30
May
Patient access to new digital therapies: challenges and opportunities of digital therapeutics in the EU
This article has been first published on April 30, 2024 on the International Bar Association (IBA)'s newsletter.
23
Apr
Italian Data Protection Authority publishes rules for platforms (websites or apps) connecting patients and healthcare professionals
The evolution of online platforms and apps that connect patients with healthcare professionals has made medical care more accessible, but it has also raised important issues concerning privacy and the protection of personal data.
18
Apr
Chatbots and virtual assistants: How might they be used in pharmaceuticals?
The pharmaceutical sector is not immune to the paradigm shift in user/patient relations, connected to the development and implementation of artificial intelligence systems: when browsing the web and using smartphone applications, users increasingly encounter chatbots and virtual assistants that interact with them.
8
Nov 23
Digital therapeutics: A bill for regulation in Italy
Bill 1208 “Provisions on digital therapies” was presented in June 2023: the document is designed to regulate in Italy new technologies that offer therapeutic interventions guided by advanced software programs, with a focus on reimbursement.
14
Sep 23
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.
13
Sep 23
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.