Topic outline

  • Course Introduction

    Collapse all Expand all

    • Course type: e-learning
    • Time duration: 1 hour
    • Audience: citizens, health care providers, industry, regulators, researchers
    • Author: Karolien Maerten, Director Public, Regulatory and Permits - Deloitte Legal - Lawyers
    • Language: English
    • Learning goals: explaining and providing an overview of the proposal regulation on European Health Data Space (EHDS)


      We wish you a happy learning!




      The general objective of the European Health Data Space (EHDS) is to have easier and more secure rules, structures, and processes across the EU Member States to access and share electronic health data across borders. The European Health Data Space (EHDS) is currently only a proposal for a regulation that is under discussion. 

      Below's video and readable e-learning gives an introduction to this European context and the regulation proposal. This e-learning is based on the latest available version of the proposal, as published by the European Parliament on 13 December 2023.This course is meant for health data professionals as well as interested citizens. 

      The objective of this e-learning is to give an understanding about the concepts of primary versus secondary use of data, the role of Health Data Access Bodies and the context of cross-border data access.

       
       

    • 1. What is the EHDS?

      • 1.1 What is the objectvie of the EHDS?

        The European Health Data Space (EHDS) is a proposal for a regulation. Note that this e-learning is based on the latest available version of the proposal, as published by the European Parliament on 13 December 2023.

        The general objective: easier and more secure rules, structures, and processes across EU Member States to access and share electronic health data across borders


        “ensure that natural persons in the EU have increased control in practise over their electronic health data. It also aims to ensure a legal framework consisting of trusted EU and Member State governance mechanisms and a secure processing environment. This would allow researchers, innovators, policymakers and regulators at EU and Member State level to access relevant electronic health data to promote better diagnosis, treatment and well-being of natural persons, and lead to better and well- informed policies. It also aims to contribute to a genuine single market for digital health products and services, by harmonising rules, and so boost healthcare system efficiencies”. 

        Source: The Proposal for a Regulation of the European Parliament and of the Council on the EHDS


        1.2 What are the pillars of the EHDS?

        Three pillars of the EHDS


        1.3 Who are the beneficiaries and impacted stakeholders of the EHDS?

        Beneficiaries/Impacted by EHDS


      • The historical context in which the legislative process around the EHDS arose:

        History of Moving towards a proposal for regulation on EHDS

    • 2. Why have an EHDS?

      • What is the relevance of the EHDS as a governance system?

        • The EHDS extends the scope of the primary use and will now also regulate secondary use of health data (the re-use of aggregated health data by for example researchers, policy makers, innovators and industry). The EHDS Regulation dedicates particular attention to the secondary use of electronic health data.
        • The EHDS complements following legislative acts and contains more specific rules for the health care sector. The EHDS-Regulation builds on the European data governance Regulation (EU 2022/868). The European data governance Regulation (horizontal framework) establishes exclusively general conditions for the secondary use of public data, without effectively creating a right to the secondary use of such data. The proposed data regulation strengthens the transferability of certain user-generated data, which could include health data, but does not contain rules for all health data.
        • The EHDS aims the creation of a new and decentralised EU infrastructure for secondary use of health data (HealthData@EU) that will connect health data access bodies which should be set up in all Member States. Health data access bodies will monitor and contribute to a consistent application of the rules throughout the EU, including by advising the European Commission, while cooperating with other EU bodies and stakeholders (e.g. patient organisations).
        • The European Health Data Space Board will be established to facilitate cooperation and the exchange of information among Member States. It is composed of the high level representatives of digital health authorities and the health data access bodies from all the Member States.


    • 3. Secondary Use of Electronic Health Data

      • The European Health Data Space is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at:
        1. Primary use of data: empowering individuals through increased digital access to and control of their electronic personal health data, at national level and EU-wide, and support to their free movement, as well as fostering a genuine single market for electronic health record systems, relevant medical devices and high risk AI systems.
        2. Secondary use of data: providing a consistent, trustworthy and efficient set-up for the use of health data for research, innovation, policy-making and regulatory activities.

        EHDS and Primary/Secondary Use


        3.1 What is Secondary use of electronic Health Data?

        It is “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 Chapter IV of this Regulation” Source: Proposal for a Regulation, art. 2

        The EHDS thus defines the further processing of health data (for example: data previously collected and stored in hospitals or by other healthcare providers) as secondary use data. Whether the data was initially collected for primary use or directly for secondary use is irrelevant in this regard.


      • 3.2 What is the current problem regarding the secondary use of health data (for research, innovation, policy making and regulatory purposes)?

        • Studies are often performed in a small set of databases, clustered in a few EU Member States. This limits their geographical and demographic sample sizes.
        • To overcome this fragmentation and the over-reliance on consent, some Member States started to adopt national laws. For instance, 13 Member States have started to put forward more centralised national systems to provide access to data, but there is no link between them at EU level, the system remains fragmented and there are differences between tasks, even though they share many commonalities. Some Member States have created Health Data Access Bodies such as Findata, French Data Hub, German Forschungsdatenzentren, and others.

        3.3 What is the Purpose of the EHDS?

        • The common framework for secondary use would reduce the fragmentation and barriers for cross-border accesses.
        • The EHDS aims to advance digital health for all Member States and to make the healthcare systems of the EU ready for the digital future.
        • On secondary use of electronic health data, researchers, innovators, policy makers and regulators would be able to have access to quality data for their work in a secure way, with a trusted governance and at lower costs than relying on consent.

      • 3.4 What are the categories of Electronic health data available for secondary use?

        1. Electronic health data from electronic health records systems (EHRs) ;
        2. Data on factors impacting on health, including socio-economic, environmental behavioural determinants of health ;
        3. Relevant pathogen data, impacting on human health ;
        4. Healthcare-related administrative data, including claims and reimbursement data ;
        5. Extracts from human genetic, genomic and proteomic data, such as genetic markers ;
        6. Automatically generated electronic health data, via medical devices ;
        7. Data from wellness applications ;
        8. Identification data related to healthcare providers and categories of health professionals involved in the treatment of a natural person or in research ;
        9. Population wide health data registries (public health registries) ;
        10. Electronic health data from medical registries for specific diseases ;
        11. Electronic health data from clinical trials subject to transparency provisions under Union law ;
        12. Electronic health data from medical devices and from registries for medicinal products and medical devices ;
        13. Data from research cohorts, questionnaires and surveys related to health ;
        14. Electronic health data from biobanks and dedicated databases ;
        15. Electronic health data containing various improvements such as correction, annotation, enrichment received by the data holder following a processing based on a data permit.

      • 3.5 What are the Permitted and Prohibited purposes for secondary use of electronic health data?

        EHDS sets out limited permitted purposes for secondary use of health data (exhaustive list of purposes):
        1. Activities for reasons of public interest in the area of public 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 ;
        2. To support public sector bodies and Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates where processing is necessary for reasons of substantial public interest in the area of public health ;
        3. To produce national, multi-national and Union level official statistics defined in Regulation (EU) No 223/2009 related to health or care sectors ;
        4. Scientific research related to health or care sectors […] ;
        5. Improving delivery of care, treatment optimisation and providing personalised healthcare.

        It is prohibited to use the data to take decisions detrimental to individuals, to increase insurance premiums, to market health products towards health professionals or patients or to design harmful products or services.

        Permitted and Prohibited use of secondary data according to EHDS proposal

      • 3.6 What does it mean to have an EHDS?

        The EHDS allows researchers and innovators from third countries to access data for secondary use.

        All Member States (their agencies involved in health research) are required to participate in the EU-infrastructure for secondary use (HealthData@EU) to facilitate cross-border studies.

    • 4. The role of Health Data Access Bodies?

      • 4.1 What are Health Data Access Bodies?

        Member States have to set up one or more health data access bodies (with a coordination body), that can provide access to electronic health data to third parties, either as a new organisation or part of an existing organization.

        Health data access bodies monitor, examine and supervise compliance by data users and data holders with the requirements in the EHDS Regulation. 

        Tasks of the health data access bodies (non-exhaustive list):
        • Decide on data access applications, including deciding on whether the data shall be made accessible in anonymised or pseudonymised form based on its own thorough assessment of any reasons provided by the health data applicant
        • Authorise and issue data permits (see further slide 14)
        • Ensure data is made available to data user
        • Request electronic health data from relevant health data holders pursuant to a data permit or a data request granted
        • Process electronic health data, including the combination, preparation, anonymisation and pseudonymisation and disclosure of those data for secondary use on the basis of a data permit
        • Facilitate cross-border access to electronic health data for secondary use hosted in other Member States through HealthData@EU and cooperate closely with each other and with the Commission
        • Maintain a management system to record and process data access applications, data requests, the decisions on those applications and the data permits issued and data requests answered, providing at least information on the name of the data applicant, the purpose of access the date of issuance, duration of the data permit and a description of the data application or the data request
        • Contribute to data altruism activities
        • Etc.

      • 4.2 What do Health Data Access Bodies have to do?

        Each health data access body shall act with complete independence in performing its tasks and exercising its powers and in cooperation with relevant stakeholders’ representatives.

        EHDS - Reporting Obligations

        Obligations of the health data access bodies towards natural persons – HDA makes the conditions under which electronic health data is made available for secondary use publicly available, easily searchable and accessible for natural persons:
        1. Legal basis under which access is granted ;
        2. Technical and organisational measures taken to protect the rights of natural persons ;
        3. Applicable rights of natural persons in relation to secondary use of electronic health data, including to opt-in and opt-out ;
        4. Modalities for natural persons to exercise their rights in accordance with Chapter III of Regulation (EU) 2016/679 ;
        5. Record on who has been granted access to which sets of electronic health data and a justification regarding the purposes for processing them ;
        6. Results or outcomes of the projects for which the electronic health data were used ;
        Health data access bodies are required to publish an annual report and make it publicly available on its website. As a minimum, the annual report should contain certain information set out in (Article 39 of) the EHDS Regulation proposal. In addition, data users must make public the results of their electronic health data uses and inform the health data access bodies of any significant findings relevant for the health of individuals.

        Natural and legal persons have the right to lodge a complaint (individually or, where relevant, collectively) with the health data access body.

        Penalties: 
        • By health data access bodies: e.g. notify the data holder or user that there is no compliance with the requirements, revoke the data permit and exclude the data user from any access to electronic health data (for a period of up to 5 years), etc.
        • By the Member States (applicable to infringements of the Regulation): effective, proportionate and dissuasive.

      • 4.3 The HDA as Health Data Access Body

        The HDA will act as one of the health data access bodies in Belgium

        HDA has been legally assigned the following tasks (by art. 5 law of 14 March establishing and organising the Health Data Agency - NL wettekst HDA / FR Loi HDA).

        HDA Taskes according to law of 14th of March 2023

    • 5. Cross-Border access to electronic health data for secondary use?

      • Each Member State designates a national contact point for secondary use of electronic health data, responsible for making electronic health data available for secondary use in a cross-border context.

        These national contact points are authorised participants in the cross-border infrastructure for secondary use of electronic health data (HealthData@EU).

    • About the training