The Joint Action Towards the European Health Data Space (TEHDAS) is a consortium of 26 EU MS and other countries that work to improve cross-border use of health data for the benefit of citizens’ health, for public health, research and innovation.TEHDAS builds on earlier EU actions fostering the digital transformation of European health systems. It contributes to responding to the Member States’ call at the October 2020 European Council to set up a European Health Data Space and proposed by the von der Leyen Commission.The Joint Action helps Members States and the Commission in developing and promoting concepts for sharing of data so that in the future Europe, citizens, communities and companies benefit from a protected and seamless access to health data regardless where it is stored.TEHDAS will suggest options for an operational framework and governance in order to overcome legal and technical differences between countries. TEHDAS is grounded on the principles of transparency, trust and citizen empowerment. It will work on technical and semantic challenges, propose services, architectural and infrastructural elements required in the European Health Data Space.Citizens increasingly manage their data which requires a better understanding and a European perspective. To maintain trust in fair and secure data sharing, TEHDAS will suggest strengthened governance mechanisms for cross-sector use of health data in common data spaces at the EU and Member State levels.TEHDAS will reach out and engage with many types of stakeholders to reflect their needs and expectations, explore views on economic issues, and suggest concrete ways to integrate results into the future the European Health Data Space.


Topic: • Addressing differences in national General Data Protection Regulation (GDPR) implementation in the health sector, including the European Health Data Space and the health data use


GAPP Joint Action (facilitatinG the Authorisation of Preparation Process for blood and tissues and cells) is a 36 months JA aiming at facilitating the development of a common and optimal approach to assess and authorise preparation processes in blood and tissues establishments (BEs and TEs). Particular attention will be devoted to innovative processes that might come up taking advantage of the work developed in previous EU funded projects/actions. This Joint Action will clearly contribute to the implementation of Union legislation in the fields of human tissues and cells, blood, providing tools and training to increase harmonisation of those MS activities that regulate the areas of blood transfusion, transplantation of tissues and cells and assisted reproduction, in strong abidance with art 4.5 of Annex I of Regulation 282/2014. These are fields of healthcare that involve a considerable amount of movement of donated substances of human origin between MS and also movement of citizens between MS for treatment, particularly in the field of assisted reproduction. The aim of the action is to prepare a “Good Practice Guidelines to authorisation and preparation process in blood, tissues and cells” and its three technical annexes respectively on i) authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution (divided in three part blood, tissues and cells, and reproductive tissues and cells); ii) assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA; iii) assessing clinical data as part of PPA. In addition to this it will be built a model and a tool to facilitate sharing of information among European Union Competent Authorities and a number of CA inspectors will be trained specifically to assess and authorise preparation processes of tissues, cells, reproductive cells and blood products.
