### 4. where access to electronic health data has been restricted by the natural person , the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person , including where the provider or professional is informed of the existence and nature of the restricted electronic health data. in cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person , the healthcare provider or health professional may get access to the restricted electronic health data. following such access , the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. member states’ law may add additional safeguards. ### 4. where access to electronic health data has been restricted by the natural person , the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person , in which case the provider or professional will be informed of the existence and nature of the restricted electronic health data. in cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person , the healthcare provider or health professional may get access to the restricted electronic health data. following such access , the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. member states’ law may add additional safeguards.


### electronic prescriptions; ### electronic prescriptions in any language of the union;


### medical images and image reports; ### medical images , image reports , audio and video;


### discharge reports. ### patient discharge reports.


### 1. the commission shall , by means of implementing acts , lay down the technical specifications for the priority categories of personal electronic health data referred to in article 5 , setting out the european electronic health record exchange format. the format shall include the following elements: ### 1. the commission shall , by means of implementing acts , lay down the technical specifications for the priority categories of personal electronic health data referred to in article 5 , setting out the european electronic health record exchange format. the exchange format must be chosen in accordance with the feasibility of technical and organisational measures pursuant to article 32 of regulation (eu) 2016/679. the format shall include the following elements:


### 1. the commission shall , by means of implementing acts , lay down the technical specifications for the priority categories of personal electronic health data referred to in article 5 , setting out the european electronic health record exchange format. the format shall include the following elements: ### 1. the commission shall , by means of implementing acts , lay down the technical specifications for the priority categories of personal electronic health data referred to in article 5 , setting out the european electronic health record exchange format , ensuring consistency with the technical specifications prevailing in the member states. the format shall include the following elements:


### article 8 ### deleted


### ensure the implementation , at national level , of the european electronic health record exchange format , in cooperation with national authorities and stakeholders; ### ensure the implementation , at national level , of the european electronic health record exchange format , in cooperation with national authorities and stakeholders , in particular healthcare professionals;


### contribute , at union level , to the development of the european electronic health record exchange format and to the elaboration of common specifications addressing interoperability , security , safety or fundamental right concerns in accordance with article 23 and of the specifications of the eu database for ehr systems and wellness applications referred to in article 32; ### contribute , at union level , and in cooperation with the local and regional level within the member states , to the development of the european electronic health record exchange format and to the elaboration of common specifications addressing interoperability , security , safety or fundamental right concerns in accordance with article 23 and of the specifications of the eu database for ehr systems and wellness applications referred to in article 32;


### cooperate with other relevant entities and bodies at national or union level , to ensure interoperability , data portability and security of electronic health data , as well as with stakeholders representatives , including patients’ representatives , healthcare providers , health professionals , industry associations; ### cooperate with other relevant entities and bodies at national or union level , to ensure interoperability , data portability and security of electronic health data , as well as with stakeholders representatives , including patients’ representatives , healthcare providers , health professionals , including professional associations representing them , social security institutions , industry associations;


### cooperate with other relevant entities and bodies at national or union level , to ensure interoperability , data portability and security of electronic health data , as well as with stakeholders representatives , including patients’ representatives , healthcare providers , health professionals , industry associations; ### cooperate with other relevant entities and bodies at local , regional , national or union level , to ensure interoperability , data portability and security of electronic health data , as well as with stakeholders representatives , including patients’ representatives , healthcare providers , health professionals , industry associations;


### 5. in the performance of its tasks , the digital health authority shall actively cooperate with stakeholders’ representatives , including patients’ representatives. members of the digital health authority shall avoid any conflicts of interest. ### 5. essential health stakeholders representatives on national level , including patient organisations , social security institutions and healthcare professionals , shall be present in the governance and decision-making structures of the digital health authority. in the performance of its tasks , the digital health authority shall actively cooperate with stakeholders’ representatives , including patients’ representatives. members of the digital health authority shall avoid any conflicts of interest.


### 5. in the performance of its tasks , the digital health authority shall actively cooperate with stakeholders’ representatives , including patients’ representatives. members of the digital health authority shall avoid any conflicts of interest. ### 5. in the performance of its tasks , the digital health authority shall actively cooperate with stakeholders’ representatives , including patients’ representatives. members of the digital health authority shall avoid any conflicts of interest. essential health stakeholders’ representatives on national level , including patient organisations , healthcare professionals and industry associations shall be present in the governance and decision-making structures of the digital health authority.


### 5. in the performance of its tasks , the digital health authority shall actively cooperate with stakeholders’ representatives , including patients’ representatives. members of the digital health authority shall avoid any conflicts of interest. ### 5. in the performance of its tasks , the digital health authority shall actively cooperate with stakeholders’ representatives , including representatives of patients , the industrial sector , smes , medical institutions , civil society , the university sector and research bodies. members of the digital health authority shall avoid any conflicts of interest.


### 6. member states shall ensure that pharmacies operating on their territories , including online pharmacies , are enabled to dispense electronic prescriptions issued by other member states , under the conditions laid down in article 11 of directive 2011/24/eu. the pharmacies shall access and accept electronic prescriptions transmitted to them from other member states through myhealth@eu. following dispensation of medicinal products based on an electronic prescription from another member state , pharmacies shall report the dispensation to the member state that issued the prescription , through myhealth@eu. ### 6. member states shall ensure that pharmacies operating on their territories are enabled to dispense electronic prescriptions issued by other member states , under the conditions laid down in article 11 of directive 2011/24/eu. the pharmacies shall access and accept electronic prescriptions transmitted to them from other member states through myhealth@eu , granted that the requirements in article 11 of directive 2011/24/eu are fulfilled. following dispensation of medicinal products based on an electronic prescription from another member state , pharmacies shall report the dispensation to the member state that issued the prescription , through myhealth@eu.


### 6. member states shall ensure that pharmacies operating on their territories , including online pharmacies , are enabled to dispense electronic prescriptions issued by other member states , under the conditions laid down in article 11 of directive 2011/24/eu. the pharmacies shall access and accept electronic prescriptions transmitted to them from other member states through myhealth@eu. following dispensation of medicinal products based on an electronic prescription from another member state , pharmacies shall report the dispensation to the member state that issued the prescription , through myhealth@eu. ### 6. member states shall ensure that pharmacies operating on their territories are enabled to dispense electronic prescriptions issued by other member states , under the conditions laid down in article 11 of directive 2011/24/eu. the pharmacies shall access and accept electronic prescriptions transmitted to them from other member states through myhealth@eu. following dispensation of medicinal products based on an electronic prescription from another member state , pharmacies shall report the dispensation to the member state that issued the prescription , through myhealth@eu.


### 2. this chapter shall not apply to general software used in a healthcare environment. ### 2. this chapter shall not apply to general software used in a healthcare environment. manufacturers of ehr systems that also qualify as medical devices as defined under article 2(1) of regulation (eu) 2017/745 and claim interoperability of those medical devices with ehr systems under this regulation shall prove compliance with the essential requirements for interoperability laid down in section 2 of annex ii to this regulation. article 23 of this regulation shall be applicable to those medical devices.


### ensure that their ehr systems are in conformity with the essential requirements laid down in annex ii and with the common specifications in accordance with article 23; ### ensure that their ehr systems are in conformity with the essential requirements laid down in annex ii and with the common specifications in accordance with article 23 and interoperable between member states;


### the commission shall , by means of implementing acts , adopt common specifications in respect of the essential requirements set out in annex ii , including a time limit for implementing those common specifications. where relevant , the common specifications shall take into account the specificities of medical devices and high risk ai systems referred to in paragraphs 3 and 4 of article 14. ### the commission shall , by means of implementing acts , adopt common specifications in respect of the essential requirements set out in annex ii , including a common template document and a time limit for implementing those common specifications. those common specifications shall be based on existing harmonised standards or international standards and shall be adopted only after consulting the european standardisation organisations as well as the relevant stakeholders. where relevant , the common specifications shall take into account the specificities and verify compatibility with sectorial legislation and harmonized standards of medical devices and high risk ai systems referred to in paragraphs 3 and 4 of article 14 , including the state-of-the art standards for health informatics and the european electronic health record exchange format.


### the commission shall , by means of implementing acts , adopt common specifications in respect of the essential requirements set out in annex ii , including a time limit for implementing those common specifications. where relevant , the common specifications shall take into account the specificities of medical devices and high risk ai systems referred to in paragraphs 3 and 4 of article 14. ### the commission shall , by means of implementing acts , adopt common specifications in respect of the essential requirements set out in annex ii , including a time limit for implementing those common specifications. those common specifications shall be issued in accordance with article 10 of regulation (eu) 1025/2012 , and where relevant based on existing harmonised standards or relevant international standards , and shall be adopted only after consulting the european standardisation organisations as well as other relevant stakeholders. where relevant , the common specifications shall take into account the specificities of medical devices and high risk ai systems referred to in paragraphs 3 and 4 of article 14.


### such notification shall be made , without prejudice to incident notification requirements under directive (eu) 2016/1148 , immediately after the manufacturer has established a causal link between the ehr system and the serious incident or the reasonable likelihood of such a link , and , in any event , not later than 15 days after the manufacturer becomes aware of the serious incident involving the ehr system. ### such notification shall be made , without prejudice to incident notification requirements under directive (eu) 2016/1148 , immediately after the manufacturer has established a causal link between the ehr system and the serious incident or the reasonable likelihood of such a link , and , in any event , not later than 7 days after the manufacturer becomes aware of the serious incident involving the ehr system.


### 1. data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this chapter: ### 1. data holders shall make the following categories of electronic data available , taking into account the differences in administrative , logistical and resource requirements for each category in the member states , for secondary use in accordance with the provisions of this chapter:


### 1. data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this chapter: ### 1. this chapter shall apply to the following categories of electronic data for secondary use , in accordance with the provisions of this chapter:


### ehrs; ### electronic health data from ehrs , including the categories in article 5 of this regulation.


### ehrs; ### electronic health data from ehrs;


### data impacting on health , including social , environmental behavioural determinants of health; ### data on factors impacting on health , including social environmental behavioural determinants of health , but excluding data relating to criminal convictions and offences;


### data impacting on health , including social , environmental behavioural determinants of health; ### data on factors impacting on health , including social , environmental behavioural determinants of health;


### health-related administrative data , including claims and reimbursement data; ### health-related administrative data for population-wide predominantly publicly funded treatments , including claims and reimbursement data;


### human genetic , genomic and proteomic data; ### deleted


### identification data related to health professionals involved in the treatment of a natural person; ### identification data related to health professionals involved in research should be limited to data which is absolutely necessary;


### population wide health data registries (public health registries); ### population wide electronic health data registries (public health registries);


### electronic health data from clinical trials; ### deleted


### electronic health data from clinical trials; ### electronic health data from fully completed clinical trials in accordance with definitions in article 2(2) and article 2(26) of regulation (eu) no 536/2014;


### electronic health data from clinical trials; ### electronic health data from clinical trials in so far as they have been completed;


### research cohorts , questionnaires and surveys related to health; ### research cohorts , questionnaires and surveys related to health , including patient-reported outcome measures and patient-reported experience measures;


### research cohorts , questionnaires and surveys related to health; ### data from research cohorts , questionnaires and surveys related to health;


### electronic health data from biobanks and dedicated databases; ### deleted


### 2. the requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in article 2 of the annex to commission recommendation 2003/361/ec59. ### 2. the requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in article 2 of the annex to commission recommendation 2003/361/ec59. the requirement in the first subparagraph shall not apply to data holders who fall within the category of small enterprises in the context of health professional practices.


### 2. the requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in article 2 of the annex to commission recommendation 2003/361/ec59. ### 2. the requirement in the first sentence of the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in article 2 of the annex to commission recommendation 2003/361/ec59.


### (2) the requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in article 2 of the annex to commission recommendation 2003/361/ec59. ### (2) the requirement in the first sentence of the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in article 2 of the annex to commission recommendation 2003/361/ec59.


### 3. the electronic health data referred to in paragraph 1 shall cover data processed for the provision of health or care or for public health , research , innovation , policy making , official statistics , patient safety or regulatory purposes , collected by entities and bodies in the health or care sectors , including public and private providers of health or care , entities or bodies performing research in relation to these sectors , and union institutions , bodies , offices and agencies. ### 3. the electronic health data referred to in paragraph 1 shall cover data processed for the provision of health or care or for public health , research , innovation , policy making , official statistics , patient safety or regulatory purposes , collected by entities and bodies in the health sector , including public and private providers of health or care , entities or bodies performing research in relation to these sectors , and union institutions , bodies , offices and agencies.


### (3) the electronic health data referred to in paragraph 1 shall cover data processed for the provision of health or care or for public health , research , innovation , policy making , official statistics , patient safety or regulatory purposes , collected by entities and bodies in the health or care sectors , including public and private providers of health or care , entities or bodies performing research in relation to these sectors , and union institutions , bodies , offices and agencies. ### (3) the electronic health data referred to in paragraph 1 shall cover data processed for the provision of health or care or for public health , research , innovation , policy making , official statistics , patient safety or regulatory purposes , collected by entities and bodies in the health sector , including public and private providers of health or care , entities or bodies performing research in relation to these sectors , and union institutions , bodies , offices and agencies.


### 4. electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights and trade secrets shall be taken. ### 4. without prejudice to the law relating to the protection of intellectual property and industrial property (including of trade secrets) (“ip rights”) and commercial property , electronic health data entailing protected ip rights from private enterprises shall be made available for secondary use. data sharing should be based on a data sharing agreement persuant to articles 46.6(g) and 46a between data holders and data users that respects the conditions of use listed in article 33(4a). where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights , including trade secrets , shall be taken in advance. the data holder shall identify the data which are protected as trade secrets. when no agreement is reached regarding the necessary measures to preserve the confidentiality of trade secrets or the recepient fails to implement those measures , the data holder is entitled to refuse the user’s access to data which are protected as trade secrets.


### 4. electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights and trade secrets shall be taken. ### 4. without prejudice to the law relating to the protection of intellectual property , industrial property and commercial property rights , and subject to other provisions of this regulation , electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use only if all measures necessary to preserve the confidentiality of ip rights (including trade secrets) are taken. data sharing should be based on a data sharing agreement that respects the provisions of union legislation , in particular of directive on the protection of trade secrets (directive (eu) 2016/943 , article 6(2)(e) of the data act , article 39 of trips , and of articles 9 , 11 and 13 directive 2004/48 on the enforcement of intellectual property rights in relation to preliminary injunctions , injunctions and damages.


### 4. electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights and trade secrets shall be taken. ### 4. without prejudice to the law relating to the protection of intellectual property and industrial property (including of trade secrets)(“ip rights”) and commercial property , and subject to other provisions of this regulation , electronic health data entailing protected ip rights from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights (including trade secrets) shall be taken. data sharing for secondary use shall be based on a data sharing agreement pursuant to articles 46.6(g) and 46a.


### 4. electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights and trade secrets shall be taken. ### 4. without prejudice to applicable legislation on intellectual property rights , regulatory data protection and trade secrets , electronic health data entailing protected intellectual property , regulatory data protection or trade secrets from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights , protected regulatory data and trade secrets shall be taken.


### 4. electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights and trade secrets shall be taken. ### 4. electronic health data entailing protected intellectual property and trade secrets shall not be made available for secondary use.


### 4. electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights and trade secrets shall be taken. ### 4. electronic health data entailing protected intellectual property and trade secrets from private enterprises shall only be made available for secondary use when all measures necessary to preserve the confidentiality of ip rights and trade secrets have been taken.


### 4. electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights and trade secrets shall be taken. ### 4. electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use if and to the extent that all measures necessary to preserve the confidentiality of ip rights and trade secrets can be taken , for example by taking the following measures:


### (4) electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights and trade secrets shall be taken. ### (4) electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use if and to the extent that all measures necessary to preserve the confidentiality of ip rights and trade secrets can be taken , for example by taking the following measures:


### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data. ### deleted


### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data. ### 5. natural persons that are subjects to secondary use of health data shall have the right to decline the processing of their health data. health data access bodies shall provide for an accessible and easily understandable opt-out mechanism , whereby natural persons must be offered the possibility to restrict full or partial access to their personal health data for all or parts of secondary use. data subjects should indicate this decision to the health data access bodies. in situation where natural persons explicitly express their wish to use opt-out mechanism to data holders , data holders shall direct natural persons to the health data access bodies , which shall provide an opt-out template for the data subject. the exercise of this right to opt-out shall not affect the lawfulness of the processing that took place under chapter iv before the individual opted-out. the opt-out mechanism shall function without prejudice to article 21(6) of regulation (eu) 2016/679 , whereby the right to object may be restricted when the processing of personal data is necessary for the performance of a task carried out for reasons of public interest.


### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data. ### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data. natural persons persons that are subjects to secondary use of health data shall have the right to decline the processing of their health data. health data access bodies shall provide for an accessible and easily understandable opt-out mechanism , whereby natural persons must be offered the possibility to explicitly express their wish not to have all or part of their personal electronic health data processed for some or all secondary use purposes. in situation where natural persons explicitly express their wish to use opt-out mechanism to data holders , data holders shall direct natural persons to the health data access bodies. the exercise of this right to opt-out shall not affect the lawfulness of the processing that took place under this chapter iv before the individual opted-out.


### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data. ### 5. natural persons that are subjects to secondary use of health data shall have the right to decline the processing of their health data , except for the uses covered under article 34(1) (a)-(c). in all other cases , health data access bodies shall provide for an accessible and easily understandable opt-out mechanism , whereby natural persons must be offered the possibility to explicitly express their wish not to have all or part of their personal electronic health data processed for some or all secondary use purposes. in situation where natural persons explicitly express their wish to use the opt-out mechanism to data holders , data holders shall direct natural persons to the health data access bodies.


### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data. ### 5. to the extent the electronic health data referred to in paragraph 1(a) includes personal data , the individual concerned shall be offered an additional safeguard in the form of a right to opt-out from the use of his personal data under chapter iv of this regulation. the exercise of this right to opt-out shall not affect the lawfulness of the processing that took place under this chapter iv before the individual opted-out


### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data. ### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data.


### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data. ### 5. the consent of the natural persons or their representatives must be sought for the processing of all or part of the electronic health data for secondary use. they shall also have the right to refuse , or alter their decision on , the processing of health data for secondary use , without this in any way affecting the quality of the healthcare received.


### (5) where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data. ### deleted


### 6. where a public sector body obtains data in emergency situations as defined in article 15 , point (a) or (b) of the regulation […] [data act com/2022/68 final] , in accordance with the rules laid down in that regulation , it may be supported by a health data access body to provide technical support to process the data or combing it with other data for joint analysis. ### 6. where a public sector body obtains data in emergency situations as defined in article 15 , point (a) or (b) of the regulation […] [data act com/2022/68 final] , in accordance with the rules laid down in that regulation , it may be supported by a health data access body or a pseudonymisation body to provide technical support to process the data or combing it with other data for joint analysis.


### (6) where a public sector body obtains data in emergency situations as defined in article 15 , point (a) or (b) of the regulation […] [data act com/2022/68 final] , in accordance with the rules laid down in that regulation , it may be supported by a health data access body to provide technical support to process the data or combing it with other data for joint analysis. ### (6) where a public sector body obtains data in emergency situations as defined in article 15 , point (a) or (b) of the regulation […] [data act com/2022/68 final] , in accordance with the rules laid down in that regulation , it may be supported by a health data access body or a pseudonymisation body to provide technical support to process the data or combing it with other data for joint analysis.


### 7. the commission is empowered to adopt delegated acts in accordance with article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data. ### 7. the commission shall periodically review the list in paragraph 1. the commission is empowered to adopt delegated acts in accordance with article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data. the ehds board shall be consulted as part of the periodical review.


### 8. health data access bodies may provide access to additional categories of electronic health data that they have been entrusted with pursuant to national law or based on voluntary cooperation with the relevant data holders at national level , in particular to electronic health data held by private entities in the health sector. ### deleted


### (8) health data access bodies may provide access to additional categories of electronic health data that they have been entrusted with pursuant to national law or based on voluntary cooperation with the relevant data holders at national level , in particular to electronic health data held by private entities in the health sector. ### deleted


### 1. health data access bodies shall only provide access to electronic health data referred to in article 33 where the intended purpose of processing pursued by the applicant complies with: ### 1. application processing bodies shall only authorise access to electronic health data referred to in article 33 where the intended purpose of processing pursued by the applicant complies with:


### (1) health data access bodies shall only provide access to electronic health data referred to in article 33 where the intended purpose of processing pursued by the applicant complies with: ### (1) application processing bodies shall only authorise access to electronic health data referred to in article 33 where the intended purpose of processing pursued by the applicant complies with:


### activities for reasons of public interest in the area of public and occupational health , such as protection against serious cross-border threats to health , public health surveillance or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices; ### activities for reasons of public interest in the area of public and occupational health , such as protection against serious cross-border threats to health , public health surveillance or ensuring high levels of quality , safety and efficacy of healthcare and of medicinal products or medical devices;


### activities for reasons of public interest in the area of public and occupational health , such as protection against serious cross-border threats to health , public health surveillance or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices; ### activities for reasons of public interest in the area of public and occupational health , such as protection against serious cross-border threats to health , public health surveillance or ensuring high levels of quality and safety and efficacy of healthcare and of medicinal products or medical devices , for the purpose of the evaluation of the benefits and risks of medicinal products and of the identification and assessment of threats to human health posed by infectious diseases the ema and ecdc shall be granted rapid and unrestricted access to the health data within the ehds;


### to produce national , multi-national and union level official statistics related to health or care sectors; ### to produce national , multi-national and union level official , gender sensitive statistics related to health or care sectors;


### development and innovation activities for products or services contributing to public health or social security , or ensuring high levels of quality and safety of health care , of medicinal products or of medical devices; ### development and innovation activities for products or services contributing to public health or social security , or ensuring high levels of quality and safety of health care , of medicinal products , medical devices or in vitro diagnostic medical devices;


### development and innovation activities for products or services contributing to public health or social security , or ensuring high levels of quality and safety of health care , of medicinal products or of medical devices; ### development and innovation activities for products or services contributing to public health , or ensuring high levels of quality and safety of health care , of medicinal products or of medical devices;


### training , testing and evaluating of algorithms , including in medical devices , ai systems and digital health applications , contributing to the public health or social security , or ensuring high levels of quality and safety of health care , of medicinal products or of medical devices; ### training , testing and evaluating of algorithms , including in medical devices , in vitro diagnostic medical devices , ai systems and digital health applications , contributing to the public health or social security , or ensuring high levels of quality and safety of health care , of medicinal products , medical devices or in vitro diagnostic medical devices;


### training , testing and evaluating of algorithms , including in medical devices , ai systems and digital health applications , contributing to the public health or social security , or ensuring high levels of quality and safety of health care , of medicinal products or of medical devices; ### training , testing and evaluating of algorithms , including in medical devices , ai systems and digital health applications , contributing to public health , or ensuring high levels of quality and safety of health care , of medicinal products or of medical devices;


### providing personalised healthcare consisting in assessing , maintaining or restoring the state of health of natural persons , based on the health data of other natural persons. ### improving delivery of healthcare , optimising patient pathways and providing personalised healthcare consisting in assessing , maintaining or restoring the state of health of natural persons , based on the health data of other natural persons and real world evidence.


### 4. public sector bodies or union institutions , agencies and bodies that obtain access to electronic health data entailing ip rights and trade secrets in the exercise of the tasks conferred to them by union law or national law , shall take all specific measures necessary to preserve the confidentiality of such data. ### 4. public sector bodies or union institutions , agencies and bodies that obtain access to electronic health data entailing ip rights , regulatory data protection or trade secrets in the exercise of the tasks conferred to them by union law or national law , shall , upon consultation with the data holder , take all specific measures necessary to preserve the confidentiality of such data.


### 4. public sector bodies or union institutions , agencies and bodies that obtain access to electronic health data entailing ip rights and trade secrets in the exercise of the tasks conferred to them by union law or national law , shall take all specific measures necessary to preserve the confidentiality of such data. ### 4. public sector bodies or union institutions , agencies and bodies that obtain access to electronic health data entailing ip rights and trade secrets in the exercise of the tasks conferred to them by union law or national law , must take all specific measures necessary to preserve the confidentiality of such data.


### taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums; ### deleted


### taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums; ### taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums or taking any other decisions in relation to a natural person or groups of natural persons to discriminate on the basis of the health data obtained;


### advertising or marketing activities towards health professionals , organisations in health or natural persons; ### advertising or marketing activities towards health professionals , organisations in health or natural persons with the exception of communication in line with approved regulatory information or to provide up-to date , verifiable and complete scientific information to health care professionals for educational purpose in line with directive 2001/83/ec;


### developing products or services that may harm individuals and societies at large , including , but not limited to illicit drugs , alcoholic beverages , tobacco products , or goods or services which are designed or modified in such a way that they contravene public order or morality. ### developing products or services that may harm individuals and societies at large , including , but not limited to illicit drugs , alcoholic beverages or tobacco products.


### health data access bodies ### bodies involved in accessing health data


### 1. member states shall designate one or more health data access bodies responsible for granting access to electronic health data for secondary use. member states may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions set out in this article. where a member state designates several health data access bodies , it shall designate one health data access body to act as coordinator , with responsibility for coordinating requests with the other health data access bodies. ### 1. member states shall each designate one or more bodies involved in accessing health data that are responsible for granting access to electronic health data for secondary use. member states may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies or private legal persons that fulfil the conditions set out in this article. where a member state designates several bodies involved in accessing health data , it shall designate one body to act as coordinator , with responsibility for coordinating requests with the other bodies involved in accessing health data. the following legally and organisationally independent bodies may be involved in accessing electronic health data:


### (1) member states shall designate one or more health data access bodies responsible for granting access to electronic health data for secondary use. member states may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions set out in this article. where a member state designates several health data access bodies , it shall designate one health data access body to act as coordinator , with responsibility for coordinating requests with the other health data access bodies. ### (1) member states shall each designate one or more bodies involved in accessing health data that are responsible for granting access to electronic health data for secondary use. member states may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies or private legal persons that fulfil the conditions set out in this article. where a member state designates several bodies involved in accessing health data , it shall designate one body to act as coordinator , with responsibility for coordinating requests with the other bodies involved in accessing health data. the following legally and organisationally independent bodies may be involved in accessing electronic health data:


### 2. member states shall ensure that each health data access body is provided with the human , technical and financial resources , premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers. ### 2. member states shall ensure that each body involved in accessing health data is provided with the human , technical and financial resources , premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers. certification shall be required for approval and designation as an application processing body. application processing bodies shall carry out their tasks in an impartial , transparent , consistent and timely manner. senior managers and staff members of the authorities responsible shall not engage in any activity that may conflict with their independence of judgment or integrity in carrying out the tasks entrusted to them.


### 2. member states shall ensure that each health data access body is provided with the human , technical and financial resources , premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers. ### 2. member states shall ensure that each health data access body is provided with the human , technical and financial resources , premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers. this shall include sufficient administrative , technical and scientific personnel , including expertise in relevant areas such as data management , data protection , data science , healthcare and intellectual property rights.


### (2) member states shall ensure that each health data access body is provided with the human , technical and financial resources , premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers. ### (2) member states shall ensure that each body involved in accessing health data is provided with the human , technical and financial resources , premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers. certification shall be required for approval and designation as an application processing body. application processing bodies shall carry out their tasks in an impartial , transparent , consistent and timely manner. senior managers and staff members of the authorities responsible shall not engage in any activity that may conflict with their independence of judgement or integrity in carrying out the tasks entrusted to them.


### 3. in the performance of their tasks , health data access bodies shall actively cooperate with stakeholders’ representatives , especially with representatives of patients , data holders and data users. staff of health data access bodies shall avoid any conflicts of interest. health data access bodies shall not be bound by any instructions , when making their decisions. ### 3. in the performance of their tasks , health data access bodies shall actively cooperate with stakeholders’ representatives , especially with representatives of patients , data holders and data users. staff of health data should be trained at local level on how to operate the health data space. appropriate funding should be ensured by the member state for regular trainings and regular digital literacy courses as means to reduce fragmentation and build trust. staff of health data access bodies shall avoid any conflicts of interest. health data access bodies shall not be bound by any instructions , when making their decisions and a conflict of interest policy should be put into place


### 3. in the performance of their tasks , health data access bodies shall actively cooperate with stakeholders’ representatives , especially with representatives of patients , data holders and data users. staff of health data access bodies shall avoid any conflicts of interest. health data access bodies shall not be bound by any instructions , when making their decisions. ### 3. in the performance of their tasks , health data access bodies shall actively cooperate with stakeholders’ representatives , especially with representatives of patients , data holders and data users. staff of health data access bodies shall avoid any conflicts of interest. health data access bodies shall not be bound by any instructions , when making their decisions. member states shall ensure that essential health stakeholders’ representatives , including patient organisations , healthcare professional and industry associations shall be present in the governance and decision-making structures of the health data access bodies.


### 3. in the performance of their tasks , health data access bodies shall actively cooperate with stakeholders’ representatives , especially with representatives of patients , data holders and data users. staff of health data access bodies shall avoid any conflicts of interest. health data access bodies shall not be bound by any instructions , when making their decisions. ### 3. member states shall ensure that essential health stakeholders’ representatives , including patient organisations , healthcare professionals and research community shall be present in the governance and decision-making structures of the health data access bodies. in the performance of their tasks , health data access bodies shall actively cooperate with stakeholders’ representatives , especially with representatives of patients , data holders and data users. staff of health data access bodies shall avoid any conflicts of interest. health data access bodies shall not be bound by any instructions , when making their decisions.


### (3) in the performance of their tasks , health data access bodies shall actively cooperate with stakeholders’ representatives , especially with representatives of patients , data holders and data users. staff of health data access bodies shall avoid any conflicts of interest. health data access bodies shall not be bound by any instructions , when making their decisions. ### (3) in the performance of their tasks , bodies involved in accessing health data shall actively cooperate with stakeholders’ representatives , especially with representatives of patients , data holders and data users. staff of bodies involved in accessing health data shall avoid any conflicts of interest. bodies involved in accessing health data shall not be bound by any instructions , when making their decisions.


### (1) whereas: the aim of this regulation is to establish the european health data space (‘ehds’) in order to improve access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data) , as well as for other purposes that would benefit the society such as research , innovation , policy-making , patient safety , personalised medicine , official statistics or regulatory activities (secondary use of electronic health data). in addition , the goal is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development , marketing and use of electronic health record systems (‘ehr systems’) in conformity with union values. ### (1) whereas: the aim of this regulation is to establish the european health data space (‘ehds’) in order to improve access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data) , as well as for other purposes in the health sector that would benefit the society such as research , innovation , policy-making , patient safety , personalised medicine , official statistics or regulatory activities (secondary use of electronic health data). in addition , the goal is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development , marketing and use of electronic health record systems (‘ehr systems’) in conformity with union values.


### (37) for the secondary use of the clinical data for research , innovation , policy making , regulatory purposes , patient safety or the treatment of other natural persons , the possibilities offered by regulation (eu) 2016/679 for a union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. this regulation provides the legal basis in accordance with articles 9(2) (g) , (h) , (i) and (j) of regulation (eu) 2016/679 for the secondary use of health data , establishing the safeguards for processing , in terms of lawful purposes , trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment , as well as modalities for data processing , set out in the data permit. at the same time , the data applicant should demonstrate a legal basis pursuant to article 6 of regulation (eu) 2016/679 , based on which they could request access to data pursuant to this regulation and should fulfil the conditions set out in chapter iv. more specifically: for processing of electronic health data held by the data holder pursuant to this regulation , this regulation creates the legal obligation in the sense of article 6(1) point (c) of regulation (eu) 2016/679 for disclosing the data by the data holder to health data access bodies , while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. this regulation also meets the conditions for such processing pursuant to articles 9(2) (h) ,(i) ,(j) of the regulation (eu) 2016/679. this regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment , processing data before they are used , etc.) in the sense of article 6(1)(e) of regulation (eu) 2016/679 to the health data access bodies , and meets the requirements of article 9(2)(h) ,(i) ,(j) of the regulation (eu) 2016/679. therefore , in this case , this regulation provides the legal basis under article 6 and meets the requirements of article 9 of that regulation on the conditions under which electronic health data can be processed. in the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this regulation) , the data user should demonstrate its legal basis pursuant to articles 6(1) , points (e) or (f) , of regulation (eu) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this regulation: on the basis of the applicable legislation , where the legal basis under regulation (eu) 2016/679 is article 6(1) , point (e) , or on article 6(1) , point (f) , of regulation (eu) 2016/679. if the user relies upon a legal basis offered by article 6(1) , point (e) , it should make reference to another eu or national law , different from this regulation , mandating the user to process personal health data for the compliance of its tasks. if the lawful ground for processing by the user is article 6(1) , point (f) , of regulation (eu) 2016/679 , in this case it is this regulation that provides the safeguards. in this context , the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data. ### (37) for the secondary use , not requiring consent , of certain clinical data for health-related research , innovation , policy making , regulatory purposes , patient safety or the treatment of other natural persons , the possibilities offered by regulation (eu) 2016/679 for a union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. this regulation provides the legal basis in accordance with articles 9(2) (g) , (h) , (i) and (j) of regulation (eu) 2016/679 for the secondary use , not requiring consent , of certain health data , establishing the safeguards for processing , in terms of lawful purposes , trusted governance for providing access to that health data (through health data access bodies) and processing in a secure environment , as well as modalities for data processing , set out in the data permit. at the same time , the data applicant should demonstrate a legal basis pursuant to article 6 of regulation (eu) 2016/679 , based on which they could request access to data pursuant to this regulation and should fulfil the conditions set out in chapter iv. more specifically: for processing of certain electronic health data held by the data holder pursuant to this regulation , this regulation , in certain cases , creates the legal obligation in the sense of article 6(1) point (c) of regulation (eu) 2016/679 for disclosing that data , for secondary use , by the data holder to health data access bodies , while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. this regulation also meets the conditions for such processing pursuant to articles 9(2) (h) ,(i) ,(j) of the regulation (eu) 2016/679. this regulation assigns tasks in the public interest to the bodies involved in health data access (running the secure processing environment , processing data before they are used , etc.) in the sense of article 6(1)(e) of regulation (eu) 2016/679 to the health data access bodies , and meets the requirements of article 9(2)(h) ,(i) ,(j) of the regulation (eu) 2016/679. this applies equally to the activities of the application processing body that examines and , where appropriate , approves data access applications by data users , without storing health data itself , and to the activities of the pseudonymisation body that pseudonymises the electronic health data prior to storage at health data access bodies. therefore , in this case , this regulation provides the legal basis under article 6 and meets the requirements of article 9 of that regulation on the conditions under which certain electronic health data can be processed. in the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this regulation) , the data user should demonstrate its legal basis pursuant to articles 6(1) , points (e) or (f) , of regulation (eu) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this regulation: on the basis of the applicable legislation , where the legal basis under regulation (eu) 2016/679 is article 6(1) , point (e) , or on article 6(1) , point (f) , of regulation (eu) 2016/679. if the user relies upon a legal basis offered by article 6(1) , point (e) , it should make reference to another eu or national law , different from this regulation , mandating the user to process personal health data for the compliance of its tasks. if the lawful ground for processing by the user is article 6(1) , point (f) , of regulation (eu) 2016/679 , in this case it is this regulation that provides the safeguards. in this context , the data permits issued by the application processing bodies are an administrative decision defining the conditions for the access to the data.


### (aa) ‘data permit’ means an administrative decision issued to a data user by a health data access body or data holder to process the electronic health data specified in the data permit for the secondary use purposes specified in the data permit based on conditions laid down in this regulation; ### (aa) ‘data permit’ means an administrative decision issued to a data user by an application processing body or data holder to process the electronic health data specified in the data permit for the secondary use purposes specified in the data permit based on conditions laid down in this regulation;


### (4) member states shall communicate to the commission the identity of the health data access bodies designated pursuant to paragraph 1 by the date of application of this regulation. they shall also communicate to the commission any subsequent modification of the identity of those bodies. the commission and the member states shall make this information publicly available. ### (4) member states shall communicate to the commission the identity of the bodies designated pursuant to paragraph 1 by the date of application of this regulation. they shall also communicate to the commission any subsequent modification of the identity of those bodies. the commission and the member states shall make this information publicly available.


### tasks of health data access bodies ### tasks of bodies involved in accessing health data


### (1) health data access bodies shall carry out the following tasks: ### (1) bodies involved in accessing health data shall carry out the following tasks:


### decide on data access applications pursuant to article 45 , authorise and issue data permits pursuant to article 46 to access electronic health data falling within their national remit for secondary use and decide on data requests in accordance with chapter ii of regulation […] [data governance act com/2020/767 final] and this chapter; ### application processing bodies shall decide on data access applications pursuant to article 45 , authorise and issue data permits pursuant to article 46 to access electronic health data falling within their national remit for secondary use and decide on data requests in accordance with chapter ii of regulation […] [data governance act com/2020/767 final] and this chapter;


### support public sector bodies in carrying out the tasks enshrined in their mandate , based on national or union law; ### access bodies shall support public sector bodies in carrying out the tasks enshrined in their mandate , based on national or union law;


### support union institutions , bodies , offices and agencies in carrying out tasks enshrined in the mandate of union institutions , bodies , offices and agencies , based on national or union law; ### access bodies shall support union institutions , bodies , offices and agencies in carrying out tasks enshrined in the mandate of union institutions , bodies , offices and agencies , based on national or union law;


### process electronic health data for the purposes set out in article 34 , including the collection , combination , preparation and disclosure of those data for secondary use on the basis of a data permit; ### access bodies shall process electronic health data for the purposes set out in article 34 , including the collection , combination , preparation and disclosure of those data for secondary use on the basis of a data permit;


### process electronic health data from other relevant data holders based on a data permit or a data request for a purposes laid down in article 34; ### access bodies shall process electronic health data from other relevant data holders based on a data permit or a data request for a purposes laid down in article 34;


### take all measures necessary to preserve the confidentiality of ip rights and of trade secrets; ### bodies involved in accessing health shall take all measures necessary to preserve the confidentiality of ip rights and of trade secrets;


### gather and compile or provide access to the necessary electronic health data from the various data holders whose electronic health data fall within the scope of this regulation and put those data at the disposal of data users in a secure processing environment in accordance with the requirements laid down in article 50; ### where electronic health data is not accessed directly between data holder and data user , or where the data of a number of holders need to be merged , the access bodies concerned , with the assistance of pseudonymisation bodies , shall gather and compile the necessary electronic health data from the various data holders whose electronic health data fall within the scope of this regulation and put those data at the disposal of data users in a secure processing environment in accordance with the requirements laid down in article 50;


### support the development of ai systems , the training , testing and validating of ai systems and the development of harmonised standards and guidelines under regulation […] [ai act com/2021/206 final] for the training , testing and validation of ai systems in health; ### access bodies shall support the development of ai systems , the training , testing and validating of ai systems and the development of harmonised standards and guidelines under regulation […] [ai act com/2021/206 final] for the training , testing and validation of ai systems in health;


### cooperate with and supervise data holders to ensure the consistent and accurate implementation of the data quality and utility label set out in article 56; ### application processing bodies shall cooperate with and supervise data holders to ensure the consistent and accurate implementation of the data quality and utility label set out in article 56;


### maintain a management system to record and process data access applications , data requests and the data permits issued and data requests answered , providing at least information on the name of the data applicant , the purpose of access the date of issuance , duration of the data permit and a description of the data application or the data request; ### application processing bodies shall maintain a management system to record and process data access applications , data requests and the data permits issued and data requests answered , providing at least information on the name of the data applicant , the purpose of access the date of issuance , duration of the data permit and a description of the data application or the data request;


### maintain a public information system to comply with the obligations laid down in article 38; ### application processing and access bodies shall jointly maintain a public information system to comply with the obligations laid down in article 38;


### cooperate at union and national level to lay down appropriate measures and requirements for accessing electronic health data in a secure processing environment; ### access bodies shall cooperate at union and national level to lay down appropriate measures and requirements for accessing electronic health data in a secure processing environment;


### cooperate at union and national level and provide advice to the commission on techniques and best practices for electronic health data use and management; ### access bodies shall cooperate at union and national level and provide advice to the commission on techniques and best practices for electronic health data use and management;


### facilitate cross-border access to electronic health data for secondary use hosted in other member states through healthdata@eu and cooperate closely with each other and with the commission. ### access bodies shall facilitate cross-border access to electronic health data for secondary use hosted in other member states through healthdata@eu and cooperate closely with each other and with the commission;


### make public , through electronic means: ### application processing bodies shall make public , through electronic means:


### (iii) penalties applied pursuant to article 43; ### deleted


### fulfil obligations towards natural persons pursuant to article 38; ### bodies involved in accessing health data shall fulfil obligations towards natural persons pursuant to article 38;


### request from data users and data holders all the relevant information to verify the implementation of this chapter; ### access bodies shall , if they have reasonable grounds to suspect an infringement , request from data users and data holders all the relevant information to verify the implementation of this chapter;


### fulfil any other tasks related to making available the secondary use of electronic health data in the context of this regulation. ### bodies involved in accessing health data shall fulfil any other tasks related to making available the secondary use of electronic health data in the context of this regulation to the extent that these tasks fall within their remit.


### (2) in the exercise of their tasks , health data access bodies shall: ### (2) in the exercise of their tasks , bodies involved in accessing health data shall proceed as follows:


### inform the relevant supervisory authorities under regulation (eu) 2016/679 and regulation (eu) 2018/1725 where a health data access body has imposed penalties or other measures pursuant to article 43 in relation to processing personal electronic health data and where such processing refers to an attempt to re-identify an individual or unlawful processing of personal electronic health data; ### access bodies shall inform the relevant supervisory authorities under regulation (eu) 2016/679 and regulation (eu) 2018/1725 where a health data access body has imposed penalties or other measures pursuant to article 43 in relation to processing personal electronic health data and where such processing refers to an attempt to re-identify an individual or unlawful processing of personal electronic health data;


### cooperate with stakeholders , including patient organisations , representatives from natural persons , health professionals , researchers , and ethical committees , where applicable in accordance with union and national law; ### bodies involved in accessing health data shall cooperate with stakeholders , including patient organisations , representatives from natural persons , health professionals , researchers , and ethical committees , where applicable in accordance with union and national law;


### cooperate with stakeholders , including patient organisations , representatives from natural persons , health professionals , researchers , and ethical committees , where applicable in accordance with union and national law; ### cooperate with all relevant stakeholders , including patient organisations , representatives from natural persons , health professionals , researchers , industry representatives and ethical committees , where applicable in accordance with union and national law;


### cooperate with other national competent bodies , including the national competent bodies supervising data altruism organisations under regulation […] [data governance act com/2020/767 final] , the competent authorities under regulation […] [data act com/2022/68 final] and the national competent authorities for regulations (eu) 2017/745 and regulation […] [ai act com/2021/206 final]. ### bodies involved in accessing health data shall cooperate with other national competent bodies , including the national competent bodies supervising data altruism organisations under regulation […] [data governance act com/2020/767 final] , the competent authorities under regulation […] [data act com/2022/68 final] and the national competent authorities for regulations (eu) 2017/745 and regulation […] [ai act com/2021/206 final].


### (4) the commission is empowered to adopt delegated acts in accordance with article 67 to amend the list of tasks in paragraph 1 of this article , to reflect the evolution of activities performed by health data access bodies. ### (4) the commission is empowered to adopt delegated acts in accordance with article 67 to amend the list of tasks in paragraph 1 of this article , to reflect the evolution of activities performed by bodies involved in accessing health data in the field of health covered by this regulation.


### 1. notes that the gender pay gap in the 28 eu member states stands at 15.7 % , that women are more affected by atypical and flexible contracts (zero-hour contracts , temporary work , part-time work , etc.) than men , and that women are more likely to experience poverty and fall into the category of the poorest workers as a result of these low-security contracts; ### 1. notes that the gender pay gap in the 28 eu member states stands at 15.7 % , and the average gender employment gap at 11.5% , that women are more affected by flexible work forms , atypical and flexible contracts (zero-hour contracts , temporary work , part-time work , etc.) than men , and that women are more likely to experience poverty and fall into the category of the poorest workers as a result of these low-security contracts combined with other intersectional elements such as single family household , carer for dependant parent , women with disabilities , women with low education or insufficient care services provisions;


### — – having regard to the european pillar of social rights , ### — having regard to the european pillar of social rights and , in particular , principles 5 and 6 ,


### 2. notes that , following the global economic and financial crisis in 2008 , in-work poverty in the eu increased from 8 % to 10 % , and that the current unprecedented global covid-19 pandemic will have even greater economic and financial consequences , which will have a direct impact in terms of increasing poverty , especially among women and the other most vulnerable groups in society , as its effects will be felt most keenly by workers in the service sector , the self-employed , temporary and seasonal workers , etc. , among whom a higher proportion are women; ### 2. notes that , following the global economic and financial crisis in 2008 , in-work poverty in the eu increased from 8 % to 10 % , and that the current unprecedented global covid-19 pandemic will have even greater economic and financial consequences , which will have a direct impact in terms of increasing poverty , especially among women and the most vulnerable groups in society , as its effects will be felt most keenly by workers in the service sector , the self-employed , temporary and seasonal workers , etc. , among whom a higher proportion are women , this also in various other economic sectors which will be impacted through job losses , wage and/or working time reduction as well as through increased care services needs during the pandemic;


### 3. notes that , although poverty rates among women vary considerably from one member state to another , the risk of poverty in the risk groups to which older women , single women and single mothers , homosexual , bisexual and transgender women and women with disabilities belong is the same; ### 3. notes that , although poverty rates among women vary considerably from one member state to another , the risk of poverty in the risk groups to which older women , single women and single mothers , homosexual , bisexual and transgender women and women with disabilities belong is the same high , the average trend being that women are more affected than men by the risk of poverty and social exclusion (22 ,8% in 2018 in the eu) , this combined with other intersectional risk factors such as inactivity , lack of care services provision for children and dependant family , thus observing that some specific categories are more vulnerable to poverty risks;


### 3. notes that , although poverty rates among women vary considerably from one member state to another , the risk of poverty in the risk groups to which older women , single women and single mothers , homosexual , bisexual and transgender women and women with disabilities belong is the same; ### 3. notes that , although poverty rates among women vary considerably from one member state to another , the risk of poverty in the risk groups to which older women , single women and single mothers , homosexual , bisexual and transgender women and women with disabilities belong is the same , that is very high , and that it may be even higher where a person belongs to two or more of these categories;


### 4. points out that , according to eurostat , there are currently 64.6 million women and 57.6 million men living in poverty in the eu member states , which shows that the impact of poverty on women and men is different; ### 4. points out that , according to eurostat , there are currently 64.6 million women and 57.6 million men living in poverty in the eu member states , which shows that the impact of poverty on women and men is different , those numbers show the scale of women affected and have to be examined together with other indicators (such as age , life expectancy , income inequalities , gender pay gap , type of household , social transfers) to understand their full significance and in order to find ways to address them in each of its components;


### 5. notes with concern that poverty among women increases with age , with the gender pension gap remaining at around 39 %; ### 5. notes with concern that poverty among women increases with age , with the gender pension gap remaining at around 39% , representing the accumulation of various inequalities experienced throughout work life (job intensity , duration of work , gender pay gap , periods of absence from labour market) , this being one of the factors behind the higher poverty faced by women in general; stresses therefore the need for awareness about consequences of women’s choices in the labour market and the importance of their economic independence to prevent from poverty and social exclusion;


### 6. stresses that female poverty is a multifaceted problem directly influenced by unequal access to property , career breaks due to the raising and care of children , caring for sick and dependent persons , and segregation in education and , subsequently , in the labour market , which means that women account for the largest share of low-paid workers; ### 6. stresses that female poverty is a multifaceted problem directly influenced by career breaks due to the raising and care of children , caring for sick and dependent persons , and segregation in education and , subsequently , in the labour market , which means that women account for the largest share of low-paid workers , therefore in order to reduce persisting inequalities and the feminisation of poverty , actions and policies have to be promoted in various fields and steps , starting from education and training to systematically address labour market segregation;


### 6. stresses that female poverty is a multifaceted problem directly influenced by unequal access to property , career breaks due to the raising and care of children , caring for sick and dependent persons , and segregation in education and , subsequently , in the labour market , which means that women account for the largest share of low-paid workers; ### 6. stresses that female poverty is a multifaceted problem directly influenced by unequal access to property , career breaks due to the raising and care of children , including with disabilities , caring for sick and dependent persons , and segregation in education and , subsequently , in the labour market , which means that women account for the largest share of low-paid workers;


### 7. calls on the commission to come forward as soon as possible with proposals to close the gender pay gap. ### 7. calls on the commission to come forward as soon as possible with proposals to close the gender pay gap by championing the principle of equal pay for equal work for men and women and welcomes its commitment to take action in the recently announced gender equality strategy , awaits for the proposal on a binding framework for pay transparency , with due account to the impact of covid 19 pandemic , as well as for the other measures to tackle women’s labour market participation and to promote equal opportunities;


### 7. calls on the commission to come forward as soon as possible with proposals to close the gender pay gap. ### 7. calls on the commission to come forward as soon as possible with proposals to close the gender pay gap , while fully respecting the principle of subsidiarity , the member states' competence with regard to the labour market , and the autonomy of the social partners in all member states.


### 7. calls on the commission to come forward as soon as possible with proposals to close the gender pay gap. ### 7. calls on the commission to come forward as soon as possible with proposals to close the gender pay gap , mindful of an intersectional approach to human rights;


### 1. stresses the importance of the use of the eu charter of fundamental rights by member states at a national level by national courts and through inclusion in legislative procedures; regrets that there has only been a limited attempt at promoting the application of its provisions , even though it is an obligation stated in article 51 of the charter; ### 1. stresses the importance of the use of the eu charter of fundamental rights by member states at a national level by national courts and through inclusion in legislative procedures , when implementing eu law and regrets the uneven application by member states of its provisions; reminds that the expectations of eu citizens regarding the protection of their fundamental rights , as demonstrated by petitions , go beyond the field of application of the charter; considers that a better promotion of the charter is needed in order to render its provisions more effective and to promote its use by legislators and judges as positive source of interpretation even in cases that do not fall within the scope of eu law;


### 1. highlights that article 51(1) of the charter of fundamental rights states that the member states must ‘respect the rights , observe the principles and promote the application thereof’; regrets that , according to the european union agency for fundamental rights (fra) , some member states do not appear to be making sufficient efforts to promote awareness , or the implementation , of charter provisions; ### 1. highlights that article 51(1) of the charter of fundamental rights states that the member states must ‘respect the rights , observe the principles and promote the application thereof’; regrets that , according to the european union agency for fundamental rights (fra) , some member states do not appear to be making sufficient efforts to promote awareness , or the implementation , of charter provisions; underlines that a better promotion of the charter is needed in order to render its provisions more effective and possibly to encourage its use by national legislators and judges as a positive source of interpretation even in cases that do not necessarily fall within the scope of eu law;


### 2. notes with concern that a number of member states have not fully or correctly implemented the council framework decision of 28 november 2008 on combating certain forms and expressions of racism and xenophobia by means of criminal law1 and its minimum standards on offences of denying , condoning and grossly trivialising certain crimes; ### 2. notes with concern that a number of member states have not fully or correctly implemented the council framework decision of 28 november 2008 on combating certain forms and expressions of racism and xenophobia by means of criminal law1 and its minimum standards on offences of denying , condoning and grossly trivialising certain crimes; highlights that citizens belonging to vulnerable groups remain the main target of such actions; considers that hate speech and xenophobia should have no place in any aspect of social life , including sport events;


### – having regard to principle 19 of the european pillar of social rights , which states that ‘access to social housing or housing assistance of good quality shall be provided for those in need’ , ### – having regard to the european pillar of social rights ,


### – having regard to article 31 of the revised european social charter on the right to housing , ### – having regard to the revised european social charter on the right to housing ,


### – having regard to the views adopted by the un committee on economic , social and cultural rights under the optional protocol to the international covenant on economic , social and cultural rights on 11 october 2019 concerning communication no. 37/2018 (e/c.12/66/d/37/2018) (lópez albán v spain) , ### deleted


### – having regard to article 34(3) of the charter of fundamental rights of the european union (‘the charter’) , which affirms the right to social and housing assistance in order to combat social exclusion and poverty , ### deleted


### – having regard to the commissioner for human rights of the council of europe’s view of 29 june 2018 entitled ‘greece: immediate action needed to protect human rights of migrants’ , ### deleted


### – having regard to article 2 of the revised european social charter , ### deleted


### – having regard to article 31 of the charter , ### deleted


### – having regard to the council recommendation of 9 april 2019 on the economic policy of the euro area2 , ### deleted


### – having regard to the report of the council of europe’s group of experts on action against trafficking in human beings of 7 july 2017 concerning the implementation of the council of europe convention on action against trafficking in human beings by ireland (greta(2017)28) , ### deleted


### – having regard to principle 16 of the european pillar of social rights , which stresses that everyone has the right to timely access to affordable , preventive and curative healthcare of good quality , ### deleted


### – having regard to its resolution of 12 april 2016 on the situation in the mediterranean and the need for a holistic eu approach to migration6 , ### deleted


### – having regard to its resolution of 5 october 2017 on prison systems and conditions7 , ### deleted


### 5. reiterates that women and girls must have control over their bodies and sexualities; calls on all the member states to guarantee comprehensive sexuality education , ready access for women to family planning , and the full range of reproductive and sexual health services , including modern contraceptive methods and safe and legal abortion; ### 5. reiterates the importance of upholding the highest possible standard of reproductive health , which involves the right of men and women to be informed and to have access to safe , effective , affordable and acceptable methods of family planning of their choice , and the right of access to appropriate health-care services that will enable women to go safely through pregnancy and childbirth and provide couples with the best chance of having a healthy infant;


### a. whereas the committee on petitions conducted a fact-finding visit to famagusta , cyprus , on 7-8 may 2018; whereas the purpose of the mission was to reassess and update its information on the situation in famagusta , and in particular varosha (the section of the city sealed off by the turkish army) , following on from petition 733/2004 , 10 years after the committee’s previous fact-finding visit , which took place on 25-28 november 2007; ### a. whereas the committee on petitions conducted a fact-finding visit to famagusta , cyprus , on 7-8 may 2018 , in the context of petition 733/2004 submitted by loizos afxentiou , on behalf of the famagusta refugee movement; whereas the purpose of the mission was to reassess and update its information on the situation in famagusta , and in particular varosha (the section of the city sealed off by the turkish army) , following on from petition 733/2004 , 10 years after the committee’s previous fact-finding visit , which took place on 25-28 november 2007;


### a. whereas being a candidate country presumes a willingness to progressively approach in all aspects the values , interests , standards and policies of the eu; ### a. whereas being a candidate country presumes a willingness to progressively approach and align itself in all aspects with the common european values and principles , foreign and security interests , democratic , human rights and rule of law standards and policies of the eu as enshrined in the treaties; reiterates that respect for the rule of law and fundamental rights , including the separation of powers , democracy , freedom of expression and the media , human rights , the rights of minorities and religious freedom , freedom of association and the right to peaceful protest , the fight against corruption and the fight against racism and discrimination against vulnerable groups are at the core of the negotiation process;


### a. whereas being a candidate country presumes a willingness to progressively approach in all aspects the values , interests , standards and policies of the eu; ### a. whereas turkey is a candidate country and an important partner of the eu and is expected to uphold the highest standards of democracy , respect of human rights and rule of law including compliance with international conventions and whereas this presumes the commitment to progressively align in all aspects with the values , interests , standards and policies and the acquis of the eu;


### a. whereas being a candidate country presumes a willingness to progressively approach in all aspects the values , interests , standards and policies of the eu; ### a. whereas being a candidate country presumes the commitment to progressively align in all aspects with the values , interests , standards policies and the acquis of the eu;


### b. whereas , in its report of 21 november 2018 following the fact-finding visit , the committee on petitions established that the return of varosha to its lawful inhabitants is a matter of enforcement of the resolutions tabled by the existing un security council , the only supranational organisation that can exert real pressure on turkey; ### b. whereas , in its report of 21 november 2018 following the fact-finding visit , the committee on petitions established that the return of varosha to its lawful inhabitants is a matter of enforcement of the resolutions tabled by the existing un security council , the supranational organisation par excellence that can exert real pressure on turkey;


### b. whereas an analysis of the commission’s reports on turkey since 2014 and , in particular , the 2019 and 2020 reports , reveals that turkey has increasingly and rapidly distanced itself from the eu’s values and its normative framework; ### b. whereas an analysis of the commission’s reports on turkey since 2014 and , in particular , the 2019 and 2020 reports , reveals that turkey has increasingly and rapidly distanced itself from the eu’s values and its normative framework; and even begins to be hostile and anti-eu;


### b. whereas an analysis of the commission’s reports on turkey since 2014 and , in particular , the 2019 and 2020 reports , reveals that turkey has increasingly and rapidly distanced itself from the eu’s values and its normative framework; ### b. whereas an analysis of the commission’s reports on turkey since 2014 and , in particular the 2019 and 2020 reports , reveals that turkey has increasingly and rapidly distanced itself from the eu’s values and its normative framework expected from the candidate country;


### g. whereas the turkish government continued to act in total disregard of the aforementioned calls of the international community , including the un security council , with the vice-president of turkey visiting the sealed-off area of varosha on 15 february 2020 , together with members of the turkish-cypriot leadership and clearly stating turkey’s intention to open varosha under the ‘administration’ of the illegal secessionist entity in the occupied part of cyprus; ### g. whereas the turkish government continued to act in total disregard of the aforementioned calls of the international community , including the un security council , when a conference was held in the occupied territories on creating the legal basis for ‘turning varosha into a large turkish city in the eastern mediterranean’ on 15 february 2020 , in the presence of the vice-president of turkey together with members of the turkish-cypriot leadership and clearly stating turkey’s intention to open varosha under the ‘administration’ of the illegal secessionist entity in the occupied part of cyprus;


### i. whereas the return of varosha to its lawful inhabitants would constitute a formidable confidence-building measure , and could become the catalyst for a comprehensive settlement , by creating conditions of cooperation , mutual respect and trust between the two communities in cyprus; ### i. whereas the return of varosha to its lawful inhabitants would constitute a formidable confidence-building measure , and could become the catalyst for a fair , comprehensive and viable settlement , in accordance with relevant unsc resolutions , and in line with the values and principles on which the eu is founded and the acquis , by creating conditions of cooperation , mutual respect and trust between the two communities in cyprus;


### 1. notes with concern that turkey’s continuous and growing distancing from european values and standards has brought eu-turkey relations to a historical low point , having deteriorated to such an extent that it requires both parties to profoundly reassess the current framework of relations; ### 1. notes with great concern that turkey’s continuous backsliding in the rule of law and fundamental rights have resulted in significant disengagement from european values and standards , and that this , together with turkey's unilateral actions in the eastern mediterranean against eu member states greece and cyprus , has brought eu-turkey relations to a historical low point , having deteriorated to such an extent that it requires both parties to profoundly reassess the current framework of relations;


### 1. notes with concern that turkey’s continuous and growing distancing from european values and standards has brought eu-turkey relations to a historical low point , having deteriorated to such an extent that it requires both parties to profoundly reassess the current framework of relations; ### 1. notes with great indignation that turkey’s continuous and growing distancing from european values and standards has brought eu-turkey relations to a historical low point , having deteriorated to such an extent that it requires both parties to profoundly reassess the current framework of relations , leading to the decision to conclude and end relations with turkey and to start a new kind of relationship with turkey;


### 1. notes with concern that turkey’s continuous and growing distancing from european values and standards has brought eu-turkey relations to a historical low point , having deteriorated to such an extent that it requires both parties to profoundly reassess the current framework of relations; ### 1. notes with concern that turkey’s continuous and growing distancing from european values and standards has brought eu-turkey relations to a historical low point , having deteriorated to such an extent that it requires both parties to profoundly reassess the current framework of relations which should effectively solve the root causes of the current conflicts;


### 1. notes with concern that turkey’s continuous and growing distancing from european values and standards has brought eu-turkey relations to a historical low point , having deteriorated to such an extent that it requires both parties to profoundly reassess the current framework of relations; ### 1. despite the fact that turkey is a candidate country , notes with concern and regret that ankara continues to move further away from the european union , its values and standards and deplores the current state of affairs;


### 1. notes with concern that turkey’s continuous and growing distancing from european values and standards has brought eu-turkey relations to a historical low point , having deteriorated to such an extent that it requires both parties to profoundly reassess the current framework of relations; ### 1. notes with concern that turkey’s continuous and growing distancing from european values and standards has brought eu-turkey relations to a historical low point , having deteriorated to such an extent that it requires both parties to put an end to the current framework of relations;