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.
19
Jun 23
Non-promotional communication: Boost for digital from the Farmindustria Code?
The recent amendments to the Farmindustria Code on non-promotional drug interactions may boost pharmaceutical companies’ communication via digital and other channels.
6
Oct 22
In a first, the European Commission blocks a below-threshold transaction under the EU Merger Regulation (Grail/Illumina)
On September 6, 2022, the European Commission (the “Commission”) blocked the acquisition of Grail by Illumina—although the deal didn’t meet the turnover threshold of the EU or any Member State—arguing that the merger would have prevented innovation and competition in the blood-based early cancer detection test market.
5
Oct 22
<!--:it-->European Health Data Space: Early indications of the future of circulation of health information in the European Union<!--:-->
The establishment of a European Health Data Space sits within the broader framework of the strategy developed by European institutions to create a single market for data.
