Recital 27

This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to 33 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj). 34 Regulation (EU) 2022/1925 of the European Parliament and of the Council of 14 September 2022 on contestable and fair markets in the digital sector and amending Directives (EU) 2019/1937 and (EU) 2020/1828 (Digital Markets Act) (OJ L 265, 12.10.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/1925/oj). determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council35. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act.

This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. and faster Europe: Communication on implementation and simplification, COM(2025)47 final, 11 February 2025

This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. and faster Europe: Communication on implementation and simplification, COM(2025)47 final, 11 February 2025

This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection.

This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection.

This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection.

This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection.

This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection.

[...]

[...]

[...]

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection.

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection.

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15 . The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given person or entity where that person or entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. To ascertain whether means are reasonably likely to be used to identify the natural person, account should be taken of all objective factors, such as the costs of and the amount of time required for identification, taking into consideration the available technology at the time of the processing and technological developments. The principles of data protection should therefore not apply to anonymous information, namely information which does not relate to an identified or identifiable natural person or to personal data rendered anonymous in such a manner that the data subject is not or no longer identifiable. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council. It should also be clarified that information, which is apparently impersonal, may still be considered personal data if the data subject can be identified with additional information obtained from another person or entity through means reasonably likely to be used making it possible to identify the data subject. In such circumstances, the fact that the information enabling the data subject to be identified is in the hands of other people does not prevent that data subject from being identifiable for the controller. The Court of Justice of the European Union has also held that information which are in themselves impersonal may become personal in nature where the controller puts them, or is likely to put them, at the disposal of other persons or entities who have means reasonably likely to enable the data subject to be identified. It is apparent, in particular, that if that information is put at these other persons or entities’ disposal – then this information is personal data for these persons and entities and, indirectly, for the controller. Accordingly, in so far as it cannot be ruled out that those persons or entities have means reasonably allowing them to attribute pseudonymised data to the data subject, such as cross-checking with other data at their disposal, the data subject must be regarded as identifiable as regards both that transfer and any subsequent processing of those data by those persons and entities. In such circumstances, pseudonymised data should be considered to be personal data. The Commission, together with the European Data Protection Board, may support controllers in the application of this updated definition by stipulating technical criteria in an implementing act.

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same or higher level of data protection. The definition of personal data determines the fundamental threshold for the application of data protection rights and must remain completely objective. Personal data which have undergone pseudonymisation, and which could be attributed to a natural person by the use of additional information, must be considered as personal data, as data related to identified or identifiable natural person across all processing participants, independent of an individual controller's subjective intent, technical capabilities, or internal commercial restrictions.

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. In assessing means reasonably likely to be used to identify the natural person, account should be taken not only of the means available to the entity processing the information, but also of means reasonably accessible to third parties operating within the same relevant sectoral or territorial environment. For data generated in the course of primary economic activities characterised by a strong territorial dimension, such as agriculture, forestry, fisheries and aquaculture, the combination of geographical, production-related and size-related variables constitutes a specific risk factor for the identification of the natural person and, as a general rule, supports maintaining the classification of such data as personal data. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. In assessing means reasonably likely to be used to identify the natural person, account should be taken not only of the means available to the entity processing the information, but also of means reasonably accessible to third parties operating within the same relevant sectoral or territorial environment. For data generated in the course of primary economic activities characterised by a strong territorial dimension, such as agriculture, forestry, fisheries and aquaculture, the combination of geographical, production-related and size-related variables constitutes a specific risk factor for the identification of the natural person and, as a general rule, supports maintaining the classification of such data as personal data. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15 . The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable for a given entity. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15 . The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. (Recital 27 - Regulation (EU) 2016/679) _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15 . The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15 . The assessment of whether a controller possesses the means reasonably likely to be used to identify the natural person directly or indirectly should take into account technical and organisational measures, as well as state of the art technology. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly, while respecting fundamental human rights and freedoms. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable, without fundamental rights and freedoms being affected. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act, while respecting fundamental human rights and freedoms. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15 . The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) Regulation (EU) 2016/679 protects natural persons with regard to the processing of personal data. Personal data originate from a natural person and derive their protected character from that origin. Any clarification of the notion of identifiability must therefore preserve the link between the data and the natural person from whom they originate, and may not have the effect of removing from the scope of that Regulation data which relate to a natural person merely because a given entity is not, at a given moment, in a position to identify that person. This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. The definition of personal data as currently laid down in Regulation (EU) 2016/679 shall not be called into question. Personal data originates from a natural person; whether it remains personal data depends on whether that person is identifiable, the degree of re-identifiability being assessed through the notions of pseudonymous, pseudonymised and anonymised data. The assessment of whether a natural person is identifiable shall be distinguished from the definition of personal data, except for anonymised data, which lose their qualification as personal data. The new specifications introduced by this Regulation apply to the notions of 'pseudonymous' and 'pseudonymisation'. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15 . The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst seeking to preserve the same or higher level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person and should be interpreted in line with the case-law of the Court of Justice of the European Union concerning the definition of personal data and to provide further clarity on when a natural person should be considered to be identifiable.

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council15. The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. __________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst seeking to preserve the same or higher level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person and should be interpreted in line with the case-law of the Court of Justice of the European Union. Supervisory authorities within the European Data Protection Board, should continue supporting controllers and processors in the application of Regulation (EU) 2016/679 while remaining independent. __________________ 15 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

[...]