Clinical investigation of medical devices: implementation rules set out in Italy
In Italy, the process of establishing national regulations for clinical investigation of medical devices continues: in June, four new decrees were published, dealing with the modalities for submitting clinical investigation applications and communications according to the national procedure.
Data protection enforcement in the healthcare: What can we learn from it?
In recent years, since the GDPR was fully implemented and inspections focused on enforcement of the new rules began, the Italian Data Protection Authority has focused on breaches of the rules applicable to processing health data in the context of the Electronic Health Record, the Health File, and online medical reports.
European Commission proposals for new regulation of compulsory licensing
On April 27, 2023, the European Commission published proposals for a new set of regulations aimed at establishing a more transparent and effective framework for patent rights.
Processing health data on online platforms: The Garante rules on fairness
With order no. 368 of November 10, 2022, the Italian Data Protection Authority ruled that the provider of an online platform aimed at connecting healthcare professionals with patients was in breach of the personal data protection rules provided by the GDPR in processing data via their platform.