Tag Archives: agenas

Understanding EDS: The Health Data Ecosystem Explained

Legal news, , ,

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.

New Rules on Continuing Medical Education

Legal news, , , , , , ,

The rules on continuing medical education (“CME”) have changed since a new agreement between the Italian government, the Italian Regions and the autonomous provinces of Trento and Bolzano has come into force on February 2, 2018. You may find the new agreement here or here (only in Italian, sorry).

The agreement is an “upgraded version” of the previous principles, which remain largely unchanged, but are now better defined, stricter and hopefully more effective.

  • THE RIGHT TO CME. Health care professionals (“HCPs”) have the right to obtaining CME and regulators will need to remove impediments in order to allow the exercise of such right.
  • ACCREDITATION OF PROVIDERS. As before, providers of CME need to be accredited, but accreditation will be subject to stricter rules, which particularly focus on avoiding any conflicts of interest. Providers will also need to adopt an internal regulation setting forth how to prevent and exclude (even potential) conflicts of interest.
  • SPONSORSHIP OF EVENTS. Sponsorship of CME events will be possible by private companies, provided that the principles of transparency, objectivity, impartiality and independence are complied with. No advertisement of medicinal products or medical devices can be carried out during the CME event, but only before, after and outside the event. No direct payments or reimbursements are allowed to speakers or moderators of the CME events.
  • NO ACCESS TO PERSONAL DATA OF HCPs. On the data protection front, note that sponsors of CME cannot have access to lists and addresses of participants, speakers or moderators.
  • SPONSORSHIP OF HCPs. Lastly, HCPs may be sponsored by commercial firms operating in the health industry, but cannot fulfil more than one third of their CME requirement through such sponsorship. This is bound to change how CME has been handled before, forcing HCPs to bear the cost of at least two thirds of their CME requirements.

Have a great weekend!