### 6. natural persons may insert their electronic health data in their own ehr or in that of natural persons whose health information they can access , through electronic health data access services or applications linked to these services. that information shall be marked as inserted by the natural person or by his or her representative. ### 6. natural persons may insert , access and export their electronic health data in and from their own ehr or in that of natural persons whose health information they can access , through electronic health data access services and applications linked to these services. that information shall be marked as inserted by the natural person or by his or her representative as non-validated , and information shall only be considered as a clinical fact if validated by an identified , registered health professional with the relevant competence. natural persons shall not have the possibility to directly change data inserted by healthcare professionals. the process must be secure.


### 6. natural persons may insert their electronic health data in their own ehr or in that of natural persons whose health information they can access , through electronic health data access services or applications linked to these services. that information shall be marked as inserted by the natural person or by his or her representative. ### 6. natural persons may insert their electronic health data in their own ehr or in that of natural persons whose health information they can access , through electronic health data access services or applications linked to these services. that information shall be marked as inserted by the natural person or by his or her representative. these data are not the responsibility of healthcare providers who therefore do not have to ensure that they correspond to the requirements of the regulation.


### 7. member states shall ensure that , when exercising the right to rectification under article 16 of regulation (eu) 2016/679 , natural persons can easily request rectification online through the electronic health data access services referred to in paragraph 5 , point (a) , of this article. ### 7. member states shall ensure that , when exercising the right to rectification under article 16 of regulation (eu) 2016/679 , natural persons can easily request rectification online through the electronic health data access services referred to in paragraph 5 , point (a) , of this article. the rectification of a clinical fact in the ehr must be validated by an identified , registered health professional with the appropriate competence. the process must be secure.


### natural persons shall have the right to give access to or request a data holder from the health or social security sector to transmit their electronic health data to a data recipient of their choice from the health or social security sector , immediately , free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder. ### natural persons shall have the right to give access to or request a data holder from the health or social security sector to transmit partially or totally , their electronic health data to a data recipient of their choice from the health or social security sector , immediately , free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder.


### natural persons shall have the right to give access to or request a data holder from the health or social security sector to transmit their electronic health data to a data recipient of their choice from the health or social security sector , immediately , free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder. ### natural persons shall have the right to give access to or request a data holder from the health or social security sector to transmit their electronic health data to a data recipient of their choice from the health or social security sector , as soon as possible free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder.


### by way of derogation from article 9 of regulation […] [data act com/2022/68 final] , the data recipient shall not be required to compensate the data holder for making electronic heath data available. ### by way of derogation from article 9 of regulation […] [data act com/2022/68 final] , the data recipient shall not be required to compensate the data holder for making electronic health data available.


### natural persons shall have the right that , where priority categories of personal electronic health data referred to in article 5 are transmitted or made available by the natural person according to the european electronic health record exchange format referred to in article 6 , such data shall be read and accepted by other healthcare providers. ### natural persons shall have the right that , where priority categories of personal electronic health data referred to in article 5 are transmitted or made available by the natural person according to the european electronic health record exchange format referred to in article 6 , such data shall be read and recognised as valid by other healthcare providers.


### 9. notwithstanding article 6(1) , point (d) , of regulation (eu) 2016/679 , natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. member states shall establish the rules and specific safeguards regarding such restriction mechanisms. ### 9. notwithstanding article 6(1) , point (d) , of regulation (eu) 2016/679 , natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. for judicial reasons strictly related to medical liability of health professionals , the date and time of omitted information must be recorded and only visible to the health data access bodies under these circumstances. the european commission shall establish the rules and specific safeguards regarding such restriction mechanisms through a delegated act.


### 9. notwithstanding article 6(1) , point (d) , of regulation (eu) 2016/679 , natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. member states shall establish the rules and specific safeguards regarding such restriction mechanisms. ### 9. notwithstanding article 6(1) , point (d) , of regulation (eu) 2016/679 , natural persons shall have the right to confidentially restrict access of health professionals to all or part of their electronic health data , and the fact that such data has been restricted. member states shall establish the rules and specific safeguards regarding such restriction mechanisms , which shall also include the possibility to exercise geographical and temporal restrictions and restrictions related to a specific category of health professionals.


### 9. notwithstanding article 6(1) , point (d) , of regulation (eu) 2016/679 , natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. member states shall establish the rules and specific safeguards regarding such restriction mechanisms. ### 9. notwithstanding article 6(1) , point (d) , of regulation (eu) 2016/679 , member states may grant natural persons the right to restrict access of health professionals to all or part of their electronic health data. member states shall establish the rules and specific safeguards regarding such restriction mechanisms , including the conditions of medical liability and whether such restrictions apply to health data for research or quality development purposes. the restricted information must be easily identified in the ehr.


### 10. natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. the information shall be provided immediately and free of charge through electronic health data access services. ### 10. natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. in order to demonstrate compliance with this right , all relevant entities shall maintain a system of automated recording showing unequivocally who , when and where had access to data , accessible to the patient. the information shall be provided immediately and free of charge through electronic health data access services in a commonly accepted , interoperable format.


### 10. natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. the information shall be provided immediately and free of charge through electronic health data access services. ### 10. natural persons shall have the right to know if healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. the information shall be provided free of charge through electronic health data access services. member states may provide that the right to obtain information does not apply whenever necessary for reasons related to the protection and safety of healthcare providers and health professionals.


### 10. natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. the information shall be provided immediately and free of charge through electronic health data access services. ### 10. natural persons shall have the right to receive automatically information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. all relevant entities shall maintain a record of those who have had access to data. the information shall be provided immediately and free of charge through electronic health data access services.


### 11. the supervisory authority or authorities responsible for monitoring the application of regulation (eu) 2016/679 shall also be responsible for monitoring the application of this article , in accordance with the relevant provisions in chapters vi , vii and viii of regulation (eu) 2016/679. they shall be competent to impose administrative fines up to the amount referred to in article 83(5) of that regulation. those supervisory authorities and the digital health authorities referred to in article 10 of this regulation shall , where relevant , cooperate in the enforcement of this regulation , within the remit of their respective competences. ### 11. the supervisory authority or authorities responsible for monitoring the application of regulation (eu) 2016/679 shall also be responsible for monitoring the application of this article , in accordance with the relevant provisions in chapters vi , vii and viii of regulation (eu) 2016/679. they shall be competent to impose administrative fines up to the amount referred to in article 83(5) of that regulation.


### 12. the commission shall , by means of implementing acts , determine the requirements concerning the technical implementation of the rights set out in this article. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). ### 12. the commission shall , by means of delegated acts , determine the requirements concerning the technical implementation of the rights set out in this article , including technical and organisational measures to ensure the process of authentication of the authorised person referred to in point (b) of paragraph 5.


### have access to the electronic health data of natural persons under their treatment , irrespective of the member state of affiliation and the member state of treatment; ### have access to the electronic health data of natural persons under their care and restrict to their functions of action , irrespective of the member state of affiliation and the member state of treatment;


### have access to the electronic health data of natural persons under their treatment , irrespective of the member state of affiliation and the member state of treatment; ### have access on a need-to-know basis to the electronic health data of natural persons under their treatment , irrespective of the member state of affiliation and the member state of treatment;


### ensure that the personal electronic health data of the natural persons they treat are updated with information related to the health services provided. ### ensure that the personal electronic health data of the natural persons they care are updated with information related to the health services provided and , if not , update data concerning the health services provided by them.


### 2. in line with the data minimisation principle provided for in regulation (eu) 2016/679 , member states may establish rules providing for the categories of personal electronic health data required by different health professions. such rules shall not be based on the source of electronic health data. ### 2. in line with the data minimisation principle provided for in regulation (eu) 2016/679 , member states shall establish rules providing for the categories of personal electronic health data required by different health professions. such rules shall not be based on the source of electronic health data.


### 3. member states shall ensure that access to at least the priority categories of electronic health data referred to in article 5 is made available to health professionals through health professional access services. health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services , free of charge. ### 3. member states shall ensure that access to at least the priority categories of electronic health data referred to in article 5 is made available to health professionals lawfully exercising their activities through health professional access services and that health professionals can easily select specific relevant information in the ehr. health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services , free of charge. to this end , they may cooperate , where appropriate , with professional associations under the terms provided for by national rules.


### 3. member states shall ensure that access to at least the priority categories of electronic health data referred to in article 5 is made available to health professionals through health professional access services. health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services , free of charge. ### 3. member states shall ensure that access to the priority categories of electronic health data referred to in article 5 is made available to health professionals through health professional access services , where the processing of health data is necessary. health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services , free of charge , where the processing of health data is necessary.


### 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. 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. the existence of a restriction must be clearly indicated in the ehr. 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. 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 , 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 health data has been restricted by the natural person , the healthcare provider or health professionals shall not be informed of the content of those health data without prior authorisation by the natural person. the provider or professional shall however be able to see that there is health data to which access has been restricted. in cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person , or an obvious public interest , the healthcare provider or health professional may obtain 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.


### where data is processed in electronic format , member states shall implement access to and exchange of personal electronic health data for primary use fully or partially falling under the following categories: ### where data is processed in electronic format , member states shall implement access to and exchange of personal electronic health data for primary use fully or partially falling under the following categories:


### discharge reports. ### discharge reports;


### access to and exchange of electronic health data for primary use may be enabled for other categories of personal electronic health data available in the ehr of natural persons. ### deleted


### 2. the commission is empowered to adopt delegated acts in accordance with article 67 to amend the list of priority categories of electronic health data in paragraph 1. such delegated acts may also amend annex i by adding , modifying or removing the main characteristics of the priority categories of electronic health data and indicating , where relevant , deferred application date. the categories of electronic health data added through such delegated acts shall satisfy the following criteria: ### deleted


### datasets containing electronic health data and defining structures , such as data fields and data groups for the content representation of clinical content and other parts of the electronic health data; ### harmonised datasets containing electronic health data and defining structures , such minimum as data fields and data groups for the content representation of clinical content and other parts of the electronic health data , that can be enlarged to include disease-specific data;


### 3. member states shall ensure that the priority categories of personal electronic health data referred to in article 5 are issued in the format referred to in paragraph 1 and such data shall be read and accepted by the data recipient. ### 3. member states shall ensure that the priority categories of personal electronic health data referred to in article 5 are issued in the format referred to in paragraph 1 and such data shall be read and recognised as valid by the data recipient including measures aimed at ensuring priority categories of personal electronic health data are translated as necessary for the provision of healthcare to the language of the patient or the healthcare professional.


### 3. member states shall ensure that the priority categories of personal electronic health data referred to in article 5 are issued in the format referred to in paragraph 1 and such data shall be read and accepted by the data recipient. ### 3. member states shall ensure that the priority categories of personal electronic health data referred to in article 5 are processed in electronic format across the continuum of care and are issued in the format referred to in paragraph 1 and such data shall be read and accepted by the data recipient


### 1. member states shall ensure that , where data is processed in electronic format , health professionals systematically register the relevant health data falling under at least the priority categories referred to in article 5 concerning the health services provided by them to natural persons , in the electronic format in an ehr system. ### 1. member states shall ensure that , where data is processed in electronic format , health professionals systematically register the relevant health data falling under at least the priority categories referred to in article 5 concerning the health services provided by them to natural persons , in the electronic format in an ehr system , and shall be responsible for ensuring their confidentiality.


### 1. member states shall ensure that , where data is processed in electronic format , health professionals systematically register the relevant health data falling under at least the priority categories referred to in article 5 concerning the health services provided by them to natural persons , in the electronic format in an ehr system. ### 1. where data is processed in electronic format , member states shall facilitate health professionals to systematically register the relevant health data falling under at least the priority categories referred to in article 5 concerning the health services provided by them to natural persons , in the electronic format in an ehr system.


### 1. member states shall ensure that , where data is processed in electronic format , health professionals systematically register the relevant health data falling under at least the priority categories referred to in article 5 concerning the health services provided by them to natural persons , in the electronic format in an ehr system. ### 1. member states shall ensure that , where data is processed in electronic format , health professionals register the relevant health data falling under the priority categories referred to in article 5 concerning the health services provided by them to natural persons , in the electronic format in an ehr system.


### 2. where electronic health data of a natural person is registered in a member state that is not the member state of affiliation of that person , the member state of treatment shall ensure that the registration is performed under the person identification data of the natural person in the member state of affiliation. ### 2. where electronic health data of a natural person is registered in a member state that is not the member state of affiliation of that person , the member state of treatment shall ensure that the registration is performed under the person identification data of the natural person in the member state of affiliation , and shall be responsible for ensuring they remain confidential.


### the commission shall , by means of implementing acts , determine the requirements for the registration of electronic health data by healthcare providers and natural persons , as relevant. those implementing acts shall establish the following: ### the commission shall , by means of delegated acts , determine the requirements for the registration of electronic health data by healthcare providers and natural persons , as relevant. those delegated acts shall establish the following:


### where a member state accepts the provision of telemedicine services , it shall , under the same conditions , accept the provision of the services of the same type by healthcare providers located in other member states. ### deleted


### where a member state accepts the provision of telemedicine services , it shall , under the same conditions , accept the provision of the services of the same type by healthcare providers located in other member states. ### where a member state accepts the provision of telemedicine services , it shall , under the same conditions , accept the provision of the services of the same type by healthcare providers located in other member states with the same rights and obligations to access and register electronic health data. telemedicine services shall respect the national law of the member state in which is being provided.


### 2. the commission shall , by means of implementing acts , determine the requirements for the interoperable , cross-border identification and authentication mechanism for natural persons and health professionals , in accordance with regulation (eu) no 910/2014 as amended by [com(2021) 281 final]. the mechanism shall facilitate the transferability of electronic health data in a cross-border context. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). ### 2. the commission shall , by means of delegated acts , determine the requirements for the interoperable , cross-border identification and authentication mechanism for natural persons and health professionals , in accordance with regulation (eu) no 910/2014 as amended by [com(2021) 281 final]. the mechanism shall facilitate the transferability of electronic health data in a cross-border context. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2).


### 2. the commission shall , by means of implementing acts , determine the requirements for the interoperable , cross-border identification and authentication mechanism for natural persons and health professionals , in accordance with regulation (eu) no 910/2014 as amended by [com(2021) 281 final]. the mechanism shall facilitate the transferability of electronic health data in a cross-border context. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). ### 2. the commission shall , by means of delegated acts , determine the requirements for the interoperable , cross-border identification and authentication mechanism for natural persons and health professionals , in accordance with regulation (eu) no 910/2014 as amended by [com(2021) 281 final]. the mechanism shall facilitate the transferability of electronic health data in a cross-border context.


### 3. the commission shall implement services required by the interoperable , cross-border identification and authentication mechanism referred to in paragraph 2 of this article at union level , as part of the cross-border digital health infrastructure referred to in article 12(3). ### 3. the member states and the commission shall implement services required by the interoperable , cross-border identification and authentication mechanism referred to in paragraph 2 of this article at union level , as part of the cross-border digital health infrastructure referred to in article 12(3).


### 4. the digital health authorities and the commission shall implement the cross-border identification and authentication mechanism at union and member states’ level , respectively. ### 4. the member states and the commission shall implement the cross-border identification and authentication mechanism at union and member states’ level , respectively.


### 1. each member state shall designate a digital health authority responsible for the implementation and enforcement of this chapter at national level. the member state shall communicate the identity of the digital health authority to the commission by the date of application of this regulation. where a designated digital health authority is an entity consisting of multiple organisations , the member state shall communicate to the commission a description of the separation of tasks between the organisations. the commission shall make this information publicly available. ### 1. each member state shall designate a digital health authority responsible for the implementation and enforcement of this chapter at national level. implementation shall be harmonised at national level and across member states with the ehds board conducting an oversight and leadership role in achieving this. the member state shall communicate the identity of the digital health authority to the commission by the date of application of this regulation. where a designated digital health authority is an entity consisting of multiple organisations , the member state shall communicate to the commission a description of the separation of tasks between the organisations. the commission shall make this information publicly available.


### ensure that complete and up to date information about the implementation of rights and obligations provided for in in chapters ii and iii is made readily available to natural persons , health professionals and healthcare providers; ### ensure that complete and up to date information about the implementation of rights and obligations provided for in in chapters ii and iii is made readily available to natural persons , health professionals and healthcare providers and that appropriate training initiatives are undertaken at the local level;


### 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 , to the development of the european electronic health record exchange format and to the elaboration of common specifications addressing interoperability , the access period and the access process per se , and 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;


### offer , in compliance with national legislation , telemedicine services and ensure that such services are easy to use , accessible to different groups of natural persons and health professionals , including natural persons with disabilities , do not discriminate and offer the possibility of choosing between in person and digital services; ### offer , in compliance with national legislation , telemedicine services and ensure that such services are easy to use , accessible and equitable to different groups of natural persons and health professionals , including natural persons with disabilities , do not discriminate and offer the possibility of choosing between in person and digital services;


### 3. the commission is empowered to adopt delegated acts in accordance with article 67 to supplement this regulation by entrusting the digital health authorities with additional tasks necessary to carry out the missions conferred on them by this regulation and to modify the content of the annual report. ### 3. the commission is empowered to adopt delegated acts in accordance with article 67 to supplement this regulation by entrusting the digital health authorities with additional tasks necessary to carry out the missions conferred on them by this regulation.


### 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’ and healthcare professionals’ representatives. members of the digital health authority shall avoid any conflicts of interest. the commission shall be empowered to adopt delegated acts setting out what is likely to constitute a conflict of interest together with the procedure to be followed in such cases.


### 1. without prejudice to any other administrative or judicial remedy , natural and legal persons shall have the right to lodge a complaint , individually or , where relevant , collectively , with the digital health authority. where the complaint concerns the rights of natural persons pursuant to article 3 of this regulation , the digital health authority shall inform the supervisory authorities under regulation (eu) 2016/679. ### 1. without prejudice to any other administrative or judicial remedy , natural and legal persons shall have the right to lodge a complaint , individually or , where relevant , collectively , with the digital health authority , where their rights laid down in this regulation are affected. where the complaint concerns the rights of natural persons pursuant to article 3 of this regulation , the digital health authority shall send a copy of the complaint to the supervisory authorities under regulation (eu) 2016/679. the decision of the digital health authority shall not prejudice any measures taken by the data protection authorities within their competences under regulation (eu) 2016/679.


### 2. the digital health authority with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken. ### 2. the digital health authority with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken and inform the legal authorities if applicable.


### 4. the commission shall , by means of implementing acts , adopt the necessary measures for the technical development of myhealth@eu , detailed rules concerning the security , confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to myhealth@eu and conditions for temporary or definitive exclusion from myhealth@eu. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). ### 4. the commission shall , by means of implementing acts , adopt the necessary measures for the technical development of myhealth@eu , detailed rules concerning the security , confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to myhealth@eu and conditions for temporary or definitive exclusion from myhealth@eu. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). the european union agency for cyber security shall be consulted and closely involved in all steps of the procedure. any measures adopted shall meet the highest technical standards in terms of security , confidentiality and protection of electronic health data.


### 4. the commission shall , by means of implementing acts , adopt the necessary measures for the technical development of myhealth@eu , detailed rules concerning the security , confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to myhealth@eu and conditions for temporary or definitive exclusion from myhealth@eu. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). ### 4. the commission shall , by means of implementing acts , adopt the necessary measures for the technical development of myhealth@eu , detailed rules concerning the security , confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to myhealth@eu and conditions for temporary or definitive exclusion from myhealth@eu. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). the implementing act shall include the agreement of target implementation dates , including for improved cross-border health data interoperability , in consultation with the ehds board.


### 5. member states shall ensure connection of all healthcare providers to their national contact points for digital health and shall ensure that those connected are enabled to perform two-way exchange of electronic health data with the national contact point for digital health. ### 5. member states shall support and ensure connection of all regional and local healthcare providers to their national contact points for digital health and shall ensure that those connected are enabled to perform two-way exchange of electronic health data with the national contact point for digital health.


### 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 across the continuum of care operating on their territories , including online , hospital and ambulatory/day hospital 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 , all pharmacies shall report the dispensation to the member state that issued the prescription , through myhealth@eu.


### 2. the commission and member states may facilitate the exchange of electronic health data with other infrastructures , such as the clinical patient management system or other services or infrastructures in the health , care or social security fields which may become authorised participants to myhealth@eu. the commission shall , by means of implementing acts , set out the technical aspects of such exchanges. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). the connection of another infrastructure to the central platform for digital health shall be subject to a decision of the joint controllership group for myhealth@eu referred to in article 66. ### 2. the commission and member states may facilitate the exchange of electronic health data with other infrastructures , such as the clinical patient management system or other services or infrastructures in the health , care or social security fields which may become authorised participants to myhealth@eu. the commission shall , by means of implementing acts , set out the technical aspects of such exchanges , with a focus on the mode and period of access , in compliance with patient data security measures. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). the connection of another infrastructure to the central platform for digital health shall be subject to a decision of the joint controllership group for myhealth@eu referred to in article 66.


### member states and the commission shall seek to ensure interoperability of myhealth@eu with technological systems established at international level for the exchange of electronic health data. the commission may adopt an implementing act establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of myhealth@eu for the purposes of the electronic health data exchange. before adopting such an implementing act , a compliance check of the national contact point of the third country or of the system established at an international level shall be performed under the control of the commission. ### member states and the commission shall seek to ensure interoperability of myhealth@eu with technological systems established at international level for the exchange of electronic health data. the commission may adopt a delegated act establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of myhealth@eu for the purposes of the electronic health data exchange. before adopting such a delegated act , a compliance check of the national contact point of the third country or of the system established at an international level shall be performed under the control of the commission , including on whether the health data transfer stemming from such exchange complies with the rules in chapter v of regulation (eu) 2016/679.


### 1. ehr systems may be placed on the market or put into service only if they comply with the provisions laid down in this chapter. ### 1. ehr systems may be placed on the market or put into service only after a notified body has assessed and verified that the ehr system complies with the provisions laid down in this chapter.


### 1. ehr systems may be placed on the market or put into service only if they comply with the provisions laid down in this chapter. ### 1. ehr systems may be placed on the market or put into service only after a notified body has confirmed that they comply with the provisions laid down in this chapter.


### draw up the technical documentation of their ehr systems in accordance with article 24; ### draw up the technical documentation of their ehr systems in accordance with article 24 before placing their system on the market;


### draw up an eu declaration of conformity as referred to in article 26; ### carry out the relevant conformity assessment procedures as referred to in article 27a;


### affix the ce marking in accordance with article 27; ### deleted


### take without undue delay any necessary corrective action in respect of their ehr systems which are not in conformity with the essential requirements laid down in annex ii , or recall or withdraw such systems; ### take without undue delay any necessary corrective action in respect of their ehr systems which are not or are no longer in conformity with the essential requirements laid down in annex ii , or recall or withdraw such systems;


### inform the market surveillance authorities of the member states in which they made their ehr systems available or put them into service of the non-conformity and of any corrective action taken; ### inform the market surveillance authorities and notified bodies of the member states in which they made their ehr systems available or put them into service of the non-conformity and of any corrective action taken;


### upon request of a market surveillance authority , provide it with all the information and documentation necessary to demonstrate the conformity of their ehr system with the essential requirements laid down in annex ii. ### upon request of a market surveillance authority or a notified body , provide it with all the information and documentation necessary to demonstrate the conformity of their ehr system with the essential requirements laid down in annex ii.


### cooperate with market surveillance authorities , at their request , on any action taken to bring their ehr systems in conformity with the essential requirements laid down in annex ii. ### cooperate with market surveillance authorities and notified bodies , at their request , on any action taken to bring their ehr systems in conformity with the essential requirements laid down in annex ii.


### 2. manufacturers of ehr systems shall ensure that procedures are in place to ensure that the design , development and deployment of an ehr system continues to comply with the essential requirements laid down in annex ii and the common specifications referred to in article 23. changes in ehr system design or characteristics shall be adequately taken into account and reflected in the technical documentation. ### 2. manufacturers shall ensure that procedures are in place for ehr systems to remain in conformity with this regulation. changes in ehr system design or characteristics and changes in the harmonised standards or the technical specifications referred to in annex ii and iii by reference to which the conformity of the ehr system is declared or by application of which its conformity is verified shall be adequately taken into account and reflected in the technical documentation.


### 3. manufacturers of ehr systems shall keep the technical documentation and the eu declaration of conformity for 10 years after the last ehr system covered by the eu declaration of conformity has been placed on the market. ### 3. manufacturers of ehr systems shall keep the technical documentation and the eu declaration of conformity , where relevant , at the disposal of the market surveillance authorities for 10 years after the last ehr system conformity assessment. where relevant , the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from the competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in annex ii.


### keep the eu declaration of conformity and the technical documentation at the disposal of market surveillance authorities for the period referred to in article 17(3); ### keep the eu declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for the period referred to in article 17(3);


### cooperate with the market surveillance authorities , at their request , on any corrective action taken in relation to the ehr systems covered by their mandate. ### cooperate with the competent national authorities , at their request , on any corrective action taken in relation to the ehr systems covered by their mandate.


### the manufacturer has drawn up the technical documentation and the eu declaration of conformity; ### the manufacturer has drawn up the technical documentation


### the ehr system bears the ce marking of conformity; ### the ehr system bears the ce marking of conformity referred to in article 27 ;


### 5. where an importer considers or has reason to believe that an ehr system is not in conformity with the essential requirements in annex ii , it shall not make that system available on the market until that system has been brought into conformity. the importer shall inform without undue delay the manufacturer of such ehr system and the market surveillance authorities of the member state in which it made the ehr system available , to that effect. ### 5. where an importer considers or has reason to believe that an ehr system , which they have placed on the market , is not in conformity with the essential requirements in annex ii , it shall not make that system available on the market until that system has been brought into conformity. in situations where the ehr system is already on the market , importers shall immediately take the corrective measures necessary to bring that ehr system into conformity , to withdraw it or recall it , as appropriate. the importer shall inform without undue delay the manufacturer of such ehr system and the national competent authorities of the member state in which it made the ehr system available , to that effect , giving details , in particular , of the non-conformity and of any corrective measures taken.


### 6. importers shall keep a copy of the eu declaration of conformity at the disposal of the market surveillance authorities for the period referred to in article 17(3) and ensure that the technical documentation can be made available to those authorities , upon request. ### 6. importers shall keep a copy of the eu declaration of conformity at the disposal of the market surveillance authorities for the period referred to in article 17(3) and ensure that the technical documentation can be made available to those authorities , upon request. where relevant , the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in annex ii.


### 7. importers shall , further to a reasoned request from a market surveillance authority , provide it with all the information and documentation necessary to demonstrate the conformity of an ehr system in the official language of the member state where the market surveillance authority is located. they shall cooperate with that authority , at its request , on any action taken to bring their ehr systems in conformity with the essential requirements laid down in annex ii. ### 7. importers shall , further to a reasoned request from a competent national authority , provide it with all the information and documentation necessary to demonstrate the conformity of an ehr system in the official language of the member state where the competent national authority is located. they shall cooperate with that authority , at its request , on any action taken to bring their ehr systems in conformity with the essential requirements laid down in annex ii.


### the manufacturer has drawn up the eu declaration of conformity; ### deleted


### 4. distributors shall , further to a reasoned request from a market surveillance authority , provide it with all the information and documentation necessary to demonstrate the conformity of an ehr system. they shall cooperate with that authority , at its request , on any action taken to bring their ehr systems in conformity with the essential requirements laid down in annex ii. ### 4. distributors shall , further to a reasoned request from a competent national authority , provide it with all the information and documentation necessary to demonstrate the conformity of an ehr system. they shall cooperate with that authority , at its request , on any action taken to bring their ehr systems in conformity with the essential requirements laid down in annex ii.


### 1. the eu declaration of conformity shall state that the manufacturer of the ehr system has demonstrated that the essential requirements laid down in annex ii have been fulfilled. ### 1. the eu declaration of conformity shall state that the manufacturer of the ehr system has demonstrated that the essential requirements laid down in annex ii have been fulfilled.


### 4. by drawing up the eu declaration of conformity , the manufacturer shall assume responsibility for the conformity of the ehr system. ### 4. by issuing the eu declaration of conformity to the health data access body , the notified body shall assume responsibility for the conformity of the ehr system.


### 1. where a market surveillance authority finds that an ehr system presents a risk to the health or safety of natural persons or to other aspects of public interest protection , it shall require the manufacturer of the ehr system concerned , its authorised representative and all other relevant economic operators to take all appropriate measures to ensure that the ehr system concerned no longer presents that risk when placed on the market to withdraw the ehr system from the market or to recall it within a reasonable period. ### 1. where a market surveillance authority of one member state have sufficient reason to believe that an ehr system presents a risk to the health , safety or rights of natural persons or to other aspects of public interest protection , they shall carry out an evaluation in relation to the ehr system concerned covering all relevant requirements laid down in this regulation. its authorised representatives and all other relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose and take all appropriate measures to ensure that the ehr system concerned no longer presents that risk when placed on the market to withdraw the ehr system from the market or to recall it within a reasonable period.


### 1. where a market surveillance authority finds that an ehr system presents a risk to the health or safety of natural persons or to other aspects of public interest protection , it shall require the manufacturer of the ehr system concerned , its authorised representative and all other relevant economic operators to take all appropriate measures to ensure that the ehr system concerned no longer presents that risk when placed on the market to withdraw the ehr system from the market or to recall it within a reasonable period. ### 1. where a market surveillance authority , or , in cases involving personal data , a supervisory authority under regulation (eu) 2016/679 , finds that an ehr system presents a risk to the health or safety of natural persons , to the protection of personal data or to other aspects of public interest protection , it shall require the manufacturer of the ehr system concerned , its authorised representative and all other relevant economic operators to take all appropriate measures to ensure that the ehr system concerned no longer presents that risk when placed on the market to withdraw the ehr system from the market or to recall it within a reasonable period.


### 3. the market surveillance authority shall immediately inform the commission and the market surveillance authorities of other member states of the measures ordered pursuant to paragraph 1. that information shall include all available details , in particular the data necessary for the identification of the ehr system concerned , the origin and the supply chain of the ehr system , the nature of the risk involved and the nature and duration of the national measures taken. ### 3. the market surveillance authority , or , where applicable , the supervisory authority under regulation (eu) 2016/679 , shall immediately inform the commission and the market surveillance authorities , or , if applicable , the supervisory authorities under regulation (eu) 2016/679 , of other member states of the measures ordered pursuant to paragraph 1. that information shall include all available details , in particular the data necessary for the identification of the ehr system concerned , the origin and the supply chain of the ehr system , the nature of the risk involved and the nature and duration of the national measures taken.


### manufacturers of ehr systems placed on the market shall report any serious incident involving an ehr system to the market surveillance authorities of the member states where such serious incident occurred and the corrective actions taken or envisaged by the manufacturer. ### manufacturers of ehr systems placed on the market shall report any serious incident involving an ehr system to the market surveillance authorities , or , in cases involving personal data , the supervisory authorities under regulation (eu) 2016/679 of the member states where such serious incident occurred and the corrective actions taken or envisaged by the manufacturer.


### 5. the market surveillance authorities referred to in paragraph 4 shall inform the other market surveillance authorities , without delay , of the serious incident and the corrective action taken or envisaged by the manufacturer or required of it to minimise the risk of recurrence of the serious incident. ### 5. the authorities referred to in paragraph 4 shall inform the other authorities , without delay , of the serious incident and the corrective action taken or envisaged by the manufacturer or required of it to minimise the risk of recurrence of the serious incident.


### article 31 ### deleted


### 1. where a manufacturer of a wellness application claims interoperability with an ehr system and therefore compliance with the essential requirements laid down in annex ii and common specifications in article 23 , such wellness application may be accompanied by a label , clearly indicating its compliance with those requirements. the label shall be issued by the manufacturer of the wellness application. ### 1. where a manufacturer of a wellness application claims interoperability with an ehr system and therefore compliance with the essential requirements laid down in annex ii and common specifications in article 23 , such wellness application shall be accompanied by a label , clearly indicating its compliance with those requirements. the label shall be issued by the manufacturer of the wellness application and the health data access body shall be informed.


### 3. the commission may , by means of implementing acts , determine the format and content of the label. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). ### 3. the commission shall , by means of implementing acts , determine the format and content of the label. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2).


### 4. the label shall be drawn-up in one or more official languages of the union or languages determined by the member state(s) in which the in which the wellness application is placed on the market. ### 4. the label shall be drawn-up in one or more official languages of the union , and obligatorily in the language of the member state(s) in which the wellness application is placed on the market.


### 1. the commission shall establish and maintain a publicly available database with information on ehr systems for which an eu declaration of conformity has been issued pursuant to article 26 and wellness applications for which a label has been issued pursuant to article 31. ### 1. the commission shall establish and maintain a publicly available database with information on ehr systems for which an eu declaration of conformity has been issued pursuant to articles 26 and 26a.


### minimum categories of electronic data for secondary use ### categories of electronic data for secondary use


### 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 , through a secure system ensuring protection of the patients’ data , 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 for secondary use in accordance with the provisions of this chapter: ### 1. data holders shall make the following categories of electronic data available , upon request and verifying that the natural person has not rejected the option of sharing their 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; ### deleted


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


### relevant pathogen genomic data , impacting on human health; ### relevant pathogen genomic data , impacting on human health , provided that it is rendered anonymous;


### health-related administrative data , including claims and reimbursement data; ### healthcare-related administrative data , including claims and reimbursement data;


### health-related administrative data , including claims and reimbursement data; ### healthcare-related administrative data;


### health-related administrative data , including claims and reimbursement data; ### deleted


### human genetic , genomic and proteomic data; ### extracts from human genetic , genomic and proteomic data , such as genetic markers;


### person generated electronic health data , including medical devices , wellness applications or other digital health applications; ### deleted


### identification data related to health professionals involved in the treatment of a natural person; ### deleted


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


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


### electronic data related to insurance status , professional status , education , lifestyle , wellness and behaviour data relevant to health; ### 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 and small enterprises as defined in article 2 of the annex to commission recommendation 2003/361/ec59in the context of healthcare provision.


### 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. ### 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. ### 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. an accessible and easily understandable mechanism shall be provided to natural persons , whereby they shall be asked for their consent to have their health data processed for some or all of the purposes of secondary use , by one or more data users. if a natural person does not give explicit consent , their health data shall not be processed for secondary use. natural persons shall retain the right to withdraw their consent at any moment. where data users process electronic health data solely on the basis of consent within the meaning of article 4(11) of regulation (eu) 2016/679 , the scope of all possible processing should be determined by the scope of the prior obtained consent.


### 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. health data access bodies shall ensure that national requirements for access to electronic health data , such as the consent of natural persons , a right to object to the disclosure of their health data or the involvement of ethics committees , are met before providing access to electronic health data.


### 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. ### 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. health data access bodies shall only provide access to electronic health data referred to in article 33 to a health data user where the processing of the data by the applicant is necessary for one of the following purposes , in accordance with article 6(1)(c) and article 9(2)(g) , (h) , (i) and (j) of regulation (eu) 2016/679:


### 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; ### the protection against serious cross-border threats to health , and 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 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 , monitoring and evaluating health programmes or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices;


### to support public sector bodies or union institutions , agencies and bodies including regulatory authorities , in the health or care sector to carry out their tasks defined in their mandates; ### to support public sector bodies or union institutions , agencies and bodies including regulatory authorities , in the health or care sector to carry out their tasks defined in their mandates , where processing is necessary for reasons of substantial public interest;


### to support public sector bodies or union institutions , agencies and bodies including regulatory authorities , in the health or care sector to carry out their tasks defined in their mandates; ### to support public sector bodies or union institutions , agencies and bodies including regulatory authorities , as well as , where national laws apply , professional associations , in the health or care sector to carry out their tasks defined in their mandates;


### education or teaching activities in health or care sectors; ### deleted


### education or teaching activities in health or care sectors; ### university and post-university teaching activities in health or care sectors;


### scientific research related to health or care sectors; ### scientific research related to health or care sectors for prevention , early detection , diagnosis , treatment , rehabilitation or healthcare management , including fundamental , exploratory or applied healthcare research;


### scientific research related to health or care sectors; ### scientific research related to health or care sectors , 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 or of medical devices; ### deleted


### 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 and intended for healthcare or long-term care purposes , 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; ### deleted


### 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 the public health or social security and intended for healthcare or long-term care purposes , 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. ### providing personalised healthcare.


### 2. access to electronic health data referred to in article 33 where the intended purpose of processing pursued by the applicant fulfils one of the purposes referred to in points (a) to (c) of paragraph 1 shall only be granted to public sector bodies and union institutions , bodies , offices and agencies exercising their tasks conferred to them by union or national law , including where processing of data for carrying out these tasks is done by a third party on behalf of that public sector body or of union institutions , agencies and bodies. ### 2. access to electronic health data referred to in article 33 where the intended purpose of processing pursued by the applicant fulfils one of the purposes referred to in points (a) to (c) of paragraph 1 shall only be granted to public sector bodies and union institutions , bodies , offices and agencies exercising their tasks conferred to them by union or national law , including where processing of data for carrying out these tasks is done by a third party on behalf of that public sector body or of union institutions , agencies and bodies , meaning that the provisions of the gdpr must be respected.


### taking decisions detrimental to a natural person based on their electronic health data; in order to qualify as “decisions” , they must produce legal effects or similarly significantly affect those natural persons; ### taking decisions detrimental to a natural person or a group of natural persons based on their electronic health data; in order to qualify as “decisions” , they must produce legal effects or similarly significantly affect those natural persons;


### taking decisions detrimental to a natural person based on their electronic health data; in order to qualify as “decisions” , they must produce legal effects or similarly significantly affect those natural persons; ### taking any decision related to a natural person based on their electronic health data; in order to qualify as “decisions” , they must produce legal effects or similarly significantly affect those natural persons;


### 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 or credit contract or to modify their contributions and insurance premiums or conditions of loans or exclude them from the benefit of participating in clinical trials;


### 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 or credit contract or to modify their contributions and insurance premiums or durations of loans;


### advertising or marketing activities towards health professionals , organisations in health or natural persons; ### advertising or marketing activities;


### 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 , tobacco and nicotine products , weaponries or products , goods or services which are designed or modified in such a way that they incite chemical , behavioural or any other type of addiction or that they contravene public order or morality.


### 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 , including for the pseudonymisation of the 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 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 in a timely manner.


### (4) the processing of personal electronic health data is subject to the provisions of regulation (eu) 2016/679 of the european parliament and of the council43and , for union institutions and bodies , regulation (eu) 2018/1725 of the european parliament and of the council44. references to the provisions of regulation (eu) 2016/679 should be understood also as references to the corresponding provisions of regulation (eu) 2018/1725 for union institutions and bodies , where relevant. ### (4) the processing of personal electronic health data is subject to the provisions of regulation (eu) 2016/679 of the european parliament and of the council43and , for union institutions and bodies , regulation (eu) 2018/1725 of the european parliament and of the council44. references to the provisions of regulation (eu) 2016/679 should be understood also as references to the corresponding provisions of regulation (eu) 2018/1725 for union institutions and bodies , where relevant. in addition , the regulation should comply with cyber resilience act.


### 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 average gender pay gap in the eu stands at 16 % , 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;


### 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 other most vulnerable groups in society , as its effects will be felt most keenly by workers in the service , tourism , hospitality and care sectors , the self-employed , temporary and seasonal workers , etc. , among whom a higher proportion are women;


### 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 and social exclusion in the risk groups to which older women , single women and single mothers , refugee and migrant women , women of colour , 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; ### 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 women with children , single mothers , homosexual , bisexual and transgender women and women with disabilities belong is the same;


### 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 % and underlines that this is caused by the wage loss of working women with children , called the "motherhood pay gap";


### 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 and pension gap;


### 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 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. 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’; notes that not all member states appear to be making the same effort to promote awareness , or the implementation , of charter provisions;


### 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 law1and 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; calls on the member states to take action , in accordance with the charter , to guarantee that citizens are given universal access to high-quality health services , justice , social services and education;


### 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 , since 1999 ,turkey enjoys the most ambitious and mutually demanding model of relations the eu can offer to a third state , that is the candidate status for becoming a member; 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 in all aspects the values , interests , standards and policies of the eu; ### a. whereas being a candidate country requires the willingness together with concrete actions 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 in all aspects the values , interests , standards and policies of the eu; ### a. whereas being a candidate country presumes the commitment to progressively converge in all aspects with the values , interests , standards , legislation and policies of the eu;


### 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;


### - having regard to its previous resolutions on turkey , in particular those of 13 march 2019 on the 2018 commission report on turkey1 , of 19 september 2019 on the situation in turkey , notably the removal of elected mayors2 , of 24 october 2019 on the turkish military operation in northeast syria and its consequences3 , and of 17 september 2020 on the preparation of the special european council summit focusing on the dangerous escalation and the role of turkey in the eastern mediterranean4 , ### - having regard to its previous resolutions on turkey , in particular those of 13 march 2019 on the 2018 commission report on turkey1 , of 19 september 2019 on the situation in turkey , notably the removal of elected mayors2 , of 24 october 2019 on the turkish military operation in northeast syria and its consequences3 , of 17 september 2020 on the preparation of the special european council summit focusing on the dangerous escalation and the role of turkey in the eastern mediterranean4 and of 26 november 2020 on escalating tensions in varosha following the illegal actions by turkey and the urgent need for the resumption of talks4a ,


### - having regard to its previous resolutions on turkey , in particular those of 13 march 2019 on the 2018 commission report on turkey1 , of 19 september 2019 on the situation in turkey , notably the removal of elected mayors2 , of 24 october 2019 on the turkish military operation in northeast syria and its consequences3 , and of 17 september 2020 on the preparation of the special european council summit focusing on the dangerous escalation and the role of turkey in the eastern mediterranean4 , ### - having regard to its previous resolutions on turkey , in particular those of 13 march 2019 on the 2018 commission report on turkey1 , of 19 september 2019 on the situation in turkey , notably the removal of elected mayors2 , of 24 october 2019 on the turkish military operation in northeast syria and its consequences3 , and of 17 september 2020 on the preparation of the special european council summit focusing on the dangerous escalation and the role of turkey in the eastern mediterranean4 and of 26 november 2020 on escalating tensions in varosha following the illegal actions by turkey and the urgent need for the resumption of talks 4a ,


### - having regard to the negotiating framework for turkey of 3 october 2005 , ### - having regard to the negotiating framework for turkey of 3 october 2005 , and to the fact that , as is the case for all candidate countries , turkey’s accession to the eu depends on full compliance with the copenhagen criteria , and to the need to normalize its relations with all eu member states , including the republic of cyprus;


### - having regard to the council conclusions of 15 july and 14 october 2019 on turkey’s illegal drilling activities in the eastern mediterranean , to the european council conclusions of 1 october 2020 , to the statements of the eu foreign ministers of 15 may 2020 and 14 august 2020 on the situation in the eastern mediterranean , to the outcome of the informal meeting of eu foreign ministers (gymnich) of 28 august 2020 , and to all previous relevant council and european council conclusions , ### - having regard to the council conclusions of 18 june 2019 on the standstill of turkey's accession process , 15 july and 14 october 2019 on turkey’s illegal drilling activities in the eastern mediterranean , to the european council conclusions of 12 december 2019 on the illegal memorandum of understanding between turkey and libya , of 1 october 2020 , to the statements of the eu foreign ministers of 15 may 2020 and 14 august 2020 on the situation in the eastern mediterranean , to the outcome of the informal meeting of eu foreign ministers (gymnich) of 28 august 2020 , and to all previous relevant council and european council conclusions ,


### - having regard to the council conclusions of 15 july and 14 october 2019 on turkey’s illegal drilling activities in the eastern mediterranean , to the european council conclusions of 1 october 2020 , to the statements of the eu foreign ministers of 15 may 2020 and 14 august 2020 on the situation in the eastern mediterranean , to the outcome of the informal meeting of eu foreign ministers (gymnich) of 28 august 2020 , and to all previous relevant council and european council conclusions , ### - having regard to the council conclusions of 15 july and 14 october 2019 on turkey’s illegal drilling activities in the eastern mediterranean , to the european council conclusions of 1 october 2020 and 16 october 2020 , to the statements of the eu foreign ministers of 15 may 2020 and 14 august 2020 on the situation in the eastern mediterranean , to the outcome of the informal meeting of eu foreign ministers (gymnich) of 28 august 2020 , and to all previous relevant council and european council conclusions ,


### c. whereas in its previous annual report , parliament called on the commission and the member states to formally suspend accession negotiations with turkey; ### c. whereas in its previous annual report , in view of the consolidation of this serious backsliding , parliament called on the commission and the member states , in accordance with the negotiating framework , to formally suspend accession negotiations with turkey;


### d. whereas , in spite of this principled stance by parliament and all of the current circumstances , the european council , in its conclusions of 1 october 2020 , offered turkey a renewed and broad positive agenda , provided that constructive efforts are sustained , in a further attempt to restore our relations; ### d. whereas , in spite of this principled stance by parliament , the destabilising actions of turkey in libya , syria and south caucasus and its illegal actions in eastern mediterranean , the european council , in its conclusions of 1 october 2020 , offered turkey a renewed and broad positive agenda , provided that turkey would stop its illegal activities , in a further attempt to restore our relations;


### d. whereas , in spite of this principled stance by parliament and all of the current circumstances , the european council , in its conclusions of 1 october 2020 , offered turkey a renewed and broad positive agenda , provided that constructive efforts are sustained , in a further attempt to restore our relations; ### d. whereas , in spite of this principled stance by parliament and all of the current circumstances , the european council , in its conclusions of 1 october 2020 , offered turkey a renewed and broad positive agenda , provided that constructive efforts to stop illegal activities vis-à-vis greece and cyprus are sustained , in a further attempt to restore our relations;


### 2. notes that turkey’s lack of commitment to carrying out the reforms assumed in the accession process has made the latter inadequate to frame a complex relationship that has progressively become more transactional and driven by circumstances; ### 2. notes that turkey’s lack of commitment to carrying out the reforms assumed in the accession process has made the latter inadequate to frame a complex relationship that has progressively become more transactional and driven by circumstances , with little to do with the logic of the original format of gradual alignment to predetermined benchmarks;


### 3. is deeply concerned that , over the years , the lack of progress in turkey’s convergence has now transformed into a full withdrawal , marked by a stark regression in three main areas: backsliding on the rule of law and fundamental rights , adopting regressive institutional reforms and pursuing a confrontational foreign policy; is further concerned by the fact that this regression has increasingly been accompanied by an explicit anti-eu narrative; calls , in this context , on turkey to reassess the sincerity of its commitment to the eu path , as an indispensable component of the viability of the entire accession process; ### 3. is deeply concerned by the ongoing dispute in the eastern mediterranean and the related risk of a military escalation; condemns turkey’s illegal activities in greek and cypriot waters , as well as turkey’s violations of greek national airspace , including overflights of inhabited areas , and territorial sea , which violate both the sovereign rights of eu member states and international law; expresses its full solidarity with greece and the republic of cyprus; urges turkey to engage in the peaceful settlement of disputes and to refrain from any illegal action or threat , including the unilateral attempt to abolish the maritime borders , in particular of the greek island of kastellorizo;


### 3. is deeply concerned that , over the years , the lack of progress in turkey’s convergence has now transformed into a full withdrawal , marked by a stark regression in three main areas: backsliding on the rule of law and fundamental rights , adopting regressive institutional reforms and pursuing a confrontational foreign policy; is further concerned by the fact that this regression has increasingly been accompanied by an explicit anti-eu narrative; calls , in this context , on turkey to reassess the sincerity of its commitment to the eu path , as an indispensable component of the viability of the entire accession process; ### 3. is deeply concerned that , over the years , the lack of progress in turkey’s convergence has now transformed into a full withdrawal , marked by a stark regression in three main areas: backsliding on the rule of law and fundamental rights , adopting regressive institutional reforms and pursuing a confrontational foreign policy; is further concerned by the fact that this regression has increasingly been accompanied by an explicit anti-eu narrative , amplified in the country by the pro-government media outlets; calls , in this context , on turkey to reassess the sincerity of its commitment to the eu path , as an indispensable component of the viability of the entire accession process;


### 3. is deeply concerned that , over the years , the lack of progress in turkey’s convergence has now transformed into a full withdrawal , marked by a stark regression in three main areas: backsliding on the rule of law and fundamental rights , adopting regressive institutional reforms and pursuing a confrontational foreign policy; is further concerned by the fact that this regression has increasingly been accompanied by an explicit anti-eu narrative; calls , in this context , on turkey to reassess the sincerity of its commitment to the eu path , as an indispensable component of the viability of the entire accession process; ### 3. is deeply concerned that , over the years , the lack of progress in turkey’s convergence has now transformed into a full withdrawal , marked by a stark regression in three main areas: backsliding on the rule of law and fundamental rights , adopting regressive institutional reforms and pursuing a confrontational and destabilised foreign policy; is further concerned by the fact that this regression has increasingly been accompanied by an explicit anti-eu narrative by government officials; calls , in this context , on turkey to reassess the sincerity of its commitment to the eu path , as an indispensable component of the viability of the entire accession process;


### 4. stresses that no incentive that the eu could offer can ever replace the much-needed political will to build a mature democracy and , in turn , become a member of the eu; ### 4. acknowledges the persistent strategy of openness and good will adopted by the eu and lately materialized in the renewed positive agenda offered by the european council in october 2020; stresses that no incentive that the eu could offer can ever replace the much-needed political will to build a mature democracy and , in turn , become a reliable ally and ultimately a member of the eu; notes that ever since the last european council conclusions , no efforts were attempted by turkish authorities to advance towards benchmarks laid down in this broad agenda and that turkey's confrontational attitude and rhetoric has even deteriorated;


### 4. stresses that no incentive that the eu could offer can ever replace the much-needed political will to build a mature democracy and , in turn , become a member of the eu; ### 4. stresses that no incentive that the eu could offer can ever replace the much-needed political will to build a mature democracy and , in turn , become a member of the eu; recalls that accession process is and will remain a merit-based process fully dependent on the objective progress achieved by each country , including turkey;