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EHDS II – HealthData@EU

  • Skepsis zum EHDS: Viele EU-Bürger würden Daten nicht mit Ärzten im Ausland teilen

    Skepsis zum EHDS: Viele EU-Bürger würden Daten nicht mit Ärzten im Ausland teilen

    Laut einer Umfrage von BEUC (Europäischer Verbraucherverband) lehnen viele Bürgerinnen und Bürger der Europäischen Union es ab, Ihre Gesundheitsdaten mit Ärzten im Ausland zu teilen. Die repräsentative Umfrage in acht EU-Ländern, darunter Deutschland, zeigt deutliche Unterschiede dahingehend auf, welche Daten welchen Institutionen preisgegeben würden.

    • Die Mehrheit (61 Prozent) der Befragten habe beispielsweise kein Problem damit, allgemeine Informationen zum Gesundheitszustand, unter anderem zu Allergien und Krankheiten, zu teilen.
    • Knapp 70 Prozent wollen laut Umfrage aber keine Auskunft über Gewohnheiten wie Ernährung, Bewegung und Drogenkonsum geben. Genetische Daten oder Angaben zur sexuellen Gesundheit will kaum jemand teilen.
    • Die Bereitschaft, Daten zu teilen, hänge auch stark von Vertrauen ab: Ihrem Hausarzt würden 88 Prozent der Befragten ihre Daten anvertrauen, ihrer Versicherung nur 8 Prozent.

    Hintergrund der Arbeit ist der Verordungsentwurf der EU-Kommission für den Europäischen Gesundheitsdatenraum (European Health Data Space – EHDS)“: Patienten könnten ihre Krankengeschichte, Testergebnisse oder Verschreibungen dann mit Krankenhäusern und Ärzten in der gesamten EU teilen. Europaparlament und die EU-Staaten müssen noch einen Kompromiss aushandeln.

    Ein Arzt in Frankreich könne dann etwa die Krankengeschichte eines Portugiesen einsehen, der in Paris krank wird, und die richtigen Medikamente verschreiben, sagte EU-Gesundheitskommissarin Stella Kyriakides vor genau einem Jahr. Unnötige Untersuchungen würden überflüssig. Das zweite Ziel des Vorschlags ist, dass Forscher, Industrie und öffentliche Institutionen das Potenzial der Daten nutzen können.

    BEUC-Studie: Download des Ergebnisberichts

    Executive summary: With the European Union institutions currently working to create a European health data space, which would allow the access and sharing of people’s health data across the EU, nine consumer organisations from eight EU countries have surveyed people to get a better insight on what they think about sharing their health data.

    This survey sheds light on consumer attitudes and unveils what type of data they are willing to share, with whom and for what purpose (for provision of healthcare, for scientific research, or for public health reasons).

    • Our survey reveals that consumers are generally cautious about sharing their health data through online health platforms and want to decide for themselves what data they share and with whom.
    • Health data is rightly regarded as both extremely sensitive and of great value by all kinds of entities, from public health authorities and businesses to people themselves.
    • As a result, it is crucial that EU legislators respect consumers’ interests, and our evidence-based recommendations should provide food for thought at this critical juncture.
  • TEHDAS study: Member states to harmonise national legislation to enable the secondary use of health data

    TEHDAS study: Member states to harmonise national legislation to enable the secondary use of health data

    Differing interpretations of the data protection regulation hinder the use of health data at the expense of health research, policymaking and innovation. TEHDAS has developed recommendations for member states to develop legislation on the secondary use of health data.

    The recent report of the joint action Towards the European Health Data Space (TEHDAS) urges EU member states to harmonise national provisions on data protection and consider abolishing national derogations on the General Data Protection Regulation (GDPR). The report also provides recommendations on drafting national legislation on the secondary use of health data that can expedite the realisation of the European health data space (EHDS) when it enters into force.

    Currently, countries have national legislation or rules on the use of health data for secondary purposes in addition to the GDPR. The GDPR provides a harmonised approach to data protection across the EU, but it allows member states to adopt national legislation which causes a lack of harmonisation. TEHDAS has previously concluded that the main obstacle for the cross-border use of health data for research, innovation and policymaking is differing interpretations of the law.

    The report presents nine recommendations for the member states on planning and implementing national legislation to regulate the secondary use of health data to complement the European health data space. They include choosing public interest as the legal basis for collecting health data, addressing security by design to avoid problems in practice when using data, and ensuring proper financial and human resources for processing data access applications and preparing data for its users.

    There are also aspects of national laws that are specifically relevant to consider concerning the cross-border sharing of health data, for instance data security legislation prohibiting the transfer of data out of the country. Member states should consider harmonising such regulation.

    Furthermore, a general recommendation for facilitating cross-border sharing of health data would be necessary to avoid divergent national regulations, since this is one of the main reasons that the full potential of sharing data cross-border has not yet been realised.

    Because the negotiations on the EHDS proposal are ongoing, TEHDAS hopes that the member states can benefit from the recommendations as they plan their national legislation on the secondary use of health data. This could smooth the transition to European health data space.

    The report is based on a study conducted in six European countries.

    TEHDAS Report laden (TEHDAS WP5.2 Deliverable)

    Joint Action Towards the European Health Data Space – TEHDAS

    The TEHDAS Joint Action develops European principles for the secondary use of health data. TEHDAS is being carried out by 25 European countries and co-ordinated by the Finnish Innovation Fund, Sitra. The project started in February 2021. It is based on the European Commission’s Health Programme 2020.

    TEHDAS Factsheet

  • HealthData@EU Pilot launches Proof of Concept

    HealthData@EU Pilot launches Proof of Concept

    Launched in October 2022, the HealthData@EU Pilot project reached a first milestone by framing the scope and activities that will be performed during the Proof Of Concept (PoC) phase. The framing phase saw the drafting of a first high-level vision of the target architecture and defining an organisational framework to implement an EHDS solution. Starting in March 2023, the PoC phase aims to deliver and deploy a Minimum Viable Product (MVP) at the end of 2023 enabling the two first steps of the user journey :

    The target MVP expected for December 2023, will focus on connecting three nodes (France, Denmark and Finland) and the European Central Services by setting up an eDelivery network. This MVP network will be used to centralize national dataset catalogues to the European one and to forward data permit requests from central services to the three nodes.

    eDelivery network (Europe, Denmark, Finland, France), Source: https://www.ehds2pilot.eu/

    A first high level vision of the target architecture

    The design of the target solution has been driven by three main guidelines : (1) build a scalable and distributed network that can easily onboard new nodes or host a new technical use cases, (2) leverage open source technologies and (3) propose a security- oriented solution. The infrastructure for each node comprises a cross-border gateway in charge of eDelivery communication with other nodes, a national
    connector that provides all necessary features to fulfill the needs of the user journey steps to the nodes and crossborder engines that translate existing national capabilities of the nodes to a crossborder standard.

    An iterative approach to deliver the Minimum Viable Product (MVP)

    The full specifications of the solution are strongly dependent to tasks performed by work packages 6 and 7 and won’t be provided at the beginning of the POC phase (i.e. definition of the metadata standards or definition of the information that needs to be provided by an applicant during a Data Permit process). In order to parallelise tasks, the implementation of the solution will be done incrementally, by delivering multiple functional versions of the solution. We plan to deliver three product increments before December 2023, each one being an improvement to the prior version.

    Impementations planning. Source: https://www.ehds2pilot.eu/

    EHDS2Pilot Work Package 5 „Proof of Concept“ information and planning document.

    About the EHDS2 HealthData@EU Pilot project

    The EHDS2 Pilot HealthData@EU project brings together national data permit authorities, public health infrastructures and health research infrastructures, in order to enable linking and integrating data between data sources. This pilot project is a major first step that will allow practical validation of this concept i.e. the access to health data in Europe. 

    The EHDS2 Pilot project is very important because it taps into the wealth of health data which today is fragmented across Europe and research has difficulty to access this data for science.

    Press release announcing the launch of EHDS2Pilot incl. list of partners

    EHDS2Pilot Cross-border use cases
    Work packages for building the technical infrastructure