Sessions

EHDS - Status and negotiation process

The Health Data Guide is intended to provide an overview of managing health data effectively so that the goals of improving the health of individuals can be more easily realized. Part One should provide a brief overview of the health data area and insights into a series of typical hurdles to overcome and ditches to avoid. It should provide the newcomer to the area with sufficient orientation to facilitate the discussion with various experts and partners. The more detailed Part Two is under development.

In order to unite Europe under a digital single market and increase mobility within Europe, the EU Commission has initiated the X-eHealth project with the aim to develop functional and technical specifications for new E-health services to exchange medical information in the areas of laboratory results, medical images, discharge reports and patient summary for rare diseases.Manne and Espen talks in detail about the X-eHealth project, its content and results and how the project's mission is connected to the European Health Data Space, EHDS.

European Ethical Principles for Digital Health is an initiative of the French Presidency of the council of the European union. The legislative work on the European Health Data Space started under the French Presidency. It aims to give European citizens the guarantees of trust they are expecting for the processing of their health data. The sharing of health data can raise legitimate questions: clarifying these European Principles of Ethics for Digital Health will make it possible to go beyond the GDPR and to condition the choices of methods underlying digital health initiatives. This presentation will highlight important principles and how they are implemented in the member states. As well as the continuous work that needs to be done to ensure the trust from the European citizens.

Industry players, the for-profit organizations, are important stakeholders in global and European health and care systems. The profiles of these industry actors vary, as do their business models, resulting in diverse expectations and requirements when it comes to EU regulations in this domain. In this session, we aim to analyze the motivating and demotivating factors that influence industry players' engagement in adopting the upcoming European Health Data Space proposal. We will explore the impact on solution providers specializing in primary data usage, Electronic Health Records and Clinical decision support vendors. Additionally, we will examine the impact on the downstream market, particularly organizations investing long-term in clinical research. Furthermore, we will strive to determine whether industry representatives should actively participate in the EHDS implementation process or simply comply with the legislation once it comes into effect.

The TEHDAS Joint Action carried out country visits to map the state-of-play of national health data management systems and their preparedness to join a future EHDS for secondary use. The presentation will present the findings of 12 country visits carried out between December 2021 and December 2022, focusing on different themes (e.g., data sources, access procedures, data governance), with a focus on the overall preparedness and the needs and expectations of countries to be able to join the EHDS

Finnish Social and Health Data Permit Authority Findata is the first one-stop shop in the world that issues permits for secondary use of social welfare and health care data. This presentation highlights the Finnish experiences of secondary use from past three years, as the whole EU is now planning to take similar steps towards the European Health Data Space.

This is a session presenting basic recommendations intended to facilitate the planning (and implementation) of national legislation on secondary use of health data. These recommendations are based on a summary on a multinational level of the experiences and conclusions of pioneering European countries that already have such national legislation, in combination with the needs of other European countries in this respect.

EHDS (European Health Data Space) proposes a common European legislation which among other things ensures access to health data for secondary use.In this presentation, we look at the informatics associated with secondary use of health data, established standards and techniques for making data available for secondary use (including OMOP), international real world examples and how healthcare organizations can benefit internally from tools for secondary use.