TEHDAS 2
Towards the European Health Data Space
The European Health Data Space aims to harmonise the secondary use of health data by creating a common legal framework. Efforts both at Member State level and the EU level are needed to ensure an aligned path on the common measures for EHDS implementation. TEHDAS2 brings together the best current knowledge from 68 organisations and 30 European countries to develop guidelines and technical specifications for common use by all Members States and the European Commission. The main aim of the joint action is to prepare ground for harmonised implementation of the EHDS on secondary use of health data and develop collaboration between all key stakeholders. TEHDAS2 will provide 20 guidelines and technical specifications which will guide Member States and the Commission in developing solutions and operationalising cross-border collaboration. TEHDAS2 results will guide the Health Data Access Bodies in their future tasks and obligations, as well as data holders and users in fulfilling their forthcoming duties in the proposed regulation. The results will address, inter alia, the discovery and description of datasets; advancing access to health data by key players along the health data lifecycle; a technical framework for secure processing environments; involving citizens; and creating operational and collaboration models for the common policies. TEHDAS2 builds on earlier projects, in particular the first Joint Action Towards the European Health Data Space (TEHDAS) and HealthData@EU, and it will work closely with relevant ongoing projects and initiatives to create complementarities and synergies. TEHDAS2 results will be relevant to all EU Member States, and a broad outreach will be achieved through active communication and dissemination. The Joint Action brings together the best knowledge to develop in active cooperation guidelines and technical specifications for the common use by all Members States and the Commission towards implementing the EHDS on secondary use of health data.
People
Maria Papaioannou
Co-lead for WP8
Member of the eHealth Lab in the Department of Cyprus. She holds a PhD in Computational Intelligence applied to diagnostic systems in the healthcare sector. Currently, she is an interoperability expert in eHealth systems, specializing in the HL7 FHIR standard. She serves as a project manager for national and EU-funded projects related to biobanking and the eHealth sector, focusing on the design and development of citizen-centered eHealth systems and applications.
Panayiotis Savva
Specializing in HL7 FHIR standards, he has successfully delivered advanced solutions, including the proposed implementation for Cyprus’ national Electronic Health Record (EHR). With over 12 years of experience in the payment and credit card industry, he has led large software development teams, collaborating across functional teams from requirements gathering to quality assurance, ensuring the successful delivery of projects.
Constantinos Yiasemi
Special Scientist at the University of Cyprus, focusing on e-health systems. My work includes developing applications for national identity and health certification, leveraging React Native and React, and automating deployments with Kubernetes and Docker. Previously, I’ve led projects as a Full Stack Developer and UI Team Lead, where I developed front-end solutions and back-end services for various companies
General objectives
The Joint Action brings together the best current knowledge to develop in active cooperation guidelines and technical specifications for common use by all Members States and the Commission, towards implementing the EHDS on secondary use of health data.
The general objectives have been laid out in the Work Programme 2023 of EU4Health (C(2022) 8510 final, ANNEX 1)4 that focuses in this area ensuring the rollout of the European Health Data Space (EHDS), with the aim of harnessing digital health data to enable better healthcare for patients across the EU.
The call document defines the objectives and the scope of the joint action EU4H-2023-JA-IBA-10 – DI-g-23-79, Direct grants to Member States’ authorities: preparatory activities for the reuse of data in the proposed European Health Data Space.
- The main objective of the joint action is to prepare the ground for the harmonised implementation of common measures, enabling the secondary use of health data in the proposed EHDS.
As outlined in the call, the joint action must be built on the work of national and EU initiatives and projects, such as TEHDAS joint action and the HealthData@EU (EHDS2) pilot for an EU infrastructure ecosystem for the secondary use of health data for research, innovation, policy-making and regulatory purposes.
The TEHDAS2 joint action was initiated to respond to the needs and objectives raised in the call. TEHDAS2 will strengthen the efforts in this area, enabling further measures at EU and member state level that are crucial in paving the way towards EHDS implementation. The efforts will ultimately accelerate digital transformation and secondary use of health data in public health and healthcare across Europe. The harmonised framework for better harnessing the potential of data will boost research, innovation and enable evidence-based policymaking to improve public health and knowledge valorisation. The TEHDAS2 joint action contributes to the realisation of the EU4Health Programme’s general objective of strengthening health systems outlined in Article 3 (d) of Regulation (EU) 2021/5225 by improving their resilience and resource efficiency, through the following notions:
- supporting integrated and coordinated work between Member States;
- promoting the implementation of best practices and promoting data sharing;
- advancing digital transformation.
Furthermore, TEHDAS2 contributes to the EU4Health Programme’s specific objectives, especially through the specific objective defined in Article 4 (f) of Regulation (EU) 2021/522 on strengthening the use and re-use of health data for the provision of healthcare and for research and innovation, promoting the uptake of digital tools and services, as well as the digital transformation of healthcare systems, including by supporting the creation of a European health data space.
- The secoond main objective is to continue and develop collaboration between the Member State authorities, the European Commission and stakeholders, and to ensure complementarity with other actions and projects relevant for secondary use of health data.
TEHDAS2 – Second Joint Action Towards European Health Data Space – will be paving the way towards the operationalisation of EHDS to ensure harmonised implementation of the regulation. The Joint Action focuses on making better data sharing a reality for research, innovation, policy making and regulatory purposes. It builds on the TEHDAS Joint Action that run in 2021- 2023 and supported Member States and the European Commission in developing principles, options and recommendations for the secondary use of health data in the EU. It also expands on the work of the HealthData@EU (EHDS2) pilot, which has provided crucial insights into cross-border sharing of data through several case studies. Many of the TEHDAS2 partners have been directly involved in TEHDAS and HealthData@EU pilot, advancing the utilisation of their results and continuing to build on the synergies with these initiatives. Simultaneously, TEHDAS2 recognises the need to reflect and develop its own ways of working with new partner countries and organisations, extending the learnings but also engaging in novel discussions and deep diving into the collaborative work, with the partners but also with external stakeholders, to reach its objectives.
WP8 Description – Serving Citizens
| Name | Serving Citizens | ||
| Objectives | The main objective of this work package is to strengthen the engagement of citizens towards the European Health Data Space regarding the secondary use of health data. The specific objectives of this work package are to: O1: Establish a framework for recognizing and acknowledging citizens involvement in EHDS and in voluntary data sharing initiatives including potential incentives O2: Involve citizens in the understanding of how their health data is utilized and for which concrete secondary use purpose. O3: Provide guidance on key responsibilities of data users regarding research outcomes derived from secondary use of data | ||
| Task 8.1 | Name | Citizen involvement in the secondary use of health data within the EHDS | |
| Description | This task will focus on building public trust through citizen involvement in the secondary use of health data within the EHDS and enforcement of citizens’ rights, including data altruism and further models of voluntary data sharing. The overall objective of this Task is to provide guidance to HDABs on obligations towards natural persons. The guidance will focus on the enforcement of citizens’ rights under EU legislation, especially the rights provided by GDPR, and the interaction between GDPR and the EHDS Regulation. In addition, T8.1 will suggest measures to enhance the involvement of citizens in the processes related to the secondary use of their health data, including data altruism or further models of voluntary data sharing, particularly with respect to the legislative process of the regulation on the EHDS. Thus, the guidelines will identify ways for HDABs to engage and incentivise citizens to participate in the secondary use of health data within the implementation of the EHDS and advise HDABs on ways they can foster public trust through practical implementation of citizen engagement. Furthermore, the guidelines will analyse the relevance of voluntary data sharing and data altruism for the EHDS, and the relationship of data altruism organisations and/or data intermediaries with the EHDS framework. (M2-21) | ||
| Task 8.2 | Name | Informing natural persons about the use of health data -“Citizen Information Point” | |
| Description | This task will implement EHDS Regulation Proposal Art. 38 (Council’s version as of 12-2023: Art.35E, 35F, 35G). The aim is to develop guidelines for HDABs how to keep citizens informed about the use of health data according to the legal requirements provided in the then adopted EHDS Regulation. The information should enable citizens to exercise their rights, incl. Art. 35F. This could take the form of a citizen information point (CIP). One element could be a project register, listing all data access permits and explain the purposes of the data use in an understandable form to citizens. The work will include a landscape analysis of existing portals and drafting of the guideline including e.g. contents of draft Art. 35E a-e, the right to object (by addressing the different scenarios laid out by the draft Art. 35F), options how information on incidental findings can be provided to data holders (e.g., for relaying the information back to individual citizens) laid out by the draft regulation Art. 35G; Draft guideline will be discussed in focus groups topic by topic with citizen/patient groups to implement a co-development approach. (M2-30) | ||
| Task 8.3 | Name | Data users’ duties regarding research outcomes | |
| Description | The overall objective of this task is to outline key duties and responsibilities of secondary data users regarding research outcomes derived from secondary use of data and provide guidelines for them. The guidelines will provide e.g. potential obligations in case of clinically significant findings with impact on the health of a natural person, obligations of the secondary data users, in terms of registering the peer- reviewed research publications, policy documents, regulatory procedures using data accessed via EHDS, register the number of digital health products and services, including AI applications, developed using data accessed via EHDS. (M5-30) | ||
Partners
| 1 | SUOMEN ITSENAISYYDEN JUHLARAHASTO | FI | Coordinator |
| 2 | CSC-TIETEEN TIETOTEKNIIKAN KESKUS OY | FI | Affiliated |
| 3 | TERVEYDEN JA HYVINVOINNIN LAITOS | FI | Affiliated |
| 4 | HUS-YHTYMA | FI | Affiliated |
| 5 | TEKNOLOGIAN TUTKIMUSKESKUS VTT OY | FI | Affiliated |
| 6 | GESUNDHEIT OSTERREICH GMBH | AT | Partner |
| 7 | 7 SERVICE PUBLIC FEDERAL SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET , ENVIRONNEMENT | BE | Partner |
| 8 | SCIENSANO | BE | Affiliated |
| 9 | Health Data Agency | BE | Affiliated |
| 10 | MINISTERSTVO NA ZDRAVEOPAZVANETO | BG | Partner |
| 11 | HRVATSKI ZAVOD ZA JAVNO ZDRAVSTVO | HR | Partner |
| 12 | ETHNIKI ARCHI ILEKTRONIKIS IGEIAS | CY | Partner |
| 13 | The Karaiskakio Foundation | CY | Affiliated |
| 14 | CYENS CENTRE OF EXCELLENCE | CY | Affiliated |
| 15 | MINISTERSTVO ZDRAVOTNICTVI CESKE REPUBLIKY | CZ | Partner |
| 16 | Masarykova univerzita | CZ | Affiliated |
| 17 | SUNDHEDSDATASTYRELSEN | DK | Partner |
| 18 | AARHUS UNIVERSITETSHOSPITAL | DK | Affiliated |
| 19 | MIDTJYLLANDS EU KONTOR FORENING | DK | Affiliated |
| 20 | REGION MIDTJYLLAND | DK | Affiliated |
| 21 | The Danish Clinical Quality Program DK Affiliated | DK | Affiliated |
| 22 | SOTSIAALMINISTEERIUM | EE | Partner |
| 23 | MINISTERE DE LA SANTE ET DE LA PREVENTION | FR | Partner |
| 24 | PLATEFORME DES DONNEES DE SANTE | FR | Affiliated |
| 25 | BUNDESMINISTERIUM FUER GESUNDHEIT | DE | Partner |
| 26 | BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPROD | DE | Affiliated |
| 27 | GEMATIK GMBH | DE | Affiliated |
| 28 | TMF – TECHNOLOGIE UND METHODENPLATTFORM FUR D | DE | Affiliated |
| 29 | MINISTRY OF HEALTH | EL | Partner |
| 30 | NATIONAL INFRASTRUCTURES FOR RESEARCH AND TECHNOLOGY | EL | Affiliated |
| 31 | ILEKTRONIKI DIAKYVERNISI KOINONIKISASFALISIS AE | EL | Affiliated |
| 32 | ORSZAGOS KORHAZI FOIGAZGATOSAG | HU | Partner |
| 33 | ESZFK EGESZSEGINFORMATIKAI SZOLGALTATO ES FEJLES | HU | Affiliated |
| 34 | SEMMELWEIS EGYETEM | HU | Affiliated |
| 35 | LANDLAEKNIS EMBAETTID | IS | Partner |
| 36 | DEPARTMENT OF HEALTH | IE | Partner |
| 37 | MINISTERO DELLA SALUTE | IT | Partner |
| 38 | ALMA MATER STUDIORUM – UNIVERSITA DI BOLOGNA | IT | Affiliated |
| 39 | AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA | IT | Affiliated |
| 40 | AZIENDA UNITA’ SANITARIA LOCALE DI BOLOGNA | IT | Affiliated |
| 41 | AZIENDA ULSS 4 VENETO ORIENTALE | IT | Affiliated |
| 42 | REGIONE EMILIA ROMAGNA | IT | Affiliated |
| 43 | UNIVERSITA CATTOLICA DEL SACRO CUORE | IT | Affiliated |
| 44 | REGIONE LOMBARDIA | IT | Affiliated |
| 45 | SLIMIBU PROFILAKSES UN KONTROLES CENTRS | LV | Partner |
| 46 | LATVIJAS BIOMEDICINAS PETIJUMU UN STUDIJU CENTRS | LV | Affiliated |
| 47 | Statistics Lithuania | LT | Partner |
| 48 | PNED GIE | LU | Partner |
| 49 | Ministry for Health – Government of Malta | MT | Partner |
| 50 | RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU | NL | Affiliated |
| 51 | STICHTING NATIONAAL ICT INSTITUUT IN DE ZORG | NL | Affiliated |
| 52 | HELSEDIREKTORATET | NO | Partner |
| 53 | FOLKEHELSEINSTITUTTET | NO | Affiliated |
| 54 | THE MINISTRY OF HEALTH OF THE REPUBLIC OF POLAND | PL | Partner |
| 55 | CENTRUM E-ZDROWIA PL Affiliated | PL | Affiliated |
| 56 | SPMS – SERVICOS PARTILHADOS DO MINISTERIO DA SAUDE EPE | PT | Partner |
| 57 | INSTITUTUL NATIONAL DE MANAGEMENT AL SERVICIILOR DE SANATATE | RO | Partner |
| 58 | NARODNE CENTRUM ZDRAVOTNICKYCH INFORMACII | SK | Partner |
| 59 | NACIONALNI INSTITUT ZA JAVNO ZDRAVJE | SI | Partner |
| 60 | MINISTERIO DE SANIDAD | ES | Partner |
| 61 | E-HALSOMYNDIGHETEN | SE | Partner |
| 62 | REGION SKANE | SE | Affiliated |
| 63 | KAROLINSKA INSTITUTET | SE | Affiliated |
| 64 | REGION STOCKHOLM | SE | Affiliated |
| 65 | VETENSKAPSRADET – SWEDISH RESEARCH COUNCIL | SE | Affiliated |
| 66 | SOCIALSTYRELSEN | SE | Affiliated |
| 67 | UPPSALA UNIVERSITET | SE | Affiliated |
| 68 | NATIONAL HEALTH SERVICE OF UKRAINE | UA | Partner |