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17 Jan
Artificial intelligence and health care: News and issues in light of guidance from the Italian Data Protection Authority and the WHO
The use of AI in the healthcare field could facilitate improvement of treatment and prevention, and result in more effective allocation of resources in the field. However, there is trepidation about the consequences of possible errors and incorrect use.
14 Sep 23
Drug advertising: New rules on advertising for over-the-counter and non-prescription medicines (OTC and SOP)
The Italian Ministry of Health updated the guidelines regulating the use of media to publish advertising messages regarding OTC and SOP: a good step in terms of streamlining and simplification of the applicable regulatory framework. Thanks to Denise Moretti for collaborating on this article
23 Jun 23
Data protection enforcement in the healthcare: What can we learn from it?
In recent years, since the GDPR was fully implemented and inspections focused on enforcement of the new rules began, the Italian Data Protection Authority has focused on breaches of the rules applicable to processing health data in the context of the Electronic Health Record, the Health File, and online medical reports.
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.
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.
8 Sep 21
Artificial Intelligence and Machine Learning in Clinical Trials: Regulatory attempts by European and national authorities
In the last few years, use of Artificial Intelligence and Machine Learning systems in the performance of Clinical Trials has increased.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the Life Sciences-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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