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19 Jan
New Public Procurement Code: Changes as of January 1, 2024
Multiple provisions of the new Public Procurement Code became effective on January 1, 2024, concerning the digitization of the procurement lifecycle. Changes should lead to fully digital management of public procurement, designed to enhance the efficiency of public administrations.
18 Jan
Doctors and the use of social media and electronic communication systems: The new FNOMCeO recommendations
FNOMCeO presented a set of Recommendations for the use of social media, e-mail, and instant messaging in the medical setting and in physician-patient communication, to prevent the potential negative repercussions of improper use of these tools.
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.
16 Jan
Software medical devices in combination with hardware: The new MDCG guidelines
Medical device softwares (“MDSW”) that work in combination with hardware or hardware components to achieve their medical purposes: this is the topic of the guidelines issued by the MDCG-4, addressing manufacturers directly in an effort to provide regulatory guidance.
16 Jan
New procurement code and sub-threshold awarding: Contracting authorities are still free to use standard tendering procedures
Approved the possibility for contracting stations to employ standard selection procedures by publishing notices in awarding contracts for work, services, and supplies with values below the thresholds indicated the Public Procurement Code.
8 Nov 23
Digital therapeutics: A bill for regulation in Italy
Bill 1208 “Provisions on digital therapies” was presented in June 2023: the document is designed to regulate in Italy new technologies that offer therapeutic interventions guided by advanced software programs, with a focus on reimbursement.
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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