Digital Therapeutics: EFPIA recommendations for access to digital therapies in the EU
The European Federation of Pharmaceutical Manufacturers & Associations ("EFPIA") published a report on Improving access to digital therapeutics in Europe, aiming to promote a structured approach to the regulation of digital therapeutics ("DTx") on the European market.
Sunshine Act: Draft decree for the Sanità Trasparente electronic register published
Now available the draft decree and technical specifications envisaged by the Sunshine Act, establishing the structure and technical characteristics of the “Sanità Trasparente” electronic register, and the modalities for manufacturing companies to transmit notifications.
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.