European Patients' Rights Day 2025

Introduction and aim of the initiative
Many people have probably never really thought about what happens to their health data and how it could be used for the common good. It can be difficult to understand how a person's data can impact public health. However, health data sharing is an intricate process, rapidly evolving thanks to technological progress, that holds great promise for the future of healthcare.

In recent years, the digital revolution has radically changed the way data is stored, shared and analysed. Incredibly, more scientific data have been produced in the last five years than in the entire human history. Moreover, the rise of artificial intelligence (AI) promises to reshape the landscape of healthcare data use, bringing with it both opportunities and challenges.

In order to fully exploit the benefits of data sharing, it is crucial to fill the knowledge and commitment gaps between stakeholders. The abundance of information already available has begun to transform public health and its potential is enormous. However, to realise this potential, a deeper understanding of its value and importance is needed. Strengthening the role of patients and their associations is crucial to the success of this transformation, as they play a key role in raising awareness of the importance of health data.

For all these reasons, the European Patients' Rights Day 2025 will focus on a number of critical topics related to health data sharing, its benefits and challenges. The conference will explore the following key areas and examples:

1. Role of the European Health Data Space:
   The creation of the European Health Data Space (EHDS) is shaping the future of electronic health data management in the EU. The EHDS is designed to facilitate the sharing of health data, particularly for scientific research, while ensuring that data are used ethically and effectively across all Member States. This new framework has the potential to transform the landscape of health data governance in Europe. Health data are collected by different organisations for specific purposes. Hospitals, for instance, analyse patient data to improve the quality, timeliness and safety of their services. However, this data can also be aggregated at the population level for the benefit of disease prevention and healthcare delivery in regions and countries. By making health data more accessible and engaging, we can improve health care outcomes, promote learning and foster cross-border collaboration.
2. Benefits of sharing and returning health data to patients, the example of clinical trials:
   Sharing health data can make healthcare systems more responsive, efficient and sustainable. Patients have long demanded value in return for the use of their data.
   Giving participants data from individual clinical trials, for example, not only provides them with valuable information for healthcare or disease management, but also empowers them by making them part of the decision-making process. This redefines the relationship between patients, research and industry. The conference will highlight concrete examples
   (such as the IHI FACILITATE project on the return of individual research results and secondary use of clinical trial data; the EU funded project PROPHET on personalized prevention; etc..) as key initiatives that address the crucial need for transparency, patient empowerment and ethical data use, aligning with our goals of improving patient rights and data governance in Europe.
3. Addressing security and privacy issues:
   For health data sharing to be successful, individuals must feel confident that their data is secure and that their privacy is respected. Ensuring strong protections and transparent processes for data consent is crucial to gaining public trust. The balance between the need to ensure data privacy and the imperative to use health data for medical research and system improvement needs to be explored and discussed among all stakeholders.
   As a national example, in Italy, Cittadinanzattiva has been working on a decalogue to review, in terms of accountability, the rules governing citizens/patients' consent, which is essential for the processing and sharing of data and collaboration between researchers.

This conference will emphasise the importance of transparency in the use of health data and the oversight required to ensure its safe and effective sharing. By understanding the benefits of sharing health data and addressing privacy and security concerns, we can work towards a more engaged and informed population. This will ultimately lead to better health outcomes for patients and more sustainable and equitable healthcare systems. The concrete experiences we will present are a powerful example of how returning value to patients for the use of their data can redefine the landscape of clinical research and healthcare.