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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
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.
7 Feb 22
Digitization of Instructions for Use: the European Commission has endorsed a new Implementing Regulation on the use of electronic instructions for use (eIFUs) of medical devices
On December 14 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council relating to electronic instructions for use of medical devices.
12 Nov 21
Health data and digital healthcare: MedTech Europe Recommendations
On June 16, 2021, the European trade association representing the medical technology industries named MedTech Europe published a document containing recommendations for maximizing benefits from use of health data collected via medical devices.
1 Mar 21
E-prescriptions now available also for drugs not reimbursed by the NHS
On December 30, 2020, the Ministry of Economy and Finance adopted a decree (“Ministerial Decree”) that provided the possibility for doctors to issue e-prescriptions for drugs not reimbursed by the National Health Service (“NHS”).
18 Feb 21
Telemedicine: The New National Guidelines
Healthcare services provided remotely are officially a part of the National Healthcare Service (“NHS”), now that the State-Regions Conference has approved the document entitled “National guidelines for the provision of telemedicine services,” drafted by the Ministry of Health (hereinafter the “Guidelines”).
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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