Article 4

(a) in point 1, the following sentences are added: ‘Information relating to a natural person is not necessarily personal data for every other person or entity, merely because another entity can identify that natural person. Information shall not be personal for a given entity where that entity cannot identify the natural person to whom the information relates, taking into account the means reasonably likely to be used by that entity. Such information does not become personal for that entity merely because a potential subsequent recipient has means reasonably likely to be used to identify the natural person to whom the information relates.’

Justification

There is no substantive impact assessment on changing the definition of personal data, which would have significant effects on protection of consumers and the conduct of businesses in the internal market.

(a) in point 1, the following sentences are added: ‘Information relating to a natural person is not necessarily personal data for every other person or entity, merely because another entity can identify that natural person. Information shall not be personal for a given entity where that entity cannot identify the natural person to whom the information relates, taking into account the means reasonably likely to be used by that entity. Such information does not become personal for that entity merely because a potential subsequent recipient has means reasonably likely to be used to identify the natural person to whom the information relates.’

Justification

The text proposed by the Commission risks undermining the implementation of the European Health Data Space Regulation in relation to trust on accessing and sharing of personal electronic health data. Weakening the definition of personal data erodes the foundation of trust between doctors and patients — a relationship that ensures clinical data are accurate, complete, and valid. The integrity of the treatment relationship is critical to generating reliable data for safe digital solutions. Weakening the definition does not drive innovation but risks undermining the quality and safety of digital health initiatives.

‘Information relating to a natural person is not necessarily personal data for every other person or entity, merely because another entity can identify that natural person. Information shall not be personal for a given entity where that entity cannot identify the natural person to whom the information relates, taking into account the means reasonably likely to be used by that entity. Such information does not become personal for that entity merely because a potential subsequent recipient has means reasonably likely to be used to identify the natural person to whom the information relates.’

Information relating to a natural person is not necessarily personal data for every other person or entity, merely because another entity can identify that natural person. Information shall not be personal for a given entity where that entity cannot identify the natural person to whom the information relates, taking into account the means reasonably likely to be used in practice by that entity, considering all objective factors, such as the costs, technological resources and the amount of time required for identification and the safeguards applied to the processing. Such information does not become personal for that entity merely because the entity which sent the data to that entity or a potential subsequent recipient has means reasonably likely to be used to identify the natural person to whom the information relates.

Information relating to a natural person is not necessarily personal data for every other person or entity, merely because another entity can identify that natural person. Information shall not be personal for a given entity where that entity cannot identify the natural person to whom the information relates, taking into account the means reasonably likely to be used by that entity. Such information does not become personal for that entity merely because a potential subsequent recipient has means reasonably likely to be used to identify the natural person to whom the information relates. In assessing the means reasonably likely to be used by a given entity, account shall be taken of the technical and organisational measures implemented by that entity, including pseudonymisation and privacy-enhancing technologies.

Justification

Confirms that data rendered non identifiable by advanced techniques is not personal data for an entity that cannot re-identify it, narrowing the scope of the GDPR and removing compliance cost for anonymised/pseudonymised processing.

(38) “scientific research” means any research which can also support innovation, such as technological development and demonstration. These actions shall contribute to existing scientific knowledge or apply existing knowledge in novel ways, be carried out with the aim of contributing to the growth of society’s general knowledge and wellbeing and adhere to ethical standards in the relevant research area. This does not exclude that the research may also aim to further a commercial interest.

Justification

Due to the lack of impact assessment such a change is not adequately justified and therefore should not be proposed unless potential consequences on consumers and businesses in the internal market are clear.

(38) “scientific research” means any research which can also support innovation, such as technological development and demonstration. These actions shall contribute to existing scientific knowledge or apply existing knowledge in novel ways, be carried out with the aim of contributing to the growth of society’s general knowledge and wellbeing and adhere to ethical standards in the relevant research area. This does not exclude that the research may also aim to further a commercial interest. Scientific research shall not include the profiling of natural persons, direct marketing, monitoring the behaviour of individuals or activities aimed at influencing or directing the behaviour of natural persons, even if these activities use scientific methods.

(38) “scientific research” means any research which can also support innovation, such as technological development and demonstration. These actions shall contribute to existing scientific knowledge or apply existing knowledge in novel ways, be carried out with the aim of contributing to the growth of society’s general knowledge and wellbeing and adhere to ethical standards in the relevant research area. This does not exclude that the research may also aim to further a commercial interest. An activity does not lose its scientific research character solely because it is privately funded, is carried out within a commercial undertaking or because the results of that research are subsequently used for commercial activities.

Justification

Confirms that private funding or a commercial dimension does not disqualify scientific research.

(38) “scientific research” means any research which can also support innovation, such as technological development and demonstration. These actions shall contribute to existing scientific knowledge or apply existing knowledge in novel ways, be carried out with the aim of contributing to the growth of society’s general knowledge and wellbeing and adhere to ethical standards in the relevant research area. This does not exclude that the research may also aim to further a commercial interest.This does not exclude research testing or development of AI systems or AI models prior to their being placed on the market or put into service or the aim to further a commercial interest.