Sittings · Document

DRAFT OPINION (COM(2022)0197 – C90167/2022 – 2022/0140(COD)) 2023-02-14

On the proposal for a regulation of the European Parliament and of the Council on European Health Data Space

Committee on Industry, Research and Energy · Rapporteur: CristianSilviu Buşoi

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SHORT JUSTIFICATION

The Rapporteur supports many elements of the European Health Data Space (EHDS) initiative, especially the provisions aimed at providing better health outcomes and promoting health innovation and research. The Rapporteur believes that the availability of cross-border health data can significantly improve patient care and contribute to more effective health policies at a European level. The Rapporteur also believes that this proposal can lead to significant benefits for individuals, patients, healthcare professionals, and society as a whole. Additionally, the Rapporteur supports this proposal as it can boost research and innovation, support the development of new drugs, devices, and treatments, and increase the efficiency and sustainability of healthcare systems.

However, the Rapporteur is of the opinion that some changes are necessary to ensure the success of the initiative. The Rapporteur believes that a prudent implementation of the GDPR is necessary to avoid unnecessary restrictions for health research and data sharing, key to apply artificial intelligence and machine learning tools to research, and to enabling the digital transformation of healthcare, to tackle disparities in prevention, diagnosis, and treatment around Europe. The EHDS will be a critical tool in managing and sharing health data across the European Union, but it must do so in a way that respects the privacy and rights of patients. As contact person for the EMA, the Rapporteur understands that the EMA and other regulatory authorities, such as national medicines’ agencies need to be seen and treated differently from all other data users in EHDS. The legal proposal already foresees this by recognizing regulatory authorities’ needs, and the Rapporteur further strengthens the text by allowing better informed regulatory decision making on benefits and risks of medicinal products, robust and speed up regulatory assessment of new medicinal products with the goal of making them faster available to patients and enhanced tools and processes available to monitor safety and effectiveness of medicines to the benefit of EU patients. Furthermore, the Rapporteur thinks that in order for health data to be useful across different systems, it is essential that we establish interoperable and common rules and standards. This means that data should be able to be exchanged seamlessly between different health systems, regardless of the platform or software used. Therefore, the Rapporteur opinion also underline that the lack of standardization in health data is a major obstacle to interoperability.

Finally, the Rapporteur is of the opinion that EHDS should build upon the already existing legislation such as the Data Governance Act and Data Act. These acts provide a solid foundation for the governance and management of health data, and we should work to align our efforts with their provisions. By doing so, the Rapporteur wants to ensure that the collection, processing, and use of health data is conducted in a responsible and transparent manner, while also protecting the privacy and security of individuals.

AMENDMENTS

The Committee on Industry, Research and Energy calls on the Committee on Civil Liberties, Justice and Home Affairs, as the committee responsible, to take into account the following amendments:

Amendment 1

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) The processing of personal electronic health data is subject to the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council43 and, for Union institutions and bodies, Regulation (EU) 2018/1725 of the European Parliament and of the Council44 . References to the provisions of Regulation (EU) 2016/679 should be understood also as references to the corresponding provisions of Regulation (EU) 2018/1725 for Union institutions and bodies, where relevant.

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43 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

44 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

Or. en

Amendment 2

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity in standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category. Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of categories of electronic health data is needed. Categories of electronic health data such as patient summary, electronic prescription and dispensation, laboratory results and reports, hospital discharge reports, medical images and reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission. When further needs for the exchange of more categories of electronic health data are identified for healthcare purposes, the list of priority categories should be expanded. The Commission should be empowered to extend the list of priority categories, after analysing relevant aspects related to the necessity and possibility for the exchange of new datasets, such as their support by systems established nationally or regionally by the Member States. Particular attention should be given to the data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general.

(17) The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity in standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category. Specifications should be commonly agreed and aligned with activities for furthering the maturity of global standardisation and harmonisation and existing standards that address different data domains. Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of categories of electronic health data is needed. Categories of electronic health data such as patient summary, electronic prescription and dispensation, laboratory results and reports, hospital discharge reports, medical images and reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission. When further needs for the exchange of more categories of electronic health data are identified for healthcare purposes, the list of priority categories should be expanded. The Commission should be empowered to extend the list of priority categories, after analysing relevant aspects related to the necessity and possibility for the exchange of new datasets, such as their support by systems established nationally or regionally by the Member States. Particular attention should be given to the data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general.

Or. en

Amendment 3

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission

Amendment

(22 a) This Regulation contributes to reducing inequalities in quality healthcare access across Europe. There should be no first and second-class citizens in Europe. Therefore, barriers to reimbursement for telemedicine and other barriers should be removed.

Or. en

Amendment 4

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

(29) Software or module(s) of software which falls within the definition of a medical device or high-risk artificial intelligence (AI) system should be certified in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council49 and Regulation […] of the European Parliament and of the Council [AI Act COM/2021/206 final], as applicable. The essential requirements on interoperability of this Regulation should only apply to the extent that the manufacturer of a medical device or high-risk AI system, which is providing electronic health data to be processed as part of the EHR system, claims interoperability with such EHR system. In such case, the provisions on common specifications for EHR systems should be applicable to those medical devices and high-risk AI systems.

(29) Software or module(s) of software which falls within the definition of a medical device or high-risk artificial intelligence (AI) system should be certified in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council49 and Regulation […] of the European Parliament and of the Council [AI Act COM/2021/206 final], as applicable. The essential requirements on interoperability of this Regulation should only apply to the extent that the manufacturer of a medical device or high-risk AI system, which is providing electronic health data to be processed as part of the EHR system, claims interoperability with such EHR system, within the meaning of the EHDS Regulation. In such case, the provisions on common specifications for EHR systems should be applicable to those medical devices and high-risk AI systems.

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49 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

Or. en

Amendment 5

Proposal for a regulation

Recital 63

Text proposed by the Commission

Amendment

(63) The use of funds should also contribute to attaining the objectives of the EHDS. Public procurers, national competent authorities in the Member States, including digital health authorities and health data access bodies, as well as the Commission should make references to applicable technical specifications, standards and profiles on interoperability, security and data quality, as well as other requirements developed under this Regulation when defining the conditions for public procurement, calls for proposals and allocation of Union funds, including structural and cohesion funds. EU funds must be distributed adequately among the Member States taking into account different levels of health system digitalisation and the costs involved in making national data infrastructures interoperable and compatible with the requirements of the EHDS.

Or. en

Amendment 6

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. This Regulation establishes the European Health Data Space (‘EHDS’) by providing for rules, common standards and practices, infrastructures and a governance framework for the primary and secondary use of electronic health data.

1. This Regulation establishes the European Health Data Space (‘EHDS’) by providing for common and harmonized rules, standards and practices, interoperable infrastructures and a governance framework for the primary and secondary use of electronic health data.

Or. en

Amendment 7

Proposal for a regulation

Article 1 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) controllers and processors established in the Union processing electronic health data of Union citizens and third-country nationals legally residing in the territories of Member States;

(b) controllers and processors established in the Union processing personal electronic health data of Union citizens and third-country nationals legally residing in the territories of Member States;

Or. en

Justification

Alignment with GDPR provisions and Recital 5 of the current proposal.

Amendment 8

Proposal for a regulation

Article 1 – paragraph 3 – point b a (new)

Text proposed by the Commission

Amendment

(b a) health data holders and data holders as defined in this regulation when the relevant provisions concern non-personal electronic health data.

Or. en

Amendment 9

Proposal for a regulation

Article 1 – paragraph 3 – point d

Text proposed by the Commission

Amendment

(d) data users to whom electronic health data are made available by data holders in the Union.

(d) data recipients and data users to whom electronic health data are made available by data holders in the Union.

Or. en

Amendment 10

Proposal for a regulation

Article 1 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. This regulation shall be without prejudice to the Directive on the Protection of Trade Secrets (Directive (EU) 2016/943) which shall take precedence.

Or. en

Amendment 11

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) ‘non-personal electronic health data’ means data concerning health and genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;

(b) ‘non-personal electronic health data’ means on a case by case, anonymised or pseudonymised data concerning health and genetic data relevant for health research in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;

Or. en

Amendment 12

Proposal for a regulation

Article 2 – paragraph 2 – point d

Text proposed by the Commission

Amendment

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

(d) ‘primary use of electronic health data’ means the processing of personal electronic health data for the provision of health services to assess, maintain or restore the state of health of the natural person to whom that data relates, including the prescription, dispensation and provision of medicinal products and medical devices, as well as related services aimed at promoting their safe and rational use and at ensuring better treatment, as well as for relevant social security, administrative or reimbursement services;

Or. en

Amendment 13

Proposal for a regulation

Article 2 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) ‘secondary use of electronic health data’ means the processing of electronic health data for purposes set out in Chapter IV of this Regulation. The data used may include personal electronic health data initially collected in the context of primary use, but also electronic health data collected for the purpose of the secondary use;

(e) ‘secondary use of electronic health data’ means the compatible further processing of electronic health data for purposes set out in Chapter IV of this Regulation, and where such electronic health data is personal data, in accordance with Article 5(1)(b) of Regulation (EU) 2016/679 . The data used may include personal electronic health data initially collected in the context of primary use, but also electronic health data collected for the purpose of the secondary use;

Or. en

Justification

The definition of "secondary use of electronic health data" needs to be clarified to exclude the processing of electronic health data otherwise than for the purposes of Chapter IV and by ensuring compatibility with secondary use as described in GDPR.

Amendment 14

Proposal for a regulation

Article 2 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals, involving the exchange of information and knowledge without changing the content of the data between these organisations, software applications or devices, through the processes they support;

(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact, connect and communicate in a compatible and coordinated manner, allowing the exchange of information and knowledge without changing the content of the data between these organisations, software applications or devices, through the processes they support, and without effort from the end user;

Or. en

Amendment 15

Proposal for a regulation

Article 2 – paragraph 2 – point g

Text proposed by the Commission

Amendment

(g) ‘European electronic health record exchange format’ means a structured, commonly used and machine-readable format that allows transmission of personal electronic health data between different software applications, devices and healthcare providers;

(g) ‘European electronic health record exchange format’ means a structured, standardized, commonly used and machine-readable format that allows transmission of personal electronic health data between different software applications, devices and healthcare providers;

Or. en

Amendment 16

Proposal for a regulation

Article 2 – paragraph 2 – point k

Text proposed by the Commission

Amendment

(k) ‘data recipient’ means a natural or legal person that receives data from another controller in the context of the primary use of electronic health data;

(k) ‘health data recipient’ means a natural or legal person that receives data from another controller in the context of the primary use of electronic health data;

Or. en

Justification

This amendment should apply across the whole text.

Amendment 17

Proposal for a regulation

Article 2 – paragraph 2 – point y

Text proposed by the Commission

Amendment

(y) ‘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;

(y) ‘health data holder’ means any natural or legal person, which is an entity or a body in the health or care sector, or performing research in relation to these sectors, as well as Union 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 and through both control of the technical design of a product and related services, and as allowed by the natural or legal person owning, renting or leasing the product or related services, and:

- acts as a controller under the GDPR regarding the processing of personal electronic health data for primary use, and/or

- has an obligation under the Regulation, other Union law or national legislation implementing Union law to make electronic health data available for secondary use, and/or

- in the case of non-personal electronic health data, controls and has the ability to make data generated by a medical device, authorized wellness application, EHR system or related services available

Or. en

Justification

The addition of health to 'data holder' should apply across the whole text

Amendment 18

Proposal for a regulation

Article 2 – paragraph 2 – point z

Text proposed by the Commission

Amendment

(z) ‘data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data for secondary use;

(z) ‘health data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data for secondary use;

Or. en

Justification

The amendment should apply across the whole text.

Amendment 19

Proposal for a regulation

Article 10 – paragraph 2 – point g

Text proposed by the Commission

Amendment

(g) ensure the implementation, at national level, of the European electronic health record exchange format, in cooperation with national authorities and stakeholders;

(g) ensure the implementation, at national level, of the European electronic health record exchange format to be interoperable, inter alia cross-border, in cooperation with national authorities and stakeholders;

Or. en

Amendment 20

Proposal for a regulation

Article 10 – paragraph 2 – point h

Text proposed by the Commission

Amendment

(h) contribute, at Union level, to the development of the European electronic health record exchange format and to the elaboration of common specifications addressing interoperability, security, safety or fundamental right concerns in accordance with Article 23 and of the specifications of the EU database for EHR systems and wellness applications referred to in Article 32;

(h) contribute, at Union level, to the development of the European electronic health record exchange format and to the elaboration of common specifications addressing interoperability, inter alia cross-border, security, safety or fundamental right concerns in accordance with Article 23 and of the specifications of the EU database for EHR systems and wellness applications referred to in Article 32;

Or. en

Amendment 21

Proposal for a regulation

Article 10 – paragraph 2 – point k

Text proposed by the Commission

Amendment

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

(k) offer, in compliance with national legislation, telemedicine services, joint telemedicine solutions, and ensure that such services are available as provided for in Directive 2011/24/EC, and are easy to use, accessible to different groups of natural persons and health professionals, including natural persons with disabilities, do not discriminate and offer the possibility of choosing between in person and digital services;

Or. en

Amendment 22

Proposal for a regulation

Article 23 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a time limit for implementing those common specifications. Where relevant, the common specifications shall take into account the specificities of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14.

The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a time limit for implementing those common specifications. Where relevant, the common specifications shall take into account the existing standardisation and harmonisation of different data domains and the specificities of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14.

Or. en

Amendment 23

Proposal for a regulation

Article 23 – paragraph 5

Text proposed by the Commission

Amendment

5. Where common specifications covering interoperability and security requirements of EHR systems affect medical devices or high-risk AI systems falling under other acts, such as Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], the adoption of those common specifications may be preceded by a consultation with the Medical Devices Coordination Group (MDCG) referred to in Article 103 of Regulation (EU) 2017/745 or the European Artificial Intelligence Board referred to in Article 56 of Regulation […] [AI Act COM/2021/206 final], as applicable.

5. Where common specifications covering interoperability and security requirements of EHR systems affect medical devices or high-risk AI systems falling under other acts, such as Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], the adoption of those common specifications shall be preceded by a consultation with the Medical Devices Coordination Group (MDCG) referred to in Article 103 of Regulation (EU) 2017/745 or the European Artificial Intelligence Board referred to in Article 56 of Regulation […] [AI Act COM/2021/206 final], as applicable.

Or. en

Amendment 24

Proposal for a regulation

Article 33 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter, with the right to refuse access to their data for reasons set out in paragraph 1a new:

Or. en

Amendment 25

Proposal for a regulation

Article 33 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) health-related administrative data, including claims and reimbursement data;

(d) healthcare-related administrative data, including claims and reimbursement data;

Or. en

Amendment 26

Proposal for a regulation

Article 33 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) dispensing and prescribing data;

Or. en

Amendment 27

Proposal for a regulation

Article 33 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) identification data related to health professionals involved in the treatment of a natural person;

(g) identification data related to health professionals involved in research should be limited to data which is absolutely necessary;

Or. en

Amendment 28

Proposal for a regulation

Article 33 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) electronic health data from clinical trials;

(j) electronic health data from fully completed clinical trials and in accordance with Regulation (EU) No 536/2014;

Or. en

Justification

There is already an existing mechanism for the disclosure of data as already required in Clinical Trial Regulation and EHSD should comply with.

Amendment 29

Proposal for a regulation

Article 33 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) research cohorts, questionnaires and surveys related to health;

(l) data from research cohorts, questionnaires and surveys related to health;

Or. en

Amendment 30

Proposal for a regulation

Article 33 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Health data holders have the right to refuse access to their data if there are legal or contractual impediments that prevent the data holder from sharing; if it could compromise the scientific integrity of a scientific research study, including a clinical trial; or if it could compromise the protection of data entailing IP rights (including trade secrets) or commercial property, with the scope of each category of data to be further clarified.

Or. en

Amendment 31

Proposal for a regulation

Article 33 – paragraph 2

Text proposed by the Commission

Amendment

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59 .

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59 and to health data holders that qualify as small enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC.

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59 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

Or. en

Amendment 32

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

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

4. Without prejudice to the law relating to the protection of intellectual property, industrial property and commercial property rights, electronic health data entailing protected intellectual property rights from private enterprises shall be made available for secondary use. Data sharing should be based on a data sharing agreement that respects the provisions of Union legislation, in particular of Directive on the Protection of Trade Secrets (Directive (EU) 2016/943, Article 6(2)(e) of the Data Act, Article 39 of TRIPS, and of Articles 9, 11 and 13 Directive 2004/48 on the enforcement of intellectual property rights in relation to preliminary injunctions, injunctions and damages. Where such data is made available for secondary use, all measures necessary to preserve the confidentiality of IP rights and trade secrets shall be taken.

Or. en

Amendment 33

Proposal for a regulation

Article 33 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8 a. Clinical trial data sharing under the EHDS shall be without prejudice to existing sectoral legislation, such as Clinical Trials Regulation and IP rights.

Or. en

Amendment 34

Proposal for a regulation

Article 34 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) activities for reasons of public interest in the area of public and occupational health, such as protection against serious cross-border threats to health, public health surveillance or ensuring high levels of quality, safety and efficacy of healthcare and of medicinal products or medical devices, for the purpose of the evaluation of the benefits and risks of medicinal products the EMA and ECDC shall be granted rapid and unrestricted access to the health data within the EHDS;

Or. en

Amendment 35

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

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

Or. en

Amendment 36

Proposal for a regulation

Article 36 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall designate one or more health data access bodies responsible for granting access to electronic health data for secondary use. Member States may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions set out in this Article. Where a Member State designates several health data access bodies, it shall designate one health data access body to act as coordinator, with responsibility for coordinating requests with the other health data access bodies.

1. Member States shall designate one or more health data access bodies responsible for fullfilling the tasks set out in Article 37, 38 and 39. 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 to access to electronic health data with the other health data access bodies.

Or. en

Amendment 37

Proposal for a regulation

Article 39 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Each health data access body shall publish an annual activity report which shall contain at least the following:

1. Each health data access body shall publish an biennial activity report which shall include summary data only containing the following:

Or. en

Amendment 38

Proposal for a regulation

Article 39 – paragraph 1 – point n a (new)

Text proposed by the Commission

Amendment

(n a) Restricted information on patent rights which could appear as part of a disclosure of a “summary of the results of the electronic health data uses”, aligned closely with the existing transparency requirements under the Clinical Trials Regulation and the Appendix.

Or. en

Amendment 39

Proposal for a regulation

Article 39 – paragraph 1 – point n b (new)

Text proposed by the Commission

Amendment

(n b) Information from health data holders only after prior consultation on any results or output of the secondary use being made publicly available to allow for vetting for any unauthorised disclosure related to the IP rights, trade secrets and confidential information of data holders.

Or. en

Amendment 40

Proposal for a regulation

Article 39 – paragraph 1 – point n c (new)

Text proposed by the Commission

Amendment

(n c) Information on clinical trials should be restricted based on the rules applicable to current disclosures and notifications.

Or. en

Amendment 41

Proposal for a regulation

Article 39 – paragraph 2

Text proposed by the Commission

Amendment

2. The report shall be transmitted to the Commission.

2. The report shall be sent to the Commission.

Or. en

Amendment 42

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.

3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user or for the purpose of regulatory procedures impacting public health, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.

Or. en

Amendment 43

Proposal for a regulation

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

By derogation from Article 46 of this Regulation, a data permit shall not be required to access the electronic health data under this Article. When carrying out those tasks under Article 37 (1), points (b) and (c), the health data access body shall inform public sector bodies and the Union institutions, offices, agencies and bodies, about the availability of data within 2 months of the data access application, in accordance with Article 9 of Regulation […] [Data Governance Act COM/2020/767 final]. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final ], the health data access body may extend the period by 2 additional months where necessary, taking into account the complexity of the request. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless it specifies that it will provide the data within a longer specified timeframe.

By derogation from Article 46 of this Regulation, a data permit shall not be required to access the electronic health data under this Article. For the purpose of the evaluation of the benefits and risks of medicinal products, the EMA and ECDC shall be granted rapid and unrestricted access to the health data within the EHDS. When carrying out those tasks under Article 37 (1), points (b) and (c), the health data access body shall inform public sector bodies and the Union institutions, offices, agencies and bodies, about the availability of data within 2 months of the data access application, in accordance with Article 9 of Regulation […] [Data Governance Act COM/2020/767 final]. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final ], the health data access body may extend the period by 2 additional months where necessary, taking into account the complexity of the request. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless it specifies that it will provide the data within a longer specified timeframe.

Or. en

Amendment 44

Proposal for a regulation

Article 52 – paragraph 2

Text proposed by the Commission

Amendment

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 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. The national contact points shall cooperate closely with each other and with the Commission.

Or. en

Amendment 45

Proposal for a regulation

Article 56 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. The data quality and utility label shall comply with the following elements:

3. The data quality and utility label shall comply with the following standardized elements:

Or. en

Amendment 46

Proposal for a regulation

Article 61 – paragraph 1

Text proposed by the Commission

Amendment

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.

Or. en

Justification

Inconsistent with GDPR provisions for data concerning health.

Amendment 47

Proposal for a regulation

Article 62

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

This provisions are already covered in GDPR.

Amendment 48

Proposal for a regulation

Article 63

Text proposed by the Commission

Amendment

Article 63

deleted

International access and transfer of personal electronic health data

In the context of international access and transfer of personal electronic health data, Member States may maintain or introduce further conditions, including limitations, in accordance with and under the conditions of article 9(4) of the Regulation (EU) 2016/679.

Or. en

Justification

This provisions are already covered in GDPR.