On March 5, 2025 the Ministry of Health’s decree on “EDS” was finally published. What is EDS and why is it important for life sciences companies?

“EDS” stands for “ECOSISTEMA DATI SANITARI” (health data eco system), a system regarding health data that will be active by March 31, 2026. The new ministerial decree clarifies the architecture of EDS, its content and its necessary safety measures.

EDS will be populated with data deriving from the electronic health record (fascicolo sanitario elettronico). With regard to processing for cure, prevention and international prophylaxis purposes, personal health data will be processed on the basis of consent and subject to information to the patient. Only in case of emergency access to EDS will be temporarily possible to healthcare providers even in the absence of consent.

Anonymized health data included in EDS will be available for the purpose of study and scientific research in the medical, biomedical and epidemiological field.

What’s new? Private and public entities with an institutional research mission may request an extraction of anonymized data by submitting a description of the scientific research they intend to carry out that complies with data protection recommendations. Agenas will evaluate data requests and grant access to the anonymized data.