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19 Jun
Processing health data on online platforms: The Garante rules on fairness
With order no. 368 of November 10, 2022, the Italian Data Protection Authority ruled that the provider of an online platform aimed at connecting healthcare professionals with patients  was in breach of the personal data protection rules provided by the GDPR in processing data via their platform.
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 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
<!--:it-->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.
6 Jul 22
<!--:it-->Draft EMA guidelines on transparency in clinical trials: Protecting commercially confidential information<!--:-->
On April 7, 2022, the EMA published draft guidelines on the transparency of information uploaded to the Clinical Trial Information System for the specific purpose of giving operational guidance on the management of commercially confidential information and personal data
6 Jul 22
Clinical trials and pharmacovigilance: Spanish Code of Conduct leads the way in data management
In an effort to expand the regulatory framework with self-regulatory instruments, the Spanish Data Protection Authority recently approved a “Code of conduct for the processing of personal data in the field of clinical trials and other clinical research and of pharmacovigilance” supported by Farmaindustria, the national trade association for the pharmaceutical industry in Spain.
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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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
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
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