4.5.2016
EN
Official Journal of the European Union
L 119/97
significant economic or social disadvantage; where data subjects might be deprived of their rights and freedoms
or from exercising control over their personal data; where personal data are processed which reveal racial or
ethnic origin, political opinions, religion or philosophical beliefs or trade union membership; where genetic data
or biometric data are processed in order to uniquely identify a person or where data concerning health or data
concerning sex life and sexual orientation or criminal convictions and offences or related security measures are
processed; where personal aspects are evaluated, in particular analysing and 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 children, are processed; or where processing involves a large amount of personal data and
affects a large number of data subjects.
(52)
The likelihood and severity of the risk should be determined by reference to the nature, scope, context and
purposes of the processing. Risk should be evaluated on the basis of an objective assessment, through which it is
established whether data-processing operations involve a high risk. A high risk is a particular risk of prejudice to
the rights and freedoms of data subjects.
(53)
The protection of the rights and freedoms of natural persons with regard to the processing of personal data
requires that appropriate technical and organisational measures are taken, to ensure that the requirements of this
Directive are met. The implementation of such measures should not depend solely on economic considerations.
In order to be able to demonstrate compliance with this Directive, the controller should adopt internal policies
and implement measures which adhere in particular to the principles of data protection by design and data
protection by default. Where the controller has carried out a data protection impact assessment pursuant to this
Directive, the results should be taken into account when developing those measures and procedures. The
measures could consist, inter alia, of the use of pseudonymisation, as early as possible. The use of pseudonymi
sation for the purposes of this Directive can serve as a tool that could facilitate, in particular, the free flow of
personal data within the area of freedom, security and justice.
(54)
The protection of the rights and freedoms of data subjects as well as the responsibility and liability of controllers
and processors, also in relation to the monitoring by and measures of supervisory authorities, requires a clear
attribution of the responsibilities set out in this Directive, including where a controller determines the purposes
and means of the processing jointly with other controllers or where a processing operation is carried out on
behalf of a controller.
(55)
The carrying-out of processing by a processor should be governed by a legal act including a contract binding the
processor to the controller and stipulating, in particular, that the processor should act only on instructions from
the controller. The processor should take into account the principle of data protection by design and by default.
(56)
In order to demonstrate compliance with this Directive, the controller or processor should maintain records
regarding all categories of processing activities under its responsibility. Each controller and processor should be
obliged to cooperate with the supervisory authority and make those records available to it on request, so that
they might serve for monitoring those processing operations. The controller or the processor processing personal
data in non-automated processing systems should have in place effective methods of demonstrating the
lawfulness of the processing, of enabling self-monitoring and of ensuring data integrity and data security, such as
logs or other forms of records.
(57)
Logs should be kept at least for operations in automated processing systems such as collection, alteration,
consultation, disclosure including transfers, combination or erasure. The identification of the person who
consulted or disclosed personal data should be logged and from that identification it should be possible to
establish the justification for the processing operations. The logs should solely be used for the verification of the
lawfulness of the processing, self-monitoring, for ensuring data integrity and data security and criminal
proceedings. Self-monitoring also includes internal disciplinary proceedings of competent authorities.
(58)
A data protection impact assessment should be carried out by the controller where the processing operations are
likely to result in a high risk to the rights and freedoms of data subjects by virtue of their nature, scope or
purposes, which should include, in particular, the measures, safeguards and mechanisms envisaged to ensure the
protection of personal data and to demonstrate compliance with this Directive. Impact assessments should cover
relevant systems and processes of processing operations, but not individual cases.
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