Article 2

(4c) ‘access’ means data use, in accordance with specific technical, legal or organisational requirements, without necessarily implying the transmission or downloading of data;

(4c) ‘access’ means data use, in accordance with specific technical, legal or organisational requirements, without necessarily implying the transmission or downloading of data;‘access’ means the act of viewing, retrieving and using data or collected by a connected product, including metadata, in accordance with specific technical, legal or organisational requirements

(13) ‘data holder’ means a natural or legal person that has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation adopted in accordance with Union law, to use orand make available data, including, where contractually agreed, product data or related service data, which it has retrieved or generated during the provision of a related service;

"(22)‘placing on the market’ means the first making available of a connected product on the Union market;, meaning that if at least one individual unit has been lawfully placed on the market or put into service before the date specified in Article 50, other individual units of the same type and model of connected products are subject to the grace period provided in Article 50 and thus may continue to be placed on the market, made available or put into service on the Union market without any additional obligations, requirements or the need for additional certification."

(ba) Point (5) is replaced by the following:

(5) ‘connected product’ means an item thatwhose obtainsprimary function is to obtain, generatesgenerate or collectscollect data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, and whose primary function is not the storing, processing or transmission of data on behalf of any party other than the user;"

"‘connected product’ means an item thatwhose obtainsprimary function is obtaining, generatesgenerating, or collectscollecting data concerning its use or environment and that is able to communicate product data via an electronic communications service, physical connection or on-device access, andexcluding any item whose primary function is not the storing, processing or transmission of data on behalf of any party other than thedata userconcerning its use or environment;"

(38a) ‘data intermediation service’ means a service which aims to establish relationships of an economic character for the purposes of data sharing between an undetermined number of data subjects or data holders and data users, through technical, legal or other means, including for the purpose of exercising the rights of data subjects in relation to personal data, and which: (1) do not have as their main purpose the intermediation of copyright-protected content; (2) are not jointly procured by several legal persons for exclusive use among them;

(38b) ‘data altruism’ means the voluntary sharing of data on the basis of the consent of data subjects to process personal data pertaining to them, or of permissions of data holders to allow the use of their non-personal data without seeking or receiving a reward that goes beyond fair compensation related to the costs that they incur where they make their data available for objectives of general interest as provided for in national and Union law, where applicable, such as healthcare, combating climate change, improving mobility, facilitating the development, production and dissemination of official statistics, improving the provision of public services, public policy making or scientific research purposes in the general interest;

Justification

Due to the loss of certain provisions on data altruism organisations an explicit definition of data altruism organisations is suggested.

"‘public emergency’ means an exceptional situation, limited in time, such as a public health emergency, an emergency resulting from natural disasters, a human-induced major disaster, including a major cybersecurity incident, negatively affecting the population of the Union or the whole or part of a Member State, with a risk of serious and lasting repercussions for living conditions or economic stability, financial stability, or the substantial and immediate degradation of economic assets in the Union or the relevant Member State and which is determined or officially declared in accordance with the relevant procedures under Union or national law, for the purposes of this Regulation, “responding to a public emergency” refers to immediate actions necessary to address and manage the emergency while it is ongoing, whereas “mitigating or supporting the recovery from a public emergency” refers to immediate actions taken after or once the immediate phase of the emergency has passed, aimed at limiting its consequences and restoring normal conditions within a timely manner;"

(50) ‘research data’ means data , other than scientific publications, which are collected or produced in the course of scientific research activities, in accordance with Article 4(38) of Regulation (EU) 2026/679, and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results. Research data do not include data collected or produced in the context of processing with the principal aim of observing, establishing the profile or influencing the behaviour of natural persons for commercial purposes, in particular for behavioural advertising or the commercial targeting of individuals even where scientific methods are used;

(50) ‘research data’ means data , other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results; it also includes research information, such as abstracts, citations, metadata and other information used to understand and assess research;

(51) ‘re-use’ means the use by natural persons or legal entitiespersons of data or documents held by:

(52) ‘high-value datasets’ means datapersonal and non-personal data, as well as 50 documents the re-use of which is associated with important benefits for society, the environment and the economy, in particular because of their suitability for the creation of value-added services, applications and new, high-quality and decent jobs, and because of the number of potential beneficiaries of the value-added services and applications based on those data and documents;

(54) ‘secure processing environment’ means the physical or virtual environment and organisational means to ensure compliance with Union law in particular with regard to data subjects’ rights, intellectual property rights, and commercial and statistical confidentiality, integrity and accessibility, as well as with applicable national law, in order to protect personal data and data relating to identifiable natural persons from re-identification, personal data breaches and any unlawful use or trading, and to allow the entity providing the secure processing environment to determine and supervise all data processing actions, including the display, storage, download and export of data and the calculation of derivative data through computational algorithms;

(58) ‘formal open standard’ means a freely accessible standard which has been laid down in written form, detailing specifications for the requirements on how to ensure software interoperability;

(60) ‘data localisation requirement’ means any obligation, prohibition, condition, limit or other requirement provided for in the laws, regulations or administrative provisions of a Member State or resulting from general and consistent administrative practices in a Member State and in bodies governed by public law, including in the field of public procurement, without prejudice to Directive 2014/24/EU, which imposes the processing of data in the territory of a specific Member State or hinders the processing of data in any other Member State. A requirement shall not constitute a data localisation requirement within the meaning of this point where it is justified by reasons or public security or where it is necessary and proportionate in order to protect personal data, sensitive data or high-value datasets from any access, transfer or use resulting from the extra-territorial application of a law of a third country that may be cause harm to the Union or its Member States;

Justification

This amendment is connected to the following addition on access to connected products which aims to ensure that data access is made possible and operational without the data first being transmitted to, or made contingent upon the availability of, a server or cloud infrastructure operated by the manufacturer.