Case-law clarifications concerning telemedicine
On June 20, 2019, the Court of Cassation issued a relevant ruling on telemedicine. Indeed, it clarified which activities, in the context of telemedicine, shall be qualified as typical health services and, therefore, are subject to the prior authorization of the competent Italian Region under Article 193 of Royal Decree No. 1265 of July 27, 1934 (hereinafter, “TULPS”).
The First Italian Case on Electronic Cigarettes’ Advertising
On November 5, 2019, the Court of Rome, by giving a very restrictive interpretation of Italian legislation, ordered two companies to stop (almost) any commercial communications relating to electronic cigarettes (e-cigs) and liquid refills, as an urgent measure.
Under what circumstances may an incumbent associate with a competitor in a public tender? The ICA provides useful guidance in the field of plasma derivatives.
In January 2018, the Italian Competition Authority (AGCM, or “ICA”) launched an investigation for a possible breach of Article 101 TFEU against two international manufacturers of blood-based pharmaceuticals – Kedrion S.p.A (“Kedrion”) and Grifols Italia S.p.A (“Grifols”) – for participating as a joint venture in a public tender (issued by a contracting authority acting on behalf of a group Italian regions, “Intercent-ER”) to collect blood and plasma, to produce plasma derivatives and to deliver these to the Italian National Health System (NHS).
Medical Devices Regulation: transitional provisions on the validity of certificates issued under the former Directives
On May 26, 2020, the new Medical Device Regulation 2017/745/EU (“MDR”) will enter into force.
Ban on the marketing of Cannabis sativa L and its derivatives for recreational use: the ruling of the Unified Divisions of the Supreme Court of Cassation
With Judgment no. 30475 of July 10th, 2019, the Unified Divisions of the Supreme Court of Cassation stated that the marketing of Cannabis sativa L and its derivates (leaves, inflorescences, oil and resin) to the public for recreational use is unlawful unless those derivatives are, in practice, devoid of any doping or psychotropic effect.
Artificial Intelligence in healthcare between opportunities and new challenges
Artificial Intelligence (AI) is becoming an increasingly important protagonist in the healthcare sector, undoubtedly gaining its place among tomorrow’s main challenges.