### 3. data users seeking access to electronic health data from more than one member state shall submit a single application to one of the concerned health data access bodies of their choice which shall be responsible for sharing the request with other health data access bodies and authorised participants in healthdata@eu referred to in article 52 , which have been identified in the data access application. for requests to access electronic health data from more than one member states , the health data access body shall notify the other relevant health data access bodies of the receipt of an application relevant to them within 15 days from the date of receipt of the data access application. ### 3. data users seeking access to electronic health data from more than one member state shall submit a single application to one of the concerned health data access bodies of their choice which shall be responsible for sharing the application with the other health data access bodies and authorised participants in healthdata@eu referred to in article 52 , which have been identified in the data access application. in such a case , the health data access body shall notify the other relevant health data access bodies of the receipt of an application relevant to them within 15 days from the date of receipt of the data access application.


### a description of how the processing would comply with article 6(1) of regulation (eu) 2016/679; ### a description of how the processing would comply with article 6(1) and 9(2) of regulation (eu) 2016/679 or articles 5(1) and 10(2) of regulation (eu) 2018/1725;


### information on the assessment of ethical aspects of the processing , where applicable and in line with national law. ### deleted


### where the public sector bodies and the union institutions , bodies , offices and agencies intend to access the electronic health data in pseudonymised format , a description of how the processing would comply with article 6(1) of regulation (eu) 2016/679 or article 5(1) of regulation (eu) 2018/1725 , as applicable , shall also be provided. ### deleted


### 6. the commission may , by means of implementing acts , set out the templates for the data access application referred to in this article , the data permit referred to in article 46 and the data request referred to in article 47. those implementing acts shall be adopted in accordance with the procedure referred to in article 68(2). ### 6. the commission shall , by means of implementing acts , set out the templates for the data access application referred to in this article , the data permit referred to in article 46 and the data request referred to in article 47. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 68(2a).


### 7. the commission is empowered to adopt delegated acts in accordance with article 67 to amend the list of information in paragraphs 2 , 4 , 5 and 6 of this article , to ensure the adequacy of the list for processing a data access application at national or cross-border level. ### 7. the commission is empowered to adopt delegated acts in accordance with article 67 to amend the list of information in paragraphs 2 , 4 , 5 of this article , to ensure the adequacy of the list for processing a data access application at national or cross-border level.


### 1. health data access bodies shall assess if the application fulfils one of the purposes listed in article 34(1) of this regulation , if the requested data is necessary for the purpose listed in the application and if the requirements in this chapter are fulfilled by the applicant. if that is the case , the health data access body shall issue a data permit. ### 1. when health data access bodies decide whether to grant or refuse a data permit , they shall assess if the health data access application referred to in article 45 fulfils the following criteria:


### 2. health data access bodies shall refuse all applications including one or more purposes listed in article 35 or where requirements in this chapter are not met. ### 2. if the health data access body in its independent assessment concludes that the requirements listed in paragraph 1 of this article are met , as well as all other requirements of this chapter , the health data access body shall grant the health data permit. health data access bodies shall refuse all applications where the requirements in this chapter are not met.


### 3. a health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. by way of derogation from that regulation […] [data governance act com/2020/767 final] , the health data access body may extend the period for responding to a data access application by 2 additional months where necessary , taking into account the complexity of the request. in such cases , the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application , together with the reasons for the delay. where a health data access body fails to provide a decision within the time limit , the data permit shall be issued. ### 3. a health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. by way of derogation from that regulation (eu) 2022/868 , the health data access body may extend the period for responding to a data access application by a maximum of 3 additional months where necessary , taking into account the complexity of the request. in such cases , the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application , together with the reasons for the delay.


### types and format of electronic health data accessed , covered by the data permit , including their sources; ### categories and format of electronic health data accessed , covered by the data permit , including their sources;


### purpose for which data are made available; ### a detailed description of the purpose for which data are made available;


### fees to be paid by the data user; ### fees to be paid by the data user to the health data access body;


### 8. the commission is empowered to adopt delegated acts to amend the list of aspects to be covered by a data permit in paragraph 7 of this article , in accordance with the procedure set out in article 67. ### 8. the commission is empowered to adopt delegated acts to amend the list of aspects to be covered by a data permit in paragraph 6 of this article , in accordance with the procedure set out in article 67.


### 9. a data permit shall be issued for the duration necessary to fulfil the requested purposes which shall not exceed 5 years. this duration may be extended once , at the request of the data user , based on arguments and documents to justify this extension provided , 1 month before the expiry of the data permit , for a period which cannot exceed 5 years. by way of derogation from article 42 , the health data access body may charge increasing fees to reflect the costs and risks of storing electronic health data for a longer period of time exceeding the initial 5 years. in order to reduce such costs and fees , the health data access body may also propose to the data user to store the dataset in storage system with reduced capabilities. the data within the secure processing environment shall be deleted within 6 months following the expiry of the data permit. upon request of the data user , the formula on the creation of the requested dataset shall be stored by the health data access body. ### 9. a data permit shall be issued for the duration necessary to fulfil the requested purposes which shall not exceed 5 years. this duration may be extended once , at the request of the data user , based on arguments and documents to justify this extension provided , 1 month before the expiry of the data permit , for a period which cannot exceed 5 years. by way of derogation from article 42 , the health data access body may charge increasing fees to reflect the costs and risks of storing electronic health data for a longer period of time exceeding the initial 5 years. in order to reduce such costs and fees , the health data access body may also propose to the data user to store the dataset in storage system with reduced capabilities. the data within the secure processing environment shall be deleted following the expiry of the data permit. upon request of the data user , the formula on the creation of the requested dataset shall be stored by the health data access body for a period of 5 years.


### 11. data users shall make public the results or output of the secondary use of electronic health data , including information relevant for the provision of healthcare , no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in article 47. those results or output shall only contain anonymised data. the data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites. whenever the data users have used electronic health data in accordance with this chapter , they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the ehds. ### deleted


### 11. data users shall make public the results or output of the secondary use of electronic health data , including information relevant for the provision of healthcare , no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in article 47. those results or output shall only contain anonymised data. the data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites. whenever the data users have used electronic health data in accordance with this chapter , they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the ehds. ### 11. data users shall make public the results or output of the secondary use of electronic health data , including information relevant for the provision of healthcare , no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in article 47. those results or output shall only contain anonymised data. the data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites without compromising on ip rights and trade secrets defined in relevant union legislation. whenever the data users have used electronic health data in accordance with this chapter , they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the ehds.


### 11. data users shall make public the results or output of the secondary use of electronic health data , including information relevant for the provision of healthcare , no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in article 47. those results or output shall only contain anonymised data. the data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites. whenever the data users have used electronic health data in accordance with this chapter , they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the ehds. ### 11. data users shall make public the results or output of the secondary use of electronic health data , including information relevant for the provision of healthcare , no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in article 47. those results or output shall only contain anonymised data. the data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites without compromising on ip and trade secrets defined in relevant union legislation. whenever the data users have used electronic health data in accordance with this chapter , they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the ehds.


### 12. data users shall inform the health data access body of any clinically significant findings that may influence the health status of the natural persons whose data are included in the dataset. ### deleted


### 14. the liability of health data access bodies as joint controller is limited to the scope of the issued data permit until the completion of the processing activity. ### 14. the liability of health data access bodies as controller is limited to the scope of the issued data permit and in accordance with article 51.


### 1. this regulation establishes the european health data space (‘ehds’) by providing for rules , common standards and practices , infrastructures and a governance framework for the primary and secondary use of electronic health data. ### 1. this regulation establishes the european health data space (‘ehds’) by providing for rules , common standards and practices , infrastructures and a governance framework for the primary and secondary use of electronic health data. the european health data space (‘ehds’) shall , with respect for the principle of subsidiarity , complement and not replace member states' national rules and policy principles for the use of both primary and secondary health data.


### 1. this regulation establishes the european health data space (‘ehds’) by providing for rules , common standards and practices , infrastructures and a governance framework for the primary and secondary use of electronic health data. ### 1. this regulation establishes the european health data space (‘ehds’) by providing for rules , interoperable common standards , practices , and infrastructures and a governance framework for the primary and secondary use of electronic health data.


### 1. this regulation establishes the european health data space (‘ehds’) by providing for rules , common standards and practices , infrastructures and a governance framework for the primary and secondary use of electronic health data. ### 1. this regulation establishes the european health data space (‘ehds’) by providing for rules , common and interoperable standards , practices and infrastructures and a governance framework for the primary and secondary use of electronic health data.


### strengthens the rights of natural persons in relation to the availability and control of their electronic health data; ### strengthens the rights of natural persons in relation to the availability , sharing and control of their electronic health data;


### manufacturers and suppliers of ehr systems and wellness applications placed on the market and put into service in the union and the users of such products; ### manufacturers and suppliers of ehr systems and products claiming interoperability with ehr systems , including medical devices , high-risk ai systems and wellness applications placed on the market and put into service in the union and the users of such products;


### data users to whom electronic health data are made available by data holders in the union. ### data recipients and users to whom electronic health data are made available by data holders in the union.


### the definitions in regulation (eu) 2016/679; ### the definitions of ‘personal data’ , ‘processing’ , ‘pseudonymisation’ , ‘controller’ , ‘processor’ , ‘genetic data’ , ‘data concerning health’ , ‘cross-border processing’ , ‘international organisation’ pursuant to article 4 (1) , (2) , (5) , (7) , (8) , (13) , (15) , (23) , and (26) of regulation (eu) 2016/679;


### ‘personal electronic health data’ means data concerning health and genetic data as defined in regulation (eu) 2016/679 , as well as data referring to determinants of health , or data processed in relation to the provision of healthcare services , processed in an electronic form; ### ‘personal electronic health data’ means data concerning health and genetic data as defined in regulation (eu) 2016/679 , processed in an electronic form;


### ‘personal electronic health data’ means data concerning health and genetic data as defined in regulation (eu) 2016/679 , as well as data referring to determinants of health , or data processed in relation to the provision of healthcare services , processed in an electronic form; ### ‘personal electronic health data’ means data concerning health and genetic data as defined in regulation (eu) 2016/679 , that are processed in an electronic form;


### ‘non-personal electronic health data’ means data concerning health and genetic data in electronic format that falls outside the definition of personal data provided in article 4(1) of regulation (eu) 2016/679; ### ‘non-personal electronic health data’ means data concerning health and genetic data in electronic format that falls outside the definition of personal data provided in article 4(1) of regulation (eu) 2016/679; and on a case by case basis pseudonymised data according to article 4(5) of regulation (eu) 2016/679;


### ‘non-personal electronic health data’ means data concerning health and genetic data in electronic format that falls outside the definition of personal data provided in article 4(1) of regulation (eu) 2016/679; ### ‘non-personal electronic health data’ means data concerning health and genetic data in electronic format that falls outside the definition of personal data provided in article 4(1) of regulation (eu) 2016/679; and on a case by case basis pseudonymised data according to article 4(5) of regulation (eu) 2016/679


### ‘primary use of electronic health data’ means the processing of personal electronic health data for the provision of health services to assess , maintain or restore the state of health of the natural person to whom that data relates , including the prescription , dispensation and provision of medicinal products and medical devices , as well as for relevant social security , administrative or reimbursement services; ### ‘primary use of electronic health data’ means the processing of personal electronic health data for the provision of health services to assess , maintain or restore the state of health of the natural person to whom that data relates , including the prescription , dispensation and provision of medicinal products and medical devices , as well as for administration relevant for the provision of healthcare services;


### ‘secondary use of electronic health data’ means the processing of electronic health data for purposes set out in chapter iv of this regulation. the data used may include personal electronic health data initially collected in the context of primary use , but also electronic health data collected for the purpose of the secondary use; ### ‘secondary use of electronic health data’ means:


### ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals , involving the exchange of information and knowledge without changing the content of the data between these organisations , software applications or devices , through the processes they support; ### ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to process , exchange and use data in order to perform their functions in an accurate , effective and consistent manner without changing the content of the data between these organisations , software applications or devices , through the processes they support;


### ‘data recipient’ means a natural or legal person that receives data from another controller in the context of the primary use of electronic health data; ### ‘health data recipient’ means recipient as defined in article 4(9) of regulation (eu) 2016/679 , in the context of the primary use of electronic health data;


### ‘ehr’ (electronic health record) means a collection of electronic health data related to a natural person and collected in the health system , processed for healthcare purposes; ### ‘ehr’ (electronic health record) means a collection of electronic health data related to a natural person and collected in the health system , processed for the purpose of the provision of healthcare services;


### ‘ehr system’ (electronic health record system) means any appliance or software intended by the manufacturer to be used for storing , intermediating , importing , exporting , converting , editing or viewing electronic health records; ### ‘ehr system’ (electronic health record system) means any appliance or software the primary purpose of which , intended by the manufacturer , is storing , intermediating , importing , exporting , converting , editing or viewing electronic health records between health professionals;


### ‘data holder’ means any natural or legal person , which is an entity or a body in the health or care sector , or performing research in relation to these sectors , as well as union institutions , bodies , offices and agencies who has the right or obligation , in accordance with this regulation , applicable union law or national legislation implementing union law , or in the case of non-personal data , through control of the technical design of a product and related services , the ability to make available , including to register , provide , restrict access or exchange certain data; ### ‘health data holder’ means any natural or legal person , which is an entity or a body in the health or care sector , or performing research in relation to these sectors , as well as union institutions , bodies , offices and agencies , which:


### ‘data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data for secondary use; ### ‘health data user’ means a natural or legal person as well as union institutions , bodies , offices and agencies , who has been granted access , in accordance with this regulation , to one or more of the categories of personal or non-personal electronic health data for secondary use;


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


### 3. in accordance with article 23 of regulation (eu) 2016/679 , member states may restrict the scope of this right whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on his or her health. ### 3. in accordance with article 23 of regulation (eu) 2016/679 , member states may restrict the scope of the rights referred to in paragraphs 1 and 2 whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on his or her health.


### 4. where the personal health data have not been registered electronically prior to the application of this regulation , member states may require that such data is made available in electronic format pursuant to this article. this shall not affect the obligation to make personal electronic health data registered after the application of this regulation available in electronic format pursuant to this article. ### deleted


### establish one or more electronic health data access services at national , regional or local level enabling the exercise of rights referred to in paragraphs 1 and 2; ### establish one or more electronic health data access services at national or regional level enabling the exercise of rights referred to in this article;


### establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf. ### establish one or more proxy services enabling:


### the proxy services shall provide authorisations free of charge , electronically or on paper. they shall enable guardians or other representatives to be authorised , either automatically or upon request , to access electronic health data of the natural persons whose affairs they administer. member states may provide that authorisations do not apply whenever necessary for reasons related to the protection of the natural person , and in particular based on patient safety and ethics. the proxy services shall be interoperable among member states. ### the proxy services shall provide authorisations in a transparent and easily understandable way , free of charge , electronically or on paper. authorised natural persons and those acting on their behalf shall be informed about what authorisation rights they have , how to exercise them , and what they can expect from the authorisation process.


### 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 until a relevant health professional validates the information , which would then be marked as confirmed by a healthcare professional.


### 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. data rectification requests shall be assessed and , where relevant , implemented by the data controllers on a case by case basis , if necessary involving health professionals.


### 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 sector and providing healthcare to transmit their electronic health data or only specific part of health data identified by the requesting natural persons or necessary for the purpose at stake to a health 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.


### 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 selected health professionals to all or a specific part of their electronic health data. such restriction shall be easily identifiable in the ehr. when restricting the information , natural persons shall be made aware that restricting access may impact the provision of healthcare provied to them.


### 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 providing healthcare , including pursuant to article 4(4) of this regulation. the information shall be provided immediately and free of charge through electronic health data access services and stored for at least 3 years.


### 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 automatic notifications via email to be informed 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.


### 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. ### deleted


### 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 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 examination procedure referred to in article 68(2a).


### 1. where they process data in an electronic format , health professionals shall: ### 1. where they process data in an electronic format , health professionals , including care management teams , shall:


### 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 treatment and for its sole purpose , including relevant administration , irrespective of the member state of affiliation and the member state of treatment , in accordance with article 9(2) point (h) of regulation 2016/679;


### 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 may establish rules providing for the categories of personal electronic health data required by different health professions , based on their qualification and area of expertise. such rules shall not be based on the geographical 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 through health professional access services. health professionals shall have access to electronic health data through health professional access services for the sole purpose of providing healthcare treatment , including relevant administration , and only through recognised electronic identification and authentication means , free of charge. the electronic health data in the electronic health records shall be structured in a user-friendly manner to allow for an easy use by health professionals.


### 4. where access to electronic health data has been restricted by the natural person , the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person , including where the provider or professional is informed of the existence and nature of the restricted electronic health data. in cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person , the healthcare provider or health professional may get access to the restricted electronic health data. following such access , the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. member states’ law may add additional safeguards. ### 4. where access to electronic health data has been restricted by the natural person according to article 3(9) , 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. however , health professionals should always be able to distinguish between the case where there is no data , and where there is data but access is restricted. in cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person , the healthcare provider or health professional may get access to the restricted electronic health data. following such access , the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. member states’ law may add additional safeguards


### 4. where access to electronic health data has been restricted by the natural person , the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person , including where the provider or professional is informed of the existence and nature of the restricted electronic health data. in cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person , the healthcare provider or health professional may get access to the restricted electronic health data. following such access , the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. member states’ law may add additional safeguards. ### 4. where access to electronic health data has been restricted by the natural person , pursuant to article 3(9) , the healthcare provider or health professionals shall not be informed of the content of the restricted electronic health data without prior explicit consent as defined in article 9(2)(a) of regulation (eu) 2016/679 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 , in line with article 6(1)(d) of of regulation (eu) 2016/679. following such access , the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. member states’ law may add additional safeguards.


### 4. where access to electronic health data has been restricted by the natural person , the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person , including where the provider or professional is informed of the existence and nature of the restricted electronic health data. in cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person , the healthcare provider or health professional may get access to the restricted electronic health data. following such access , the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. member states’ law may add additional safeguards. ### 4. where access to electronic health data has been restricted by the natural person according to article 3(9) , 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. however , health professionals should always be able to distinguish between the case where there is no data and where there is data , but access is restricted. in cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person , the healthcare provider or health professional may get access to the restricted electronic health data. following such access , the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. member states’ law may add additional safeguards.


### electronic prescriptions; ### electronic prescriptions and medication plans;


### medical images and image reports; ### medical images and image reports and medical test results;


### discharge reports. ### hospital discharge reports.


### 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: ### 2. the commission is empowered to adopt delegated acts in accordance with article 67 to amend annex i by adding , modifying or removing the main characteristics of the priority categories of electronic health data.


### the category is relevant for health services provided to natural persons; ### deleted


### according to the most recent information , the category is used in a significant number of ehr systems used in member states; ### deleted


### international standards exist for the category that have been examined for the possibility of their application in the union. ### 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 as minimum data fields and data groups for the content representation of clinical content and other parts of the electronic health data that may be enlarged to include disease specific data;


### 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 implementing acts , determine:


### categories of healthcare providers that are to register health data electronically; ### deleted


### categories of health data that are to be registered systematically in electronic format by healthcare providers referred to in point (a); ### 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 enables the provision of telemedicine services , it shall , under the same conditions and in a non-discriminatory manner , accept the provision of the services of the same type by healthcare providers located in other member states.


### 1. where a natural person uses telemedicine services or personal health data access services referred to in article 3(5) , point (a) , that natural person shall have the right to identify electronically using any electronic identification means which is recognised pursuant to article 6 of regulation (eu) no 910/2014. ### 1. where a natural person uses telemedicine services , that natural person shall have the right to identify electronically using any electronic identification means which is recognised pursuant to article 6 of regulation (eu) no 910/2014.


### 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 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] with provisions for transition periods. the mechanism shall facilitate the transferability of electronic health data in a cross-border context. the commission shall ensure that state-of-art technology is in place to meet the requirements. 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 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 and allow natural persons to easily access their electronic health record by identification and authentication under the new eid system. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2).


### ensure the implementation of the rights and obligations provided for in chapters ii and iii by adopting necessary national , regional or local technical solutions and by establishing relevant rules and mechanisms; ### ensure the implementation of the rights and obligations provided for in chapters ii and iii by adopting necessary national or regional technical solutions and by establishing relevant rules and mechanisms;


### 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 to natural persons and health professionals , including natural persons with disabilities , under the same non-discriminatory conditions and offer the possibility of choosing between in person and digital services;


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


### 4. each member state shall ensure that each digital health authority is provided with the human , technical and financial resources , premises and infrastructure necessary for the effective performance of its tasks and exercise of its powers. ### 4. each member state shall ensure that each digital health authority is provided with the human , technical and financial resources , premises and infrastructure necessary for the effective performance of its tasks and exercise of its powers. digital health authorities and their members and staff shall have the qualifications , experience and skills required to carry out their duties and exercise their powers.


### 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 health professionals , patients and consummers' representatives. the stakeholders' representatives shall take part in the governance and decision-making structures of the digital health authority. members of the digital health authority shall avoid any conflicts of interest.


### 5. in the performance of its tasks , the digital health authority shall actively cooperate with stakeholders’ representatives , including patients’ representatives. members of the digital health authority shall avoid any conflicts of interest. ### 5. in the performance of its tasks , the digital health authority shall actively cooperate and consult with essential health stakeholders’ representatives , including patients’ representatives , health professionals and healthcare providers. members of the digital health authority shall avoid any conflicts of interest.


### 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 the complaint concerns the rights of natural persons pursuant to article 3 of this regulation , or any data protection aspects , the digital health authority shall inform the supervisory authorities under regulation (eu) 2016/679 and send them a copy of the complaint in order to facilitate their assessment and investigation. where a complaint concerning rights of natural persons pursuant to article 3 is made solely to the supervisory authorities , they shall inform the digital health authorities and send them a copy.


### 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 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 and shall consult and cooperate with them in the handling of such complaints.


### 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. where the complaint concerns data protection aspects , the digital health authority shall inform the complainant that the complaint was referred to the relevant supervisory authority under regulation (eu) 2016/679 , and that the supervisory authority will , from that time on , be the sole point of contact for the complainant in that matter.


### 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 provides the complainant with information on the status of the complaint proceedings and of the decision taken to ensure full transparency of the process.


### 3. digital health authorities shall cooperate to handle and resolve complaints , including by exchanging all relevant information by electronic means , without undue delay. ### 3. digital health authorities shall cooperate to handle and resolve complaints , including by exchanging all relevant information by electronic means , without undue delay and communicate on processing time and complaint resolution time.


### 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 examination procedure referred to in article 68(2a). the implementing act shall include target implementation dates , including for cross-border health data interoperability , in consultation with the ehds board.


### 6. member states shall ensure that pharmacies operating on their territories , including online pharmacies , are enabled to dispense electronic prescriptions issued by other member states , under the conditions laid down in article 11 of directive 2011/24/eu. the pharmacies shall access and accept electronic prescriptions transmitted to them from other member states through myhealth@eu. following dispensation of medicinal products based on an electronic prescription from another member state , pharmacies shall report the dispensation to the member state that issued the prescription , through myhealth@eu. ### 6. member states shall ensure that pharmacies operating on their territories , 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 , without prejudice to article 11 of directive 2011/24. 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.


### 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. ### deleted


### the implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the procedure referred to in article 68. the connection of the national contact point of the third country or of the system established at an international level to the central platform for digital health , as well as the decision to be disconnected shall be subject to a decision of the joint controllership group for myhealth@eu referred to in article 66. ### deleted


### 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 if they comply with the provisions laid down in this chapter. that compliance shall be accredited through an ehr conformity assessment procedure performed by notified bodies for ehr systems and products claiming interoperability , including technical solutions on interoperability and security.


### ensure that their ehr systems are in conformity with the essential requirements laid down in annex ii and with the common specifications in accordance with article 23; ### ensure that their ehr systems are in conformity with the essential requirements laid down in annex ii and with the common specifications in accordance with article 23 and that they follow the principles of data minimisation and data protection by design; for the latter , the manufacturers shall be encouraged to consult relevant supervisory authorities under regulation (eu) 2016/679.


### ensure that their ehr systems are in conformity with the essential requirements laid down in annex ii and with the common specifications in accordance with article 23; ### obtain for their ehr systems a certificate of compliance from an independent third-party body to attest their conformity with the essential requirements laid down in annex ii and with the common specifications in accordance with article 23;


### 6. if the wellness application is embedded in a device , the accompanying label shall be placed on the device. 2d barcodes may also be used to display the label. ### 6. if the wellness application is embedded in a device , the accompanying label shall be placed on the device and in the case of software a digital label. 2d barcodes may also be used to display the label.


### 6. if the wellness application is embedded in a device , the accompanying label shall be placed on the device. 2d barcodes may also be used to display the label. ### 6. if the wellness application is embedded in a device , the accompanying label shall be placed on the device and in the case of software , a digital label. 2d barcodes may also be used to display the label.


### minimum categories of electronic data for secondary use ### minimum categories of electronic health 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. this chapter shall apply to the following categories of electronic health data available for secondary use:


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


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


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


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


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


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


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


### population wide health data registries (public health registries); ### population wide health data registries (public health registries) and patient demographic data;


### electronic health data from medical registries for specific diseases; ### electronic health data from medical registries;


### electronic health data from clinical trials; ### electronic health data from fully concluded or terminated clinical trials , in accordance with regulation 536/2014;


### electronic health data from clinical trials; ### electronic health data from fully completed or terminated clinical trials in accordance with regulation (eu) no 536/2014;


### electronic health data from clinical trials; ### electronic health data from clinical trials in accordance with regulation (eu) no 536/2014;


### electronic health data from medical devices and from registries for medicinal products and medical devices; ### electronic health data from medical devices and from registries for medicinal products and medical devices , including medical audio and video material;


### research cohorts , questionnaires and surveys related to health; ### research cohorts , questionnaires and surveys related to health , including patient-reported outcomes and experience measures (proms and prems);


### electronic data related to insurance status , professional status , education , lifestyle , wellness and behaviour data relevant to health; ### deleted


### electronic data related to insurance status , professional status , education , lifestyle , wellness and behaviour data relevant to health; ### electronic data related to insurance status , professional status , education;


### electronic data related to insurance status , professional status , education , lifestyle , wellness and behaviour data relevant to health; ### electronic data related to insurance status , professional status , and education;


### 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. ### deleted


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


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


### 4. electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights and trade secrets shall be taken. ### 4. electronic health data entailing protected intellectual property and trade secrets from health data holders shall be made available for secondary use. for data defined under article 33 (k) (medical devices) where data holder can demonstrate that data are derived or inferred by means of complex proprietary algorithms and can lead to reverse engineering , data holder should be entitled to refer to data coordinator as established under article 31 of regulation (data act) to request a restriction or limitation of the sharing of data. where such data is made available for secondary use , all measures necessary to preserve ip rights and confidentiality of trade secrets shall be taken. this regulation is without prejudice to union and national legal acts providing for the protection of intellectual property rights , including directive 2001/29/ec , directive 2004/48/ec , directive (eu) 2016/943 and directive (eu) 2019/790.


### 4. electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. where such data is made available for secondary use , all measures necessary to preserve the confidentiality of ip rights and trade secrets shall be taken. ### 4. electronic health data entailing protected intellectual property and trade secrets from health data holders shall be made available for secondary use. where such data is made available for secondary use , all technical and organisational measures necessary to preserve the confidentiality of ip rights and confidentiality of trade secrets shall be taken by the health data access body and in consultation with the data holder. this regulation is without prejudice to existing relevant union legislation , including directive 2004/48/ec , directive 2001/29/ec , directive (eu) 2016/943 and directive (eu) 2019/790.


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


### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data. ### 5. natural persons that are subjects to secondary use of health data shall be asked for explicit consent prior to the processing of their health data. health data access bodies shall provide for an accesible and easily understandable opt-in mechanism.


### 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 intended purpose of processing is one or more of the following:


### 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 willing to processing for the following purposes:


### activities for reasons of public interest in the area of public and occupational health , such as protection against serious cross-border threats to health , public health surveillance or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices; ### activities for reasons of public interest in the area of public and occupational health , such as protection against serious cross-border threats to health , public health surveillance or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices , identification of environmental factors on health , identification of work related risks and evaluation of preventive measure taken;


### 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: 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;


### 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 , including optmising patient pathway;


### education or teaching activities in health or care sectors; ### higher education , continuing proffessional development or higher education teaching activities in health or care sectors;


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


### development and innovation activities for products or services contributing to public health or social security , or ensuring high levels of quality and safety of health care , of medicinal products or of medical devices; ### development and innovation activities for products or services contributing to public health or social security , or ensuring high levels of quality and safety of health care , of medicinal products or of medical devices and ensuring benefit to end-users of the innovation , such as patients , health professionals and health administrators.


### 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 demonstrably contributing to public health or social security , or ensuring high levels of quality and safety of health or care , of medicinal products or of medical devices , including scientific research into their efficiency and efficacy and post-market safety monitoring;


### 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; ### acitivities for the development , placing on the market , advancement and surveillance of products or services related to health or care sectors;


### development and innovation activities for products or services contributing to public health or social security , or ensuring high levels of quality and safety of health care , of medicinal products or of medical devices; ### activities for the development , placing on the market , advancement and surveillance of products or services related to health or care sectors;


### 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 , or ensuring high levels of quality and safety of health care , of medicinal products or of medical devices and ensuring benefit to the end-users , such as patients , healthcare professionals and health administrators;


### 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 validating of algorithms , including in medical devices , ai systems and digital applications related to health in accordance with the ai act (com/2021/206 final);


### 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 , demonstrably 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;


### 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. ### deleted


### 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 consisting in assessing , maintaining or restoring the state of health of natural persons , based on the health data of other natural persons; analyze general trends and patterns in population health status to develop more competitive rates for insurance products


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


### 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. the purposes referred to in points (a) to (c) of paragraph 1 shall be reserved for 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.


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


### prohibited secondary use of electronic health data ### prohibited purposes of secondary use of electronic health data


### seeking access to and processing electronic health data obtained via a data permit issued pursuant to article 46 for the following purposes shall be prohibited: ### seeking access to and processing electronic health data obtained via a data permit issued pursuant to article 46 for the following purposes shall be prohibited and subject to effective , proportionate and dissuasive sanctions:


### 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; ### a) taking decisions detrimental to a natural person based on their electronic health data , including but not limited to offers of employment , offering less favourable terms in the provision of goods or services; 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 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 in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums; ### taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums; except for purposes consistent with scientific research activities , such as the analysis of general trends and patterns in the state of population health , and the development and innovation of products and services in the health or care sector , including in particular the purposes set forth in article 34 points (e) , (f) , and (h)


### 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 , or goods or services which are designed or modified in such a way that they incite addiction , contravene public order or morality.


### 1. member states shall designate one or more health data access bodies responsible for granting access to electronic health data for secondary use. member states may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions set out in this article. where a member state designates several health data access bodies , it shall designate one health data access body to act as coordinator , with responsibility for coordinating requests with the other health data access bodies. ### 1. member states shall designate one or more health data access bodies responsible for carrying out the tasks referred to in articles 37 , 38 and 39 of this regulation. member states may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions set out in this article. where a member state designates several health data access bodies , it shall designate one health data access body to act as coordinator , with responsibility for coordinating data access applications and requests with the other health data access bodies.


### 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 adequate human , technical and financial resources , premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers , including those related to the participation in the ehds board.


### 3. in the performance of their tasks , health data access bodies shall actively cooperate with stakeholders’ representatives , especially with representatives of patients , data holders and data users. staff of health data access bodies shall avoid any conflicts of interest. health data access bodies shall not be bound by any instructions , when making their decisions. ### 3. health data access bodies and their members and staff , including application review committees shall act with complete independence in performing their tasks and exercising their powers in accordance with this regulation. they shall avoid any conflicts of interest and remain free from external influence , whether direct or indirect , and shall neither seek nor take instructions from anybody. members of health data access bodies , including application review committees , shall refrain from any action incompatible with their duties and shall not , during their term of office , engage in any incompatible occupation , whether gainful or not.


### 3. in the performance of their tasks , health data access bodies shall actively cooperate with stakeholders’ representatives , especially with representatives of patients , data holders and data users. staff of health data access bodies shall avoid any conflicts of interest. health data access bodies shall not be bound by any instructions , when making their decisions. ### 3. in the performance of their tasks , health data access bodies shall actively cooperate with stakeholders’ representatives , especially with representatives of patients , data holders and data users. stakeholders' representatives , including health professionals , patients and consummers' organisations , shall take part in the governance and decision-making structures of the health data access bodies. staff of health data access bodies shall avoid any conflicts of interest. health data access bodies shall not be bound by any instructions , when making their decisions.


### cooperate at union and national level to lay down appropriate measures and requirements for accessing electronic health data in a secure processing environment; ### cooperate at union and national level to lay down common approach , technical requirements and appropriate measures for accessing electronic health data in a secure processing environment;


### 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;


### 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 mainly as a result of the impact of gendered unpaid care duties , life-long differences in pay and working time with the lower pensions that result , different retirement ages for men and women in some member states , and the fact that more older women live alone; notes with regret that the gender pension gap stands at around 39 % , more than double the gender pay gap , revealing the gradually accumulating impact of pay inequalities;


### 6. stresses that female poverty is a multifaceted problem directly influenced by unequal access to property , career breaks due to the raising and care of children , caring for sick and dependent persons , and segregation in education and , subsequently , in the labour market , which means that women account for the largest share of low-paid workers; ### 6. stresses that female poverty is a multifaceted problem directly influenced by the undervaluation of work typically carried out by women , unequal access to property , career breaks due to the raising and care of children impacting on promotion and pension advancement , unequal sharing of unpaid caring responsibilities for sick and dependent persons and domestic work , and segregation in education and , subsequently , in the labour market , which means that women account for the largest share of low-paid workers; stresses the need for accessible and affordable childcare; reiterates its call on member states to ensure the full implementation of the work-life balance directive;


### 7. calls on the commission to come forward as soon as possible with proposals to close the gender pay gap. ### 7. welcomes the commission communication , a union of equality : gender equality strategy 2020-2025 , in particular its commitment to inter alia revise the barcelona targets to ensure further upwards convergence among member states of early childhood education and care , to deliver a child guarantee , to deliver legislation on pay transparency and to explore pension credits for care-related career breaks all of which will help to address gendered poverty;


### a. whereas being a candidate country presumes a willingness to progressively approach in all aspects the values , interests , standards and policies of the eu; ### a. whereas being a candidate country presumes a willingness to progressively approach in all aspects the values , interests , standards and policies of the eu and to respect and uphold the copenhagen criteria and to align itself with eu policies and objectives;


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


### b. whereas an analysis of the commission’s reports on turkey since 2014 and , in particular , the 2019 and 2020 reports , reveals that turkey has increasingly and rapidly distanced itself from the eu’s values and its normative framework; ### b. whereas an analysis of the commission’s reports on turkey since 2014 and , in particular , the 2019 and 2020 reports , reveals that turkey has increasingly and rapidly distanced itself from the eu’s values and its normative framework; not only by the domestic democratic backsliding but also by aggressive foreign policy moves , including illegal actions against eu member states; notes that these reports state that turkey did not implement the recommendations of the previous reports , pointing to a lack of commitment from the turkish side and calling into question turkey’s wish for accession;


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


### 1. notes with concern that turkey’s continuous and growing distancing from european values and standards has brought eu-turkey relations to a historical low point , having deteriorated to such an extent that it requires both parties to profoundly reassess the current framework of relations; ### 1. notes with concern that the turkish government's continuous and growing distancing from european values and standards and the turkish president’s threats and openly provocative , on occasions insulting , statements against the eu and its leaders have brought eu-turkey relations to a historical low point , having deteriorated to such an extent that it requires both parties to profoundly reassess the current framework of relations;


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


### - 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 26 june 2018 and 18 june 2019 on enlargement and stabilisation and association process , 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 12 december 2019 , 1-2 and 15-16 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 ,


### 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 are sustained , in a further attempt to restore our relations; whereas after the european council meeting of october 2020 , no such constructive efforts were made;


### 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 1-2 october 2020 ,offered turkey a renewed and broad positive agenda , provided that constructive efforts by turkey to stop illegal activities vis-à-vis greece and cyprus are sustained , in a further attempt to restore our relations;


### 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; ### deleted


### 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 war-mongering and 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;


### 5. stresses that , since parliament’s last report , the situation , far from improving , has deteriorated even further; firmly insists , therefore , on the formal suspension of accession negotiations with turkey , in order for both sides to review in a realistic manner the appropriateness of the current framework and its ability to function , or , if necessary , to explore possible new models for future relations; ### 5. stresses that , since the parliament’s last report , the situation , far from improving , has deteriorated even further; firmly insists therefore that , in line with the negotiating framework from october 2005 , the commission should recommend the formal suspension of accession negotiations with turkey , in order for both sides to review in a realistic manner the appropriateness of the current framework and its ability to function , or , if necessary , to explore possible new models for future relations;