### contribution to the security and defence interests of the union by enhancing defence technologies which contribute to implement defence capability priorities commonly agreed by member states within the union ; and , ### contribution to the economic interests and the security and defence interests of the union by enhancing defence technologies which contribute to implement defence capability priorities commonly agreed by member states within the union ; and ,


### by 1 january 2019 and every ten years thereafter , each member state shall notify to the commission an integrated national energy and climate plan . the plans shall contain the elements set out in paragraph 2 and annex i . the first plan shall cover the period from 2021 to 2030 . the following plans shall cover the ten - year period immediately following the end of the period covered by the previous plan . ### by 1 january 2019 and every five years thereafter , each member state shall notify to the commission an integrated national energy and climate plan . the plans shall contain the elements set out in paragraph 2 and annex i . the first plan shall cover the period from 2021 to 2030 . the following plans shall cover the ten - year period immediately following the end of the period covered by the previous plan .


### member states should ensure that applicants receive the necessary health care which should include , at least , emergency care and essential treatment of illnesses , including of serious mental disorders . to respond to public health concerns with regard to disease prevention and safeguard the health of individual applicants , applicants ' access to health care should also include preventive medical treatment , such as vaccinations . member states may require medical screening for applicants on public health grounds . the results of medical screening should not influence the assessment of applications for international protection , which should always be carried out objectively , impartially and on an individual basis in line with regulation no xxx / xxx [ procedures regulation ] . ### member states should ensure that applicants receive the necessary health care which should include emergency care and essential treatment of illnesses . to respond to public health concerns with regard to disease prevention and safeguard the health of individual applicants , applicants ' access to health care should also include preventive medical treatment , such as vaccinations . member states may require medical screening for applicants on public health grounds . the results of medical screening influence the assessment of applications for international protection .


### this filing system shall record each firearm ' s type , make , model , calibre and serial number , as well as the names and addresses of the supplier and the person acquiring or possessing the firearm . the record of firearms , including deactivated firearms , shall be maintained until destruction of the firearm has been certified by the competent authorities . ### that data - filing system shall record all information relating to firearms which is needed in order to trace and identify those firearms . that information shall include each firearm ' s type , make , model , calibre and serial number , including details of any conversions or modifications , including the date of certified deactivation or destruction , as well as the names and addresses of the supplier and of each person acquiring or possessing the firearm , the dates of acquisition and , where applicable , the end of possession or transfer to another person , unless such transfer concerns a firearm which has been registered as deactivated . all records held by the national authority relating to firearms shall be maintained in an electronically retrievable format for an indefinite period , including after certified deactivation or destruction . each member state shall establish single points of contact within national authorities for the exchange of information for the purpose of tracing .


### in the light of the experience acquired and following the assessment by the commission of the functioning of the market for veterinary medicinal products , the legal framework for veterinary medicinal products should be adapted to scientific progress , the current market conditions and economic reality . ### in the light of the experience acquired and following the assessment by the commission of the functioning of the market for veterinary medicinal products , the legal framework for veterinary medicinal products should be adapted to scientific progress , the current market conditions and economic reality , with respect for animals , nature and their interaction with man .


### the scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells . at the same time , in order to ensure the widest possible availability of veterinary medicinal products in the union , the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product , including for generics of nationally authorised veterinary medicinal products . ### the scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells . thought should also be given to medicinal products that may be developed in the future and care should be taken to lay down , in advance , a legal framework to support their development and , at the same time , ensure that they comply with union regulations . at the same time , in order to ensure the widest possible availability of veterinary medicinal products in the union , the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product , including for generics of nationally authorised veterinary medicinal products . particular care must be taken in all cases to control generics , in order to ensure that they meet high quality standards .


### however , there may be situations where no suitable authorised veterinary medicinal product is available . in those situations , by way of exception , veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only . in case of food - producing animals , veterinarians should ensure that an appropriate withdrawal period is prescribed , so that harmful residues of those medicinal products do not enter the food chain . ### however , there may be situations where no suitable authorised veterinary medicinal product is available . in those situations , by way of exception , veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only . in case of food - producing animals , veterinarians should ensure that an appropriate withdrawal period is prescribed , so that harmful residues of those medicinal products do not enter the food chain , and particular care must therefore be taken when administering antibiotics to food - producing animals .


### companies have less interest in developing veterinary medicinal products for markets of a limited size . in order to promote the availability of veterinary medicinal products within the union for those markets , in some cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted , on the basis of a benefit - risk assessment of the situation and , where necessary , subject to specific obligations . in particular , this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas . ### companies have less interest in developing veterinary medicinal products for markets of a limited size . in order to promote the availability of veterinary medicinal products within the union for those markets , in some cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted . in particular , this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas . any such authorisation should be revoked if a full dossier is not submitted within a short space of time .


### it is recognised that , in some cases , a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based , and other relevant factors should be taken into account including societal , economical , ethical , environmental and welfare factors and the feasibility of controls . ### it is recognised that , in some cases , a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based , and other relevant factors should also be taken into account including societal , economical , ethical , environmental and welfare factors and the feasibility of controls .


### it is necessary , in specific cases , or from a public health and animal health perspective , to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market . therefore the obligation to conduct post - authorisation studies should be imposed on the marketing authorisation holder . ### it is necessary from a public health and animal health perspective to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market . therefore the obligation to finance the conduct of post - authorisation studies under the supervision of the authorities should be imposed on the marketing authorisation holder .


### the illegal sale of veterinary medicinal products to the public via the internet may represent a threat to public and animal health , as falsified or substandard medicines may reach the public in this way . it is necessary to address this threat . account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at union level and , therefore , member states may impose conditions for supplying medicinal products to the public within the limits of the treaty . ### the illegal sale of veterinary medicinal products to the public via the internet may represent a threat to public and animal health , as falsified or substandard medicines may reach the public in this way . it is necessary to address this threat . account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at union level and , therefore , member states must impose conditions for supplying medicinal products to the public within the limits of the treaty .


### in order to avoid any incompliance with union law and enhance transparency , member states should inform the commission of their intent to enter into negotiations with regard to new intergovernmental agreements or amendments to existing intergovernmental agreements as soon as possible . the commission should be kept informed regularly of the progress of the negotiations . member states should have the possibility to invite the commission to participate in the negotiations as an observer . ### in order to avoid any incompliance with union law and enhance transparency , member states should inform the commission of their intent to enter into negotiations with regard to new intergovernmental agreements or amendments to existing intergovernmental agreements as soon as possible . this information should include a commitment by the state that the intergovernmental agreement shall follow the rules of european union law and , generally , any amendments made to the text of the existing agreement . member states shall have the possibility , should they so desire , to invite the commission to participate in the negotiations as an observer .


### during the negotiations the commission should have the possibility to advice on how to avoid incompatibility with union law . in particular , the commission could develop , together with member states , optional model clauses or guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions . ### during the negotiations , at the request of the member state in question , the commission should have the possibility to advise on how to avoid incompatibility with union law . in particular , the commission could develop , together with member states , optional model clauses or guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions .


### in order to ensure compliance with union law , member states should notify the draft intergovernmental agreement to the commission before it becomes legally binding for the parties . in a spirit of cooperation , the commission should support the member state in identifying compliance issues of the draft intergovernmental agreement or amendment . the respective member state would then be better prepared to conclude a union law compliant agreement . the commission should have sufficient time for such an assessment in order to provide for as much legal certainty as possible while avoiding undue delays . in order to fully benefit from the commission ' s support member states should refrain from concluding an intergovernmental agreement until the commission has informed the member state of its assessment . the member states should take all necessary steps to find a suitable solution to eliminate the incompatibility identified . ### in order to ensure compliance with union law , member states should notify the draft intergovernmental agreement to the commission before it becomes legally binding for the parties . in a spirit of cooperation , the commission should support the member state in identifying compliance issues of the draft intergovernmental agreement or amendment . the commission should therefore also identify problems that may arise due to possible deviations of the law of a signatory third country from eu law . the respective member state would then be better prepared to conclude a union law compliant agreement . the commission should have sufficient time for such an assessment in order to provide for as much legal certainty as possible while avoiding undue delays . in order to fully benefit from the commission ' s support member states should refrain from concluding an intergovernmental agreement until the commission has informed the member state of its assessment . the member states should take all necessary steps to find a suitable solution to eliminate the incompatibility identified .


### where a member state gives the commission notice of negotiations pursuant to article 3 , the commission services may provide it with advice on how to avoid the incompatibility of the intergovernmental agreement or of the amendment to an existing intergovernmental agreement under negotiation with union law . that member state may also request the assistance of the commission in those negotiations . ### where a member state gives the commission notice of negotiations pursuant to article 3 , the commission services may , if the member states so requests , provide it with advice on how to avoid the incompatibility of the intergovernmental agreement or of the amendment to an existing intergovernmental agreement under negotiation with union law . that member state may also request the assistance of the commission in those negotiations .


### contaminants in ce marked fertilising products , such as cadmium , can potentially pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain . their content should therefore be limited in such products . furthermore , impurities in ce marked fertilising products derived from bio - waste , in particular polymers but also metal and glass , should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio - waste before processing . ### contaminants in ce marked fertilising products , such as cadmium , can potentially pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain . their content should therefore be limited in such products . furthermore , impurities in ce marked fertilising products derived from bio - waste , in particular polymers but also metal and glass , should be prevented to the extent technically feasible by detection of such impurities in separately collected bio - waste before processing .


### promising technical progress is being made in the field of recycling of waste , such as phosphorus recycling from sewage sludge , and fertilising product production from animal by - products , such as biochar . it should be possible for products containing or consisting of such materials to access the internal market without unnecessary delay when the manufacturing processes have been scientifically analysed and process requirements have been established at union level . for that purpose , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of defining larger or additional categories of ce marked fertilising products or component materials eligible for use in the production of such products . for animal by - products , component material categories should be expanded or added only to the extent an end point in the manufacturing chain has been determined in accordance with the procedures laid down in regulation no 1069 / 2009 , since animal by - products for which no such end point has been determined are in any event excluded from the scope of this regulation . ### promising technical progress is being made in the field of recycling of waste , such as phosphorus recycling from sewage sludge , and fertilising product production from animal by - products , such as biochar . it should be possible for products containing or consisting of such materials to access the internal market without unnecessary delay when the manufacturing processes have been scientifically analysed and process requirements have been established at union level and any health hazards have been eliminated . for that purpose , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of defining larger or additional categories of ce marked fertilising products or component materials eligible for use in the production of such products . for animal by - products , component material categories should be expanded or added only to the extent an end point in the manufacturing chain has been determined in accordance with the procedures laid down in regulation no 1069 / 2009 , since animal by - products for which no such end point has been determined are in any event excluded from the scope of this regulation .


### such a framework is a necessary part of a well - managed migration policy to reduce divergences among national resettlement practices and procedures , provide for the legal and safe arrival to the territory of the member states of third - country nationals and stateless persons in need of international protection , help reduce the risk of a large - scale irregular inflow of third - country nationals and stateless persons to the territory of the member states and thereby reducing the pressure of spontaneous arrivals on the member states ' asylum systems , be an expression of solidarity with countries in regions to which or within which a large number of persons in need of international protection has been displaced by helping to alleviate the pressure on those countries , help achieve union ' s foreign policy objectives by increasing the union ' s leverage vis - à - vis third countries , and effectively contribute to global resettlement initiatives through speaking with one voice in international fora and with third countries . ### such a framework is a necessary part of a well - managed migration policy to provide for the legal arrival to the territory of the member states only of third - country nationals and stateless persons in need of international protection , help reduce the risk of a large - scale irregular inflow of third - country nationals and stateless persons to the territory of the member states and thereby reducing the pressure of spontaneous arrivals on the member states ' asylum systems , be an expression of solidarity with countries in regions to which or within which a large number of persons in need of international protection has gathered by helping to alleviate the pressure on those countries and help achieve the union ' s foreign policy objectives .


### the resettlement procedure should be concluded as soon as possible in order to discourage persons in need of international protection to use irregular ways to enter the european union to seek protection . at the same time it should ensure that member states have sufficient time for a full and adequate examination of each case . the time - limits should correspond to what is necessary to make the different types of assessment foreseen for the ordinary and expedited procedure . ### the resettlement procedure should be concluded as soon as possible in order to discourage persons in need of international protection to use irregular ways to enter the european union to seek protection . furthermore , measures should be taken to avoid concentrating large numbers of applicants within the territory of the country of entry which is likely to lead to pressure also to grant asylum to those with no claim to it . at the same time it should ensure that member states have sufficient time for a full and adequate examination of each case . the time - limits should correspond to what is necessary to make the different types of assessment foreseen for the ordinary and expedited procedure .


### third - country nationals , who , owing to a well - founded fear of being persecuted for reasons of race , religion , nationality , political opinion or membership of a particular social group , are outside the country of nationality or the part of that country in which they formerly habitually resided , and are unable or , owing to such fear , are unwilling to avail themselves of the protection of that country , or stateless persons , who , being outside of the country of former habitual residence or of the part of that country in which they formerly habitually resided , for the same reasons as mentioned above , are unable or , owing to such fear , unwilling to return to or stay in it , or , failing that , ### third - country nationals , who , owing to a well - founded fear of being persecuted for reasons of race , religion , nationality , political opinion or membership of a particular social group , are outside the country of nationality or the part of that country in which they formerly habitually resided , and are unable to stay in their country of nationality , or stateless persons , who , being outside of the country of former habitual residence or of the part of that country in which they formerly habitually resided , for the same reasons as mentioned above , are unable to stay in it , or , failing that ,


### it is appropriate that different cases usually referred to as situations of conflict of interest be identified and treated distinctly . the notion of a ‘ conflict of interest’ should be solely used for cases where an entity or person with responsibilities for budget implementation , audit or control or an official or an agent of a union institution is in such a situation . in cases where an economic operator attempts to unduly influence a procedure or obtain confidential information , this should be treated as grave professional misconduct . in addition , economic operators may be in a situation where they should not be selected to implement a contract because of a professional conflicting interest . for instance , a company should not evaluate a project in which it has participated or an auditor should not be in a position to audit accounts it has previously certified . ### it is appropriate that different cases usually referred to as situations of conflict of interest be identified and treated distinctly . the notion of a ‘ conflict of interest’ should be clearly defined and solely used for cases where an entity or person with responsibilities for budget implementation , audit or control or an official or an agent of a union institution is in such a situation . in cases where an economic operator attempts to unduly influence a procedure or obtain confidential information , this should be treated as grave professional misconduct in addition , economic operators may be in a situation where they should not be selected to implement a contract because of a professional conflicting interest . for instance , a company should not evaluate a project in which it has participated or an auditor should not be in a position to audit accounts it has previously certified .


### (38) in the context of the ehds , the electronic health data already exists and is being collected by healthcare providers , professional associations , public institutions , regulators , researchers , insurers etc. in the course of their activities. some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records , genetic data , claims data , etc.) , others are collected also for other purposes such as research , statistics , patient safety , regulatory activities or policy making (e.g. disease registries , policy making registries , registries concerning the side effects of medicinal products or medical devices , etc.). for instance , european databases that facilitate data (re)use are available in some areas , such as cancer (european cancer information system) or rare diseases (european platform on rare disease registration , ern registries , etc.). these data should also be made available for secondary use. however , much of the existing health-related data is not made available for purposes other than that for which they were collected. this limits the ability of researchers , innovators , policy-makers , regulators and doctors to use those data for different purposes , including research , innovation , policy-making , regulatory purposes , patient safety or personalised medicine. in order to fully unleash the benefits of the secondary use of electronic health data , all data holders should contribute to this effort in making different categories of electronic health data they are holding available for secondary use. ### (38) in the context of the ehds , the electronic health data already exists and is being collected by healthcare providers , professional associations , public institutions , regulators , researchers , insurers etc. in the course of their activities. some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records , genetic data , claims data , etc.) , others are collected also for other purposes such as research , statistics , patient safety , regulatory activities or policy making (e.g. disease registries , policy making registries , registries concerning the side effects of medicinal products or medical devices , etc.). for instance , european databases that facilitate data (re)use are available in some areas , such as cancer (european cancer information system) or rare diseases (european platform on rare disease registration , ern registries , etc.). these data should also be made available for secondary use. however , much of the existing health-related data is not made available for purposes other than that for which they were collected. this limits the ability of researchers , innovators , policy-makers , regulators and doctors to use those data for different purposes , including research , innovation , scientific development , policy-making , regulatory purposes , patient safety or personalised medicine. in order to fully unleash the benefits of the secondary use of electronic health data , all data holders should contribute to this effort in making different categories of electronic health data they are holding available for secondary use.


### (38) in the context of the ehds , the electronic health data already exists and is being collected by healthcare providers , professional associations , public institutions , regulators , researchers , insurers etc. in the course of their activities. some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records , genetic data , claims data , etc.) , others are collected also for other purposes such as research , statistics , patient safety , regulatory activities or policy making (e.g. disease registries , policy making registries , registries concerning the side effects of medicinal products or medical devices , etc.). for instance , european databases that facilitate data (re)use are available in some areas , such as cancer (european cancer information system) or rare diseases (european platform on rare disease registration , ern registries , etc.). these data should also be made available for secondary use. however , much of the existing health-related data is not made available for purposes other than that for which they were collected. this limits the ability of researchers , innovators , policy-makers , regulators and doctors to use those data for different purposes , including research , innovation , policy-making , regulatory purposes , patient safety or personalised medicine. in order to fully unleash the benefits of the secondary use of electronic health data , all data holders should contribute to this effort in making different categories of electronic health data they are holding available for secondary use. ### (38) in the context of the ehds , the electronic health data already exists and is being collected by healthcare providers , professional associations , public institutions , regulators , researchers , insurers etc. in the course of their activities. some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records , genetic data , claims data , etc.) , others are collected also for other purposes such as research , statistics , patient safety , regulatory activities or policy making (e.g. disease registries , policy making registries , registries concerning the side effects of medicinal products or medical devices , etc.). for instance , european databases that facilitate data (re)use are available in some areas , such as cancer (european cancer information system) or rare diseases (european platform on rare disease registration , ern registries , etc.). these data could also be made available on a voluntary basis and with the prior informed consent of individuals to whom the data relates , for secondary use. however , much of the existing health-related data is not made available for purposes other than that for which they were collected. this limits the ability of researchers , innovators , policy-makers , regulators and doctors to use those data for different purposes , including research , innovation , policy-making , regulatory purposes , patient safety or personalised medicine.


### (39) the categories of electronic health data that can be processed for secondary use should be broad and flexible enough to accommodate the evolving needs of data users , while remaining limited to data related to health or known to influence health. it can also include relevant data from the health system (electronic health records , claims data , disease registries , genomic data etc.) , as well as data with an impact on health (for example consumption of different substances , homelessness , health insurance , minimum income , professional status , behaviour , including environmental factors (for example , pollution , radiation , use of certain chemical substances). they can also include person-generated data , such as data from medical devices , wellness applications or other wearables and digital health applications. the data user who benefits from access to datasets provided under this regulation could enrich the data with various corrections , annotations and other improvements , for instance by supplementing missing or incomplete data , thus improving the accuracy , completeness or quality of data in the dataset. to support the improvement of the original database and further use of the enriched dataset , the dataset with such improvements and a description of the changes should be made available free of charge to the original data holder. the data holder should make available the new dataset , unless it provides a justified notification against it to the health data access body , for instance in cases of low quality of the enrichment. secondary use of non-personal electronic data should also be ensured. in particular , pathogen genomic data hold significant value for human health , as proven during the covid-19 pandemic. timely access to and sharing of such data has proven to be essential for the rapid development of detection tools , medical countermeasures and responses to public health threats. the greatest benefit from pathogen genomics effort will be achieved when public health and research processes share datasets and work mutually to inform and improve each other. ### (39) the categories of electronic health data that can be processed for secondary use should be broad and flexible enough to accommodate the evolving needs of data users , while remaining limited to data related to health or known to influence health. it can also include relevant data from the health system (electronic health records , claims data , disease registries , genomic data etc.). they can also include person-generated data , such as data from medical devices , wellness applications or other wearables and digital health applications. the data user who benefits from access to datasets provided under this regulation could enrich the data with various corrections , annotations and other improvements , for instance by supplementing missing or incomplete data , thus improving the accuracy , completeness or quality of data in the dataset. to support the improvement of the original database and further use of the enriched dataset , the dataset with such improvements and a description of the changes could be made available on a voluntary basis free of charge to the original data holder. the data holder should make available the new dataset , unless it provides a justified notification against it to the health data access body , for instance in cases of low quality of the enrichment.


### (40) the data holders can be public , non for profit or private health or care providers , public , non for profit and private organisations , associations or other entities , public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. in order to avoid a disproportionate burden on small entities , micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of ehds. the public or private entities often receive public funding , from national or union funds to collect and process electronic health data for research , statistics (official or not) or other similar purposes , including in area where the collection of such data is fragmented of difficult , such as rare diseases , cancer etc. such data , collected and processed by data holders with the support of union or national public funding , should be made available by data holders to health data access bodies , in order to maximise the impact of the public investment and support research , innovation , patient safety or policy making benefitting the society. in some member states , private entities , including private healthcare providers and professional associations , play a pivotal role in the health sector. the health data held by such providers should also be made available for secondary use. at the same time , data benefiting from specific legal protection such as intellectual property from medical device companies or pharmaceutical companies often enjoy copyright protection or similar types of protection. however , public authorities and regulators should have access to such data , for instance in the event of pandemics , to verify defective devices and protect human health. in times of severe public health concerns (for example , pip breast implants fraud) it appeared very difficult for public authorities to get access to such data to understand the causes and knowledge of manufacturer concerning the defects of some devices. the covid-19 pandemic also revealed the difficulty for policy makers to have access to health data and other data related to health. such data should be made available for public and regulatory activities , supporting public bodies to carry out their legal mandate , while complying with , where relevant and possible , the protection enjoyed by commercial data. specific rules in relation to the secondary use of health data should be provided. data altruism activities may be carried out by different entities , in the context of regulation […] [data governance act com/2020/767 final] and taking into account the specificities of the health sector. ### (40) the data holders can be public , non for profit or health or care providers , public , non for profit and organisations , associations or other entities , public entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. in order to avoid a disproportionate burden on small entities , micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of ehds. the public entities often receive public funding , from national or union funds to collect and process electronic health data for research , statistics (official or not) or other similar purposes , including in area where the collection of such data is fragmented of difficult , such as rare diseases , cancer etc. such data , collected and processed by data holders with the support of union or national public funding , should be made available by data holders to health data access bodies , in order to maximise the impact of the public investment and support research , innovation , patient safety or policy making benefitting the society. public authorities and regulators should have access to such data , for instance in the event of pandemics , to verify defective devices and protect human health. in times of severe public health concerns (for example , pip breast implants fraud) it appeared very difficult for public authorities to get access to such data to understand the causes and knowledge of manufacturer concerning the defects of some devices. the covid-19 pandemic also revealed the difficulty for policy makers to have access to health data and other data related to health. such data should be made available for public and regulatory activities , supporting public bodies to carry out their legal mandate , while complying with , where relevant and possible , the protection enjoyed by commercial data. specific rules in relation to the secondary use of health data should be provided. data altruism activities may be carried out by different entities , in the context of regulation […] [data governance act com/2020/767 final] and taking into account the specificities of the health sector.


### (40) the data holders can be public , non for profit or private health or care providers , public , non for profit and private organisations , associations or other entities , public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. in order to avoid a disproportionate burden on small entities , micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of ehds. the public or private entities often receive public funding , from national or union funds to collect and process electronic health data for research , statistics (official or not) or other similar purposes , including in area where the collection of such data is fragmented of difficult , such as rare diseases , cancer etc. such data , collected and processed by data holders with the support of union or national public funding , should be made available by data holders to health data access bodies , in order to maximise the impact of the public investment and support research , innovation , patient safety or policy making benefitting the society. in some member states , private entities , including private healthcare providers and professional associations , play a pivotal role in the health sector. the health data held by such providers should also be made available for secondary use. at the same time , data benefiting from specific legal protection such as intellectual property from medical device companies or pharmaceutical companies often enjoy copyright protection or similar types of protection. however , public authorities and regulators should have access to such data , for instance in the event of pandemics , to verify defective devices and protect human health. in times of severe public health concerns (for example , pip breast implants fraud) it appeared very difficult for public authorities to get access to such data to understand the causes and knowledge of manufacturer concerning the defects of some devices. the covid-19 pandemic also revealed the difficulty for policy makers to have access to health data and other data related to health. such data should be made available for public and regulatory activities , supporting public bodies to carry out their legal mandate , while complying with , where relevant and possible , the protection enjoyed by commercial data. specific rules in relation to the secondary use of health data should be provided. data altruism activities may be carried out by different entities , in the context of regulation […] [data governance act com/2020/767 final] and taking into account the specificities of the health sector. ### (40) the data holders can be public , non for profit or private health or care providers , public , non for profit and private organisations , associations or other entities , public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. in order to avoid a disproportionate burden on small entities , micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of ehds. the public or private entities often receive public funding , from national or union funds to collect and process electronic health data for research , statistics (official or not) or other similar purposes , including in area where the collection of such data is fragmented of difficult , such as rare diseases , cancer etc. such data , collected and processed by data holders with the support of union or national public funding , could be made available by data holders to health data access bodies , in order to maximise the impact of the public investment and support research , innovation , patient safety or policy making benefitting the society. in some member states , private entities , including private healthcare providers and professional associations , play a pivotal role in the health sector. the health data held by such providers should also be made available for secondary use. at the same time , data benefiting from specific legal protection such as intellectual property from medical device companies or pharmaceutical companies often enjoy copyright protection or similar types of protection. however , public authorities and regulators should have access to such data , for instance in the event of pandemics , to verify defective devices and protect human health. in times of severe public health concerns (for example , pip breast implants fraud) it appeared very difficult for public authorities to get access to such data to understand the causes and knowledge of manufacturer concerning the defects of some devices. the covid-19 pandemic also revealed the difficulty for policy makers to have access to health data and other data related to health. such data should be made available for public and regulatory activities , supporting public bodies to carry out their legal mandate , while complying with , where relevant and possible , the protection enjoyed by commercial data. specific rules in relation to the secondary use of health data should be provided. data altruism activities may be carried out by different entities , in the context of regulation […] [data governance act com/2020/767 final] and taking into account the specificities of the health sector.


### (41) the secondary use of health data under ehds should enable the public , private , not for profit entities , as well as individual researchers to have access to health data for research , innovation , policy making , educational activities , patient safety , regulatory activities or personalised medicine , in line with the purposes set out in this regulation. access to data for secondary use should contribute to the general interest of the society. activities for which access in the context of this regulation is lawful may include using the electronic health data for tasks carried out by public bodies , such as exercise of public duty , including public health surveillance , planning and reporting duties , health policy making , ensuring patient safety , quality of care , and the sustainability of health care systems. public bodies and union institutions , bodies , offices and agencies may require to have regular access to electronic health data for an extended period of time , including in order to fulfil their mandate , which is provided by this regulation. public sector bodies may carry out such research activities by using third parties , including sub-contractors , as long as the public sector body remain at all time the supervisor of these activities. the provision of the data should also support activities related to scientific research (including private research) , development and innovation , producing goods and services for the health or care sectors , such as innovation activities or training of ai algorithms that could protect the health or care of natural persons. in some cases , the information of some natural persons (such as genomic information of natural persons with a certain disease) could support the diagnosis or treatment of other natural persons. there is a need for public bodies to go beyond the emergency scope of chapter v of regulation […] [data act com/2022/68 final]. however , the public sector bodies may request the support of health data access bodies for processing or linking data. this regulation provides a channel for public sector bodies to obtain access to information that they require for fulfilling their tasks assigned to them by law , but does not extend the mandate of such public sector bodies. any attempt to use the data for any measures detrimental to the natural person , to increase insurance premiums , to advertise products or treatments , or develop harmful products should be prohibited. ### (41) the secondary use of health data under ehds should enable the public , not for profit entities , as well as individual researchers to have access to health data for research , innovation , scientific development , policy making , educational activities , patient safety , regulatory activities or personalised medicine , in line with the purposes set out in this regulation. access to data for secondary use should contribute to the general interest of the society. activities for which access in the context of this regulation is lawful may include using the electronic health data for tasks carried out by public bodies , such as exercise of public duty , including public health surveillance , planning and reporting duties , health policy making , ensuring patient safety , quality of care , and the sustainability of health care systems. public bodies and union institutions , bodies , offices and agencies may require to have regular access to electronic health data for an extended period of time , including in order to fulfil their mandate , which is provided by this regulation. public sector bodies may carry out such research activities by using third parties , including sub-contractors , as long as the public sector body remain at all time the supervisor of these activities. the provision of the data should also support activities related to scientific research (including private non-profit research) , development and innovation , producing goods and services for the health or care sectors , such as innovation activities or training of ai algorithms that could protect the health or care of natural persons. in some cases , the information of some natural persons (such as genomic information of natural persons with a certain disease) could support the diagnosis or treatment of other natural persons. there is a need for public bodies to go beyond the emergency scope of chapter v of regulation […] [data act com/2022/68 final]. however , the public sector bodies may request the support of health data access bodies for processing or linking data. this regulation provides a channel for public sector bodies to obtain access to information that they require for fulfilling their tasks assigned to them by law , but does not extend the mandate of such public sector bodies. any attempt to use the data for any measures detrimental to the natural person , to increase insurance premiums , to advertise products or treatments , or develop harmful products should be prohibited.


### (47) health data access bodies and single data holders should be allowed to charge fees based on the provisions of regulation […] [data governance act com/2020/767 final] in relation to their tasks. such fees may take into account the situation and interest of smes , individual researchers or public bodies. data holders should be allowed to also charge fees for making data available. such fees should reflect the costs for providing such services. private data holders may also charge fees for the collection of data. in order to ensure a harmonised approach concerning fee policies and structure , the commission may adopt implementing acts. provisions in article 10 of the regulation [data act com/2022/68 final] should apply for fees charged under this regulation. ### (47) health data access bodies and single data holders should be allowed to charge fees based on the provisions of regulation […] [data governance act com/2020/767 final] in relation to their tasks. such fees may take into account the situation and interest of smes , individual researchers or public bodies. data holders should be allowed to also charge fees for making data available. such fees should reflect the costs for providing such services. data holders may also charge fees for the collection of data. in order to ensure a harmonised approach concerning fee policies and structure , the commission may adopt implementing acts. provisions in article 10 of the regulation [data act com/2022/68 final] should apply for fees charged under this regulation.


### (51) as the resources of health data access bodies are limited , they can apply prioritisation rules , for instance prioritising public institutions before private entities , but they should not make any discrimination between the national or from organisations from other member states within the same category of priorities. the data user should be able to extend the duration of the data permit in order , for example , to allow access to the datasets to reviewers of scientific publication or to enable additional analysis of the dataset based on the initial findings. this would require an amendment of the data permit and may be subject to an additonal fee. however , in all the cases , the data permit should reflect theses additionals uses of the dataset. preferably , the data user should mention them in their initial request for the issuance of the data permit. in order to ensure a harmonised approach between health data access bodies , the commission should support the harmonisation of data permit. ### (51) as the resources of health data access bodies are limited , they can apply prioritisation rules , for instance prioritising public institutions before private non-profit entities , but they should not make any discrimination between the national or from organisations from other member states or , where applicable , regions with health legislative and executive competences , within the same category of priorities. the data user should be able to extend the duration of the data permit in order , for example , to allow access to the datasets to reviewers of scientific publication or to enable additional analysis of the dataset based on the initial findings. this would require an amendment of the data permit and may be subject to an additonal fee. however , in all the cases , the data permit should reflect theses additionals uses of the dataset. preferably , the data user should mention them in their initial request for the issuance of the data permit. in order to ensure a harmonised approach between health data access bodies , the commission should support the harmonisation of data permit.


### 1. any natural or legal person may submit a data request for the purposes referred to in article 34. a health data access body shall only provide an answer to a data request in an anonymised statistical format and the data user shall have no access to the electronic health data used to provide this answer. ### deleted


### 2. a data request shall include the elements mentioned in paragraphs 2 (a) and (b) of article 45 and if needed may also include: ### deleted


### a description of the result expected from the health data access body; ### deleted


### a description of the statistic’s content. ### deleted


### 3. where an applicant has requested a result in an anonymised form , including statistical format , based on a data request , the health data access body shall assess , within 2 months and , where possible , provide the result to the data user within 2 months. ### deleted


### article 48 ### deleted


### article 49 ### deleted


### 1. where an applicant requests access to electronic health data only from a single data holder in a single member state , by way of derogation from article 45(1) , that applicant may file a data access application or a data request directly to the data holder. the data access application shall comply with the requirements set out in article 45 and the data request shall comply with requirements in article 47. multi-country requests and requests requiring a combination of datasets from several data holders shall be addressed to health data access bodies. ### deleted


### 2. in such case , the data holder may issue a data permit in accordance with article 46 or provide an answer to a data request in accordance with article 47. the data holder shall then provide access to the electronic health data in a secure processing environment in compliance with article 50 and may charge fees in accordance with article 42. ### deleted


### 3. by way of derogation from article 51 , the single data provider and the data user shall be deemed joint controllers. ### deleted


### 4. within 3 months the data holder shall inform the relevant health data access body by electronic means of all data access applications filed and all the data permits issued and the data requests fulfilled under this article in order to enable the health data access body to fulfil its obligations under article 37(1) and article 39. ### deleted


### 2. the national contact points referred to in paragraph 1 shall be authorised participants in the cross-border infrastructure for secondary use of electronic health data (healthdata@eu). the national contact points shall facilitate the cross-border access to electronic health data for secondary use for different authorised participants in the infrastructure and shall cooperate closely with each other and with the commission. ### 2. the contact points referred to in paragraph 1 shall be authorised participants in the cross-border infrastructure for secondary use of electronic health data (healthdata@eu). the contact points shall facilitate the cross-border access to electronic health data for secondary use for different authorised participants in the infrastructure and shall cooperate closely with each other and with the commission.


### 5. third countries or international organisations may become authorised participants where they comply with the rules of chapter iv of this regulation and provide access to data users located in the union , on equivalent terms and conditions , to the electronic health data available to their health data access bodies. the commission may adopt implementing acts establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of healthdata@eu for the purposes of secondary use of health data , is compliant with the chapter iv of this regulation and provides access to data users located in the union to the electronic health data it has access to on equivalent terms and conditions. the compliance with these legal , organisational , technical and security requirements , including with the standards for secure processing environments pursuant to article 50 shall be checked under the control of the commission. these implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68 (2). the commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available. ### 5. third countries or international organisations may become authorised participants where they comply with the rules of chapter iv of this regulation and provide access to data users located in the union , on equivalent terms and conditions , to the electronic health data available to their health data access bodies. the commission may adopt implementing acts establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of healthdata@eu for the purposes of secondary use of health data , is compliant with the chapter iv of this regulation and provides access to data users located in the union to the electronic health data it has access to on equivalent terms and conditions. the compliance with these legal , organisational , technical and security requirements , including with the standards for secure processing environments pursuant to article 50 shall be checked under the control of the commission. these implementing acts shall be adopted in accordance with the examination procedure referred to in article 68 (2). the commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available. in addition to the compliance check , the national security interests of the member states shall also be taken into account before adopting the implementing acts.


### 8. the member states and the commission shall set up healthdata@eu to support and facilitate the cross-border access to electronic health data for secondary use , connecting the national contact points for secondary use of electronic health data of all member states and authorised participants in that infrastructure. ### 8. the member states and the commission shall set up healthdata@eu to support and facilitate the cross-border access to electronic health data for secondary use , connecting the national or , where applicable , regional contact points for secondary use of electronic health data of all member states and authorised participants in that infrastructure.


### those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). ### those implementing acts shall be adopted in accordance with the examination procedure referred to in article 68(2).


### 1. non-personal electronic data made available by health data access bodies , that are based on a natural person’s electronic data falling within one of the categories of article 33 [(a) , (e) , (f) , (i) , (j) , (k) , (m)] shall be deemed highly sensitive within the meaning of article 5(13) of regulation […] [data governance act com/2020/767 final] , provided that their transfer to third countries presents a risk of re-identification through means going beyond those likely reasonably to be used , in view of the limited number of natural persons involved in that data , the fact that they are geographically scattered or the technological developments expected in the near future. ### 1. non-personal electronic data made available by health data access bodies , that are based on a natural person’s electronic data falling within one of the categories of article 33 [(a) , (e) , (f) , (i) , (j) , (k) , (m)] shall be deemed highly sensitive within the meaning of article 5(13) of regulation […] [data governance act com/2020/767 final].


### 2. the protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization techniques and shall be detailed in the delegated act under the empowerment set out in article 5(13) of regulation […] [data governance act com/2020/767 final]. ### 2. the enforced protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization techniques and range from denial to assignment to conditional authorization; they shall be specified and shall be detailed in the delegated act under the empowerment set out in article 5(13) of regulation […] [data governance act com/2020/767 final].


### 1. a european health data space board (ehds board) is hereby established to facilitate cooperation and the exchange of information among member states. the ehds board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the member states. other national authorities , including market surveillance authorities referred to in article 28 , european data protection board and european data protection supervisor may be invited to the meetings , where the issues discussed are of relevance for them. the board may also invite experts and observers to attend its meetings , and may cooperate with other external experts as appropriate. other union institutions , bodies , offices and agencies , research infrastructures and other similar structures shall have an observer role. ### 1. a european health data space board (ehds board) is hereby established to facilitate cooperation and the exchange of information among member states. the ehds board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the member states. other national authorities , including market surveillance authorities referred to in article 28 , european data protection board and european or national data protection supervisors may be invited or participate on their own initiative to the meetings , where the issues discussed are of relevance for them. the board may also invite experts and observers to attend its meetings , and may cooperate with other external experts as appropriate. other union institutions , bodies , offices and agencies , research infrastructures and other similar structures shall have an observer role.


### 4. stakeholders and relevant third parties , including patients’ representatives , shall be invited to attend meetings of the ehds board and to participate in its work , depending on the topics discussed and their degree of sensitivity. ### 4. stakeholders and relevant third parties , including patients’ representatives , shall be invited upon request to attend meetings of the ehds board and to participate in its work , depending on the topics discussed and their degree of sensitivity.


### 6. the commission shall chair the meetings of the ehds board. ### 6. the parliamentary committee envi , libe and itre , represented by their respective presidents or vice presidents , shall chair in rotation the meetings of the ehds board.


### to assist member states in coordinating practices of digital health authorities; ### to assist member states and , where appropriate , regions in coordinating practices of digital health authorities;


### to assist member states in coordinating practices of health data access bodies in the implementation of provisions set out in chapters iv , to ensure a consistent application of this regulation; ### to assist member states and , where appropriate , regions in coordinating practices of health data access bodies in the implementation of provisions set out in chapters iv , to ensure a consistent application of this regulation;


### 1. the commission shall establish two groups dealing with joint controllership for the cross-border infrastructures provided for in articles 12 and 52. the groups shall be composed of the representatives of the national contact points and other authorised participants in those infrastructures. ### 1. the commission shall establish two groups dealing with joint controllership for the cross-border infrastructures provided for in articles 12 and 52. the groups shall be composed of the representatives of the contact points and other authorised participants in those infrastructures.


### 1. after 5 years from the entry into force of this regulation , the commission shall carry out a targeted evaluation of this regulation especially with regards to chapter iii , and submit a report on its main findings to the european parliament and to the council , the european economic and social committee and the committee of the regions , accompanied , where appropriate , by a proposal for its amendment. the evaluation shall include an assessment of the self-certification of ehr systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies. ### 1. after 5 years from the entry into force of this regulation , the commission shall carry out a targeted evaluation of this regulation especially with regards to chapters iii and iv , and submit a report on its main findings to the european parliament and to the council , the european economic and social committee and the committee of the regions , accompanied , where appropriate , by a proposal for its amendment. the evaluation shall include an assessment of the self-certification of ehr systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies. it shall also include an evaluation of the opt-out mechanism laid down in article 33(5) and recommendations on how to strengthen it.


### the applicable rights of natural persons in relation to secondary use of electronic health data; ### the applicable rights of natural persons in relation to secondary use of electronic health data , in particular the right to opt-out pursuant to article 33(5) , including detailed and understandable information on how to exercise those rights;


### 3. where a health data access body is informed by a data user of a finding that may impact on the health of a natural person , the health data access body may inform the natural person and his or her treating health professional about that finding. ### 3. where a health data access body is informed by a data user of a finding that may impact on the health of a natural person , the health data access body shall inform the natural person and his or her treating health professional about that finding within the natural day it was informed by the data user.


### 4. member states shall regularly inform the public at large about the role and benefits of health data access bodies. ### 4. member states and , where applicable , regions shall regularly inform the public at large about the role and benefits of health data access bodies.


### 1. health data access bodies and single data holders may charge fees for making electronic health data available for secondary use. any fees shall include and be derived from the costs related to conducting the procedure for requests , including for assessing a data application or a data request , granting , refusing or amending a data permit pursuant to articles 45 and 46 or providing an answer to a data request pursuant to article 47 , in accordance with article 6 of regulation […] [data governance act com/2020/767 final] ### 1. health data access bodies and single data holders may charge fees for making electronic health data available for secondary use.


### 2. where the data in question are not held by the data access body or a public sector body , the fees may also include compensation for part of the costs for collecting the electronic health data specifically under this regulation in addition to the fees that may be charged pursuant to paragraph 1. the part of the fees linked to the data holder’s costs shall be paid to the data holder. ### 2. where the data in question are not held by the data access body or a public sector body , the fees may also include compensation for collecting the electronic health data specifically under this regulation in addition to the fees that may be charged pursuant to paragraph 1. the part of the fees linked to the data holder’s costs shall be paid to the data holder.


### 3. the electronic health data referred to in article 33(1) , point (o) , shall be made available to a new user free of charge or against a fee matching the compensation for the costs of the human and technical resources used to enrich the electronic health data. that fee shall be paid to the entity that enriched the electronic health data. ### deleted


### 4. any fees charged to data users pursuant to this article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting and making electronic health data available for secondary use , objectively justified and shall not restrict competition. the support received by the data holder from donations , public national or union funds , to set up , develop or update tat dataset shall be excluded from this calculation. the specific interests and needs of smes , public bodies , union institutions , bodies , offices and agencies involved in research , health policy or analysis , educational institutions and healthcare providers shall be taken into account when setting the fees , by reducing those fees proportionately to their size or budget. ### 4. any fees charged to data users pursuant to this article by the health data access bodies or data holders shall be transparent and proportionate workload of collecting and making electronic health data available for secondary use , objectively justified and shall not restrict competition. the specific interests and needs of smes , public bodies , union institutions , bodies , offices and agencies involved in research , health policy or analysis , educational institutions and healthcare providers shall be taken into account when setting the fees.


### 5. where data holders and data users do not agree on the level of the fees within 1 month of the data permit being granted , the health data access body may set the fees in proportion to the cost of making available electronic health data for secondary use. where the data holder or the data user disagree with the fee set out by the health data access body , they shall have access to dispute settlement bodies set out in accordance with article 10 of the regulation […] [data act com/2022/68 final]. ### deleted


### 6. the commission may , by means of implementing acts , lay down principles and rules for the fee policies and fee structures. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). ### deleted


### 4. health data access bodies shall have the power to revoke the data permit issued pursuant to article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non-compliance referred to in paragraph 3 , immediately or within a reasonable time limit , and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. in this regard , the health data access bodies shall be able , where appropriate , to revoke the data permit and to exclude the data user from any access to electronic health data for a period of up to 5 years. ### 4. health data access bodies shall have the power to terminate the data permit issued pursuant to article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non-compliance referred to in paragraph 3 , immediately or within a reasonable time limit , and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. in this regard , the health data access bodies shall be able to terminate the data permit and to exclude the data user from any access to electronic health data for a period of up to 5 years.


### 1. any natural or legal person may submit a data access application for the purposes referred to in article 34. ### 1. union citizens and third-country nationals legally residing in the eu or legal person established in the eu may submit a data access application for the purposes referred to in article 34.


### 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 be able to submit the applications through the healthdata@eu referred to in article 52 by indicating what data they request from wich member state.


### 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 , assisted by the ehds board set out in article 64 , 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 procedure referred to in article 68(2).


### 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. 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. the data authorisation shall not be granted where the data subject opted-out to the processing pursuant to article 33(5).


### 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. 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. where the output of the secondary use of the electronic health data is not comprehensive from the perspective of the underlying project , data users shall indicate where follow-up information is available.


### ‘central platform for digital health’ means an interoperability platform providing services to support and facilitate the exchange of electronic health data between national contact points for digital health; ### ‘central platform for digital health’ means an interoperability platform providing services to support and facilitate the exchange of electronic health data between national or , where applicable , regional contact points for digital health;


### ‘central platform for secondary use of electronic health data’ means an interoperability platform established by the commission , providing services to support and facilitate the exchange of information between national contact points for secondary use of electronic health data; ### ‘central platform for secondary use of electronic health data’ means an interoperability platform established by the commission , providing services to support and facilitate the exchange of information between contact points for secondary use of electronic health data;


### ‘healthdata@eu’ means the infrastructure connecting national contact points for secondary use of electronic health data and the central platform; ### ‘healthdata@eu’ means the infrastructure connecting national or , where applicable , regional contact points for secondary use of electronic health data and the central platform;


### ‘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; ### ‘data holder’ means any natural or legal person , which is a public 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;


### supervise the national contact points for digital health and cooperate with other digital health authorities and the commission on further development of myhealth@eu; ### supervise the contact points for digital health and cooperate with other digital health authorities and the commission on further development of myhealth@eu;


### 1. the commission shall establish a central platform for digital health to provide services to support and facilitate the exchange of electronic health data between national contact points for digital health of the member states. ### 1. the commission shall establish a central platform for digital health to provide services to support and facilitate the exchange of electronic health data between contact points for digital health of the member states.


### 2. each member state shall designate one national contact point for digital health to ensure the connection to all other national contact points for digital health and to the central platform for digital health. where a designated national contact point is an entity consisting of multiple organisations responsible for implementing different services , the member state shall communicate to the commission a description of the separation of tasks between the organisations. the national contact point for digital health shall be considered an authorised participant in the infrastructure. each member state shall communicate the identity of its national contact point to the commission by [the date of application of this regulation]. such contact point may be established within the digital health authority established by article 10 of this regulation. member states shall communicate to the commission any subsequent modification of the identity of those contact points. the commission and the member states shall make this information publicly available. ### 2. each member state shall designate one national contact point for digital health to ensure the connection to all other national or , where applicable , regional contact points for digital health and to the central platform for digital health. where a designated national contact point is an entity consisting of multiple organisations responsible for implementing different services , the member state shall communicate to the commission a description of the separation of tasks between the organisations. the national contact point for digital health shall be considered an authorised participant in the infrastructure. each member state shall communicate the identity of its national contact point to the commission by [the date of application of this regulation]. such contact point may be established within the digital health authority established by article 10 of this regulation. member states shall communicate to the commission any subsequent modification of the identity of those contact points. the commission and the member states shall make this information publicly available.


### 3. each national contact point for digital health shall enable the exchange of the personal electronic health data referred to in article 5 with all other national contact points. the exchange shall be based on the european electronic health record exchange format. ### 3. each contact point for digital health shall enable the exchange of the personal electronic health data referred to in article 5 with all other contact points. the exchange shall be based on the european electronic health record exchange format.


### 7. the national contact points for digital health shall act as joint controllers of the electronic health data communicated through ‘myhealth@eu’ for the processing operations in which they are involved. the commission shall act as processor. ### 7. the national or , where applicable , regional contact points for digital health shall act as joint controllers of the electronic health data communicated through ‘myhealth@eu’ for the processing operations in which they are involved. the commission shall act as processor.


### 1. member states may provide through myhealth@eu supplementary services that facilitate telemedicine , mobile health , access by natural persons to their translated health data , exchange or verification of health-related certificates , including vaccination card services supporting public health and public health monitoring or digital health systems , services and interoperable applications , with a view to achieving a high level of trust and security , enhancing continuity of care and ensuring access to safe and high-quality healthcare. the commission shall , by means of implementing acts , set out the technical aspects of such provision. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2). ### 1. member states may provide through myhealth@eu supplementary services that facilitate telemedicine , mobile health , access by natural persons to their translated health data and use of their language of preference , including all officially recognised languages in member states , exchange or verification of health-related certificates , including vaccination card services supporting public health and public health monitoring or digital health systems , services and interoperable applications , with a view to achieving a high level of trust and security , enhancing continuity of care and ensuring access to safe and high-quality healthcare. the commission shall , by means of implementing acts , set out the technical aspects of such provision. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 68(2).


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


### 3. the technical documentation shall be drawn up in one of the official languages of the union. following a reasoned request from the market surveillance authority of a member state , the manufacturer shall provide a translation of the relevant parts of the technical documentation into the official language of that member state. ### 3. the technical documentation shall be drawn up in one of the official languages of the union. following a reasoned request from the market surveillance authority of a member state , the manufacturer shall provide a translation of the relevant parts of the technical documentation into the official languages of that member state.


### 3. the eu declaration of conformity shall , as a minimum , contain the information set out in annex iv and shall be translated into one or more official union languages determined by the member state(s) in which the ehr system is made available. ### 3. the eu declaration of conformity shall , as a minimum , contain the information set out in annex iv and shall be translated into one or more official union languages determined by the member state(s) in which the ehr system is made available. manufacturers shall provide a translation of the relevant parts of the technical documentation into all the official languages of member states.


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


### 1. data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this chapter: ### 1. data holders , on a voluntary basis and with the prior informed consent of the individual persons to whom the data relates , can make the following categories of electronic data available for secondary use in accordance with the provisions of this chapter:


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


### electronic data related to insurance status , professional status , education , lifestyle , wellness and behaviour data relevant to health; ### 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 , collected by entities and bodies in the health or care sectors , including public providers of health or care , entities or bodies performing research in relation to these sectors , and union institutions , bodies , offices and agencies.


### 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 shall have the right to decline the processing of their health data. health data access bodies shall provide for an accessible and easily understandable opt-out mechanism , whereby natural persons must be offered the possibility to explicitly express their wish not to have their personal electronic health data processed for secondary use purposes.


### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data. ### 5. where the consent of the natural person is required by national law , health data access bodies shall rely on the obligations laid down in this chapter to provide access to electronic health data , if not in conflict with national legislation;


### 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. ### 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.


### activities for reasons of public interest in the area of public and occupational health , such as protection against serious cross-border threats to health , public health surveillance or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices; ### activities for reasons of public interest in the area of public and occupational health , such as protection against serious cross-border threats to health , public health surveillance or ensuring high levels of quality , safety and effectiveness of healthcare and of medicinal products or medical devices , in order to evaluate the risks and benefits of pharmaceutical products approved , authorized by or submitted for approval or authorization to the ema or other national pharmaceutical agencies;


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


### scientific research related to health or care sectors; ### scientific research related to public health or care sectors;


### 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 based on their electronic health data , such as offers of employment , offering less favourable terms in the provision of goods or services such as insurance or other financial 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 or allowing actions of any kind 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 in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums; ### taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums , or in order to limit or suspend their fundamental rights as identified by the echr;


### advertising or marketing activities towards health professionals , organisations in health or natural persons; ### advertising or marketing activities or , any other economic or financial activity aimed at making corporative profits , towards health professionals , organisations in health or natural persons;


### 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. health data access bodies shall be public entities or bodies. member states shall designate one or more public 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. stresses that , in accordance with article 31 of the charter of fundamental rights of the european union , the eu has an obligation to ensure that all workers enjoy working conditions which respect their health , safety and dignity; ### 1. stresses that , in accordance with article 31 of the charter of fundamental rights of the european union , the eu has an obligation to ensure that all workers enjoy working conditions which respect their health , safety and dignity and calls for attention to the fact that poverty and exclusion from the labour market and society exacerbate inequalities and segregation , which can lead to polarisation and instability in society;


### 1. stresses the importance of the use of the eu charter of fundamental rights by member states at a national level by national courts and through inclusion in legislative procedures; regrets that there has only been a limited attempt at promoting the application of its provisions , even though it is an obligation stated in article 51 of the charter; ### 1. stresses the importance of the use of the eu charter of fundamental rights by member states at a national level by national courts and through inclusion in legislative procedures; regrets that there has only been a limited attempt at promoting the application of its provisions , even though it is an obligation stated in article 51 of the charter; reminds the condition of primary law of the charter , with the same legal value as the treaties , as set by article 6 teu;


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