Data-Driven Healthcare in Italy: Launch of the National Health Data Ecosystem (EDS)

In recent years, the Italian healthcare system has accelerated its digital transformation, focusing on a data-driven model to improve efficiency and quality of care. The decree establishing the Health Data Ecosystem (EDS), published in the Official Gazette on March 5th, represents a fundamental step in this direction. The system will be fully operational by March 31, 2026 and will allow the centralization and optimization of health data management.

The Minister of Health, Orazio Schillaci, stated: “Italy has reached an important milestone that places it among the most advanced systems ready to take on the challenge of the newly adopted European Health Data Space regulation. A extraordinary revolution is looming for the Italian healthcare system, which will primarily benefit patients.”

What is the Health Data Ecosystem (EDS)?

The EDS is an advanced technological platform designed to collect, integrate, and share health data generated by the National Health Service (SSN) and the Electronic Health Record (FSE 2.0). Its objective is to provide a complete and secure view of each citizen’s clinical history, ensuring greater continuity of care and better use of resources.

How does the EDS work?

The EDS operates on three key principles:

1️⃣ Centralization and standardization

The EDS collects and integrates data from various sources, including hospitals, clinics, general practitioners, pharmacies, and social health services, centralizing them in a single digital ecosystem. This ensures optimal interoperability between the various health information systems and allows for consistent management of information, reducing the risk of data fragmentation.

2️⃣ Secure and controlled access

Privacy protection is a key element of the EDS. The Ministry of Health is the data controller and delegates management to Agenas, which acts as the data processor. Access to data is regulated by a specific policy andoccurs only with the consent of the data subject. To ensure security, the EDS usesseparate storage unitsto manage clear, pseudonymized, and anonymized data, limiting access to authorized profiles only.

3️⃣ Sharing and interoperability

The EDS facilitates the secure sharing of health data on a national scale, promoting greater continuity of care. In addition to clinical use, the system is designed to also support scientific research, epidemiological monitoring, and health prevention strategies, through the use of aggregated and anonymized data.

What are the benefits of the EDS?

The introduction of the EDS will bring numerous advantages, including:

✅ Improved quality of care → A single source of health data will help doctors make faster and more accurate decisions.
✅ Prevention and health surveillance → The system will be able to identify new pathogens and complications related to infectious diseases.
✅ Efficiency and cost reduction → Avoids duplication of tests and improves the management of health resources.
✅ Patient empowerment → Greater control over their health data and greater transparency in the care pathway.
✅ Support for research → Anonymized data will promote the development of new treatments and prevention strategies.

Challenges and obstacles to the implementation of the EDS

Despite the benefits, the implementation of the EDS involves some critical issues:

🔹 Technological integration → Interoperability between regional and national systems will require investments and time.
🔹 Privacy and security → The balance between data protection and accessibility will have to be managed with great care.
🔹 Time and bureaucracy → The process for granting data access for research and health governance could be complex.
🔹 Digital culture → Training and awareness will be essential to promote the adoption of the system by healthcare professionals and citizens.
🔹 Monitoring and transparency → Constant checks will be necessary to ensure that only authorized parties can access the information.

The European context and the link with the EHDS

Parallel to the EDS, Europe is also moving towards healthcare digitalization with the European Health Data Space (EHDS). The regulation will enter into force on March 26, 2025, and will guarantee European citizens access to their health data anywhere in the EU, as well as promote the secondary use of data for research and innovation.

The EDS as a pillar of Italian digital health

The Health Data Ecosystem (EDS) represents a milestone in the transformation of the Italian healthcare system towards a more modern and integrated model. Its implementation, together with the European EHDS regulation, marks a decisive step forward in ensuring intelligent and secure use of health data. Thanks to rigorous privacy protection measures and regulated access, the EDS will be able to improve the quality of care, enhance research, and optimize the resources of the healthcare system.