specifications through DPAs ===
Every DPA shall establish a list of processing operations for which a DPIA is required ("positive" list). Furthermore the DPAs can draft a list of processing operations which may not require a DPIA ("negative" list). In both cases, the national DPAs are obliged to cooperate as part of the consistency mechanism according to [[Article 63 GDPR]] (see paragraph 6 below) and to communicate their results to the Board according to [[Article 68 GDPR]]. The lists are available online on the EDPB's website.<ref>Available here: https://edpb.europa.eu/our-work-tools/consistency-findings/register-for-decisions_el?f%5B0%5D=register_decisions_topic%3A138</ref>  
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).<ref>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).</ref> 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.<ref>Available here: https://edpb.europa.eu/our-work-tools/consistency-findings/register-for-decisions_el?f%5B0%5D=register_decisions_topic%3A138</ref>  


=== (6) Consistency Mechanism is Required to Adopt Lists ===
=== (6) Consistency Mechanism is Required to Adopt Lists ===
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, the competent supervisory authority shall communicate them to the EDPB and apply the consistency mechanism referred to in [[Article 63 GDPR]].  
Where the lists referred to in paragraph 4 and 5 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, the competent supervisory authority shall communicate them to the EDPB and apply the consistency mechanism referred to in [[Article 63 GDPR]].  


=== (7) DPIA Minimum Requirements ===
=== (7) DPIA Minimum Requirements ===
Article 35(7) GDPR sets out a list of minimum requirement which shall be dealt with in the assessment.
Article 35(7) GDPR sets out a list of minimum requirement which shall be dealt with in the DPIA.  


To begin, the DPIA will provide a systematic description of the envisaged processing operations and the purposes. These elements must be described in a clear, concise and exhaustive way, Article 35(7)(a) GDPR.
To begin, under Article 35(7)(a) GDPR, the assessment must provide a systematic description of the envisaged processing operations and its purposes. In practice, the first step of the DPIA must provide a clear description of the processing operations under observation. This 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.  


The assessment will then assess and explain the necessity and proportionality of each processing with regard to the single purpose pursued. The controller shall explain for which reason a processing or a set of processing 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)(b) GDPR.  
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 the single purpose pursued. The controller shall explain for which reason a processing or a set of processing 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.  


The DPIA must also include an assessment of the risks (Article 35(7)(b) GDPR). A “risk” is a scenario describing an event and its consequences, estimated in terms of severity and likelihood. “Risk management” can be defined as the coordinated activities to direct and control an organisation with regard to risk.<ref>''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, 4 April 2017, [https://ec.europa.eu/newsroom/just/document.cfm?doc_id=47711 p.6].</ref> It is generally possible to distinguish between “implied risk” and “residual risk”. The former refers to the probability of bad consequences if no preventive measures are taken by the controller. The latter is, on the contrary, the possible negative impact which is possible after certain measures are adopted.<ref>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.”</ref>  
Article 35(7)(c) GDPR requires the controller to include an assessment of the risks to the rights and freedom of data subjects. A “risk” is a scenario describing an event and its consequences, estimated in terms of severity and likelihood.<ref>''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, 4 April 2017, [https://ec.europa.eu/newsroom/just/document.cfm?doc_id=47711 p.6].</ref> Risks can exist both within the controller's organization (e.g. employees, trainees, consultants) and from outside (e.g. hackers, suppliers) and do not have to be caused exclusively by humans (harmful computer code, animals, fire, natural disasters). The single risk is calculated by comparing the potential damage with the probability of its occurrence.<ref>''Schwendemann,'' in Sydow, Europäische Datenschutzgrundverordnung, Article 35 GDPR, margin number 27 (Beck 2018, 2<sup>nd</sup> ed.) (accessed 25 February 2022).</ref> It is generally possible to distinguish between “implied risk” and “residual risk”. The former refers to the probability of bad consequences if no preventive measures are taken by the controller. The latter is, on the contrary, the possible negative impact which is possible after certain measures are adopted.<ref>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.”</ref>  


Finally, under Article 35(7)(d) GDPR, the controller must select appropriate measures to mitigate the risk. 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 so-called 'residual risk', which is the risk that cannot be eliminated even after the containment measures have been applied.<ref>''Hansen,'' in BeckOK DatenschutzR, Article 35 GDPR, margin number 49 (Beck 2020, 38th ed.) (accessed 25 February 2022).</ref>
The data protection impact assessment must be documented, otherwise the controller will not be able to provide proof of compliance with the GDPR. The GDPR does not require the publication of the report, but in the interests of transparency towards data subjects, the essential parts of the impact assessment report can and should be published or at least made available to interested parties.<ref>''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, 4 April 2017, p. 18.</ref>
=== (8) Codes of Conducts ===
=== (8) Codes of Conducts ===
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.  
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.


=== (9) Data Subjects May be Involved in the Drafting of the DPIA ===
=== (9) Data Subjects May be Involved in the Drafting of the DPIA ===
Data subjects can or shall be involved in the preparation of the document.  
Data subjects can or shall be involved in the preparation of the document. The processor shall participate in the drafting of the DPIA and shall assist the controller by providing all necessary information ([[Article 28 GDPR|Article 28(3)(f) GDPR]]). The DPO is also involved in the drafting of the DPIA under Article 35(2) GDPR and [[Article 39 GDPR|Article 39(1)(c) GDPR]]. The DPO’s advice is recorded by the controller. Under Article 35(9) GDPR, the controller, “where appropriate” shall “seek the views of data subjects or their representatives on the intended processing”. Should the controller find the consultation “not appropriate”, it is believed it must motivate its decision. The same effort seems to be required in case the controller do involve the data subjects but then decide to overcome their negative feedback.  
 
The processor shall participate in the drafting of the DPIA and shall assist the controller by providing all necessary information ([[Article 28 GDPR|Article 28(3)(f) GDPR]]). The DPO is also involved in the drafting of the DPIA under Article 35(2) GDPR and [[Article 39 GDPR|Article 39(1)(c) GDPR]]. The DPO’s advice is recorded by the controller.
 
Under Article 35(9) GDPR, the controller, “where appropriate” shall “seek the views of data subjects or their representatives on the intended processing”. Should the controller find the consultation “not appropriate”, it is believed it must motivate its decision. The same effort seems to be required in case the controller do involve the data subjects but then decide to overcome their negative feedback.  


=== (10) National Exemptions ===
=== (10) National Exemptions ===

Revision as of 15:12, 25 February 2022

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

Legal Text


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

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

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 of the accountability principle (see Article 24 GDPR). takes into account the nature, scope, context and purposes of the processing, evaluates its potential risks and consider any remedy which can minimise or reduce such risks. The provision in question regulates the cases in which the DPIA is mandatory, what the minimum content is and other procedural aspects relating to the process of forming the analysis.

(1) Mandatory DPIA

The DPIA is an analysis document that takes into account the nature, scope, context and purposes of the processing, evaluates its potential risks and consider any remedy which can minimise or reduce such risks.[1] The party required to prepare the DPIA is the controller. Processors and device manufacturers are therefore not responsible for preparing the analysis.[2]

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”.[3] Therefore, WP29 considers that a DPIA is not required[4] 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 DPIA have been carried out;[5] (iii) the processing operations have been checked by a supervisory authority before May 2018 in specific conditions that have not changed;[6] a processing operation, pursuant to point (c) or (e) of article 6(1), has a legal basis in EU or Member State law, where the law regulates the specific processing operation and where a DPIA has already been carried out as part of the establishment of that legal basis (Article 35(10) GDPR);[7] the processing is included on the optional list (established by the supervisory authority) of processing operations for which no DPIA is required (Article 35(5) GDPR).[8]

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.[9] However DPIAs should be seen as a continuous process rather than as a one-time exercise.[10] For these reasons, it would be advisable to carry out a new DPIA in such circumstances.

(2) Involvement of the Data Protection Officer

Where an obligation to carry out the DPIA exists, the Data Protection Officer (DPO) has to be involved in the procedure. The controller has to consult the designated DPO for their advice.[11] The DPO involvement should be documented in writing in order to demonstrate that the advice has been sought. The controller is not obliged to follow the DPO’s opinion. In this case, the controller should motivate and document its reasons.[12]

(3) Likely to Result in a High Risk

Article 35(3) provides enumerates 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 above-mentioned circumstances, however, do not constitute an exclusive list. It follows that a DPIA may be required also for different types of processing which are not mentioned in the list.[13]

The use of the phrase "in particular" means that the list provided by Article 35(3) GDPR is not exhaustive. On the basis of this argument, the WP29 has developed a list of criteria for assessing the high risk of a certain type 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 exercising his or her rights or using a certain service.[14]

In most cases, a data controller can consider that a processing meeting two criteria would require a DPIA to be carried out. In general, the WP29 considers that the more criteria are met by the processing, the more likely it is to present a high risk to the rights and freedoms of data subjects, and therefore to require a DPIA, regardless of the measures which the controller envisages to adopt. 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 above mentioned 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".[15]

(4)(5) Specifications through DPAs

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).[16] 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.[17]

(6) Consistency Mechanism is Required to Adopt Lists

Where the lists referred to in paragraph 4 and 5 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, the competent supervisory authority shall communicate them to the EDPB and apply the consistency mechanism referred to in Article 63 GDPR.

(7) DPIA Minimum Requirements

Article 35(7) GDPR sets out a list of minimum requirement which shall be dealt with in the DPIA.

To begin, under Article 35(7)(a) GDPR, the assessment must provide a systematic description of the envisaged processing operations and its purposes. In practice, the first step of the DPIA must provide a clear description of the processing operations under observation. This 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 the single purpose pursued. The controller shall explain for which reason a processing or a set of processing 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 rights and freedom of data subjects. A “risk” is a scenario describing an event and its consequences, estimated in terms of severity and likelihood.[18] Risks can exist both within the controller's organization (e.g. employees, trainees, consultants) and from outside (e.g. hackers, suppliers) and do not have to be caused exclusively by humans (harmful computer code, animals, fire, natural disasters). The single risk is calculated by comparing the potential damage with the probability of its occurrence.[19] It is generally possible to distinguish between “implied risk” and “residual risk”. The former refers to the probability of bad consequences if no preventive measures are taken by the controller. The latter is, on the contrary, the possible negative impact which is possible after certain measures are adopted.[20]

Finally, under Article 35(7)(d) GDPR, the controller must select appropriate measures to mitigate the risk. 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 so-called 'residual risk', which is the risk that cannot be eliminated even after the containment measures have been applied.[21]

The data protection impact assessment must be documented, otherwise the controller will not be able to provide proof of compliance with the GDPR. The GDPR does not require the publication of the report, but in the interests of transparency towards data subjects, the essential parts of the impact assessment report can and should be published or at least made available to interested parties.[22]

(8) Codes of Conducts

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.

(9) Data Subjects May be Involved in the Drafting of the DPIA

Data subjects can or shall be involved in the preparation of the document. The processor shall participate in the drafting of the DPIA and shall assist the controller by providing all necessary information (Article 28(3)(f) GDPR). The DPO is also involved in the drafting of the DPIA under Article 35(2) GDPR and Article 39(1)(c) GDPR. The DPO’s advice is recorded by the controller. Under Article 35(9) GDPR, the controller, “where appropriate” shall “seek the views of data subjects or their representatives on the intended processing”. Should the controller find the consultation “not appropriate”, it is believed it must motivate its decision. The same effort seems to be required in case the controller do involve the data subjects but then decide to overcome their negative feedback.

(10) National Exemptions

There is no obligation to conduct a DPIA when the processing is based on European or member state law in terms of Article 6(1)(c) or (e) GDPR for which the law maker already conducted a general impact assessment (see also Recital 93 GDPR). In this regard, the law maker can decide to shift the DPIA to the process of law-making in order to reduce the resulting bureaucracy for public institutions relying on that law for their processing of personal data.[23] However, the law maker is not obliged to do so and can still request controllers to carry out their own DPIA.

(11) Review of Processing and Updates

Article 35(11) GDPR requires the controller to assess if processing is performed in accordance with the data protection impact assessment. 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. The DPIA is an ongoing process, especially where a processing operation is dynamic and subject to ongoing change. Carrying out a DPIA is a continual process, not a one-time exercise.[24]

Decisions

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

References

  1. The minimum content of the DPIA is described in detail in paragraph 7 below.
  2. Hansen, in BeckOK DatenschutzR, Article 35 GDPR, margin number 10 (Beck 2020, 36th ed.) (accessed 25 February 2022).
  3. For a detailed analysis of which processing operations are “likely to result in high risks”, please refer to the commentary on paragraph 3.
  4. 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 , 4 October 2017, p. 12-13.
  5. In such cases, the controller may use the results of a DPIA already carried out for similar processing (Article 35(1), last sentence GDPR).
  6. "Commission decisions adopted and authorisations by supervisory authorities based on Directive 95/46/EC remain in force until amended, replaced or repealed" (Recital 171).
  7. Except if Member state law states it to be necessary to carry out a DPIA prior processing activities.
  8. Such a list may contain processing activities that comply with the conditions specified by this authority, in particular through guidelines, specific decisions or authorizations, compliance rules, etc. (e.g. in France, authorizations, 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.
  9. Hansen, in BeckOK DatenschutzR, Article 35 GDPR, margin number 19 (Beck 2020, 36th ed.) (accessed 25 February 2022).
  10. Kosta, in Kuner et al., The EU General Data Protection Regulation (GDPR), Article 35 GDPR, p. 675 (Oxford University Press 2020).
  11. Jandt, in Kühling, Buchner, DS-GVO BDSG, Article 35 GDPR, margin number 18 (Beck 2020, 3rd ed.) (accessed 19 August 2021).
  12. Hansen, in BeckOK DatenschutzR, Article 35 GDPR, margin number 23 (Beck 2020, 36th ed.) (accessed 25 February 2022).
  13. Karg, in Simitis, Hornung, Spieker, Datenschutzrecht, Article 35 GDPR, margin number 36 (Beck 2019, 1st ed.) (accessed 19 August 2021).
  14. The reader is invited to consult, 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 , 4 October 2017, pp. 9-10.
  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 , 4 October 2017, p. 11-12.
  16. 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).
  17. Available here: https://edpb.europa.eu/our-work-tools/consistency-findings/register-for-decisions_el?f%5B0%5D=register_decisions_topic%3A138
  18. 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, 4 April 2017, p.6.
  19. Schwendemann, in Sydow, Europäische Datenschutzgrundverordnung, Article 35 GDPR, margin number 27 (Beck 2018, 2nd ed.) (accessed 25 February 2022).
  20. 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.”
  21. Hansen, in BeckOK DatenschutzR, Article 35 GDPR, margin number 49 (Beck 2020, 38th ed.) (accessed 25 February 2022).
  22. 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, 4 April 2017, p. 18.
  23. Karg, in Simitis, Hornung, Spieker, Datenschutzrecht, Article 35 GDPR, margin number 58 (Beck 2019, 1st ed.) (accessed 19 August 2021).
  24. 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, 4 April 2017, p.14.