21
Nov
The Dabus case: Artificial intelligence cannot be designated as the inventor in a patent
Artificial intelligence (AI) plays a fundamental role in the life sciences sector. AI offers the opportunity to facilitate various processes. For example, it can be used to analyze and process large quantities of health data that in turn may facilitate the discovery of new drugs, improve diagnostics, and customize treatments. It also can be used to automate laboratory processes and manage clinical trials, saving time and resources.
21
Nov
Transparency in clinical trials: Revised transparency rules take effect
The revised transparency rules (“Revised Rules”) for the Clinical Trials Regulation (CTR) and its Clinical Trials Information System (CTIS), issued by the EMA in October 2023, took effect on June 28, 2024, with the launch of a new version of the dedicated portal.
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.