Tag Archives: research data

Understanding EDS: The Health Data Ecosystem Explained

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.

Don’t Miss our European Biotech Week 2024 Webinars

Hungry for content? The life sciences practice of Gitti and Partners has an interesting program of webinars/seminars in store for you within the framework of the EUROPEAN BIOTECH WEEK 2024:

See you soon!

Re-Use of Research Data

It may now be easier for private companies to re-use research data generated by the public sector. Thanks to Italian legislative decree no. 200 of 2021 implementing Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information, re-use of research data – whether for commercial or non-commercial purposes – may be carried out so long as intellectual property rights and privacy rights are respected.

In other words, if research data is anonymized and does not include intellectual property, free re-use is possible whenever such research data is generated from public funding and made available by researchers or research institutions through public data bases. Research data must comply with Findability, Accessibility, Interoperability, Reusability (FAIR) principles.

What is “research data”? Research data means “documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results”.

Are you in need of an example? “Research data includes statistics, results of experiments, measurements, observations resulting from fieldwork, survey results, interview recordings and images. It also includes meta-data, specifications and other digital objects. Research data is different from scientific articles reporting and commenting on findings resulting from their scientific research” (whereas no. 27 of the 2019/1024 Directive).

Certain scholars have pointed out how the principle of scientific open data is framed in terms that are too restrictive and continue to clash with intellectual property rights, database and algorithm protection.

While the push for reuse of research data may appear timid at this point in time, the EU seems in any case determined to continue its open data agenda through the Data Governance Act.