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Portolano Cavallo Life Sciences Blog
6 Jul 22
Telemedicine: When is software a medical device? The Court responds
On February 23, 2012, the Regional Administrative Court of Lombardy—seat of Milan—issued a ruling on the qualification as a medical device of a software platform used to provide healthcare services remotely.
6 Jul 22
Clinical trial contracts: What the new NCCEC models provide
On May 31 of this year, the National Center for the Coordination of Ethics Committees updated its model drug and medical device trial contracts. They are the benchmark for regulating the relationships between sponsors, CROs, and research centers involved in clinical trials.
6 Jul 22
News on the reorganization of Ethics Committees: Latest updates
In the past few months great strides have been made to establish the national ethics committees envisaged by Law No. 3 of 2018 (the “Lorenzin Law”), which were supposed to be identified by the Ministry of Health within sixty days of the Lorenzin Law taking effect.
19 Apr 22
Deblistering: A new frontier for the “pharmacy of services”
The note on “the preparation of personalized packaging to improve therapeutic adherence of patients” released on February 3 by the Regione Lombardia sets a milestone in Italy for deblistering, which could soon become a standard service provided by Italian pharmacies as it already is provided by pharmacies in many other countries around the world.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and 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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March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
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