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1 Dec 17
EUCJ’s ruling on the classification of software as medical devices
According to a very recent ruling of the European Court of Justice (EUCJ), (C-329/16, Snitem v. Syndicat national de l’industrie des technologies médicales, published on 7 December 2017), software with at least one function that makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device, even if that software does not act directly in or on the human body.
3 Nov 17
Published the new ministerial decree on compassionate use of medicinal products
On 7 September 2017, the Italian Ministry of Health issued a new decree on compassionate use of medicinal products (“Decree”) that, starting from 2 December 2017, will replace the previous ministerial decree of 8 May 2003.
2 Nov 17
Digital health revolution, how medicine is changing
When you hear about digital health, it’s sometimes hard to understand what it is really about.
1 Nov 17
Positive outcome for ema’s policy 0070, one year after the publication of the clinical trial results
On October 18, 2017, the European Medicines Agency (EMA) published a report on the implementation of the Policy 0070 on the proactive publication of clinical trials results (Policy).
3 Oct 17
Diligent requirements for life sciences deals and earn-outs
Contingent payments (a.k.a. earn-outs in transactions among private companies, and contingent payment rights (CPRs) in transactions among listed companies) are a very common and valuable component of purchase price constructs in today’s life sciences and healthcare M&A deals.
2 Oct 17
Relevance of prosecution history in the assessment of the patent infringement by equivalents: a new trend in Italy
In a recent urgent decision, the Court of Milan held that the prosecution history must be taken into account, and is therefore relevant when assessing patent infringement by equivalence.
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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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...
July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
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