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Article 35
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Data protection impact assessment

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(72) Profiling is subject to the rules of this Regulation governing the processing of personal data, such as the legal grounds for processing or data protection principles. The European Data Protection Board established by this Regulation (the ‘Board’) should be able to issue guidance in that context.

(84) 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.

(89) 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.

(90) 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.

(91) 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.

(92) 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.

(93) 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

(94) Where a data protection impact assessment indicates that the processing would, in the absence of safeguards, security measures and mechanisms to mitigate the risk, result in a high risk to the rights and freedoms of natural persons and the controller is of the opinion that the risk cannot be mitigated by reasonable means in terms of available technologies and costs of implementation, the supervisory authority should be consulted prior to the start of processing activities. Such high risk is likely to result from certain types of processing and the extent and frequency of processing, which may result also in a realisation of damage or interference with the rights and freedoms of the natural person. The supervisory authority should respond to the request for consultation within a specified period. However, the absence of a reaction of the supervisory authority within that period should be without prejudice to any intervention of the supervisory authority in accordance with its tasks and powers laid down in this Regulation, including the power to prohibit processing operations. As part of that consultation process, the outcome of a data protection impact assessment carried out with regard to the processing at issue may be submitted to the supervisory authority, in particular the measures envisaged to mitigate the risk to the rights and freedoms of natural persons.

(95) The processor should assist the controller, where necessary and upon request, in ensuring compliance with the obligations deriving from the carrying out of data protection impact assessments and from prior consultation of the supervisory authority.

There is no recital in the Directive related to article 35.

The GDPR

The aim of the European legislator here is - as well as keeping an internal record of the processing activities - see Article 30 – to replace the general obligation of prior notification of the processing by effective mechanisms targeting processing likely to present specific risks to the rights and freedoms of data subjects.

The obligation of making an impact analysis for certain “high risk” processing activities falls into this logic: where a processing is likely to result in a high risk to the rights and freedoms of natural persons, the controller shall carry out an assessment of the impact of the envisaged processing operations on the protection of personal data to assess, in particular, the origin, the nature, the scope, the context and the severity of that risk.

In its second version, Article 35 (1) contained a non-exhaustive list of risks that justify an impact assessment such as discrimination, identity theft or impersonation, financial loss, damage to reputation, unauthorised reversal of anonymisation, loss of privacy of data protected by trade secrecy or any other material economic or social damage. The list of risks has been removed in the final version of the Regulation, but can still be found in recital 75.

According to recital 116, the impact assessment is specifically required for large-scale processing operations, which are used to process a large amount of personal data at regional, national or supranational level and may affect a significant number of data subjects. Obviously, we think of the large Big Data processes implemented through the social networks for example.

Purpose. The aim of the impact assessment is twofold. First, to assess the impact which an envisaged processing operation may have on the rights and freedoms of individuals. Second, to determine, based on the result of the assessment, the appropriate actions to ensure and to demonstrate that the processing of personal data complies with European regulations on personal data protection.

Content In its latest version, the Regulation clarifies the contents of the impact assessment in paragraph 7 of Article 35. The analysis must contain as a minimum:

- a systematic description of the envisaged processing operations and the purposes of the processing, including, where applicable, the legitimate interest pursued by the controller (a);

- an assessment of the necessity and proportionality of the processing operations in relation to the purposes (b);

- an assessment of the risks to the rights and freedoms of data subjects (c);

- 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 the Regulation, taking into account the rights and legitimate interests of data subjects and other persons concerned (d).

If a data protection officer is designated, he/she must be consulted by the controller when carrying out a data protection impact assessment (Article 35 (2)).

The processor should assist the controller, where necessary and upon request, in ensuring compliance with the obligations deriving from the carrying out of data protection impact assessments and from prior consultation of the supervisory authority (recital 95).

Compliance with approved codes of conduct referred to in Article 40 by the relevant controllers shall be taken into due account in assessing the impact of the processing operations performed within the impact assessment (see Art. 35 (8)).

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 (Article 35, (9)).

Scope. Article 35 (3) contains an illustrative list of assumptions where an impact assessment is required, such as profiling or the large-scale processing of sensitive data:

- where the controller intends to conduct 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;

- where the controller processes, on a large scale, 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;

- where the controller carries out a systematic monitoring of a publicly accessible area on a large scale.

The final version of the Regulation specifies that a single impact analysis may include a set of processing operations that present the same risk level.

Opinion of the supervisory authority. The impact assessment is a way for the authority to intervene as a complement to her power detailed in Article 58. If the assessment reveals that the processing-related risks cannot be mitigated by reasonable means within available techniques and cost of their implementation, the controller must consult the supervisory authority (see Art. 36 (2) and recitals 84 and 94). If the supervisory authority considers that the processing violates the Regulation, they shall send a written notice to the controller and, if applicable to the processor within a period of eight weeks, extendable by six weeks in case of processing complexity. These limits shall be suspended until the supervisory authority receives all the information requested for its consultation. It is advisable to consult with the authority in case of doubt concerning the assessed amount of risk.

In addition, paragraphs 4 and 5 give the supervisory authority the power to establish a list of categories of processing being or not being subject to the obligation of prior impact assessment and a list of processing categories exempted from the obligation of prior impact assessment.

These lists must be communicated to the European Data Protection Board and submitted in prior to 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 (Article 35 (6)). In other words, in these cases, the supervisory authority shall submit to the European Data Protection Board a list of processing categories subject to the requirement of a data protection impact assessment (See Article 64 (1), a)).

Exceptions. Recital 91 states that an impact assessment is not required if the processing of such data is protected by professional secrecy, like the processing of personal data of patients or clients by an individual physician, other health care professional, hospital or lawyer.

An impact assessment is not required where processing pursuant to point (c) of Article 6 (1) has a legal basis to which the controller is subject and the processing is needed for compliance with this law or for the performance of a task of public interest or relates to the exercise of the public power vested in the controller pursuant to Article 6 (1), e), unless Member States deem it to be necessary (see Article 35 (10)). 

Assessment revision. Finally, the final version of the Regulation introduced a new paragraph 5 requiring the controller to carry out a review process to ensure that the processing is consistent with the impact assessment, at least when there is a change of the risk represented by processing operations (Article 35 (11)).

The Directive

There is no corresponding provision in the Directive.

Potential issues

The first difficulty is in determining the processing, the risk of which justifies the preliminary implementation of an impact assessment. In fact, when the processing is not included in the list of cases provided for in Article 35 (3) or in the lists of the authority, the risk assessment and proceeding with an impact assessment is left to the controller.

The second difficulty will be to conduct the impact assessment itself. It will take specially trained resources, internal or external to the controller, to achieve this. The cost and effort to carry out may be significant, especially for small  organisations. It is true that the extent of the processing should normally involve controllers with substantial resources, but it will not always  be the case.

The third difficulty pertains to the task of controllers to determine whether the measures which they have identified, are sufficient to protect the rights and freedoms of individuals. In effect, controllers are required to assess the proportionality of the envisaged processing operation, given the potential interferences which may arise. This decision should be informed by the opinion of the data protection officer, as well as by the guidance documents issues by the supervisory authority. When necessary, the controller should consult the supervisory authority to determine whether their evaluation of the residual level of risk is acceptable.

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Summary

European Union

European Union

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Article 29 Working Party

Guidelines on Data Protection Impact Assessment (DPIA) - wp248rev.01 (4 october 2017)

Regulation 2016/679 (GDPR) will apply from 25 May 2018. Article 35 of the GDPR introduces the concept of a Data Protection Impact Assessment (DPIA), as does Directive 2016/680.

A DPIA is a process designed to describe the processing, assess its necessity and proportionality and help manage the risks to the rights and freedoms of natural persons resulting from the processing of personal data by assessing them and determining the measures to address them. DPIAs are important tools for accountability, as they help controllers not only to comply with requirements of the GDPR, but also to demonstrate that appropriate measures have been taken to ensure compliance with the Regulation (see also article 24). In other words, a DPIA is a process for building and demonstrating compliance.

Under the GDPR, non-compliance with DPIA requirements can lead to fines imposed by the competent supervisory authority. Failure to carry out a DPIA when the processing is subject to a DPIA (Article 35(1) and (3)-(4)), carrying out a DPIA in an incorrect way (Article 35(2) and (7) to (9)), or failing to consult the competent supervisory authority where required (Article 36(3)(e)), can result in an administrative fine of up to 10M€, or in the case of an undertaking, up to 2 % of the total worldwide annual turnover of the preceding financial year, whichever is higher.

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Regulation
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Art. 35

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.
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Art. 33

1.           Where processing operations present specific risks to the rights and freedoms of data subjects by virtue of their nature, their scope or their purposes, the controller or the processor acting on the controller's behalf shall carry out an assessment of the impact of the envisaged processing operations on the protection of personal data.

2.           The following processing operations in particular present specific risks referred to in paragraph 1:

(a)     a systematic and extensive evaluation of personal aspects relating to a natural person or for analysing or predicting in particular the natural person's economic situation, location, health, personal preferences, reliability or behaviour, which is based on automated processing and on which measures are based that produce legal effects concerning the individual or significantly affect the individual;

(b)     information on sex life, health, race and ethnic origin or for the provision of health care, epidemiological researches, or surveys of mental or infectious diseases, where the data are processed for taking measures or decisions regarding specific individuals on a large scale;

(c)     monitoring publicly accessible areas, especially when using optic-electronic devices (video surveillance) on a large scale;

(d)     personal data in large scale filing systems on children, genetic data or biometric data;

(e)     other processing operations for which the consultation of the supervisory authority is required pursuant to point (b) of Article 34(2).

3.           The assessment shall contain at least a general description of the envisaged processing operations, an assessment of the risks to the rights and freedoms of data subjects, the measures envisaged to address the risks, 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.

4.           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 the processing operations.

5.           Where the controller is a public authority or body and where the processing results from a legal obligation pursuant to point (c) of Article 6(1) providing for rules and procedures pertaining to the processing operations and regulated by  Union law, paragraphs 1 to 4 shall not apply, unless Member States deem it necessary to carry out such assessment prior to the processing activities.

6.           The Commission shall be empowered to adopt delegated acts in accordance with Article 86 for the purpose of further specifying the criteria and conditions for the processing operations likely to present specific risks referred to in paragraphs 1 and 2 and the requirements for the assessment referred to in paragraph 3, including conditions for scalability, verification and auditability. In doing so, the Commission shall consider specific measures for micro, small and medium-sized enterprises.

7.           The Commission may specify standards and procedures for carrying out and verifying and auditing the assessment referred to in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2).
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Art. 33

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 for the rights and freedoms of individuals , such as discrimination, identity theft or fraud, financial loss, damage to the reputation, unauthorized reversal of pseudonymisation, loss of confidentiality of data protected by professional secrecy or any other significant economic or social disadvantage, 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. (...).

1a. The controller shall seek the advice of the data protection officer, where designated, when carrying out a data protection impact assessment.

2. A data protection impact assessment referred to in paragraph 1 shall in particular be required in the following cases:

(a) a systematic and extensive evaluation (...) of personal aspects relating to (...) natural persons (...), which is based on profiling and on which decisions are based that produce legal effects concerning data subjects or severely affect data subjects;

(b) processing of special categories of personal data under Article 9(1) (...), biometric data or data on criminal convictions and offences or related security measures, where the data are processed for taking (...) decisions regarding specific individuals on a large scale ;

(c) monitoring publicly accessible areas on a large scale, especially when using optic-electronic devices (...);

(d)(...);

(e)(...).

2a.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 European Data Protection Board.

2b. 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 European Data Protection Board.

2c. Prior to the adoption of the lists referred to in paragraphs 2a and 2b the competent supervisory authority shall apply the consistency mechanism referred to in Article 57 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.

3. The assessment shall contain at least a general description of the envisaged processing operations, an evaluation of the risk referred to in paragraph 1, the measures envisaged to address the risk 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.

3a. Compliance with approved codes of conduct referred to in Article 38 by the relevant controllers or processors shall be taken into due account in assessing lawfulness and impact of the processing operations performed by such controllers or processors, in particular for the purposes of a data protection impact assessment.

4.The controller shall seek the views of data subjects or their representatives on the intended processing, without prejudice to theprotection of commercial or public interests or the security of the processing operations (...).

5.(...) Where the processing pursuant to point (c) or (e) of Article 6(1) has a legal basis in Union law or the law of the Member State to which the controller is subject, and such law regulates the specific processing operation or set of operations in question, paragraphs 1 to 3 shall not apply, unless Member States deem it necessary to carry out such assessment prior to the processing activities.

6.(...)

7.(...)

 

 
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No specific provision
Bulgaria
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Ordinance No. 1 on the Minimal Level of Technical and Organizational Measures and the Admissible Type of Protection of Personal Data

Article 11. (1) To determine the adequate level of technical and organizational measures and admissible type of protection the controller conducts impact assessment on the processed personal data.

(2) The impact assessment is a process for determining the level of impact on a particular individual or group of individuals depending on the nature of the personal data processed and the number of affected individuals in case of breach of confidentiality, integrity or availability of data.

(3) The impact assessment is carried out periodically every two years or when changing the nature of personal data processed and the number of affected individuals.

Article 12. When conducting the impact assessment the controller takes into account the nature of the personal data processed as follows:

1. systematization and evaluation of personal aspects relating to a natural person (profiling) for analyzing and predicting, particularly its economic situation, location, personal preferences, reliability or behavior, which is based on automated processing and the basis of which measures are taken which cause legal consequences for the individual or concern him/her significantly;

2. data revealing racial or ethnic origin, political, religious or philosophical beliefs, membership in political parties or organizations, associations with religious, philosophical, political or trade union purposes or data that relate to health, sexual life or human genome;

3. personal data created by a video from surveillance of publicly accessible areas;

4. personal data in large scale registers of personal data;

5. data whose processing according to a decision of the Commission of Personal Data Protection threatens the rights and legitimate interests of individuals.

[…]

Article 14. (1) The data controller shall conduct impact assessment of all registers kept in accordance with Annex No. 1.

(2) Each individual register is assessed under the criteria confidentiality, integrity and availability.

(3) The highest level of impact, determined by each of the criteria under Para 2 determines the level of impact on the relevant register.

(4) For group jointly stored or processed registers the impact level is the highest level determined for each of the registers of the group in accordance with Annex No. 2.
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