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10 Dec 19
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”).
5 Dec 19
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.
4 Dec 19
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).
4 Dec 19
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.
24 Oct 19
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.
22 Oct 19
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.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the Life Sciences-Healthcare industry.
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Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and Venture Capital transactions.

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November 28, 2025
EUDAMED: As of May 28, 2026, the first four modules will become mandatory
October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
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