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Portolano Cavallo Life Sciences Blog  / Scientific Research
6 Dec 22
Reuse of personal data for research purposes in light of the most recent guidelines from the Garante
In the context of clinical studies, companies are concerned about the legal conditions for use for research purposes of previously collected personal data, including data from third parties.
6 Dec 22
IRCCS reform: Upcoming changes with regard to research
The regulation of Scientific Institutes for Research, Hospitalization, and Health Care (“Istituti di Ricovero e Cura a Carattere Scientifico,” “IRCCS” or “Institutes”) is undergoing a major transformation in Italy.
25 Feb 21
Italian Data Protection Authority approved the first code of conduct in the public sector regulating the use of health data for educational and scientific publication purposes
The Italian Data Protection Authority (“Garante”) approved the first code of conduct (Decision No. 7 of January 24, 2021, doc. Web 9535354) on how to use personal data concerning health for educational and scientific publication purposes; the code of conduct was submitted by the Veneto Region (“Code of Conduct”).
21 Feb 21
No competitive procedures are needed to execute research agreements with public entities: The Italian administrative court of last instance overturns the TAR decision
The Italian administrative court of last instance (“Consiglio di Stato”) closed litigation undertaken by Technogenetics S.r.l. that challenged a research agreement entered into by DiaSorin S.p.A. and the Pavia Hospital (which is classified, under Italian law, as a scientific research and healthcare facility, or IRCCS) for the evaluation of certain molecular and serological tests to diagnose COVID-19 (the Consiglio di Stato’s judgement was published on December 17, 2020).
29 May 20
COVID-19 emergency and processing of health data for scientific research purposes
The health emergency due to the spread of COVID-19 has made the need to correctly manage the processing of health data for scientific research purposes even more topical.
11 Feb 20
EDPS: clarification on data protection and scientific research
On January 6, 2020, the European Data Protection Supervisor (EDPS) issued a preliminary opinion on data protection and scientific research, in which it provided clarification on the application of data protection rules established by the General Data Protection Regulation (GDPR) and Regulation No. 2018/1725 with regard to scientific research.
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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